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BackgroundThe high global prevalence of intimate partner violence (IPV) and its association with poor physical and mental health underscore the need for effective primary prevention. We previously developed Ghya Bharari Ekatra (GBE), a couples-based primary prevention intervention for IPV among newly married couples residing in slum communities in Pune, India. ObjectiveThrough this pilot study, we aimed to explore the acceptance, safety, feasibility, and preliminary efficacy of GBE. MethodsBetween January and May 2018, we enrolled and assigned 20 couples to receive GBE plus information on IPV support services and 20 control couples to receive information on IPV support services alone. The GBE intervention was delivered over 6 weekly sessions to groups of 3 to 5 couples by lay peer educators in the communities in which the participants resided. Intervention components addressed relationship quality, resilience, communication and conflict negotiation, self-esteem, sexual communication and sexual health knowledge, and norms around IPV. Outcome evaluation included exit interviews with participants and peers to examine acceptance and feasibility challenges and baseline and 3-month follow-up interviews to examine change in IPV reporting and mental health (by women) and alcohol misuse (by men). The process evaluation examined dose delivered, dose received, fidelity, recruitment, participation rate, and context. ResultsHalf (40/83) of the eligible couples approached agreed to participate in the GBE intervention. Retention rates were high (17/20, 85% across all 6 sessions), feedback from exit interviews suggested the content and delivery methods were very well received, and the community was highly supportive of the intervention. The principal feasibility challenge involved recruiting men with the lowest income who were dependent on daily wages. No safety concerns were reported by female participants over the course of the intervention or at the 3-month follow-up. There were no reported physical or sexual IPV events in either group, but there were fewer incidents of psychological abuse in GBE participants (3/17, 18%) versus control participants (4/16, 25%) at 3-month follow-up. There was also significant improvement in the overall mental health of female intervention participants and declines in the control participants (change in mean General Health Questionnaire-12 score: –0.13 in intervention vs 0.13 in controls; P=.10). ConclusionsGBE has high acceptance, feasibility, and preliminary efficacy in preventing IPV and improving mental health among women. Next steps include refining the intervention content based on pilot findings and examining intervention efficacy through a large-scale randomized trial with longer follow-up. Trial RegistrationClinicalTrials.gov NCT03332134; https://clinicaltrials.gov/ct2/show/NCT03332134. Clinical Trials Registry of India CTRI/2018/01/011596; http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=21443 International Registered Report Identifier (IRRID)RR2-10.2196/11533

BackgroundIntimate partner violence (IPV) is approximately twice as prevalent among transgender and gender diverse individuals (those whose current gender identity does not match their sex assigned at birth) than among cisgender individuals (those whose gender aligns with their sex assigned at birth). However, most existing scales measuring IPV are not validated among transgender and gender diverse populations and do not consider the unique forms of IPV experienced by transgender and gender diverse individuals. ObjectiveThis paper describes the protocol for Project Empower, a study that seeks to develop and validate a new scale to measure IPV as experienced by transgender and gender diverse adults. A new scale is necessary to improve the accuracy of IPV measurement among transgender and gender diverse populations and may inform the current tools used to screen and link to services for transgender and gender diverse adults who experience or perpetrate IPV. MethodsThe proposed new scale will be developed by a linear three-phase process. In Phase I, we will recruit a maximum of 110 transgender and gender diverse participants to participate in in-depth interviews and focus groups. Phase I will collect qualitative data on the experiences of IPV among transgender and gender individuals. After generating scale items from the qualitative data in Phase I, Phase II will conduct up to 10 cognitive interviews to examine understanding of scale items and refine wording. Phase III will then conduct a survey with an online recruited sample of 700 transgender and gender diverse individuals to validate the scale using factor analysis and examine the prevalence, antecedents, and linked health outcomes of IPV. This study will generate the first comprehensive IPV scale including trans-specific IPV tactics that has undergone robust mixed-methods validation for use in transgender and gender diverse populations, regardless of sex assigned at birth. ResultsProject Empower launched in August 2019, with Phases I and II expected to be complete by late 2020. Phase III (survey of 700 transgender individuals) is expected to be launched in January 2021. ConclusionsA scale that more accurately captures the forms of IPV experienced by transgender and gender diverse people not only has the potential to lead to more accurate measurements of prevalence but also can identify unique forms of violence that may form the basis of IPV prevention interventions. Additionally, identifying the forms of IPV experienced by transgender and gender diverse people has the potential to lead to the refinement of clinical screening tools used to identify and refer those who experience and perpetrate violence in clinical settings. International Registered Report Identifier (IRRID)DERR1-10.2196/23819

BackgroundSocial media platforms such as Facebook, Instagram, and Twitter, which have millions of users who interact and communicate every day, have been effective in promoting sexual health interventions and in disseminating reproductive health education. They have also been shown to be useful in health promotion and have been used to track several key metrics (eg, comments, posts) among users of all demographics. However, there is a lack of research on the impact and reach of these social media platforms as a community-based tool for disseminating sexual health information and for increasing engagement among Black adolescents and young adults, which is a targeted high-risk population. ObjectiveThe purpose of this study was to determine the social media platforms and banner advertisements that affected engagement among Black male adolescents and young adults in participating in web-based health surveys. MethodsA web-based survey was conducted from March 2019 to July 2019 to assess sexual health and health behaviors in a convenience sample of Black male adolescents and young adults in the age range of 18-24 years (N=170). Social media metrics from Facebook, Instagram, and Twitter were monitored. This cross-sectional survey comprised several categories, including basic personal information, drug-related risk behaviors, health care, sexual reproductive health questions, attitudes, norms, and perceived control, mental health, violence-related risk behaviors, and social media preferences. ResultsSocial media advertisements on the Black Male Opinion survey reached approximately 146,412 individuals. Our primary finding of the web-based survey engagement was that referral (eg, group chat, indirect social media sharing) led to as the greatest proportion of recruitment, with Twitter and YouTube as the preferred sites to receive sexual health information. ConclusionsRecognizing the variety of technologies being used among Black male young adults and adolescents can help the community, researchers, and health care providers understand the web-based engagement of this high-risk population. This information may also promote culturally sensitive, customized marketing on sexual health information for this population.

BackgroundAlthough there are a number of advantages to using the internet to recruit and enroll participants into Web-based research studies, these advantages hinge on data validity. In response to this concern, researchers have provided recommendations for how best to screen for fraudulent survey entries and to handle potentially invalid responses. Yet, the majority of this previous work focuses on screening (ie, verification that individual met the inclusion criteria) and validating data from 1 individual, and not from 2 people who are in a dyadic relationship with one another (eg, same-sex male couple; mother and daughter). Although many of the same data validation and screening recommendations for Web-based studies with individual participants can be used with dyads, there are differences and challenges that need to be considered. ObjectiveThis paper aimed to describe the methods used to verify and validate couples’ relationships and data from a Web-based research study, as well as the associated lessons learned for application toward future Web-based studies involving the screening and enrollment of couples with dyadic data collection. MethodsWe conducted a descriptive evaluation of the procedures and associated benchmarks (ie, decision rules) used to verify couples’ relationships and validate whether data uniquely came from each partner of the couple. Data came from a large convenience sample of same-sex male couples in the United States, who were recruited through social media venues for a Web-based, mixed methods HIV prevention research study. ResultsAmong the 3815 individuals who initiated eligibility screening, 1536 paired individuals (ie, data from both partners of a dyad) were assessed for relationship verification; all passed this benchmark. For data validation, 450 paired individuals (225 dyads) were identified as fraudulent and failed this benchmark, resulting in a total sample size of 1086 paired participants representing 543 same-sex male couples who were enrolled. The lessons learned from the procedures used to screen couples for this Web-based research study have led us to identify and describe four areas that warrant careful attention: (1) creation of new and replacement of certain relationship verification items, (2) identification of resources needed relative to using a manual or electronic approach for screening, (3) examination of approaches to link and identify both partners of the couple, and (4) handling of bots. ConclusionsThe screening items and associated rules used to verify and validate couples’ relationships and data worked yet required extensive resources to implement. New or updating some items to verify a couple’s relationship may be beneficial for future studies. The procedures used to link and identify whether both partners were coupled also worked, yet they call into question whether new approaches are possible to help increase linkage, suggesting the need for further inquiry.

BackgroundSexually transmitted infections (STIs) are on the rise in the United States, and adolescent girls (15-19 years old) are more susceptible to acquiring STIs than their male peers. The co-occurrence of alcohol use and sexual risk taking contribute significantly to STI acquisition. Mobile health (mHealth) interventions are ideally suited for our target population and have demonstrated increases in STI testing in young people, as well as reductions in alcohol use. ObjectiveThis pilot study used both qualitative and quantitative methods to explore the views of adolescent girls (age range 15-19 years old; 74.6%, 279/374 white) on the desired qualities and content of an mHealth app for sexual health. MethodsWe conducted nine 60-min in-depth interviews (IDIs) to gather information and identify themes of sexual health and alcohol use, and we tested the feasibility of using a two-week social media campaign to collect survey information regarding sexual health risk in adolescent girls. ResultsWe iteratively coded IDIs and identified major themes around pressure of alcohol use, lack of STI knowledge, male pressure to not use condoms, and pregnancy as a worse outcome than STIs. Results from the web-based survey on risky health behaviors, which was completed by 367 participants, support the use of a sexual health app designed for girls. ConclusionsFuture work will integrate these themes to inform the development of a culturally sensitive mHealth app to prevent STIs among adolescent girls.

BackgroundSexual well-being is fundamental to physical and emotional health, and the ability to achieve it depends on access to comprehensive sexuality information and high-quality sexual health care from evidence-informed, nonjudgmental providers. Adequate and timely delivery of these components to individuals who are at high risk for sexually transmitted infections (STIs), including HIV, and unintended pregnancies promotes sexual health and mitigates consequences arising from risky sexual behavior. Brief interventions that allow health care providers to improve the information available to clients and motivate and help them to develop risk-reduction skills are seen as efficient ways to improve knowledge, change client behavior, and reduce provider stigma regarding sexual health. ObjectiveThe aim of the study is to evaluate five aspects of feasibility (acceptability, willingness, safety, satisfaction, and process) of a brief sexuality-related communication (BSC) intervention based on motivational interviewing and behavior change techniques in primary health care settings in low- and middle-income countries (LMICs). MethodsThis protocol outlines a multisite, multiphase study of feasibility of a BSC intervention in primary health care settings in LMICs that will be examined across four phases of the study. Phases I through III involve the collection of formative, qualitative data to examine provider and client perceptions of the feasibility of the intervention, adaptation of the intervention guide, and training providers on how to implement the final version of the BSC intervention. During phase IV, the feasibility of the intervention will be tested in a nonrandomized pre-post test trial where providers and clients will be followed for 6 months and participate in multiphase data collection. ResultsPhase I is currently underway in Moldova, and phases I and II were completed in Peru in late 2019. Results are expected for the feasibility study in 2021. ConclusionsThis feasibility study will determine whether the implementation of brief intervention programs aimed at improving sexual health outcomes is possible in the constraints of LMIC health systems and will add to our understanding of factors shaping clinical practice among primary care providers. International Registered Report Identifier (IRRID)DERR1-10.2196/15569

BackgroundThere is a need to develop innovative and accessible dyadic interventions that provide male couples with the behavioral skills to manage the risk of HIV transmission within their relationship. ObjectiveWe conducted a pilot randomized controlled trial (RCT) to assess the feasibility and acceptability of the electronic health (eHealth) HIV prevention toolkit intervention to encourage seroconcordant negative male couples in the United States to establish and adhere to a sexual agreement (SA). MethodsEligible, consented couples were randomly assigned to the intervention or education control and followed up for 6 months, with assessments occurring every 3 months after baseline. Acceptability items were assessed at both follow-up assessments. Descriptive and comparative statistics summarized cohort characteristics, relationship dynamics, and SA outcomes for the entire cohort and by trial arm. To examine the association between couples’ relationship dynamics and their establishment of an SA over time and by trial arm, multilevel logistic regression analyses were performed with a random intercept to account for correlations of repeated measurements of relationship dynamics at months 3 and 6; the odds ratio (OR) of establishment of an SA and the corresponding 95% confidence interval were then reported. ResultsOverall, 7959 individuals initiated screening. Reasons for individual ineligibility varied. An electronic algorithm was used to assess couple-level eligibility, which identified 1080 ineligible and 266 eligible dyads. Eligible couples (n=149) were enrolled in the pilot RCT: 68 received the intervention and 81 received the education control. Retention was 71.5% (213/298 partnered men) over the 6 months. Participants reported high acceptability of the intervention along with some areas for improvement. A significantly higher proportion of couples who received the intervention established an SA at 6 months compared with those who received the education control (32/43, 74% vs 27/50, 54%; P=.05). The OR of establishing an SA for couples in the intervention versus those in the control condition was greater than 2 when controlling for a number of different relationship dynamics. In addition, the odds of establishing an SA increased by 88% to 322% for each unit increase in a variety of averaged relationship dynamic scores; the opposite result was found for dynamics of stigma. Differences between trial arms for SA type and adherence were nonsignificant at each assessment. However, changes in these 2 SA aspects were noted over time. The average number of items couples included in their SA was 18, and about one-fourth to one-third of couples included HIV prevention items. ConclusionsThe findings demonstrate strong evidence for the acceptability and feasibility of the eHealth toolkit as a brief, stand-alone, couples-based HIV prevention intervention. These findings support the need to update the toolkit and evaluate it in a larger clinical trial powered for efficacy. Trial RegistrationClinicalTrials.gov NCT02494817; http://clinicaltrials.gov/ct2/show/NCT02494817

