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BackgroundTransgender youth demonstrate significantly higher rates of engagement in sexual risk behaviors relative to their cisgender or gender-conforming counterparts, including high rates of condomless anal intercourse and engagement in sex work. In addition, transgender youth experience increased physical or sexual abuse, victimization, substance use, mental health disorders, incarceration, and homelessness. Owing to these syndemic health disparities, transgender youth are at substantially increased risk of HIV infection. ObjectiveThis protocol aims to describe a randomized controlled trial (RCT), Adolescent Medicine Trials Network 160 TechStep (N=250), which assesses the differential immediate and sustained effects of each of 3 conditions (text messaging, WebApp, or information-only control) for reducing sexual risk behaviors and increasing pre-exposure prophylaxis (PrEP) uptake among high-risk, HIV-negative transgender youth and young adults (aged 15-24 years). MethodsParticipants will be recruited through web-based (targeted social media sites and apps) and offline (print ads and flyers) advertisements, peer and clinic referrals, and street- and venue-based outreach, and by contacting potential participants who have requested contact for future studies. Participants will be randomized into 1 of the 3 conditions: (1) text messaging, (2) WebApp, or (3) information-only control for 6 months. Assessments will occur at baseline and at 3, 6, and 9 months. Participants who do not show improvements in sexual risk or PrEP uptake at the 3-month assessment will be rerandomized to receive weekly electronic coaching (eCoaching) sessions in addition to their assigned text messaging or WebApp intervention, or remain in the original text messaging or WebApp intervention using a 2:1 ratio. Participants originally assigned to the information-only condition are not eligible for rerandomization. ResultsFunding for TechStep was awarded in June 2017. Phase 1 was approved by the Institutional Review Board (IRB) in April 2018. Recruitment began in November 2018 for phase 1, the formative phase. Initial phase 2 IRB approval came in June 2019. The data collection for phase 2, the RCT, is expected to be completed in April 2021. As of March 2020, 54 participants have been enrolled in TechStep. The final results are anticipated in May 2021. ConclusionsBy providing culturally responsive, technology-based interventions, TechStep aims to improve sexual health outcomes among HIV-negative transgender youth and young adults at high risk of HIV. TechStep will evaluate the efficacy of technology-based interventions for reducing HIV sexual risk behaviors and increasing PrEP initiation, adherence, and persistence. The suite of technology-based interventions developed in TechStep, and assessed for efficacy in a 3-condition RCT, represents an important advancement in intervention science toward developing tailored and scalable interventions for transgender youth and young adults. Trial RegistrationClinicalTrials.gov NCT04000724; http://clinicaltrials.gov/ct2/show/NCT04000724 International Registered Report Identifier (IRRID)DERR1-10.2196/18326

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

Black and Latinx transgender women in the United States (U.S.) are at disproportionately high risk for HIV. Although HIV pre-exposure prophylaxis (PrEP) reduces the risk of HIV infection, uptake and persistence (i.e., ability to continue taking PrEP over time) can be a challenge for Black and Latinx transgender women due to myriad social and structural forces. In this qualitative study, we present unique data on the facilitators of PrEP persistence from Black and Latinx transgender women who initiated PrEP and exhibited varying levels of persistence during a demonstration project in Southern California. PrEP persistence was assessed by collecting quantitative intracellular tenofovir-diphosphate (TFV-DP) levels on dried blood spot (DBS) samples collected at weeks 12 and 48. Informed by the socioecological framework, we conducted and analyzed interviews using qualitative content analysis to determine themes on the facilitators of PrEP persistence. Individual-level facilitators included the use of reminders, having high individual-level HIV risk perception, feeling empowered to take PrEP, and reporting having improved peace of mind and mental health because of taking PrEP. Interpersonal/Community-level facilitators included feeling motivation to prevent HIV in the community, motivation to prevent HIV in the context of sex work, and having high community-level risk perception. Structural-level facilitators included having positive experiences in affirming healthcare settings and having PrEP visits combined with other gender-related healthcare visits. Interventions aiming to increase PrEP uptake and persistence among Black and Latinx transgender women in the U.S. should harness the multiple levels of support exhibited by those who were able to start and persist on PrEP in the face of the myriad social and structural barriers.

