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Objective: Oral pre-exposure prophylaxis (PrEP) is effective in preventing HIV transmission. However, oral PrEP uptake is low, particularly among sexual and gender minority youth who are vulnerable to HIV infection. Alternative methods of PrEP delivery, such as long-acting injectable (LAI) PrEP may overcome barriers and be preferred. However, attitudes and preferences of younger sexual and gender minorities towards LAI PrEP have not been well studied. The purpose of this study is to describe preferences for initiating LAI PrEP among sexual and gender minority youth., Methods: We analyzed data collected as part of an HIV prevention randomized trial from January 2022 to February 2023, using multiple regression to identify factors associated with a preference for LAI PrEP., Results: The study sample (N = 265) was 50% youth of color, mean age 25 years (SD=3.4, range=18-31), and primarily identified as gay (71%) and male (91%). Forty two percent had heard of LAI PrEP and 31% preferred LAI PrEP over other prevention methods. In multiple regression analysis, LAI PrEP preference was associated with identifying as White, previous PrEP experience, and perceived LAI PrEP efficacy., Conclusions: We conclude that gaps in awareness exist for LAI PrEP, however it may be preferred over other prevention methods especially in White youth, those with PrEP experience and higher perceptions of its efficacy. More education and outreach are needed to prevent extension of existing race and ethnicity disparities in use of oral daily PrEP to LAI PrEP., Competing Interests: Declaration of Competing Interest None., (Copyright © 2024 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.)

Effective recruitment strategies are pivotal for informatics-based intervention trials success, particularly for people living with HIV (PLWH), where engagement can be challenging. Although informatics interventions are recognized for improving health outcomes, the effectiveness of their recruitment strategies remains unclear. We investigated the application of a social marketing framework in navigating the nuances of recruitment for informatics-based intervention trials for PLWH by examining participant experiences and perceptions. We used qualitative descriptive methodology to conduct semi-structured interviews with 90 research participants from four informatics-based intervention trials. Directed inductive and deductive content analyses were guided by Howcutt et al.'s social marketing framework on applying the decision-making process to research recruitment. The majority were male (86.7%), living in the Northeast United States (56%), and identified as Black (32%) or White (32%). Most participants (60%) completed the interview remotely. Sixteen subthemes emerged from five themes: motivation, perception, attitude formation, integration, and learning. Findings from our interview data suggest that concepts from Howcutt et al.'s framework informed participants' decisions to participate in an informatics-based intervention trial. We found that the participants' perceptions of trust in the research process were integral to the participants across the four trials. However, the recruitment approach and communication medium preferences varied between older and younger age groups. Social marketing framework can provide insight into improving the research recruitment process. Future work should delve into the complex interplay between the type of informatics-based interventions, trust in the research process, and communication preferences, and how these factors collectively influence participants' willingness to engage., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

In the United States, young men who have sex with men (YMSM) and young transgender women (YTGW) are disproportionality affected by HIV. To overcome this public health problem, we created and tested the mLab application (app), a novel mobile health (mHealth) that offers HIV prevention information and an imaging algorithm for interpreting the at-home HIV test. This study assessed the mLab app usability for HIV testing and its relation to users' education and health literacy. The results showed high user satisfaction and perceived usability of mLab to provide accessible HIV testing solutions for YMSM and YTGW. Findings suggest that the rigorous user-centered design of the mLab app supported a usable app independent of education and health literacy levels.

Transgender women are disproportionately impacted by HIV infection. We report herein the findings of a pre-post evaluation of the TransLife Care (TLC) project in Chicago, Illinois, on behaviors associated with HIV transmission among transgender women. Participants who received any TLC component versus those who did not were compared using mixed-effects logistic regression with random intercepts across follow-up time points. Ninety-seven participants aged 18 to 59 (median age 24) enrolled; 76.3% were transgender women of color. There was a decrease in condomless sex without consistent PrEP use at 8 months, which was not significantly different between those who did and did not receive the TLC intervention, controlling for calendar time. Evidence does not indicate that the TLC reduces condomless sex without PrEP protection among urban transgender women. However, given the preponderance of evidence of the influence of structural barriers on condomless sex, future research should continue to test the efficacy of structural interventions.