BackgroundHealthMindr is a mobile phone HIV prevention app for men who have sex with men (MSM). In a previous pilot study, HealthMindr was found to be acceptable among users and to demonstrate preliminary effectiveness for increasing pre-exposure prophylaxis (PrEP) uptake among MSM. PrEP is a highly effective HIV prevention intervention; however, uptake remains low. ObjectiveThe aim of this study will be to assess the efficacy of a mobile app for increasing PrEP uptake among MSM in the southern United States. MethodsIn this randomized controlled trial, we will assess the efficacy of HealthMindr for increasing PrEP uptake among MSM in the following three southern US cities: Atlanta, Georgia; Jackson, Mississippi; and Washington, DC. In total, 657 men will be recruited and randomized to intervention and control arms in a 2:1 ratio. Participants in the intervention arm will receive access to the full HealthMindr app, with information and resources about PrEP (eg, frequently asked questions, risk assessment tool, and PrEP provider locator), other HIV prevention information, ability to order free HIV/sexually transmitted infection test kits, and additional resources related to substance use and mental health. Participants in the control arm will use the HealthMindr app but will only have access to the study timeline and a message center to communicate with study staff. Participants will complete quarterly surveys to assess self-reported PrEP uptake over 12 months of follow-up. Self-reported PrEP uptake will be verified by dried blood spot testing and/or uploading a photograph of a PrEP prescription. ResultsParticipant recruitment began in January 2020. ConclusionsThis trial will determine whether the HealthMindr app can increase PrEP uptake among MSM in the southern United States. Trial RegistrationClinicalTrials.gov NCT03763942; https://clinicaltrials.gov/ct2/show/NCT03763942 International Registered Report Identifier (IRRID)PRR1-10.2196/16231

BackgroundThe recognition of the role of primary partners in HIV transmission has led to a growth in dyadic-focused HIV prevention efforts. The increasing focus on male couples in HIV research has been paralleled by an increase in the development of interventions aimed at reducing HIV risk behaviors among male couples. The ability to accurately assess the efficacy of these interventions rests on the ability to successfully enroll couples into HIV prevention research. ObjectiveThis study aimed to explore factors associated with successful dyadic engagement in Web-based HIV prevention research using recruitment and enrollment data from a large sample of same-sex male couples recruited online from the United States. MethodsData came from a large convenience sample of same-sex male couples in the United States, who were recruited through social media venues for a Web-based, mixed method HIV prevention research study. The analysis examined the demographic factors associated with successful dyadic engagement in research, measured as both members of the dyad meeting eligibility criteria, consenting for the study, and completing all study processes. ResultsAdvertisements generated 221,258 impressions, resulting in 4589 clicks. Of the 4589 clicks, 3826 individuals were assessed for eligibility, of which 1076 individuals (538/1913, 28.12% couples) met eligibility criteria and were included in the study. Of the remaining 2740 ineligible participants, 1293/3826 (33.80%) were unlinked because their partner did not screen for eligibility, 48/2740 (1.75%) had incomplete partner data because at least one partner did not finish the survey, 22/2740 (0.80%) were ineligible because of 1 partner not meeting the eligibility criteria. Furthermore, 492/3826 (12.86%) individuals were fraudulent. The likelihood of being in a matched couple varied significantly by race and ethnicity, region, and relationship type. Men from the Midwest were less likely to have a partner who did not complete the survey. Men with college education and those who labeled their relationships as husband or other (vs boyfriend) were more likely to have a partner who did not complete the survey. ConclusionsThe processes used allowed couples to independently progress through the stages necessary to enroll in the research study, while limiting opportunities for coercion, and resulted in a large sample with relative diversity in demographic characteristics. The results underscore the need for additional considerations when recruiting and enrolling, relative to improving the methods associated with these research processes.

BackgroundMen who have sex with men (MSM) continue to be the predominately impacted risk group in the United States HIV epidemic and are a priority group for risk reduction in national strategic goals for HIV prevention. Modeling studies have demonstrated that a comprehensive package of status-tailored HIV prevention and care interventions have the potential to substantially reduce new infections among MSM. However, uptake of basic prevention services, including HIV testing, sexually transmitted infection (STI) testing, condom distribution, condom-compatible lubricant distribution, and preexposure prophylaxis (PrEP), is suboptimal. Further, stronger public health strategies are needed to promote engagement in HIV care and viral load suppression among MSM living with HIV. Mobile health (mHealth) tools can help inform and encourage MSM regarding HIV prevention, care, and treatment, especially among men who lack access to conventional medical services. This protocol details the design and procedures of a randomized controlled trial (RCT) of a novel mHealth intervention that comprises a comprehensive HIV prevention app and brief, tailored text- and video-based messages that are systematically presented to participants based on the participants’ HIV status and level of HIV acquisition risk. ObjectiveThe objective of the RCT was to test the efficacy of the Mobile Messaging for Men (M-Cubed, or M3) app among at least 1200 MSM in Atlanta, Detroit, and New York. The goal was to determine its ability to increase HIV testing (HIV-negative men), STI testing (all men), condom use for anal sex (all men), evaluation for PrEP eligibility, uptake of PrEP (higher risk HIV-negative men), engagement in HIV care (men living with HIV), and uptake of and adherence to antiretroviral medications (men living with HIV). A unique benefit of this approach is the HIV serostatus-inclusiveness of the intervention, which includes both HIV-negative and HIV-positive MSM. MethodsMSM were recruited through online and venue-based approaches in Atlanta, Detroit, and New York City. Men who were eligible and consented were randomized to the intervention (immediate access to the M3 app for a period of three months) or to the waitlist-control (delayed access) group. Outcomes were evaluated immediately postintervention or control period, and again three and six months after the intervention period. Main outcomes will be reported as period prevalence ratios or hazards, depending on the outcome. Where appropriate, serostatus/risk-specific outcomes will be evaluated in relevant subgroups. Men randomized to the control condition were offered the opportunity to use (and evaluate) the M3 app for a three-month period after the final RCT outcome assessment. ResultsM3 enrollment began in January 2018 and concluded in November 2018. A total of 1229 MSM were enrolled. Data collection was completed in September 2019. ConclusionsThis RCT of the M3 mobile app seeks to determine the effects of an HIV serostatus–inclusive intervention on the use of multiple HIV prevention and care-related outcomes among MSM. A strength of the design is that it incorporates a large sample and broad range of MSM with differing prevention needs in three cities with high prevalence of HIV among MSM. Trial RegistrationClinicalTrials.gov NCT03666247; https://clinicaltrials.gov/ct2/show/NCT03666247 International Registered Report Identifier (IRRID)DERR1-10.2196/16439

BackgroundThere is a pressing need to ensure that youth in high HIV prevalence settings are prepared for a safer sexual debut. Smartphone ownership is increasing dramatically in low-income and middle-income countries. Smartphone games that are appropriately grounded in behavioral theory and evidence-based practice have the potential to become valuable tools in youth HIV prevention efforts in Sub-Saharan Africa. ObjectiveTo pilot-test a theory-based, empirically grounded smartphone game for young Kenyans designed to increase age and condom use at first sex, aiming to establish directionality of effects on behavior change. MethodsTumaini (“hope for the future” in Swahili) is an interactive, narrative-based game grounded in social cognitive theory. A randomized controlled pilot study was conducted in Kisumu, Western Kenya, from April to June 2017 with 60 participants aged 11-14 (mean 12.7) years. Intervention arm participants (n=30) were provided with an Android smartphone with Tumaini installed on it and were instructed to play the game for at least 1 hour a day for 16 days; control arm participants (n=30) received no intervention. All participants completed a survey on behavioral mediators, delivered via an audio computer-assisted self-interview system at baseline (T1), post intervention (T2), and at 6 weeks postintervention (T3). The postintervention survey for intervention arm participants included questions eliciting feedback on the game. Intervention arm participants and their parents participated in 8 postintervention focus group discussions. Game log files were analyzed to calculate the length of exposure to the game. Behavioral survey data were analyzed using two-sample t tests to compare mean change from T1 to T2 and to T3 for intervention versus control arm participants. Descriptive statistics on game feedback questions were computed. Focus group transcripts were uploaded to MAXQDA software, where they were labeled with deductive and inductive codes. Data were analyzed thematically and compared across demographics. ResultsIntervention arm participants played Tumaini for a mean of approximately 27 hours. The intervention arm showed significant gains in sexual health-related knowledge and self-efficacy (both P

BackgroundMen who have sex with men (MSM) are the group most impacted by the human immunodeficiency virus (HIV) epidemic and the only subgroup in the United States among which new HIV diagnoses are not decreasing. To achieve the US National HIV/AIDS (acquired immunodeficiency syndrome) Strategy goals of reducing new diagnoses by 25%, high (eg, 30-50%) coverage of multiple HIV prevention interventions is needed in both urban and rural areas. Mobile phone “apps” are an important channel through which prevention services could be provided at scale and at low marginal cost. ObjectiveThe aim of this study was to evaluate the usability and acceptability of a theory-based Android mobile phone app for HIV prevention. MethodsThe app included self-assessment tools; prevention recommendations; commodity (condoms, HIV self-tests) ordering; reminders to MSM for basic HIV prevention services, HIV testing, condom use, screening for preexposure prophylaxis (PrEP) and nonoccupational postexposure prophylaxis (nPEP); and prevention and treatment provider locators. The study recruited HIV-negative, Android-using MSM in Atlanta and Seattle who were asked to use the app for 4 months and complete a post-use survey. We measured the use of the app and its features, ordering of commodities, self-report of establishing an HIV testing plan, being HIV tested in the community, and starting PrEP or using nPEP. Usability was assessed using the system usability scale (SUS). ResultsA total of 121 MSM were enrolled (59.5%, 72/121 from Atlanta; 40.5%, 49/121 from Seattle). Median age was 28. Nearly half (48.8%, 59/121) were nonwhite, and most (85.9%, 104/121) were gay-identified. Most had tested for HIV in the past (85.1%, 103/121), and 52 (43.0%, 52/121) had a plan to test for HIV regularly. Men used the app for an average of 17.7 minutes over the first 4 months. Over the 4-month period, over half ordered condoms (63.6%, 77/121) and HIV test kits (52.8%, 64/121) on the app. Eight of 86 (9%) PrEP-eligible MSM started PrEP during the 4-month period; of those, 6 of the 8 reported that the app influenced their decision to start PrEP. The mean SUS was 73 (above average). ConclusionsA theory-based mobile phone app was acceptable to MSM and was rated as having above-average usability. Most men used the commodity-ordering features of the app during the 4-month evaluation period, and nearly 1 in 10 PrEP-eligible men started PrEP, with most attributing their decision to start PrEP in part to the app. A broader, randomized controlled study of the impact of the app on uptake of prevention behaviors for MSM is warranted.