BackgroundAlthough gay, bisexual, and other men who have sex with men (MSM) are disproportionately affected by human immunodeficiency virus (HIV) infection, few test for HIV at regular intervals. Smartphone apps may be an ideal tool to increase regular testing among MSM. However, the success of apps to encourage regular testing among MSM will depend on how frequently the apps are downloaded, whether they continue to be used over months or years, and the degree to which such apps are tailored to the needs of this population. ObjectiveThe primary objectives of this study were to answer the following questions. (1) What features and functions of smartphone apps do MSM believe are associated with downloading apps to their mobile phones? (2) What features and functions of smartphone apps are most likely to influence MSM’s sustained use of apps over time? (3) What features and functions do MSM prefer in an HIV testing smartphone app? MethodsWe conducted focus groups (n=7, with a total of 34 participants) with a racially and ethnically diverse group of sexually active HIV-negative MSM (mean age 32 years; 11/34 men, 33%, tested for HIV ≥10 months ago) in the United States in Miami, Florida and Minneapolis, Minnesota. Focus groups were digitally recorded, transcribed verbatim, and deidentified for analysis. We used a constant comparison method (ie, grounded theory coding) to examine and reexamine the themes that emerged from the focus groups. ResultsMen reported cost, security, and efficiency as their primary reasons influencing whether they download an app. Usefulness and perceived necessity, as well as peer and posted reviews, affected whether they downloaded and used the app over time. Factors that influenced whether they keep and continue to use an app over time included reliability, ease of use, and frequency of updates. Poor performance and functionality and lack of use were the primary reasons why men would delete an app from their phone. Participants also shared their preferences for an app to encourage regular HIV testing by providing feedback on test reminders, tailored testing interval recommendations, HIV test locator, and monitoring of personal sexual behaviors. ConclusionsMobile apps for HIV prevention have proliferated, despite relatively little formative research to understand best practices for their development and implementation. The findings of this study suggest key design characteristics that should be used to guide development of an HIV testing app to promote regular HIV testing for MSM. The features and functions identified in this and prior research, as well as existing theories of behavior change, should be used to guide mobile app development in this critical area.

BackgroundThe use of stimulant drugs among men who have sex with men (MSM) with human immunodeficiency virus (HIV) is associated with decreased odds of antiretroviral therapy (ART) adherence and elevated risk of forward HIV transmission. Advancing tailored and innovative mobile phone–based ART adherence app interventions for stimulant-using HIV-positive MSM requires greater understanding of their needs and preferences in this emerging area. ObjectiveThe purpose of this study is to (1) assess reasons that stimulant-using HIV-positive MSM download and sustain their use of mobile phone apps in general, and (2) obtain feedback on features and functions that these men prefer in a mobile phone app to optimize their ART adherence. MethodsFocus groups were conducted with stimulant-using HIV-positive MSM (24-57 years of age; mostly non-Hispanic white; 42% once a week or more frequent stimulant drug use) in San Francisco and Minneapolis. Our aim was to explore the mobile phone app features and functions that they considered when deciding to download and sustain their use of general apps over time, as well as specific features and functions that they would like to see incorporated into an ART adherence mobile app. Focus groups were audiorecorded and transcribed verbatim. Thematic analysis was applied to transcripts using line-by-line open coding and organizing codes into meaningful themes. ResultsMen reported that they currently had a variety of health and wellness, social media and networking, gaming and entertainment, and utility apps on their mobile phones. Downloading apps to their mobile phones was influenced by the cost of the app, recommendations by a trusted source, and the time it takes to download. In addition, downloading and sustained use of apps was more likely to occur when men had control over most features of the app and apps were perceived to be useful, engaging, secure, and credible. Participants suggested that ART adherence mobile phone apps include social networking features, connections to local resources and their medical chart, and breaking HIV news and updates. Although some men expressed concerns about daily self-monitoring of HIV medication doses, many appreciated receiving a summary of their medication adherence over time and suggested that feedback about missed doses be delivered in an encouraging and humorous manner. ConclusionsIn this study, we were able to recruit a relatively high proportion (42%) of HIV-positive MSM reporting weekly or more stimulant use. These results suggest critical design elements that may need to be considered during development of ART adherence-related mobile phone apps for this, and possibly other, high-risk groups. In particular, finding the optimal balance of security, engagement, usefulness, control capabilities, and credibility will be critical to sustained used of HIV treatment apps.