Young men who have sex with men (YMSM) in Nigeria are ten times more likely to be living with HIV-1 than other young men. Due to stigma and criminalization of same-sex sexual behavior, YMSM sexual networks are likely to overlap with those of the general population, leading to a generalized HIV-1 epidemic. Due to limited research on social/sexual network dynamics related to HIV-1 in Nigeria, our study focused on YMSM and sought to assess the feasibility and acceptability of collecting social and sexual network data in Network Canvas from individuals newly diagnosed with HIV-1 in Ibadan, Nigeria. The Network Canvas software was piloted at three sites in Ibadan, Nigeria to collect social/sexual network data from 151 individuals newly diagnosed with HIV-1. Our study sample included 37.7% YMSM; participants reported a mean of 2.6 social alters and 2.6 sexual alters. From the 151 egos and 634 alters, 85 potential unique individuals (194 total) were identified; 65 egos/alters were collapsed into 25 unique individuals. Our success collecting network data from individuals newly diagnosed with HIV-1 in Ibadan demonstrates clear feasibility and acceptability of the approach and the use of Network Canvas to capture and manage these data., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: HIV seroprevalence in Nigeria is increasing among men who have sex with men (MSM) from 14% to 2007 to 23% in 2014, threatening progress towards ending the epidemic in the country. Expanding access to HIV testing and linkage to care for key populations, like young MSM (YMSM), is critical to end the HIV epidemic in Nigeria. The Intensive Combination Approach to Roll Back the Epidemic in Nigerian Adolescents (iCARE Nigeria) pilot intervention successfully implemented a combination of evidence-based interventions utilizing peer navigators and popular social media apps and platforms to reach young men at risk for HIV exposure, including YMSM. We conducted sequential mixed methods explanatory implementation research to expand on the previously reported effectiveness and implementation outcomes and to explore the determinants and strategies which contributed to primary study results., Methods: We conducted key informant interviews and focus group discussions with 2 peer navigators and 3 study staff at the end of the pilot. We used directed content analysis to understand the quantitative results from the pilot. Using the Implementation Research Logic Model, we were able to identify and map strategies through mechanisms of action from barriers addressed to the reported implementation outcomes including feasibility, acceptability fidelity and adoption., Results: We found that iCARE Nigeria's pilot intervention implementers reported high feasibility, acceptability fidelity and adoption were associated with implementation of strategies which addressed many challenging contextual factors, including social stigma, online social networking, legal barriers surrounding MSM behavior, and the COVID-19 pandemic. These strategies included integration of stakeholders' interests, selection of experienced peer navigators including from the targeted population, training and supportive supervision using an implementation guide, ensuring safety (COVID and legal) and identification of clinics serving the targeted population., Conclusion: Mixed methods using implementation research frameworks provided insights into the strategies and barriers and facilitators they addressed which may explain the success of the pilot. These results can inform strategies needed to scale-up the intervention to youth including YMSM in other areas in Nigeria and the region., Trial Registration Isrctn: ISRCTN94590823, https://doi.org/10.1186/ISRCTN94590823., (© 2023. The Author(s).)

Studies on HIV self-testing (HIV-ST) have been limited to adults (age 18+). The study assessed use of HIV-ST among a diverse group of young men who have sex with men (YMSM) in the United States (US) and assessed differences in uptake by demographic characteristics and requirements for parental consent. This study demonstrated feasibility of HIV-ST for YMSM as young as 14 years of age, which suggests potential for increasing HIV testing in this young age group and promoting health equity.