BackgroundMen who have sex with men (MSM) are the most affected risk group in the United States’ human immunodeficiency virus (HIV) epidemic. Sexual concurrency, the overlapping of partnerships in time, accelerates HIV transmission in populations and has been documented at high levels among MSM. However, concurrency is challenging to measure empirically and variations in assessment techniques used (primarily the date overlap and direct question approaches) and the outcomes derived from them have led to heterogeneity and questionable validity of estimates among MSM and other populations. ObjectiveThe aim was to evaluate a novel Web-based and interactive partnership-timing module designed for measuring concurrency among MSM, and to compare outcomes measured by the partnership-timing module to those of typical approaches in an online study of MSM. MethodsIn an online study of MSM aged ≥18 years, we assessed concurrency by using the direct question method and by gathering the dates of first and last sex, with enhanced programming logic, for each reported partner in the previous 6 months. From these methods, we computed multiple concurrency cumulative prevalence outcomes: direct question, day resolution / date overlap, and month resolution / date overlap including both 1-month ties and excluding ties. We additionally computed variants of the UNAIDS point prevalence outcome. The partnership-timing module was also administered. It uses an interactive month resolution calendar to improve recall and follow-up questions to resolve temporal ambiguities, combines elements of the direct question and date overlap approaches. The agreement between the partnership-timing module and other concurrency outcomes was assessed with percent agreement, kappa statistic (κ), and matched odds ratios at the individual, dyad, and triad levels of analysis. ResultsAmong 2737 MSM who completed the partnership section of the partnership-timing module, 41.07% (1124/2737) of individuals had concurrent partners in the previous 6 months. The partnership-timing module had the highest degree of agreement with the direct question. Agreement was lower with date overlap outcomes (agreement range 79%-81%, κ range .55-.59) and lowest with the UNAIDS outcome at 5 months before interview (65% agreement, κ=.14, 95% CI .12-.16). All agreements declined after excluding individuals with 1 sex partner (always classified as not engaging in concurrency), although the highest agreement was still observed with the direct question technique (81% agreement, κ=.59, 95% CI .55-.63). Similar patterns in agreement were observed with dyad- and triad-level outcomes. ConclusionsThe partnership-timing module showed strong concurrency detection ability and agreement with previous measures. These levels of agreement were greater than others have reported among previous measures. The partnership-timing module may be well suited to quantifying concurrency among MSM at multiple levels of analysis.

BackgroundThe Centers for Disease Control and Prevention recommends that sexually active men who have sex with men (MSM) in the United States test for human immunodeficiency virus (HIV) at least three times per year, but actual testing frequency is much less frequent. Though mHealth is a popular vehicle for delivering HIV interventions, there are currently no mobile phone apps that target MSM with the specific aim of building an HIV testing plan, and none that focuses on developing a comprehensive prevention plan and link MSM to additional HIV prevention and treatment resources. Previous research has suggested a need for more iterative feedback from the target population to ensure use of these interventions. ObjectiveThe purpose of this study is to understand MSM’s preferences for functionality, format, and design of a mobile phone-based HIV prevention app and to examine MSM’s willingness to use an app for HIV prevention. MethodsWe conducted focus group discussions with 38 gay and bisexual men, with two in-person groups in Atlanta, two in Seattle, and one online focus group discussion with gay and bisexual men in rural US regions. These discussions addressed MSM’s general preferences for apps, HIV testing barriers and facilitators for MSM, and ways that an HIV prevention app could address these barriers and facilitators to increase the frequency of HIV testing and prevention among MSM. During focus group discussions, participants were shown screenshots and provided feedback on potential app functions. ResultsParticipants provided preferences on functionality of the app, including the type and delivery of educational content, the value of interactive engagement, and the importance of social networking as an app component. Participants also discussed preferences on how the language should be framed for the delivery of information, identifying that an app needs to be simultaneously fun and professional. Privacy and altruistic motivation were considered to be important factors in men’s willingness to use a mobile HIV prevention app. Finally, men described the potential impact that a mobile HIV prevention app could have, identifying individual, interpersonal, and community-based benefits. ConclusionsIn summary, participants described a comprehensive app that should incorporate innovative ideas to educate and engage men so that they would be motivated to use the app. In order for an app to be useful, it needs to feel safe and trustworthy, which is essential when considering the app’s language and privacy. Participants provided a range of preferences for using an HIV prevention app, including what they felt MSM need with regards to HIV prevention and what they want in order to engage with an app. Making an HIV prevention app enjoyable and usable for MSM is a difficult challenge. However, the usability of the app is vital because no matter how great the intervention, if MSM do not use the app, then it will not be useful.

BackgroundHuman immunodeficiency virus (HIV) prevention intervention programs and related research for men who have sex with men (MSM) in the southern African region remain limited, despite the emergence of a severe epidemic among this group. With a lack of understanding of their social and sexual lives and HIV risks, and with MSM being a hidden and stigmatized group in the region, optimized HIV prevention packages for southern African MSM are an urgent public health and research priority. ObjectiveThe objective of the Sibanye Health Project is to develop and evaluate a combination package of biomedical, behavioral, and community-level HIV prevention interventions and services for MSM in South Africa. MethodsThe project consists of three phases: (1) a comprehensive literature review and summary of current HIV prevention interventions (Phase I), (2) agent-based mathematical modeling of HIV transmission in southern African MSM (Phase II), and (3) formative and stigma-related qualitative research, community engagement, training on providing health care to MSM, and the pilot study (Phase III). The pilot study is a prospective one-year study of 200 men in Cape Town and Port Elizabeth, South Africa. The study will assess a package of HIV prevention services, including condom and condom-compatible lubricant choices, risk-reduction counseling, couples HIV testing and counseling, pre-exposure prophylaxis (PrEP) for eligible men, and non-occupational post-exposure prophylaxis for men with a high risk exposure. The pilot study will begin in October 2014. ResultsPreliminary results from all components but the pilot study are available. We developed a literature review database with meta-data extracted from 3800 documents from 67 countries. Modeling results indicate that regular HIV testing and promotion of condom use can significantly impact new HIV infections among South African MSM, even in the context of high coverage of early treatment of HIV-positive men and high coverage of PrEP for at-risk HIV-negative men. Formative qualitative research consisted of 79 in-depth interviews, and six focus group discussions in Cape Town and Port Elizabeth. Analysis of these data has informed pilot study protocol development and has been documented in peer-reviewed manuscripts. Qualitative work regarding stigma faced by South African MSM resulted in finalized scales for use in the pilot study questionnaire. A total of 37 health care providers completed training designed to facilitate clinically and culturally competent care for MSM in the Eastern Cape. ConclusionsThe design of a future, larger study of the HIV prevention package will be conducted at the end of the pilot study, powered to detect efficacy of the prevention package. Data from the updated mathematical model, results of the pilot study, acceptability data, and advancements in HIV prevention sciences will be considered in developing the final proposed package and study design. Trial RegistrationClinicalTrials.gov NCT02043015; http://clinicaltrials.gov/show/NCT02043015 (Archived by WebCite at http://www.webcitation.org/6THvp7rAj).

Background: Couples HIV testing and counseling (CHTC) is now a standard of care prevention strategy recommended by the Centers for Disease Control and Prevention for sexual minority men (SMM) in relationships. Despite standard recommendations that couples complete CHTC every 6-12 months, no study has empirically evaluated the effects associated with CHTC retesting., Objective: This study aims to understand the benefits associated with continued dyadic engagement in the HIV prevention continuum through routine CHTC retesting, which is of particular importance for emerging-adult SMM in relationships who use drugs., Methods: Eligible couples for this CHTC retesting trial must already be enrolled in the 4Us trial, where they completed a CHTC session after their baseline survey. The purpose of the original 4Us trial was to test the efficacy of 2 intervention components for CHTC: a communication skills training video and a substance use module. Couples were eligible for the original 4Us trial if they identified as cisgender male, were in a relationship for 3 months or longer, were aged 17 years or older, and communicated in English. At least 1 partner had to be aged 17-29 years, report HIV negative or unknown serostatus, report use of at least 1 drug (cannabis, cocaine or crack, crystal methamphetamine, ketamine, gamma-hydroxybuterate [GHB], psychedelics, ecstasy, prescription medication misuse, opiates, and nitrates) use, and engage in condomless anal sex (CAS) acts with a casual partner or have a main partner who is nonmonogamous or serodiscordant. Those who complete the 4Us 12-month follow-up and remain in a relationship with the partner they participated in 4Us with are offered the opportunity to participate in this CHTC retesting trial. Those consenting are randomized to either CHTC retesting or individual HIV testing. Follow-up assessments are conducted 3 and 6 months after randomization to evaluate the effects of repeat CHTC on 2 primary outcomes: (1) CAS with a casual partner in the absence of preexposure prophylaxis (PrEP), and (2) CAS with a serodiscordant main partner who is not virally suppressed or concurrent CAS between main and casual partners in the absence of PrEP., Results: The CHTC retesting trial launched in January 2023, and enrollment is ongoing. As of February 2024, the study had enrolled 106 eligible participants (n=53 couples)., Conclusions: Findings from this CHTC retesting study will contribute to knowledge about the benefits associated with regular (repeated) CHTC testing versus routine individual HIV testing for SMM in relationships. The results of this trial will inform CHTC retesting guidance., Trial Registration: ClinicalTrials.gov NCT05833074; htps://www.clinicaltrials.gov/study/NCT05833074., International Registered Report Identifier (irrid): DERR1-10.2196/53023., (©Tyrel J Starks, Kory Kyre, Juan Castiblanco, Jayelin N Parker, Erin Kahle, Rob Stephenson, Demetria Cain. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.02.2024.)

Background: Transmasculine people are at risk for HIV; yet few HIV prevention interventions have been developed for this population. We adapted an existing HIV prevention smartphone app for cisgender men who have sex with men to meet the sexual health needs of transmasculine people., Objective: This study aims to assess the acceptability of the adapted app, Transpire, among transmasculine people living in Atlanta, Georgia, and Washington, DC, via in-depth interviews of participants in a pilot feasibility trial., Methods: Participants used the Transpire app for 3 months as part of a pilot study of the app. Eligible participants were aged 18-34 years. There were no eligibility criteria with respect to race and ethnicity, and most participants were non-Hispanic White. At the end of the follow-up, participants were invited to participate in web-based in-depth interviews to discuss their experiences using the app and feedback on design and content. Interviews were transcribed and coded using a constant comparative approach. Three main themes were identified: sexual behavior, app experiences and feedback, and pre-exposure prophylaxis., Results: Overall, participants found the app acceptable and thought that it would be a useful tool for themselves and their peers. Participants reported appreciating having a comprehensive information source available to them on their phones and reported learning more about HIV, sexually transmitted infections, and pre-exposure prophylaxis via the app. They also reported appreciating the inclusive language that was used throughout the app. Although the app included some resources on mental health and substance use, participants reported that they would have appreciated more resources and information in these areas as well as more comprehensive information about other health concerns, including hormone therapy. Representative quotes are presented for each of the identified themes., Conclusions: There is a desire to have greater access to reliable sexual health information among transmasculine people. Mobile apps like Transpire are an acceptable intervention to increase access to this information and other resources. More evidence is needed, however, from more racially and ethnically diverse samples of transmasculine people., (©Jeb Jones, Gareth Butler, Meaghan Woody, Amanda D Castel, Paige Kulie, Martha Sheets, Ayden I Scheim, Sari L Reisner, Rachel Valencia, Minglun Wang, Joanne D Stekler, Patrick S Sullivan, Rob Stephenson. Originally published in JMIR Formative Research (https://formative.jmir.org), 21.09.2023.)

Background: Self-collection of specimens at home and their return by mail might help reduce some of the barriers to HIV and bacterial sexually transmitted infection (STI) screening encountered by gay, bisexual, and other men who have sex with men (GBMSM). To evaluate the benefits and challenges of bringing this approach to scale, researchers are increasingly requesting GBMSM to return self-collected specimens as part of web-based sexual health studies. Testing self-collected hair samples for preexposure prophylaxis drug levels may also be a viable option to identify GBMSM who face adherence difficulties and offer them support., Objective: Project Caboodle! sought to evaluate the acceptability and feasibility of self-collecting at home and returning by mail 5 specimens (a finger-stick blood sample, a pharyngeal swab, a rectal swab, a urine specimen, and a hair sample) among 100 sexually active GBMSM in the United States aged between 18 and 34 years. In this manuscript, we aimed to describe the key lessons learned from our study's implementation and to present recommendations offered by participants to maximize the rates of self-collected specimen return., Methods: Following the specimen self-collection phase, a subset of 25 participants (11 who returned all 5 specimens, 4 who returned between 1 and 4 specimens, and 10 who did not return any specimens) was selected for in-depth interviews conducted via a videoconferencing platform. During the session, a semistructured interview guide was used to discuss the factors influencing decisions regarding returning self-collected specimens for laboratory processing. The transcripts were analyzed using template analysis., Results: University branding of web-based and physical materials instilled a sense of trust in participants and increased their confidence in the test results. Shipping the specimen self-collection box in plain unmarked packaging promoted discretion during transit and on its receipt. Using different colored bags with matching color-coded instructions to self-collect each type of specimen minimized the potential for confusion. Participants recommended including prerecorded instructional videos to supplement the written instructions, providing information on the importance of triple-site bacterial STI testing, and adding a reminder of the types of testing that would and would not be conducted on hair samples. Participants also suggested tailoring the specimen self-collection box to include only the tests that they might be interested in completing at that time, adding real-time videoconferencing to the beginning of the study to introduce the research team, and sending personalized reminders following the delivery of the specimen self-collection box., Conclusions: Our results offer valuable insights into aspects that facilitated participant engagement in self-collected specimen return, as well as areas for potential improvement to maximize return rates. Our findings can help guide the design of future large-scale studies and public health programs for home-based HIV, bacterial STI, and preexposure prophylaxis adherence testing., International Registered Report Identifier (irrid): RR2-10.2196/13647., (©Gregory Sallabank, Rob Stephenson, Monica Gandhi, Leland Merrill, Akshay Sharma. Originally published in JMIR Formative Research (https://formative.jmir.org), 06.04.2023.)