BackgroundResearchers and practitioners interested in developing online health interventions most often rely on Web-based and print resources to guide them through the process of online intervention development. Although useful for understanding many aspects of best practices for website development, missing from these resources are concrete examples of experiences in online intervention development for health apps from the perspective of those conducting online health interventions. ObjectiveThis study aims to serve as a series of case studies in the development of online health interventions to provide insights for researchers and practitioners who are considering technology-based interventional or programmatic approaches. MethodsA convenience sample of six study coordinators and five principal investigators at a large, US-based land grant university were interviewed about the process of developing online interventions in the areas of alcohol policy, adolescent health, medication adherence, and human immunodeficiency virus prevention in transgender persons and in men who have sex with men. Participants were asked questions that broadly addressed each of the four phases of the User-Centered Design Process Map from the US Department of Health and Human Services' Research-Based Web Design & Usability Guidelines. Interviews were audio recorded and transcribed. Qualitative codes were developed using line-by-line open coding for all transcripts, and all transcripts were coded independently by at least 2 authors. Differences among coders were resolved with discussion. ResultsWe identified the following seven themes: (1) hire a strong (or at least the right) research team, (2) take time to plan before beginning the design process, (3) recognize that vendors and researchers have differing values, objectives, and language, (4) develop a detailed contract, (5) document all decisions and development activities, (6) use a content management system, and (7) allow extra time for testing and debugging your intervention. Each of these areas is discussed in detail, with supporting quotations from principal investigators and study coordinators. ConclusionsThe values held by members of each participating organization involved in the development of the online intervention or program, as well as the objectives that are trying to be met with the website, must be considered. These defined values and objectives should prompt an open and explicit discussion about the scope of work, budget, and other needs from the perspectives of each organization. Because of the complexity of developing online interventions, researchers and practitioners should become familiar with the process and how it may differ from the development and implementation of in-person interventions or programs. To assist with this, the intervention team should consider expanding the team to include experts in computer science or learning technologies, as well as taking advantage of institutional resources that will be needed for successful completion of the project. Finally, we describe the tradeoff between funds available for online intervention or program development and the complexity of the project.

Gender-based violence (GBV) against transgender and nonbinary (TGNB) persons is a pervasive public health issue. GBV has been linked to mental health problems such as depression and posttraumatic stress disorder (PTSD), as well has risk for HIV seroconversion and HIV treatment nonadherence. However, the impact of GBV on HIV pre-exposure prophylaxis (PrEP) use among TGNB persons has yet to be investigated. In the current study we assessed longitudinal PrEP persistence data from dried blood spots (DBS) collected from 172 racially and ethnically diverse TGNB participants during a 48-week PrEP demonstration project in Southern California from June 2017 to September 2020. Participants were categorized into three levels of PrEP uptake and persistence based on their PrEP levels at the start and end of the study: low-low, high-low, and high-high. Individual-, social-, and structural-level variables were then entered into multinomial logistic regression models to predict levels of PrEP uptake and persistence based on hypotheses informed by syndemic and minority stress theories. The models demonstrated that experience of GBV predicted significantly lower odds of PrEP uptake and persistence and greater PTSD symptoms predicted significantly greater odds of early PrEP discontinuation. Higher levels of coping skills, already being on PrEP at baseline, and being in a steady relationship were associated with greater odds of PrEP uptake and persistence. Implications for future GBV research, advocacy, interventions, and much needed structural changes focused on improving the health and safety of TGNB individuals are discussed.