Background: Nigeria is one of six countries with half the global burden of youth living with HIV. Interventions to date have been inadequate as AIDS-related deaths in Nigeria's youth have remained unchanged in recent years. The iCARE Nigeria HIV treatment support intervention, a combination of peer navigation and SMS text message medication reminders to promote viral suppression, demonstrated initial efficacy and feasibility in a pilot trial among youth living with HIV in Nigeria. This paper describes the study protocol for the large-scale trial of the intervention., Methods: The iCARE Nigeria-Treatment study is a randomized stepped wedge trial of a combination (peer navigation and text message reminder) intervention, delivered to youth over a period of 48 weeks to promote viral suppression. Youth receiving HIV treatment at six clinical sites in the North Central and South Western regions of Nigeria were recruited for participation. Eligibility criteria included registration as a patient at participating clinics, aged 15-24 years, on antiretroviral therapy for at least three months, ability to understand and read English, Hausa, Pidgin English, or Yoruba, and intent to remain a patient at the study site during the study period. The six clinic sites were divided into three clusters and randomized to a sequence of control and intervention periods for comparison. The primary outcome is plasma HIV-1 viral load suppression, defined as viral load ≤ 200 copies/mL, in the intervention period versus the control period at 48 weeks of intervention., Discussion: Evidence-based interventions to promote viral load suppression among youth in Nigeria are needed. This study will determine efficacy of a combination intervention (peer navigation and text message reminder) and collect data on potential implementation barriers and facilitators to inform scale-up if efficacy is confirmed., Trial Registration: ClinicalTrials.gov number, NCT04950153, retrospectively registered July 6, 2021, https://clinicaltrials.gov/., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Abstract: Research regarding the impact of racism on stress among young men who have sex with men (YMSM) is sparse. Secondary data were assessed from a 2018-2020 national mHealth prevention trial for YMSM aged 13-18 years (N = 542). Linear regression models examined associations between perceived stress and interpersonal and vicarious racism, adjusting for covariates. Stratified models by race/ethnicity were included. A subanalysis (n = 288) examined associations between nine interpersonal racial discriminatory events and perceived stress. Over 50% of participants experienced racial discrimination. In the multivariable models, exposure to interpersonal (β = 1.43, p-value: .038) and vicarious (β = 1.77, p-value: .008) racism was associated with perceived stress because there were four interpersonal racial discriminatory events. Stratified analysis by race/ethnicity found significant associations between interpersonal and vicarious racism and perceived stress among some racial/ethnic groups. Racial discrimination was common among YMSM, making them susceptible to the possible effects of vicarious and interpersonal racism on stress., (Copyright © 2023 Association of Nurses in AIDS Care.)

Adolescents and young adults (AYA) in low to middle income countries (LMIC) have poorer outcomes along each step in the HIV continuum of prevention and care compared to younger children or older adults. The use of mHealth technology provides a potentially promising implementation strategy for interventions to remedy these disparities. We therefore conducted a systematic review of the English literature and conference proceedings from January 1, 2000 to April 1, 2021 evaluating mHealth interventions targeting AYA along each step of the HIV continuum of care in LMIC. We identified 27 mHealth interventions across the HIV continuum, with no interventions addressing transition from pediatric to adult care. The majority of studies were single arm, uncontrolled or underpowered, with few randomized trials resulting in mixed and inconclusive outcomes. mHealth interventions have potential to remedy disparities along the HIV continuum of care for AYA in LMIC but larger, powered randomized trials are needed., (© 2022. The Author(s).)

Adolescents and sexual minority men (SMM) are high priority groups in the United Nations' 2021 - 2016 goals for HIV prevention and viral load suppression. Interventions aimed at optimizing HIV prevention, testing and viral load suppression for adolescents must also attend to the intersectional realities influencing key sub-populations of SMM. Consequently, there is not a robust evidence-base to guide researchers and program partners on optimal approaches to implementing interventions with adolescent SMM. Using a multiple case study design, we integrated the Implementation Research Logic Model with components of the Consolidated Framework for Implementation Research and applied it as a framework for a comparative description of ten HIV related interventions implemented across five countries (Ghana, Kenya, Nigeria, Tanzania and United States). Using self-reported qualitative survey data of project principal investigators, we identified 17 of the most influential implementation determinants as well as a range of 17 strategies that were used in 90 instances to support intervention implementation. We highlight lessons learned in the implementation research process and provide recommendations for researchers considering future HIV implementation science studies with adolescent SMM., (© 2022. The Author(s).)