Background: Gay, bisexual, and other men who have sex with men (MSM), particularly Black or African American MSM (BMSM) and Hispanic or Latino MSM (HLMSM), continue to be disproportionately affected by the HIV epidemic in the United States. Previous HIV self-testing programs have yielded high testing rates, although these studies predominantly enrolled White, non-Hispanic MSM. Mobile health tools can support HIV prevention, testing, and treatment. This protocol details an implementation study of mailing free HIV self-tests (HIVSTs) nested within a randomized controlled trial designed to assess the benefit of a mobile phone app for increasing the uptake of HIV prevention and other social services., Objective: This study was a comparative effectiveness trial of innovative recruitment and testing promotion strategies intended to effectively reach cisgender BMSM and HLMSM. We evaluated the use of a mobile app for increasing access to care., Methods: Study development began with individual and group consultations that elicited feedback from 3 core groups: HIV care practitioners and researchers, HIV service organization leaders from study states, and BMSM and HLMSM living in the study states. Upon completion of the formative qualitative work, participants from 11 states, based on the observed areas of highest rate of new HIV diagnoses among Black and Hispanic MSM, were recruited through social networking websites and smartphone apps. After eligibility was verified, participants consented and were randomized to the intervention arm (access to the Know@Home mobile app) or the control arm (referral to web resources). We provided all participants with HIVSTs. The evaluation of the efficacy of a mobile phone app to support linkage to posttest prevention services that included sexually transmitted infection testing, pre-exposure prophylaxis initiation, antiretroviral treatment, and acquisition of condoms and compatible lubricants has been planned. Data on these outcomes were obtained from several sources, including HIVST-reporting surveys, the 4-month follow-up survey, laboratory analyses of dried blood spot cards returned by the participant, and data obtained from the state health department surveillance systems. Where possible, relevant subgroup analyses were performed., Results: During the formative development phase, 9 consultations were conducted: 6 in-depth individual discussions and 3 group consultations. From February 2020 through February 2021, we enrolled 2093 MSM in the randomized controlled trial from 11 states, 1149 BMSM and 944 HLMSM., Conclusions: This study was designed and implemented to evaluate the effectiveness of recruitment strategies to reach BMSM and HMSM and of a mobile app with regard to linkage to HIV prevention or treatment services. Data were also obtained to allow for the analyses of cost and cost-effectiveness related to study enrollment, HIV testing uptake, identification of previously undiagnosed HIV, sexually transmitted infection testing and treatment, and linkage to HIV prevention or treatment services., Trial Registration: ClinicalTrials.gov (NCT04219878); https://clinicaltrials.gov/ct2/show/NCT04219878., International Registered Report Identifier (irrid): DERR1-10.2196/43414., (©Ruth Dana, Stephen Sullivan, Robin J MacGowan, Pollyanna R Chavez, Kristin M Wall, Travis H Sanchez, Rob Stephenson, Lisa Hightow-Weidman, Jeffrey A Johnson, Amanda Smith, Akshay Sharma, Jeb Jones, Marissa Hannah, Monica Trigg, Wei Luo, Joanna Caldwell, Patrick Sean Sullivan. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 06.01.2023.)

Background: Sexual minority men experience intimate partner violence (IPV) at rates similar to those reported by heterosexual women in the United States. Previous studies linked both IPV victimization and perpetration to HIV risk and seroconversion; however, less is known about the impact of IPV on HIV testing, sexually transmitted infection (STI) testing, pre-exposure prophylaxis (PrEP) uptake, and the persistence of PrEP use among sexual minority men experiencing IPV. Although prior work suggests that IPV may influence HIV prevention behavior, experiences of IPV are so highly varied among sexual minority men (eg, forms, frequency, and severity; steady vs casual partnerships; perpetration vs receipt; and sexual vs physical vs psychological violence) that additional research is needed to better understand the impact that IPV has on HIV risk and protective behaviors to develop more effective interventions for sexual minority men., Objective: This study aims to contribute to our understanding of the antecedents of IPV and the direct and indirect pathways between perpetration and receipt of IPV and HIV or STI risk behavior, STIs, and use of PrEP among sexual minority men experiencing IPV., Methods: This mixed methods study has 2 phases: phase 1 involved formative qualitative interviews with 23 sexual minority men experiencing IPV and 10 key stakeholders or providers of services to sexual minority men experiencing IPV to inform the content of a subsequent web-based cohort study, and phase 2 involves the recruitment of a web-based cohort study of 500 currently partnered HIV-negative sexual minority men who reside in Centers for Disease Control and Prevention-identified Ending the HIV Epidemic priority jurisdictions across the United States. Participants will be followed for 24 months. They will be assessed through a full survey and asked to self-collect and return biospecimen kits assessing HIV, STIs, and PrEP use at 0, 6, 12, 18, and 24 months. They will also be asked to complete abbreviated surveys to assess for self-reported changes in key study variables at 3, 9, 15, and 21 months., Results: Phase 1 was launched in May 2021, and the phase 1 qualitative interviews began in December 2021 and were concluded in March 2022 after a diversity of experiences and perceptions were gathered and no new ideas emerged in the interviews. Rapid analysis of the qualitative interviews took place between March 2022 and June 2022. Phase 2 recruitment of the full cohort began in August 2022 and is planned to continue through February 2024., Conclusions: This mixed methods study will contribute valuable insights into the association that IPV has with HIV risk and protective behaviors among sexual minority men. The findings from this study will be used to inform the development or adaptation of HIV and IPV prevention interventions for sexual minority men experiencing IPV., International Registered Report Identifier (irrid): DERR1-10.2196/41453., (©Erik D Storholm, Dan E Siconolfi, Glenn J Wagner, Wenjing Huang, Carrie L Nacht, Greg Sallabank, Jennifer K Felner, Joshua Wolf, Sarita D Lee, Rob Stephenson. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 15.11.2022.)

Background: Gay, bisexual, and other men who have sex with men and transgender individuals are more heavily affected by HIV and other sexually transmitted infections (STIs) than their cisgender, heterosexual peers. In addition, sexual and gender minorities who use substances are often at a further increased risk of HIV and other STIs. Increasing testing for HIV and other STIs allows this hardly reached population to receive early intervention, prevention, and education., Objective: We explored HIV and STI testing patterns among 414 sexual and gender minority adolescents and young adults aged 15 to 29 years who self-reported substance use and lived in southeastern Michigan., Methods: We analyzed data from the baseline survey of a 4-arm randomized controlled trial that aimed to examine the efficacy of a brief substance use intervention for creating gains in engagement in HIV prevention. We fit multinomial logistic regression models to 2 categorical HIV and STI testing variables (lifetime and previous 12 months) based on self-reports of testing (never, STIs only, HIV only, or both). In addition, we compared HIV and STI testing behaviors across demographic characteristics, structural factors, psychosocial barriers, substance use, and sexual behaviors., Results: Our findings showed that 35.5% (147/414) of adolescents and young adults reported not being tested for either HIV or STIs in the previous year, and less than half (168/414, 40.6%) of the sample achieved the Centers for Disease Control and Prevention recommendation of HIV and STI testing once per year. We observed HIV and STI testing disparities across sociodemographic (eg, sexual identity, education, and income) and health (eg, substance use) correlates. Specifically, cisgender gay men who have sex with men were more likely to report being tested for HIV compared with bisexual men and transgender individuals, who were more likely to be tested for STIs., Conclusions: This study illustrates the results of an HIV prevention intervention in southeastern Michigan showing the need for HIV prevention interventions that leverage structural factors, psychosocial barriers, and substance use as key drivers to achieve HIV and STI testing rates to meet the Centers for Disease Control and Prevention guidelines., Trial Registration: ClinicalTrials.gov NCT02945436; http://clinicaltrials.gov/ct2/show/NCT02945436., International Registered Report Identifier (irrid): RR2-10.2196/resprot.9414., (©Jayelin N Parker, Seul Ki Choi, Jose A Bauermeister, Erin E Bonar, Adam W Carrico, Rob Stephenson. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 01.07.2022.)

Background: Mobile health (mHealth) interventions, including smartphone apps, have been found to be an effective means of increasing the uptake of HIV prevention tools, including HIV and sexually transmitted infection (STI) tests and pre-exposure prophylaxis. However, most HIV prevention mHealth apps tested in the United States have been tested among populations living in areas surrounding urban centers. Owing to reduced access to broadband internet and reliable cellular data services, it remains unclear how accessible and effective these interventions will be in rural areas. In addition, gay and bisexual men who have sex with men and gender minority populations in rural areas experience enhanced stigma when compared with their more urban counterparts, and these experiences might affect their willingness and interest in mHealth apps., Objective: This study aimed to conduct online focus groups with men who have sex with men and transgender and gender diverse populations in the rural southern United States to assess their interest in mHealth HIV prevention apps and the features that they would be the most interested in using., Methods: Focus group participants were recruited from a larger pool of sexual and gender minority respondents to a web-based research survey. The participants indicated that they would be willing to participate in an online focus group discussion. Focus groups were conducted via secure Zoom (Zoom Video Communications Inc) videoconferencing. During the focus group discussions, participants were asked to discuss their experiences with HIV and STI prevention and how these experiences were affected by living in a rural area. They were then shown screenshots of a new app to promote HIV and STI prevention among rural populations and asked to provide their opinions on the app's features. The transcripts of the discussions were reviewed and coded using a constant comparative approach., Results: A total of 6 focus groups were conducted with 26 participants. Most participants were cisgender gay and bisexual men who have sex with men (19/26, 73%); the remaining participants were transgender men (2/26, 8%), were nonbinary people (2/26, 8%), or had multiple gender identities (3/26, 12%). Participants reported numerous barriers to accessing HIV and STI prevention services and accurate information about HIV and STI prevention options. Overall, the participants reported a high degree of interest in mHealth interventions for HIV and STI prevention and suggested several recommendations for the features of an app-based intervention that would be the most useful for rural residents., Conclusions: These focus group discussions indicate that rural residence is not a major barrier to mHealth HIV and STI prevention intervention implementation and that there is a high degree of interest in these approaches to HIV and STI prevention., (©Jeb Jones, O Winslow Edwards, Leland Merrill, Patrick S Sullivan, Rob Stephenson. Originally published in JMIR Formative Research (https://formative.jmir.org), 13.06.2022.)

Background: Gay, bisexual, and other men who have sex with men (GBMSM) living with HIV have low antiretroviral treatment adherence in South Africa due to limited skills in managing disclosure and prevention behaviors with sexual and romantic partners. As a result, there is a high HIV transmission risk within HIV-discordant partnerships, but an existing intervention may address these outcomes, if adapted effectively. Healthy Relationships (HR) is a behavioral intervention that was originally delivered in groups and in person over 5 sessions to develop coping skills for managing HIV-related stress and sexually risky situations, enhance decision-making skills for HIV disclosure to partners, and establish and maintain safer sex practices with partners. HR effectively improves prevention behaviors but has yet to be tailored to a non-US context., Objective: We aim to adapt HR into a new culturally grounded intervention entitled Speaking Out & Allying Relationships for GBMSM and then assess its feasibility in Eastern Cape, South Africa., Methods: The study will have 2 aims. For aim 1-adaptation-we will use a human-centered design approach. Initial intervention tailoring will involve integrating Undetectable=Untransmittable and pre-exposure prophylaxis education, developing intervention content for a videoconference format, and designing role-plays and movies for skill building based on preliminary data. Afterward, interviews and surveys will be administered to GBMSM to assess intervention preferences, and a focus group will be conducted with health care providers and information technology experts to assess the intervention's design. Finally, a usability test will be performed to determine functionality and content understanding. Participants will be GBMSM living with HIV (n=15) who are in a relationship and health care providers and information technology (n=7) experts working in HIV care and programming with this population. For aim 2, we will examine the feasibility of the adapted intervention by using a pilot randomized control design. There will be 60 individuals per arm. Feasibility surveys and interviews will be conducted with the intervention arm, and behavioral and biomedical assessments for relationship and treatment adherence outcomes will be collected for both arms. All participants will be GBMSM living with HIV who are in a relationship with an HIV-negative or unknown status partner., Results: Intervention adaptation began in August 2021. Initial tailoring and the refining of GBMSM intervention preferences were completed in December 2021. Usability and feasibility assessments are due to be completed by March 2022 and February 2024, respectively., Conclusions: GBMSM need efficacious interventions that tackle partnership dynamics, HIV prevention, and treatment outcomes for antiretroviral treatment adherence and viral suppression in South Africa. Harnessing everyday technology use for social networking (eg, videoconferences), Undetectable=Untransmittable education, and pre-exposure prophylaxis to update an existing intervention for South African GBMSM has the potential to strengthen relationship communication about HIV treatment and prevention and, in turn, improve outcomes., International Registered Report Identifier (irrid): DERR1-10.2196/36845., (©Joseph Daniels, Remco P H Peters, Andrew Medina-Marino, Cikizwa Bongo, Rob Stephenson. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 16.05.2022.)