Young Latino men who have sex with men (MSM) are a highly vulnerable population for HIV infection. Pre-exposure prophylaxis (PrEP) is a novel biomedical HIV prevention tool that may aid in reducing the disparity in HIV incidence among Latino MSM. However, PrEP use is disproportionally low among Latino MSM and, therefore, identifying barriers along the PrEP continuum of care (the "PrEP cascade") would provide insight into how to best deploy PrEP interventions. Syndemics theory is a prominent framework employed in HIV prevention; however, to date, no known studies have applied this theory to PrEP. Thus, the aim of the current study was to explore the association between syndemics and the PrEP cascade, including the degree to which psychosocial and structural syndemic constructs are related to the PrEP cascade. Participants were 151 young Latino MSM (M age = 24 years; SD = 3) residing in San Diego, California, who completed a battery of online self-report measures. Results indicated high levels of syndemic indicators and varying levels of engagement across the PrEP cascade. As syndemic indicators increased, the odds of engagement across the PrEP cascade were significantly lowered. Psychosocial and structural syndemic factors accounted for unique variance in the PrEP cascade. Results highlight the need for combination interventions that address both psychosocial and structural barriers to PrEP use and persistence among young Latino MSM.

IntroductionIn the era of HIV treatment as prevention (TasP), evidence-based interventions that optimize viral suppression among people who use stimulants such as methamphetamine are needed to improve health outcomes and reduce onward transmission risk. We tested the efficacy of positive affect intervention delivered during community-based contingency management (CM) for reducing viral load in sexual minority men living with HIV who use methamphetamine.MethodsConducted in San Francisco, this Phase II randomized controlled trial tested the efficacy of a positive affect intervention for boosting and extending the effectiveness of community-based CM for stimulant abstinence to achieve more durable reductions in HIV viral load. From 2013 to 2017, 110 sexual minority men living with HIV who had biologically confirmed, recent methamphetamine use were randomized to receive a positive affect intervention (n = 55) or attention-control condition (n = 55). All individual positive affect intervention and attention-control sessions were delivered during three months of community-based CM where participants received financial incentives for stimulant abstinence. The 5-session positive affect intervention was designed to provide skills for managing stimulant withdrawal symptoms as well as sensitize individuals to natural sources of reward. The attention-control condition consisted of neutral writing exercises and self-report measures.ResultsMen randomized to the positive affect intervention displayed significantly lower log10 HIV viral load at six, twelve and fifteen months compared to those in the attention-control condition. Men in the positive affect intervention also had significantly lower risk of at least one unsuppressed HIV RNA (≥200 copies/mL) over the 15-month follow-up. There were concurrent, statistically significant intervention-related increases in positive affect as well as decreases in the self-reported frequency of stimulant use at six and twelve months.ConclusionsDelivering a positive affect intervention during community-based CM with sexual minority men who use methamphetamine achieved durable and clinically meaningful reductions in HIV viral load that were paralleled by increases in positive affect and decreases in stimulant use. Further clinical research is needed to determine the effectiveness of integrative, behavioural interventions for optimizing the clinical and public health benefits of TasP in sexual minority men who use stimulants such as methamphetamine.

Dramatic decreases in HIV transmission are achievable with currently available biomedical and behavioral interventions, including antiretroviral therapy and pre-exposure prophylaxis. However, such decreases have not yet been realized among adolescents and young adults. The Adolescent Medicine Trials Network (ATN) for HIV/AIDS interventions is dedicated to research addressing the needs of youth at high risk for HIV acquisition as well as youth living with HIV. This article provides an overview of an array of efficient and effective designs across the translational spectrum that are utilized within the ATN. These designs maximize methodological rigor and real-world applicability of findings while minimizing resource use. Implementation science and cost-effectiveness methods are included. Utilizing protocol examples, we demonstrate the feasibility of such designs to balance rigor and relevance to shorten the science-to-practice gap and improve the youth HIV prevention and care continua.