The COVID-19 pandemic has disrupted sexual health services among those most vulnerable to HIV acquisition, such as adolescent men who have sex with men (AMSM). We sought to characterize the changes in sexual-risk behaviors, HIV and other STI testing, and pre-exposure prophylaxis (PrEP) use among a longitudinal cohort of AMSM aged 13 to 18 years before and during the COVID-19 pandemic. We observed a significant decline in HIV testing and a marginal decrease in other STI testing since the pandemic began in March 2020. Outreach efforts and innovative remote delivery of sexual health services are needed to support access to healthcare services among AMSM as the pandemic persists., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose: This study examined factors associated with past-year health care utilization among young gay, bisexual, and other men who have sex with men (YMSM) using Andersen's behavioral model of health service use. Methods: From 2018 to 2020, 751 YMSM (aged 13-18) recruited online and offline for the MyPEEPS mHealth HIV prevention study completed an online survey. Hierarchical logistic regression models assessed associations between past-year health care utilization (i.e., routine checkup) and predisposing (parental education, race/ethnicity, age, and internalized homonegativity), enabling (health literacy, health care facility type, U.S. Census Divisions), and need factors (ever testing for HIV). Results: The sample included 31.8% Hispanic, 23.9% White, and 14.6% Black YMSM; median age was 16. Most (75%) reported past-year health care utilization, often from private doctor's offices (29.1%); 6% reported no regular source of care. In the final regression model, higher odds of past-year health care utilization were found for younger participants (age 13-14, adjusted odds ratio [AOR] = 1.91; 95% confidence interval [CI]: 1.07-3.43; age 15-16 AOR = 1.55; 95% CI: 1.04-2.30; reference: 17-18) and those with increasing health literacy (AOR = 1.71; 95% CI: 1.36-2.16). YMSM with lower parental education had lower odds of past-year health care utilization (AOR = 0.56; 95% CI: 0.38-0.84), as did those relying on urgent care facilities (AOR = 0.60; 95% CI: 0.41-0.87; reference: routine care facilities) and those who identified as Mixed/Other race (AOR = 0.50; 95% CI: 0.28-0.91; reference: White). Conclusions: Findings highlight opportunities to intervene in YMSM's health risk trajectory before age 17 to reduce drop-off in routine health care utilization. Interventions to improve routine health care utilization among YMSM may be strengthened by building resilience (e.g., health literacy) while removing barriers maintained through structural disadvantage, including equity in education. Clinical Trial Registration Number: NCT03167606.