Background: Gay, bisexual, and other men who have sex with men (GBMSM) face the highest burden of HIV in the United States, and there is a paucity of efficacious mobile health (mHealth) HIV prevention and care interventions tailored specifically for GBMSM. We tested a mobile app combining prevention messages and access to core prevention services for GBMSM., Objective: This study aims to measure the efficacy of the Mobile Messaging for Men (M-cubed) app and related services to increase HIV prevention and care behaviors in diverse US GBMSM., Methods: We conducted a randomized open-label study with a waitlist control group among GBMSM in 3 groups (low-risk HIV-negative group, high-risk HIV-negative group, and living-with-HIV [LWH] group) recruited online and in venues in Atlanta, Detroit, and New York City. Participants were randomly assigned to receive access to the app immediately or at 9 months after randomization. The app provided prevention messages in 6 domains of sexual health and offered ordering of at-home HIV and sexually transmitted infection test kits, receiving preexposure prophylaxis (PrEP) evaluations and navigation, and service locators. Serostatus- and risk-specific prevention outcomes were evaluated at baseline, at the end of the intervention period, and at 3, 6, and 9 months after the intervention period., Results: In total, 1226 GBMSM were enrolled and randomized; of these 611 (49.84%) were assigned to the intervention group and 608 (99.51%) were analyzed, while 615 (50.16%) were assigned to the control group and 612 (99.51%) were analyzed. For high-risk GBMSM, allocation to the intervention arm was associated with higher odds of HIV testing during the intervention period (adjusted odds ratio [aOR] 2.02, 95% CI 1.11-3.66) and with higher odds of using PrEP in the 3 months after the intervention period (aOR 2.41, 95% CI 1.00-5.76, P<.05). No changes in HIV prevention or care were associated with allocation to the intervention arm for the low-risk HIV-negative and LWH groups., Conclusions: Access to the M-cubed app was associated with increased HIV testing and PrEP use among high-risk HIV-negative GBMSM in 3 US cities. The app could be made available through funded HIV prevention providers; additional efforts are needed to understand optimal strategies to implement the app outside of the research setting., Trial Registration: ClinicalTrials.gov NCT03666247; https://clinicaltrials.gov/ct2/show/NCT03666247., International Registered Report Identifier (irrid): RR2-10.2196/16439., (©Patrick Sean Sullivan, Rob Stephenson, Sabina Hirshfield, Cyra Christina Mehta, Ryan Zahn, Jose A Bauermeister, Keith Horvath, Mary Ann Chiasson, Deborah Gelaude, Shelby Mullin, Martin J Downing Jr, Evelyn Jolene Olansky, Sarah Wiatrek, Erin Q Rogers, Eli Rosenberg, Aaron J Siegler, Gordon Mansergh. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 02.02.2022.)

Background: Recruiting large samples of diverse sexual and gender minority adolescent and young adults (AYAs) into HIV intervention research is critical to the development and later dissemination of interventions that address the risk factors for HIV transmission among substance-using, sexual and gender minority AYAs., Objective: This paper aimed to describe the characteristics of the samples recruited via social media and in-person methods and makes recommendations for strategies to recruit substance-using, sexual and gender minority AYAs, a hardly reached population that is a priority for HIV prevention research., Methods: Using data from a randomized control trial of an HIV and substance use intervention with sexual and gender minority AYAs, aged 15 to 29 years in southeastern Michigan (n=414), we examined demographic and behavioral characteristics associated with successful recruitment from a range of virtual and physical venues., Results: We found that paid advertisements on Facebook, Instagram, and Grindr offered the largest quantity of eligible participants willing to enroll in the trial. Instagram offered the largest proportion of transgender masculine participants, and Grindr offered the largest proportion of Black/African American individuals. Although we attempted venue-based recruitment at clubs, bars, community centers, and AIDS service organizations, we found it to be unsuccessful for this specific hardly reached population. Social media and geobased dating applications offered the largest pool of eligible participants., Conclusions: Understanding factors associated with successful recruitment has the potential to inform effective and efficient strategies for HIV prevention research with substance-using, sexual and gender AYAs., Trial Registration: ClinicalTrials.gov NCT02945436; https://clinicaltrials.gov/ct2/show/NCT02945436., International Registered Report Identifier (irrid): RR2-10.2196/resprot.9414., (©Jayelin N Parker, Alexis S Hunter, Jose A Bauermeister, Erin E Bonar, Adam Carrico, Rob Stephenson. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 01.12.2021.)

Background: The US HIV epidemic is driven by infections in men who have sex with men and characterized by profound disparities in HIV prevalence and outcomes for Black Americans. Black men who have sex with men living with HIV are reported to have worse care outcomes than other men who have sex with men, but the reasons for these health inequities are not clear. We planned a prospective observational cohort study to help understand the reasons for worse HIV care outcomes for Black versus White men who have sex with men in Atlanta., Objective: The aim of this study is to identify individual, dyadic, network, neighborhood, and structural factors that explain disparities in HIV viral suppression between Black and White men who have sex with men living with HIV in Atlanta., Methods: Black and White men who have sex with men living with HIV were enrolled in a prospective cohort study with in-person visits and viral suppression assessments at baseline, 12 months, and 24 months; additional surveys of care and risk behaviors at 3, 6, and 18 months; analysis of care received outside the study through public health reporting; and qualitative interviews for participants who experienced sentinel health events (eg, loss of viral suppression) during the study. The study is based on the Bronfenbrenner socioecological theoretical model., Results: Men who have sex with men (n=400) were enrolled between June 2016 and June 2017 in Atlanta. Follow-up was completed in June 2019; final study retention was 80% at 24 months., Conclusions: Health disparities for Black men who have sex with men are hypothesized to be driven by structural racism and barriers to care. Observational studies are important to document and quantify the specific factors within the socioecological framework that account for disparities in viral suppression. In the meantime, it is also critical to push for steps to improve access to care, including Medicaid expansion in Southern states, such as Georgia, which have not yet moved to expand Medicaid., International Registered Report Identifier (irrid): DERR1-10.2196/21985., (©Patrick Sean Sullivan, Jennifer Taussig, Mariah Valentine-Graves, Nicole Luisi, Carlos Del Rio, Jeb Jones, Greg Millett, Eli S Rosenberg, Rob Stephenson, Colleen Kelley. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 23.02.2021.)

Background: Gay, bisexual, and other men who have sex with men (MSM) are at elevated risk for acquiring sexually transmitted infections (STIs) in the United States, especially chlamydia and gonorrhea. While research has indicated main partners over casual partners may play a central role in STI risk, the frequency of STI screening among MSM couples is particularly low. Self-sample collection for chlamydia and gonorrhea screening has been shown to be highly accurate, and at-home STI testing has been shown to be highly acceptable among diverse populations. However, there is little research exploring the feasibility and acceptability of at-home chlamydia and gonorrhea screening among MSM couples. Our pilot study aims to help evaluate the viability of this screening modality as an intervention tool for MSM couples., Objective: The objective of this study was to assess the feasibility and acceptability of an at-home chlamydia and gonorrhea sample collection and remote lab testing program among a sample of 50 MSM couples living in the United States., Methods: This pilot study enrolled 50 MSM couples, ranging from 18-40 years old and living in the United States, who participated in a larger at-home HIV testing randomized controlled trial. Participating couples completed a pretest instructional video call and then had the option of completing at-home sample collection across three bodily sites (rectal swab, pharyngeal swab, and urine sample) for remote chlamydia and gonorrhea lab testing. For participants who completed any sample collection, they received their results via a posttest video call. All participants completed an online survey examining satisfaction and acceptability of the home testing process, experience with logistics, willingness to test at home in the future, recent sexual risk behavior, STI testing history, and linkage to care. A subset of 10 couples completed an in-depth interview about their attitudes towards the sample collection process, different decisions they made while collecting their samples, and their experience accessing treatment (for those who received a positive result)., Results: Recruitment began in September 2017, and as of March 2019 a total of 50 couples have been enrolled. Overall, 49/50 couples have returned their samples and completed the posttest delivery call, and 10 in-depth interviews have been completed and transcribed., Conclusions: Screening MSM couples at home for chlamydia and gonorrhea and providing video-facilitated results delivery may offer a tailored approach to address the increasing prevalence of these STIs. By collecting data on how MSM couples experience at-home STI screening, this project will provide valuable insight into the utility of such a service delivery program to public health interventionists and researchers alike., International Registered Report Identifier (irrid): DERR1-10.2196/14481., (©Stephen Patrick Sullivan, Patrick Sullivan, Rob Stephenson. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 01.10.2019.)

Background: Men who have sex with men (MSM) in the United States experience a disproportionate burden of HIV and bacterial sexually transmitted infections (STIs), such as gonorrhea and chlamydia. Screening levels among MSM remain inadequate owing to barriers to testing such as stigma, privacy and confidentiality concerns, transportation issues, insufficient clinic time, and limited access to health care. Self-collection of specimens at home and their return by mail for HIV and bacterial STI testing, as well as pre-exposure prophylaxis (PrEP) adherence monitoring, could be a resource-efficient option that might mitigate some of these barriers., Objective: Project Caboodle! is a mixed-methods study that explores the acceptability and feasibility of self-collecting and returning a bundle of 5 different specimens for HIV and bacterial STI testing, as well as PrEP adherence monitoring, among sexually active HIV-negative or unknown status MSM in the United States aged 18 to 34 years., Methods: Participants will be recruited using age, race, and ethnicity varied advertising on social networking websites and mobile gay dating apps. In Phase 1, we will send 100 participants a box containing materials for self-collecting and potentially returning a finger-stick blood sample (for HIV testing), pharyngeal swab, rectal swab, and urine specimen (for gonorrhea and chlamydia testing), and hair sample (to assess adequacy for potential PrEP adherence monitoring). Specimen return will not be incentivized, and participants can choose to mail back all, some, or none of the specimens. Test results will be delivered back to participants by trained counselors over the phone. In Phase 2, we will conduct individual in-depth interviews using a video-based teleconferencing software (VSee) with 32 participants from Phase 1 (half who returned all specimens and half who returned some or no specimens) to examine attitudes toward and barriers to completing various study activities., Results: Project Caboodle! was funded in May 2018, and participant recruitment began in March 2019. The processes of designing a study logo, creating advertisements, programming Web-based surveys, and finalizing step-by-step written instructions accompanied by color images for specimen self-collection have been completed. The boxes containing 5 self-collection kits affixed with unique identification stickers are being assembled, and shipping procedures (for mailing out boxes to participants and for specimen return by participants using prepaid shipping envelopes) and payment procedures for completing the surveys and in-depth interviews are being finalized., Conclusions: Self-collection of biological specimens at home and their return by mail for HIV and bacterial STI testing, as well as PrEP adherence monitoring, might offer a practical and convenient solution to improve comprehensive prevention efforts for high-risk MSM. The potentially reduced time, expense, and travel associated with this approach could facilitate a wider implementation of screening algorithms and remote monitoring strategies., International Registered Report Identifier (irrid): PRR1-10.2196/13647., (©Akshay Sharma, Rob Stephenson, Gregory Sallabank, Leland Merrill, Stephen Sullivan, Monica Gandhi. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 02.05.2019.)