Background/Objective: The aim of this study was to determine the prevalence of high-risk (HR) human papillomavirus (HPV) types by HPV vaccination status and the feasibility of using HPV L1 serology to identify HIV-negative men who have sex with men (MSM) who may be at risk for anal cancer. Methods: This cross-sectional study recruited HIV-negative MSM from a US metropolitan area. The prevalence of HR, quadrivalent, and nonavalent anorectal HPV DNA and HPV L1 serum antibodies was estimated. McNemar's chi-square and kappa statistics were used to determine significant differences in HPV detection between anorectal DNA swabs and HPV L1 serology. Results: Eighty-two men had adequate anorectal swabs and serology samples for analysis. Men who self-reported receipt of the HPV vaccine (35.6%) had detectable L1 HPV antibodies (93.1%) and a lower prevalence of active anal HPV infections (20.7%) compared to those who reported none. Conclusions: If confirmed in larger prospective studies, a combination of HPV vaccination status or HPV L1 serology and anorectal swabs for HR HPV types could identify HIV-negative MSM who do not need to undergo follow-up anal testing. [ABSTRACT FROM AUTHOR]

Interactive communications technologies facilitate identity formation and socio-sexual connection among transgender and gender-diverse young people. However, within their communities, variations in technology use along ethno-racial, sexual and gendered lines, and as facilitators of sexual resilience during the early COVID-19 pandemic, remain under-studied. Among N = 230 transgender and gender-diverse young adults, surveyed between October 2020 and September 2021, latent class analyses characterised participants by preferred functional affordances, such as finding dates, sex and friends (Model 1), and by simultaneous account-keeping across social, dating and 'hookup' apps (Model 2). Werron and Ringel's typology of pandemic practices characterised qualitative descriptions of sexual decision-making attributed to COVID-19. Both fit indices favoured two-class solutions. Model 1 detected an n = 89, 43% 'high interactive communications technologies–enabled intimacy' (versus 'low technology-enabled intimacy') class, in which digitally mediated friendships, dates, sexual encounters and gay/lesbian sexualities, predominated. An n = 38, 17% 'high socio-sexual polymedia' (versus 'low polymedia') class in Model 2 was characterised by simultaneous social media, 'hookup' and dating app usage. 'High' subgroups saw statistically significant reductions in sexual partners, with the high polymedia class also associated with reductions in HIV testing. Qualitative results contextualised these reductions as, predominantly, 'responsive' pandemic practices: reactions to stay-at-home orders. [ABSTRACT FROM AUTHOR]

Purpose: Gender minority (GM) stress, resulting from distal (i.e., external) and proximal (i.e., internal) stigma-based stressors, is thought to drive mental health disparities among transgender and gender diverse (TGD) youth. We tested the gender minority stress and resilience (GMSR) model hypotheses that distal GM stress effects on mental health are partially mediated by proximal GM stress and moderated by GM-specific resilience (i.e., community connectedness, identity pride) among a U.S. national sample of TGD youth. Methods: As part of an HIV prevention study (NCT03185975), 159 TGD youth (ages 15–24) completed an online survey that included the GMSR measure, assessing distal and proximal GM stress and GM resilience, and the 18-item Brief Symptom Inventory, assessing past-7-day psychological distress. Three models linking GMSR constructs to psychological distress were tested using PROCESS v4.0: (1) simple partial mediation, (2) moderated partial mediation, and (3) serial partial mediation. Results: A direct effect of distal GM stress was observed in all models. An indirect effect through proximal GM stress alone was observed in model 1, but not models 2 or 3. In model 2, resilience did not moderate the effects of distal or proximal GM stress. In model 3, indirect effects were observed through proximal GM stress and GM resilience serially as well as GM resilience alone. Conclusion: Larger prospective studies are needed to confirm the role of GM resilience as a mediator, rather than moderator, of GM stress effects on mental health and a critical, rather than supplementary, target for mental health intervention among TGD youth. [ABSTRACT FROM AUTHOR]