Background: The purpose of this study was to adapt and pilot-test an employment support, primary HIV intervention tailored to the needs of adolescent men who have sex with men and adolescent transgender women of color., Setting: The intervention was implemented in 2 settings: controlled environment (Phase 1) and real-world community-based (Phase 2) setting in Chicago, IL., Methods: Eighty-seven adolescent men who have sex with men and adolescent transgender women of color ages 16-24 participated in Work2Prevent , a 4-session employment and HIV prevention intervention, designed to increase job-readiness and reduce HIV risk. Intervention sessions consisted of group activities: educational games, roleplaying/modeling behavior, and self-regulation exercises. Participants were assessed at baseline, postintervention, and 8-month (Phase 1) or 3-month follow-up (Phase 2)., Results: Participants evaluated Work2Prevent as feasible and acceptable, rating intervention quality, usefulness, and satisfaction highly. Overall, 59.6% (Phase 1) and 85.0% (Phase 2) participants attended 2 or more sessions. At 8 months, Phase 1 participants reported a mean increase of 11.4 hours worked per week. Phase 2 participants reported a mean increase of 5.2 hours worked per week and an increase in job-seeking self-efficacy. Phase 2 participants also reported a decrease in transactional sex work., Conclusion: Work2Prevent is one of the first structural primary HIV interventions to specifically focus on adolescent employment readiness. Findings suggest Work2Prevent is feasible and acceptable, improved adolescent employment outcomes, and reduced HIV risk associated with transactional sex work. Our study underscores the need for alternative pathways, such as addressing socioeconomic determinants, to prevent adolescent HIV infection., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Importance: HIV transmission rates in the United States have increased among men who have sex with men. However, there are no published randomized trials examining interventions to reduce sexual risk for HIV acquisition in males younger than 18 years., Objective: To determine the efficacy of MyPEEPS Mobile, a mobile-delivered HIV prevention intervention, to reduce sexual risk behavior in same-sex attracted young males., Design, Setting, and Participants: This was a national randomized clinical trial of the efficacy MyPEEPS Mobile vs a delayed intervention among males aged 13 to 18 years to prevent or reduce sexual risk for HIV acquisition. Study activities were completed through 4 study sites in Birmingham, Alabama; New York, New York; Seattle, Washington; and Chicago, Illinois. Study staff at each site met with participants in person or via video conferencing. Data were collected from June 1, 2018, to April 7, 2020, and analyzed from July to October 2021., Interventions: The MyPEEPS Mobile intervention contains 21 online psychoeducational and skill-building modules, which participants completed over a 3-month period. Participants randomized to the intervention group received access to MyPEEPS Mobile for the first 3 months, while those randomized to the delayed intervention group received access at their 9-month visit after data for the primary efficacy analysis had been collected., Main Outcomes and Measures: The self-reported primary outcome was change in the number of condomless anal sex acts between study conditions. Secondary outcomes were change in the number of sex partners, number of condomless anal sex partners, the number of sex acts while under the influence of substances, preexposure prophylactic uptake, nonoccupational postexposure prophylaxis use, and HIV and sexually transmitted infection testing., Results: In the analytic sample of 763 racially and ethnically diverse study participants, the mean (SD) age was 16.2 (1.4) years; 736 participants (97%) were male, 13 (2%) nonbinary; and 6 (1%) genderqueer; 158 (21%) were Black or African American, 311 (41%) were Hispanic or Latino, and 284 (37%) were White. Overall, 382 were randomized to the intervention group and 381 to the delayed intervention group. At 3-month follow-up, there was a significant reduction in the number of condomless anal sex acts in the intervention group compared with the delayed intervention group (incidence rate ratio [IRR], 0.56; 95% CI, 0.32-0.99); however, there was no significant difference between groups at 6 or 9 months. In subgroup analyses, the intervention effect was pronounced among Black non-Hispanic participants at 3-month follow-up (IRR, 0.19; 95% CI, 0.04-0.94) and 6-month follow-up (IRR, 0.15; 95% CI, 0.03-0.78) compared with the delayed intervention group. There were no significant differences in the change in the number of sex partners, number of condomless anal sex partners, the number of sex acts while under the influence of substances, preexposure prophylactic uptake, nonoccupational postexposure prophylaxis use, and HIV and sexually transmitted infection testing between the intervention and delayed intervention groups., Conclusions and Relevance: In this study, the MyPEEPS Mobile intervention demonstrated a 44% overall reduction in condomless anal sex at 3-month follow-up compared with the delayed intervention group, but not at 6 or 9 months. To our knowledge, MyPEEPS Mobile is the first intervention to demonstrate evidence of short-term efficacy for reducing sexual risk among same-sex attracted young males., Trial Registration: ClinicalTrials.gov Identifier: NCT03167606.