Background: Young people aged under 25 years make up an increasing proportion of the population in emerging economies such as Kenya, where half of new adult HIV infections are among 15- to 24-year olds. Interventions targeting this age group have the potential to avert HIV infections among an increasingly large at-risk population. Interactive communication technologies offer a promising platform for reaching young people in engaging ways., Objective: Tumaini is a narrative-based smartphone game designed to help young Africans protect themselves from HIV. The objective of this study was to pilot test the game, focusing on the data needed to inform a future randomized controlled efficacy trial, including assessments of study feasibility and safety., Methods: The study took place in Kisumu Town, western Kenya, in spring 2017. The game-based intervention was pilot tested for 16 days with a sample of 60 preadolescents aged 11 to 14 years. Participant recruitment was initiated through schools. Participants were randomly assigned to the control or intervention arms of the study. One parent for each of the intervention arm participants was also recruited (n=30). The intervention arm participants were provided with smartphones on which Tumaini was loaded so that they could play the game at home. Youth completed behavioral surveys at baseline, posttest, and 6-week follow-up. The intervention arm participants provided quantitative feedback on their experience of the game-based intervention at posttest. They and their parents further participated in postintervention focus group discussions. Feasibility-related study metrics were collected on recruitment, enrollment, attrition, safety of participants, and return of phones., Results: Recruitment and enrollment of the 60 preadolescents and parents were successfully completed within 18 days. No participants were lost to follow-up: all youth completed all 3 waves of the survey and 27 intervention arm youth and 22 parents and caregivers participated in the focus groups. No safety concerns were reported. All phones were returned after the intervention period; none were damaged or lost. All intervention arm participants initiated gameplay, recording a mean exposure time just under 27 hours., Conclusions: Findings indicate that it is feasible and safe to test a smartphone-based HIV prevention intervention for very young adolescents in urban and peri-urban sub-Saharan Africa by initiating recruitment in schools and temporarily providing youth participants with smartphones on which the game is loaded. A randomized controlled trial powered to assess the efficacy of the game-based intervention is being designed to be carried out in the same geographic area as the pilot, using similar methods., Trial Registration: ClinicalTrials.gov NCT03054051; https://clinicaltrials.gov/ct2/show/NCT03054051 (Archived by WebCite at http://www.webcitation.org/6wjwpX8Bg.)., International Registered Report Identifier (irrid): DERR1-10.2196/11209., (©Gaëlle Sabben, Victor Akelo, Victor Mudhune, Ken Ondeng'e, Richard Ndivo, Rob Stephenson, Kate Winskell. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 27.03.2019.)

Background: Intimate partner violence (IPV) is frequently experienced by women of low socioeconomic status in India. It is a human rights violation and associated with negative effects on physical and mental well-being, underscoring the need for effective prevention strategies., Objective: This study aimed to develop a dyadic intervention for the primary prevention of IPV among newly married couples residing in slum communities in India., Methods: The intervention was developed using a community-based, mixed-methods design rooted in couple-interdependence theory and guided by the intervention mapping (IM) framework. It used the six critical IM steps to inform the content and delivery of the intervention: (1) needs assessment, (2) preparation of matrices of change objectives, (3) selection of theory-based methods and practical applications, (4) production of intervention components and materials, (5) intervention adoption and implementation, and (6) evaluation planning., Results: The resulting Ghya Bharari Ekatra (Take a Flight Together) intervention is intended to be delivered in 6 weekly sessions by a trained pair of male and female lay community educators to groups of 3 to 5 newly married couples in the community in which they reside. It uses games, discussions, self-reflections, and skill-building exercises to cover the following topics: enhancing relationship quality time, self-esteem and resilience, communication and conflict management, goal setting and implementation, sexual communication and sexual health and reproductive health knowledge, and redefining and challenging norms surrounding IPV occurrence. The formative work guided the protocol, including module duration and timing (2-hour sessions of convenience to participants), ordering of modules (based on potential level of interest and sensitivity of the topics), content (ie, informed scripts of role plays and films), intervention delivery methods (ie, interactive activities), and selection of the interventionists (based on capacity to connect with participants) and venue (community-based, convenient, and safe spaces). Ghya Bharari Ekatra was piloted between January and May 2018, and evaluation is presently underway., Conclusions: Ghya Bharari Ekatra is evidence-based, grounded in intervention-mapping, and developed and iteratively refined using a community-based participatory research approach, suggesting it has great potential to be an acceptable and effective solution to preventing IPV among newly married couples., Trial Registration: ClinicalTrials.gov NCT03332134; https://clinicaltrials.gov/ct2/show/NCT03332134., (©Ameeta Shivdas Kalokhe, Sandhya Iyer, Tuman Katendra, Keshav Gadhe, Ambika R Kolhe, Anuradha Paranjape, Carlos del Rio, Rob Stephenson, Seema Sahay. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.01.2019.)

Background: Young gay, bisexual, and other men who have sex with men (YMSM) continue to be the group most heavily impacted by HIV in the United States. Substantial evidence indicates that up to two-thirds of new HIV infections occur in the context of a main partnership. Couples HIV testing and counseling (CHTC) has been shown to be a promising and effective strategy for increasing HIV prevention uptake among male couples; however, YMSM who are new to relationships may not have yet developed the efficacy, negotiation, and communication skills to navigate HIV testing in their relationship and communicate around developing a prevention plan., Objective: This study aims to develop and test a relationship skills-focused HIV prevention intervention for YMSM and their partners. The intervention consists of two telehealth-delivered sessions: the first focuses on relationship skills and the second consists of CHTC and prevention planning. Both sessions are attended by both members of the dyad., Methods: This protocol describes the development of the proposed intervention (We Prevent) and pilot test to examine its feasibility and preliminary efficacy. The intervention will include two motivational interviewing-based sessions: session one is a relationship skills-building session, focused on techniques to explore and build communication skills in a relationship, to help YMSM develop and enhance necessary skills for their current and future relationships; the second session is a CHTC session with YMSM and their partners, to help them develop an HIV prevention plan. Through qualitative data collection and a one-arm pilot with YMSM, we will develop and refine a developmentally appropriate relationship skills session as an addition to the current CHTC intervention. We will then conduct a pilot randomized controlled trial (RCT), comparing the acceptability, feasibility, and preliminary efficacy of the adapted two-session telehealth intervention for YMSM versus a control group receiving one session only-a CHTC session delivered via telehealth., Results: The We Prevent intervention is designed to increase uptake of HIV prevention, shown through self-reported reductions in condomless sex and increases in knowledge and uptake of pre-exposure prophylaxis. In addition, the intervention is designed to increase HIV and sexually transmitted infection (STI) testing. STI incidence is examined as a secondary outcome. A cost-input analysis will examine the costs associated with intervention delivery to inform future scale-up of the intervention., Conclusions: Drawing on theory and existing CHTC protocols delivered with video-based counseling, this proposed intervention affords the opportunity to empower YMSM with the skills necessary to communicate with their partners and protect themselves from HIV in their current and future relationships., Trial Registration: Clinicaltrials.gov NCT03551938; https://clinicaltrials.gov/ct2/show/NCT03551938 (Archived by WebCite at http://www.webcitation.org/73omJCz1a)., International Registered Report Identifier (irrid): RR1-10.2196/10370., (©Kristi E Gamarel, Lynae A Darbes, Lisa Hightow-Weidman, Patrick Sullivan, Rob Stephenson. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 02.01.2019.)

Background: HIV epidemic among young men who have sex with men (YMSM) is characterized by strong racial disparities and concerns about the availability and access to culturally appropriate HIV prevention and care service delivery. Get Connected, a Web-based intervention that employs individual- and system-level tailoring technology to reduce barriers to HIV prevention care (eg, HIV or sexually transmitted infection [STI] testing, pre-exposure prophylaxis [PrEP]), was developed for YMSM (age 15-24 years). This protocol details the design and procedures of a 2-phase project that includes mystery shopping and a randomized controlled trial (RCT) to test the efficacy of Get Connected among YMSM in Philadelphia, Atlanta, and Houston., Objective: The objective of mystery shopping is to examine the quality of HIV test counseling and PrEP-related referrals for YMSM within local HIV or STI testing sites. The objective of the RCT is to test the efficacy of Get Connected for increasing HIV-negative or HIV-unknown YMSM's successful uptake of HIV prevention services (eg, routine HIV or STI testing), PrEP awareness, and likelihood to start PrEP (PrEP willingness), compared with those in the control condition, over a 12-month period., Methods: For Phase 1, we will create a master list of HIV and STI testing sites in each city. We will enroll and train 10-15 mystery shoppers per city; each testing site will be separately visited and assessed by 2 mystery shoppers. After each site visit, the mystery shoppers will complete a site evaluation to record their perceptions of various measures including lesbian, gay, bisexual, transgender, queer visibility and inclusivity, privacy and confidentiality, provider-patient interactions, and clinic environment. For Phase 2, we will enroll 480 YMSM for 12 months across the 3 iTech cities into a 2-arm prospective RCT. Participants randomized to the control condition are directed to the AIDSVu.org testing site locator. Participants randomized to the intervention condition will be granted access to a Web app with content tailored to their specific demographic characteristics (eg, age, race or ethnicity, location, and relationship status), HIV and STI risk behaviors (eg, HIV and STI testing history, substance use, communication with partners regarding status) and sociocultural context (eg, homelessness, incarceration). Study assessments will occur at enrollment and at 1, 3, 6, 9, and 12 months postenrollment., Results: Get Connected research activities began in September 2016 and are ongoing. To date, institutional review board (IRB) submission is complete and IRB authorization agreements are pending at several other universities., Conclusions: The deployment of Get Connected through a mobile-optimized Web app seeks to optimize the intervention's acceptability, accessibility, availability, and long-term affordability among YMSM., Trial Registration: ClinicalTrials.gov (NCT03132415); https://clinicaltrials.gov/ct2/show/NCT03132415 (Archived by WebCite at http://www.webcitation.org/70j4gSFbZ)., Registered Report Identifier: RR1-10.2196/10444., (©José A. Bauermeister, Jesse M Golinkoff, Keith J Horvath, Lisa B Hightow-Weidman, Patrick S Sullivan, Rob Stephenson. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 02.08.2018.)

Background: Few HIV interventions have demonstrated efficacy in reducing HIV risk among adolescent men who have sex with men (AMSM), and fewer still have recognized the unique needs of AMSM based on race/ethnicity or geographical setting. Recognizing that youths' HIV vulnerability is intricately tied to their development and social context, delivering life skills training during adolescence might delay the onset or reduce the consequences of risk factors for HIV acquisition and equip AMSM with the skills to navigate HIV prevention. This protocol describes the development and testing of iREACH, an online multilevel life skills intervention for AMSM., Objective: This randomized controlled trial (RCT) aims to test the efficacy of an online-delivered life skills intervention, iREACH, on cognitive and behavioral HIV-related outcomes for AMSM., Methods: iREACH is a prospective RCT of approximately 600 cisgender adolescent males aged 13 to 18 years who report same-sex attractions. The intervention will be tested with a racial/ethnically diverse sample (≥50% racial/ethnic minority) of AMSM living in four regions in the United States: (1) Chicago to Detroit, (2) Washington, DC to Atlanta, (3) San Francisco to San Diego, and (4) Memphis to New Orleans., Results: This project is currently recruiting participants. Recruitment began in March 2018., Conclusions: iREACH represents a significant innovation in the development and testing of a tailored life skills-focused intervention for AMSM, and has the potential to fill a significant gap in HIV prevention intervention programming and research for AMSM., Registered Report Identifier: RR1-10.2196/10174., (©Jose Bauermeister, Patrick S Sullivan, Laura Gravens, James Wolfe, Kristina Countryman, Neena Smith-Bankhead, Ryan A Drab, Gregory Sallabank, Jordan D Helms, Kristie Khatibi, Rebecca Filipowicz, Keith Joseph Horvath, Erin Bonar, Amanda Castel, Lisa Hightow-Weidman, Jodie Guest, Rob Stephenson. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 10.07.2018.)

Background: Young men who have sex with men (YMSM) and transgender people in the Detroit Metro Area are the only risk group for whom the incidence of HIV and sexually transmitted infections (STI) has increased since 2000, with HIV incidence nearly doubling among youth. Substance use (including alcohol), which is relatively frequent among YMSM and transgender people, creates barriers to the optimal delivery of HIV prevention and care services. Standard HIV counseling, testing, and referral (CTR) is limited in providing strategies to identify and address substance use. Hence, in its current form, CTR may not be serving the prevention needs of substance-using YMSM and transgender people. Brief counseling interventions, grounded in principles of motivational interviewing, may offer a mechanism to meet the HIV prevention and care needs of substance-using YMSM and transgender people., Objective: This prospective, 4-arm, factorial randomized controlled trial aims to examine the efficacy of an motivational interviewing-based substance use brief intervention (SUBI) on participants' substance use and engagement in HIV prevention., Methods: The research implements a prospective randomized controlled trial (Project Swerve) of 600 YMSM and transgender people recruited both online and in person. Eligibility criteria include participants who (1) are between the ages of 15 to 29 years, (2) live in the Detroit Metro Area, (3) self-identify as a man or transgender man or woman, (4) have had sexual contact with a man in the 6 months before enrollment, (5) self-report binge drinking or any substance use in the 3 months before enrollment, and (6) self-report an unknown or negative HIV status upon enrollment. Participants are randomized to receive, 3-months apart starting at baseline, 2 individual sessions. Sessions are CTR-only, SUBI-only, CTR followed by SUBI, or SUBI followed by CTR., Results: Project Swerve was launched in April 2017 and enrollment is ongoing., Conclusions: Incorporating a SUBI that utilizes the principles of motivational interviewing into HIV CTR provides an opportunity to tailor counseling services for YMSM and transgender people to address additional client barriers to HIV and STI testing., Trial Registration: ClinicalTrials.gov NCT02945436; http://clinicaltrials.gov/ct2/show/NCT02945436 (Archived by WebCite at http://www.webcitation.org/6yFyOK57w)., (©Rob Stephenson, Erin E Bonar, Adam Carrico, Alexis Hunter, Daniel Connochie, Rebecca Himmelstein, Jose Bauermeister. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 30.04.2018.)