Importance: Nigeria has the fourth-largest HIV epidemic globally, yet high levels of social stigma inhibit HIV testing among Nigerian youths and young men who have sex with men (MSM)., Objective: To report pilot data from iCARE Nigeria (Intensive Combination Approach to Roll Back the Epidemic in Nigerian Adolescents), a combination intervention using social media and peer navigation to promote HIV testing and linkage to care among high-risk youths and young men (hereinafter referred to as young men), including predominantly young MSM., Design, Setting, and Participants: This nonrandomized controlled study assessed an organizational and community-level 12-month, preintervention-postintervention pilot trial of a combination intervention designed to increase HIV testing uptake, increase the rate of identified seropositive cases, and improve linkage to care among young men, including MSM, using social media outreach and peer navigation. Data were collected from June 1, 2019, to May 30, 2020. Participants were young men aged 15 to 24 years in the city of Ibadan, Nigeria, and surrounding areas. Frequencies and percentages were examined, and a Fisher exact test was used to evaluate outcomes compared with historical surveillance data. Linkage to care was defined as 2 clinic visits, including HIV confirmation, within 2 months of a positive rapid test result., Intervention: Four peer navigators conducted social media outreach promoting sexual health and guiding individuals to HIV counseling and rapid testing in clinical, community, or home-based settings., Main Outcomes and Measures: Primary outcomes included the number of young men tested for HIV at university-based iCARE catchment clinics or by iCARE peer navigators in the community, the postintervention HIV seroprevalence of these groups, and linkage to care of participants diagnosed with HIV infection., Results: A total of 339 participants underwent testing for HIV (mean [SD] age, 21.7 [1.9] years), with 283 (83.5%) referred through social media. The main referral sources for social media were WhatsApp (124 [43.8%]), Facebook (101 [35.7%]), and Grindr (57 [20.1%]). Regarding testing location, participants chose home (134 [39.5%]), community-based (202 [59.6%]), or clinic (3 [0.9%]) settings. Eighty-six participants reported no prior HIV testing. Thirty-six participants (10.6%) were confirmed as HIV seropositive; among those, 18 (50.0%) reported negative test results within the past year, and 31 (86.1%) were linked to care. In two 6-month follow-up periods, the intervention increased HIV testing by 42% and 31%, respectively, and seroprevalence increased compared with historical trends with odds ratios of 3.37 (95% CI, 1.43-8.02; P = .002) and 2.74 (95% CI, 1.10-7.11; P = .02), respectively., Conclusions and Relevance: These findings suggest that use of iCARE Nigeria was associated with increased HIV testing and linkage to care in a high-risk, difficult-to-reach population, making it a promising combination intervention for young MSM., Trial Registration: isrctn.org Identifier: ISRCTN94590823.

Our team developed MyPEEPS (Male youth Pursuing Empowerment, Education, and Prevention around Sexuality) Mobile-a health application for young cisgender men who have sex with men to promote health and reduce sexual risk. The current study sought to better understand approaches for adapting MyPEEPS for transmasculine youth., Methods: Transmasculine youth, ages 13-18 years, who reported attraction to or sex with cisgender men were recruited to participate in focus groups in four major cities in the United States., Results: Overall, participants found MyPEEPS Mobile to be a useful educational platform for sexual health education. Participants discussed expansions of the MyPEEPS Mobile App to address interpersonal concerns and provision of a holistic approach to health promotion for transmasculine youth. Detailed suggestions for improvement included personalization; transmasculine inclusivity and relatability; expansion of population-specific educational components; and improvements to functionality, images, and graphics., Conclusions: While MyPEEPS Mobile has educational components, adaptations are needed to address specific needs of TMY and optimize user-centered design for feasibility and efficacy. If tailored to the lives of transmasculine youth, MyPEEPS has the potential to promote HIV preventive behavior.

A large proportion of HIV infections among men who have sex with men occur within primary partnerships, however, there is a lack of research focused on serodiscordant male couples. We used baseline data collected as part of Project Stronger Together-a randomized controlled trial to improve treatment outcomes among 155 serodiscordant male couples. We described engagement in HIV care/prevention using the HIV treatment cascade and PrEP care continuum. Among partners living with HIV, 86.5% were linked to care, 77.4% retained in care, 81.3% prescribed ART, 60.7% adherent, and 67.7%virally suppressed. Among HIV-negative partners, 62.6% were willing to take PrEP, 48.4% had ever taken PrEP, and 26.5% were adherent to PrEP. Black partners living with HIV had lower odds of being virally suppressed compared to White partners. Our findings provide evidence to suggest designing programs to address the racial disparities in viral suppression, addressing barriers to HIV prevention/treatment, and improving PrEP education., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: The number of youth living with HIV in the United States (US) continues to rise, and racial, ethnic, and sexual minority youth including young men who have sex with men (YMSM) and young transgender women (YTGW) bear a disproportionate burden of the HIV epidemic. Due to social and healthcare system factors, many YMSM and YTGW do not seek HIV testing services and are therefore less likely to be aware that they are infected. Mobile health technology (mHealth) has the ability to increase uptake of HIV testing among these populations. Thus, the mLab App-which combines HIV prevention information with a mobile phone imaging feature for interpreting at-home HIV test results-was developed to improve testing rates and linkage to care among Black, Latino, and other YMSM and YTGW living in New York City and Chicago and their surrounding areas., Methods: This study is a three-arm randomized controlled trial among YMSM and YTGW aged 18-29 years. Participants are randomized to either the mLab App intervention including HIV home test kits and standard of preventive care, standard of preventive care only, or HIV home test kits and standard of preventive care only., Discussion: mHealth technology used for HIV prevention is capable of delivering interventions in real-time, which creates an opportunity to remotely reach users across the country to strengthen their HIV care continuum engagement and treatment outcomes. Specifically during the COVID-19 pandemic, mHealth technology combined with at-home testing may prove to be essential in increasing HIV testing rates, especially among populations at high-risk or without regular access to HIV testing., Trial Registration: This trial was registered with Clinicaltrials.gov ( NCT03803683 ) on January 14, 2019., (© 2021. The Author(s).)

Objective: The widespread and frequent use of mobile technology among adolescents, including sexual minority adolescents, presents an opportunity for the development of mobile health (mHealth) technology to combat the continuing HIV epidemic among young men who have sex with men (YMSM). We analyzed perceptions of the quality and impact of an HIV prevention mobile app on sexual risk reduction among YMSM., Methods: Participants were recruited from a larger randomized controlled trial of the MyPEEPS Mobile app among YMSM aged 13-18 years. Data were collected via semi-structured interviews to assess quality and user satisfaction with MyPEEPS Mobile app using analysis informed by the Information Systems Success framework. Interview data were transcribed verbatim and analyzed using six themes: information quality, net benefit, user satisfaction, product quality, service quality, and health care barriers., Results: Interviews were conducted with 40 YMSM (45% Hispanic; 80% non-White; 88% non-rural resident; 28% aged 17 years). Participants' responses indicated that information quality was high, reporting that the app information was concise, easy to understand, useful, and relevant to their life. The net benefits were stated as improvements in their decision-making skills, health behaviors, communication skills with partner(s), and increased knowledge of HIV risk. There was general user satisfaction and enjoyment when using the app, although most of the participants did not intend to reuse the app unless new activities were added. Participants expressed that the product quality of the app was good due to its personalization, representation of the LGBTQIA + community, and user-friendly interface. Although no major technical issues were reported, participants suggested that adaption to a native app, rather than a web app, would improve service quality through faster loading speed. Participants also identified some health care barriers that were minimized by app use., Conclusions: The MyPEEPS Mobile app is a well received, functional, and entertaining mHealth HIV prevention tool that may improve HIV prevention skills and reduce HIV risk among YMSM., (Copyright © 2021 Elsevier B.V. All rights reserved.)