Background: Awareness of pre-exposure prophylaxis (PrEP) for HIV prevention is increasing, but little is known about the functional knowledge of PrEP and its impact on willingness to use PrEP., Objective: The objective of this study was to assess the functional knowledge of PrEP among a sample of gay, bisexual, and other men who have sex with men (MSM) participating in a Web-based survey of sexually active MSM., Methods: Men at least 18 years old, residing in the United States, and reporting sex with a man in the previous 6 months were recruited through social networking websites. PrEP functional knowledge included the following 4 questions (1) efficacy of consistent PrEP use, (2) inconsistent PrEP use and effectiveness, (3) PrEP and condom use, and (4) effectiveness at reducing sexually transmitted infections (STIs). Ordinal logistic regression was used to identify respondent characteristics associated with PrEP functional knowledge. In a subsample of participants responding to HIV prevention questions, we compared willingness to use PrEP by response to PrEP functional knowledge using logistic regression analysis adjusted for age, race and ethnicity, and education level., Results: Among 573 respondents, PrEP knowledge was high regarding adherence (488/573, 85.2%), condom use (532/573, 92.8%), and STIs (480/573, 83.8%), but only 252/573 (44.0%) identified the correct efficacy. Lower functional PrEP knowledge was associated with minority race/ethnicity (P=.005), lower education (P=.01), and not having an HIV test in the past year (P=.02). Higher PrEP knowledge was associated with willingness to use PrEP (P=.009). Younger age was not associated with higher PrEP functional knowledge or willingness to use PrEP., Conclusions: PrEP knowledge was generally high in our study, including condom use and consistent use but may be lacking in higher risk MSM. The majority of respondents did not correctly identify PrEP efficacy with consistent use, which could impact motivation to seek out PrEP for HIV prevention. Targeted messaging to increase PrEP knowledge may increase PrEP use., (©Erin M Kahle, Stephen Sullivan, Rob Stephenson. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 23.01.2018.)

Background: Transgender and gender nonconforming people experience some of the highest human immunodeficiency virus (HIV) rates in the United States, and experience many structural and behavioral barriers that may limit their engagement in HIV testing, prevention, and care. Evidence suggests that transgender and gender nonconforming youth (TY) are especially vulnerable to acquiring HIV, yet there is little research on TY and few services are targeted towards HIV testing, prevention, and care for this population. Telehealth presents an opportunity to mitigate some structural barriers that TY experience in accessing HIV testing, allowing TY to engage in HIV testing and counseling in a safe and nonjudgmental space of their choosing. Project Moxie is an HIV prevention intervention that pairs the use of HIV self-testing with remote video-based counseling and support from a trained, gender-affirming counselor. This study aims to offer a more positive HIV testing and counseling experience, with the goal of improving HIV testing frequency., Objective: Project Moxie involves a pilot randomized controlled trial (RCT) of 200 TY aged 15-24 years, who are randomized on a 1:1 basis to control or intervention arms. The aim is to examine whether the addition of counseling provided via telehealth, coupled with home-based HIV testing, can create gains in routine HIV testing among TY over a six-month follow-up period., Methods: This study implements a prospective pilot RCT of 200 TY recruited online. Participants in the control arm will receive one HIV self-testing kit and will be asked to report their results via the study's website. Participants in the experimental arm will receive one HIV self-testing kit and will test with a remotely-located counselor during a prescheduled video-counseling session. Participants are assessed at baseline, and at three and six months posttesting., Results: Project Moxie was launched in June 2017 and recruitment is ongoing. As of August 21, 2017, the study had enrolled 130 eligible participants., Conclusions: Combining home-based HIV testing and video-based counseling allows TY, an often stigmatized and marginalized population, to test for HIV in a safe and nonjudgmental setting of their choosing. This approach creates an opportunity to reduce the high rate of HIV among TY through engagement in care, support, and linkage to the HIV treatment cascade for those who test positive., Trial Registration: ClinicalTrials.gov NCT03185975; https://clinicaltrials.gov/ct2/show/NCT03185975 (Archived by WebCite at http://www.webcitation.org/6vIjHJ93s)., (©Rob Stephenson, Nicholas Metheny, Akshay Sharma, Stephen Sullivan, Erin Riley. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 28.11.2017.)

Background: An estimated one- to-two-thirds of new human immunodeficiency virus (HIV) infections among US men who have sex with men (MSM) occur within the context of primary partnerships. Despite this fact, there remains a lack of prevention interventions that focus on male sero-discordant dyads. Interventions that provide male couples with skills to manage HIV risk, and to support each other towards active engagement in HIV prevention and care, are urgently needed., Objective: The objective of this paper is to describe the protocol for an innovative dyadic intervention (Stronger Together) that combines couples' HIV testing and dyadic adherence counseling to improve treatment adherence and engagement in care among HIV sero-discordant male couples in the United States., Methods: The research activities involve a prospective randomized controlled trial (RCT) of approximately 165 venue- and clinic-recruited sero-discordant male couples (330 individuals: 165 HIV sero-negative and 165 HIV sero-positive). Couples randomized into the intervention arm receive couples' HIV counseling and testing plus dyadic adherence counseling, while those randomized to the control arm receive individual HIV counseling and testing. The study takes place in three cities: Atlanta, GA (study site Emory University); Boston, MA (study site The Fenway Institute); and Chicago, IL (study site Ann & Robert H. Lurie Children's Hospital of Chicago). Cohort recruitment began in 2015. Couples are followed prospectively for 24 months, with study assessments at baseline, 6, 12, 18, and 24 months., Results: Stronger Together was launched in August 2014. To date, 160 couples (97% of the target enrollment) have been enrolled and randomized. The average retention rate across the three sites is 95%. Relationship dissolution has been relatively low, with only 13 couples breaking up during the RCT. Of the 13 couples who have broken up, 10 of the 13 HIV-positive partners have been retained in the cohort; none of these HIV-positive partners have enrolled new partners into the RCT., Conclusions: The intervention offers a unique opportunity for sero-discordant couples to support each other towards common HIV management goals by facilitating their development of tailored prevention plans via couples-based HIV testing and counseling, as well as problem-solving skills in Partner Strategies to Enhance Problem-solving Skills (STEPS)., Trial Registration: ClinicalTrials.gov NCT01772992; https://clinicaltrials.gov/ct2/show/NCT01772992 (Archived by WebCite at http://www.webcitation.org/6szFBVk1R)., (©Rob Stephenson, Nicolas A Suarez, Robert Garofalo, Marco A Hidalgo, Samuel Hoehnle, Jennie Thai, Matthew J Mimiaga, Emily Brown, Anna Bratcher, Taylor Wimbly, Patrick Sullivan. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 31.08.2017.)

Background: Rates of new HIV infections continue to increase worldwide among men who have sex with men (MSM). Despite effective prevention strategies such as condoms and pre-exposure prophylaxis (PrEP), low usage of both methods in many parts of the world hinder prevention efforts. An individual's perceptions of the risk of acquiring HIV and the seriousness they afford to seroconversion are important drivers of behavioral risk-taking. Understanding the behavioral factors suppressing the uptake of HIV prevention services is a critical step in informing strategies to improve interventions to combat the ongoing HIV pandemic among MSM., Objective: The study aimed to examine cross-national perceptions of HIV/AIDS seriousness, risk, and threat and the association between these perceptions and sociodemographic characteristics, relationships, and high-risk sexual behaviors among MSM., Methods: Participants in Australia, Brazil, Canada, Thailand, South Africa, the United Kingdom, and the United States were recruited for a self-administered survey via Facebook (N=1908). Respondents were asked to rate their perceived seriousness from 1 (not at all serious) to 5 (very serious) of contracting HIV, their perceived risk from 1 (no risk) to 10 (very high risk) of contracting HIV based on their current behavior, and their perception of the threat of HIV-measured as their confidence in being able to stay HIV-negative throughout their lifetimes-on a scale from 1 (will not have HIV by the end of his lifetime) to 5 (will have HIV by the end of his lifetime). Covariates included sociodemographic factors, sexual behavior, HIV testing, drug use, and relationship status. Three ordered logistic regression models, one for each outcome variable, were fit for each country., Results: Contracting HIV was perceived as serious (mean=4.1-4.6), but perceptions of HIV risk (mean=2.7-3.8) and threat of HIV (mean=1.7-2.2) were relatively low across countries. Older age was associated with significantly lower perceived seriousness of acquiring HIV in five countries (Australia: odds ratio, OR 0.97, 95% CI 0.94-0.99; Brazil: OR 0.95, 95% CI 0.91-0.98; Canada: OR 0.96, 95% CI 0.93-0.98; South Africa: OR 0.96, 95% CI 0.94-0.98; United Kingdom: OR 0.95, 95% CI 0.92-0.98). Being in a male-male sexual relationship was associated with significantly lower perceived risk of HIV in four countries (Australia: OR 0.47, 95% CI 0.30-0.75; Canada: OR: 0.54, 95% CI 0.35-0.86; United Kingdom: OR 0.38, 95% CI 0.24-0.60; United States: OR 0.5, 95% CI 0.31-0.82). Drug use in the previous year was associated with greater threat of contracting HIV in two countries (Canada: OR 1.81, 95% CI 1.13-2.91; United Kingdom: OR 1.7, 95% CI 1.06-2.74)., Conclusions: Few measures of behavioral or sexual risk-taking were significantly associated with perceived HIV seriousness, risk, or threat across countries. Overall, low levels of reported risk were identified, and results illustrate important gaps in the understanding of risk among MSM across societies that could be addressed through culturally-tailored prevention messaging., (©Anna N Chard, Nicholas Metheny, Rob Stephenson. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 20.06.2017.)

Background: HIV prevalence remains high among men who have sex with men (MSM) in the United States, yet the majority of research has focused on MSM as individuals, not as dyads, and has discussed HIV risks primarily in the context of casual sex. Nexus is an online prevention program that combines home-based HIV testing and couples HIV testing and counseling (CHTC). It allows partners in dyadic MSM relationships to receive HIV testing and care in the comfort of their designated residence, via video-based chat. By using video-based technologies (eg, VSee video chat), male couples receive counseling and support from a remote online counselor, while testing for HIV at home., Objective: This randomized control trial (RCT) aims to examine the effects of video-based counseling combined with home-based HIV testing on couples' management of HIV risk, formation and adherence to explicit sexual agreements, and sexual risk-taking., Methods: The research implements a prospective RCT of 400 online-recruited male couples: 200 self-reported concordant-negative couples and 200 self-reported discordant couples. Couples in the control arm will receive one or two home-based HIV self-testing kits and will be asked to report their results via the study's website. Couples in the experimental arm will receive one or two home-based HIV self-testing kits and will conduct these tests together under the facilitation of a remotely located counselor during a prescheduled VSee-based video CHTC session. Study assessments are taken at baseline, as well as at 3- and 6-month follow-up sessions., Results: Project Nexus was launched in April 2016 and is ongoing. To date, 219 eligible couples have been enrolled and randomized., Conclusions: Combining home-based HIV testing with video-based counseling creates an opportunity to expand CHTC to male couples who (1) live outside metro areas, (2) live in rural areas without access to testing services or LGBTQ resources, or (3) feel that current clinic-based testing is not for them (eg, due to fears of discrimination associated with HIV and/or sexuality)., Trial Registration: ClinicalTrials.gov NCT02335138; https://clinicaltrials.gov/ct2/show/NCT02335138 (Archived by WebCite at http://www.webcitation.org/6qHxtNIdW)., (©Rob Stephenson, Ryan Freeland, Stephen P Sullivan, Erin Riley, Brent A Johnson, Jason Mitchell, Deborah McFarland, Patrick S Sullivan. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 30.05.2017.)

Background: Gay, bisexual, and other men who have sex with men (GBMSM) in the United States remain disproportionately affected by human immunodeficiency virus (HIV). Yet their testing frequency is suboptimal and condomless anal sex (CAS) is increasing. Behavioral theories posit that information about HIV is a pivotal construct in individual risk reduction. However, measurements of knowledge have traditionally focused on ever hearing about HIV and being aware of the most common routes of spread., Objective: Using a national Web-based sample of sexually active GBMSM, we sought to (1) quantify levels of detailed knowledge about HIV epidemiology and transmission dynamics, (2) describe variations in detailed knowledge levels across demographic strata, and (3) evaluate potential associations of increasing levels of detailed knowledge with HIV testing in the past year and engaging in CAS with a male partner in the past 3 months., Methods: GBMSM were recruited through a social networking website (Facebook) from August to September 2015 and asked 17 knowledge-based questions pertaining to the following 2 domains using a Web-based survey: HIV epidemiology (9 questions including statistics on incidence, prevalence, and distribution) and HIV transmission dynamics (8 questions including modes of spread and per-act transmission probabilities). Ordinal domain-specific indices of detailed knowledge were created for each respondent by summing their number of correct responses. Separate cumulative logit models were used to identify factors independently associated with each index, and multivariable logistic regression models were used to characterize associations with HIV testing history and recently engaging in CAS., Results: Of the 1064 participants in our study, only half (49.62%, 528/1064) had been tested for HIV in the past year, and almost half (47.84%, 509/1064) had engaged in CAS with a male partner in the past 3 months. Majority scored 3 of 9 epidemiology questions correct (26.88%, 286/1064) and 5 of 8 transmission dynamics questions correct (25.00%, 266/1064). Participants younger than 35 years, of non-Hispanic non-white or Hispanic race and ethnicity, with lower educational levels, and who reported a sexual orientation other than homosexual or gay were significantly less knowledgeable about HIV transmission dynamics. Increasing levels of knowledge about this domain were independently associated with testing in the past year (adjusted odds ratio for each additional correct response: 1.10, 95% CI 1.01-1.20) but not with recent CAS. Increasing knowledge about HIV epidemiology was not associated with either outcome., Conclusions: Increasing detailed knowledge about HIV epidemiology might not be as important as educating sexually active GBMSM regarding transmission dynamics. Researchers and practitioners designing prevention messages targeting GBMSM should bear in mind that not all knowledge is equal and that some aspects might have a greater positive impact than others. Future research to identify influential content and contemporary modes of delivery is needed., (©Akshay Sharma, Stephen P Sullivan, Rob B Stephenson. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 06.03.2017.)

Background: Web-based surveys are increasingly used to capture data essential for human immunodeficiency virus (HIV) prevention research. However, there are challenges in ensuring the informed consent of Web-based research participants., Objective: The aim of our study was to develop and assess the efficacy of alternative methods of administering informed consent in Web-based HIV research with men who have sex with men (MSM)., Methods: From July to September 2014, paid advertisements on Facebook were used to recruit adult MSM living in the United States for a Web-based survey about risk and preventive behaviors. Participants were randomized to one of the 4 methods of delivering informed consent: a professionally produced video, a study staff-produced video, a frequently asked questions (FAQs) text page, and a standard informed consent text page. Following the behavior survey, participants answered 15 questions about comprehension of consent information. Correct responses to each question were given a score of 1, for a total possible scale score of 15. General linear regression and post-hoc Tukey comparisons were used to assess difference (P<.001) in mean consent comprehension scores. A mediation analysis was used to examine the relationship between time spent on consent page and consent comprehension., Results: Of the 665 MSM participants who completed the comprehension questions, 24.2% (161/665) received the standard consent, 27.1% (180/665) received the FAQ consent, 26.8% (178/665) received the professional consent video, and 22.0% (146/665) received the staff video. The overall average consent comprehension score was 6.28 (SD=2.89). The average consent comprehension score differed significantly across consent type (P<.001), age (P=.04), race or ethnicity (P<.001), and highest level of education (P=.001). Compared with those who received the standard consent, comprehension was significantly higher for participants who received the professional video consent (score increase=1.79; 95% CI 1.02-2.55) and participants who received the staff video consent (score increase=1.79; 95% CI 0.99-2.59). There was no significant difference in comprehension for those who received the FAQ consent. Participants spent more time on the 2 video consents (staff video median time=117 seconds; professional video median time=115 seconds) than the FAQ (median=21 seconds) and standard consents (median=37 seconds). Mediation analysis showed that though time spent on the consent page was partially responsible for some of the differences in comprehension, the direct effects of the professional video (score increase=0.93; 95% CI 0.39-1.48) and the staff-produced video (score increase=0.99; 95% CI 0.42-1.56) were still significant., Conclusions: Video-based consent methods improve consent comprehension of MSM participating in a Web-based HIV behavioral survey. This effect may be partially mediated through increased time spent reviewing the consent material; however, the video consent may still be superior to standard consent in improving participant comprehension of key study facts., Trail Registration: Clinicaltrials.gov NCT02139566; https://clinicaltrials.gov/ct2/show/NCT02139566 (Archived by WebCite at http://www.webcitation.org/6oRnL261N)., (©Eric William Hall, Travis H Sanchez, Aryeh D Stein, Rob Stephenson, Maria Zlotorzynska, Robert Craig Sineath, Patrick S Sullivan. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 06.03.2017.)

Background: As interest increases in the development of eHealth human immunodeficiency virus (HIV)-preventive interventions for gay male couples, Web-based methods must also be developed to help increase the likelihood that couples enrolled and data collected from them represent true unique dyads. Methods to recruit and collect reliable and valid data from both members of a couple are lacking, yet are crucial for uptake of novel sexual health and HIV-prevention eHealth interventions. Methods to describe best practices to recruit male couples using targeted advertisements on Facebook are also lacking in the literature, yet could also help in this uptake., Objective: The objective of our study was to describe challenges and lessons learned from experiences from two phases (developmental phase and online randomized controlled trial [RCT]) of an eHealth HIV-prevention intervention for concordant HIV-negative male couples in terms of (1) recruiting male couples using targeted advertisements on Facebook, (2) validating that data came from two partners of the couple, and (3) verifying that the two partners of the couple are in a relationship with each other., Methods: The developmental phase refined the intervention via in-person focus groups, whereas the pilot-testing phase included an online RCT. For both phases, couples were recruited via targeted Facebook advertisements. Advertisements directed men to a study webpage and screener; once eligible, participants provided consent electronically. A partner referral system was embedded in the consenting process to recruit the relationship partner of the participant. Both men of the couple had to meet all eligibility criteria-individually and as a couple-before they could enroll in the study. Verification of couples' relationships was assessed via the concurrence of predetermined screener items from both partners, done manually in the developmental phase and electronically in the pilot-testing phase. A system of decision rules was developed to assess the validity that data came from two unique partners of a couple., Results: Several important lessons were learned from these experiences, resulting in recommendations for future eHealth studies involving male couples. Use of certain "interests" and types of images (eg, shirtless) in targeted Facebook advertisements should be avoided or used sparingly because these interests and types of images may generate adverse reactions from a broader audience. Development of a systematic approach with predetermined criteria and parameters to verify male couples' relationships is strongly recommended. Further, researchers are encouraged to develop a system of decision rules to detect and handle suspicious data (eg, suspicious email addresses/names, multiple entries, same IP address used in multiple entries) to help validate the legitimacy of male couples' relationships online., Conclusions: These lessons learned combined with recommendations for future studies aim to help enhance recruitment efforts and the validity and reliability of collecting dyadic data from male couples for novel eHealth HIV-preventive interventions., Competing Interests: Conflicts of Interest: None declared.

Background: An estimated one- to two-thirds of new human immunodeficiency virus (HIV) infections among US men who have sex with men (MSM) occur within the context of primary partnerships. Thus, HIV interventions that recognize and harness the power of relationships are needed. Increasingly, HIV prevention efforts are being directed toward improving engagement across the HIV care continuum from testing to linkage to care, antiretroviral therapy (ART) adherence, engagement in care, and viral suppression. However, to our knowledge, no behavioral interventions have attempted to address the HIV care continuum using a dyadic approach., Objective: The objective of this paper is to describe the development of and protocol for an innovative couples-based approach to improving treatment adherence and engagement in care among HIV serodiscordant and concordant HIV-positive same sex male couples in the United States., Methods: We developed the Partner Steps intervention by drawing from relationship-oriented theory, existing efficacious individual-level ART adherence interventions, couple-focused HIV prevention interventions, and expert consultation. We incorporated new content to address all aspects of the HIV care continuum (eg, linkage to and retention in care) and to draw on relationship strengths through interactive activities., Results: The resulting theory-based Partner Steps intervention is delivered by a trained bachelors-level counselor (interventionist) over 2 in-person sessions with male-male dyads in which at least 1 partner has recent suboptimal engagement in HIV care. Each session is designed to use relationship strengths to increase motivation for HIV care and treatment, and cover sequential intervention "steps" relating to specific challenges in HIV care engagement and barriers to ART adherence. For each step, couples work with a trained interventionist to identify their unique challenges, actively problem-solve with the interventionist, and articulate and commit to working together to implement a plan in which each partner agrees to complete specific tasks., Conclusions: We drew on theory and evidence to develop novel intervention strategies that leverage strengths of relationships to address engagement across the entire HIV care continuum. We provide details on intervention development and content that may be of use to researchers as well as medical and mental health professionals for whom a dyadic approach to HIV prevention and care may best suit their patient population., Competing Interests: Conflicts of Interest: None declared.

Background: Gay, bisexual, and other men who have sex with men (MSM) regularly experience homophobic discrimination and stigma. While previous research has examined homophobic and HIV-related intergroup stigma originating from non-MSM directed at MSM, less is known about intragroup stigma originating from within MSM communities. While some research has examined intragroup stigma, this research has focused mostly on HIV-related stigma. Intragroup stigma may have a unique influence on sexual risk-taking behaviors as it occurs between sexual partners. Online sexual networking venues provide a unique opportunity to examine this type of stigma., Objective: The purpose of this study is to examine the presence and patterns of various types of intragroup stigma represented in Men Seeking Men Craigslist sex ads., Methods: Data were collected from ads on Craigslist sites from 11 of the 12 US metropolitan statistical areas with the highest HIV/AIDS prevalence. Two categories of data were collected: self-reported characteristics of the authors and reported biases in the ads. Chi-square tests were used to examine patterns of biases across cities and author characteristics., Results: Biases were rarely reported in the ads. The most commonly reported biases were against men who were not "disease and drug free (DDF)," representing stigma against men living with HIV or a sexually transmitted infection. Patterns in bias reporting occurred across cities and author characteristics. There were no variations based on race, but ageism (mostly against older men) varied based on the ad author's age and self-reported DDF status; bias against feminine gender expression varied based on self-reported sexual orientation; bias against "fat" men varied by self-reported DDF status; bias against "ugly" men varied by a self-report of being good-looking; and bias against people who do not have a DDF status varied based on self-reported HIV status and self-reported DDF status., Conclusions: Despite an overall low reporting of biases in ads, these findings suggest that there is a need to address intragroup stigma within MSM communities. The representation of biases and intragroup stigma on Craigslist may result from internalized stigma among MSM while also perpetuating further internalization of stigma for men who read the sex ads. Understanding patterns in the perpetuation of intragroup stigma can help to better target messages aimed at making cultural and behavioral shifts in the perpetration of intragroup stigma within MSM communities.

Background: Gay, bisexual, and other men who have sex with men (MSM) account for a disproportionate burden of new HIV infections in the United States. Mobile technology presents an opportunity for innovative interventions for HIV prevention. Some HIV prevention apps currently exist; however, it is challenging to encourage users to download these apps and use them regularly. An iterative research process that centers on the community's needs and preferences may increase the uptake, adherence, and ultimate effectiveness of mobile apps for HIV prevention., Objective: The aim of this paper is to provide a case study to illustrate how an iterative community approach to a mobile HIV prevention app can lead to changes in app content to appropriately address the needs and the desires of the target community., Methods: In this three-phase study, we conducted focus group discussions (FGDs) with MSM and HIV testing counselors in Atlanta, Seattle, and US rural regions to learn preferences for building a mobile HIV prevention app. We used data from these groups to build a beta version of the app and theater tested it in additional FGDs. A thematic data analysis examined how this approach addressed preferences and concerns expressed by the participants., Results: There was an increased willingness to use the app during theater testing than during the first phase of FGDs. Many concerns that were identified in phase one (eg, disagreements about reminders for HIV testing, concerns about app privacy) were considered in building the beta version. Participants perceived these features as strengths during theater testing. However, some disagreements were still present, especially regarding the tone and language of the app., Conclusions: These findings highlight the benefits of using an interactive and community-driven process to collect data on app preferences when building a mobile HIV prevention app. Through this process, we learned how to be inclusive of the larger MSM population without marginalizing some app users. Though some issues in phase one were able to be addressed, disagreements still occurred in theater testing. If the app is going to address a large and diverse risk group, we cannot include niche functionality that may offend some of the target population.