In the United States, transgender women are disproportionately affected by HIV. However, few evidence-based prevention interventions exist for this key population. We describe two promising, locally developed interventions that are currently being implemented and evaluated through the Centers for Disease Control and Prevention Combination HIV Prevention for Transgender Women Project: (a) ChiCAS, designed to promote the uptake of pre-exposure prophylaxis (PrEP), condom use, and medically supervised hormone therapy among Spanish-speaking transgender Latinas, and (b) TransLife Care, designed to address the structural drivers of HIV risk through access to housing, employment, legal services, and medical services, including HIV preventive care (e.g., PrEP use) among racially/ethnically diverse urban transgender women. If the evaluation trials determine that these interventions are effective, they will be among the first such interventions for use with transgender women incorporating PrEP, thereby contributing to the evidence-based resources that may be used to reduce HIV risk among this population.

Engagement in HIV care and a high level of antiretroviral therapy (ART) adherence for people living with HIV is crucial to treatment success and can minimize the population burden of the disease. Despite this, there is a critical gap in HIV prevention science around the development of interventions for serodiscordant male couples. This paper reports on the results of a randomized controlled trial to assess the efficacy of Stronger Together, a dyadic counseling intervention aimed at increasing engagement in and optimizing HIV care among serodiscordant male couples in Atlanta, GA, Boston, MA, and Chicago, IL. Between 2014 and 2017, 159 male serodiscordant couples (total N = 318) in Atlanta, GA, Boston, MA, and Chicago, IL were enrolled and equally randomized to either the Stronger Together intervention arm (a three-session dyadic intervention involving HIV testing and adherence counseling) or a standard of care (SOC) control arm. Couples completed individual study assessments via an audio computer assisted self-interviewing (ACASI) system at baseline, 6, 12 and 18 months. Primary outcomes included being prescribed and currently taking ART, and fewer missed doses of ART in the past 30 days; because the trial was not powered to examine viral suppression, we examined this as an exploratory outcome. Longitudinal data analysis was by an intention-to-treat approach. Participants ages ranged from 18 to 69 (mean = 35.9), and are predominantly white (77.5%), and college educated (68.4% earned a college degree or higher). Participants randomized to the Stronger Together arm had a significantly greater odds of being prescribed and currently taking ART over time than those in the SOC arm (at 12 months OR 2.75, 95%CI 1.35-4.67, p-value 0.020, and at 18 months OR 2.91, 95%CI 1.61-4.88, p-value 0.013). Similarly, those in the Stronger Together arm had a significantly lower odds of missing a dose of ART in the past 30 days over time compared to those in the SOC arm (at 12 months OR 0.28, 95%CI 0.09-0.81, p-value 0.019, and at 18 months OR 0.25, 95%CI 0.07-0.82, p-value 0.023). Among male couples in serodiscordant relationships, the Stronger Together intervention resulted in significantly improved HIV treatment outcomes at both 12 and 18 months of follow-up. This trial is the first to date to demonstrate evidence of efficacy for a dyadic counseling intervention and has the potential to fill a critical gap in secondary HIV prevention interventions for serodiscordant male couples.

Improving access to HIV testing among youth at high risk is essential for reaching those who are most at risk for HIV and least likely to access health care services. This study evaluates the usability of mLab, an app with image-processing feature that analyzes photos of OraQuick HIV self-tests and provides real-time, personalized feedback. mLab includes HIV prevention information, testing reminders, and instructions. It was developed through iterative feedback with a youth advisory board ( N = 8). The final design underwent heuristic ( N = 5) and end-user testing ( N = 20). Experts rated mLab following Nielsen's heuristic checklist. End-users used the Health Information Technology Usability Evaluation Scale. While there were some usability problems, overall study participants found mLab useful and user-friendly. This study provides important insights into using a mobile app with imaging for interpreting HIV test results with the goal of improving HIV testing and prevention in populations at high risk.

Background: Consistent with the global trend, youth with HIV (YWH) in Nigeria have high rates of viral nonsuppression. Hence, novel interventions are needed., Setting: Infectious Diseases Institute, College of Medicine, University of Ibadan, Nigeria., Methods: In a single-arm trial, participants aged 15-24 years received 48 weeks of a combination intervention, comprising daily 2-way text message medication reminders plus peer navigation. The primary outcome measure was viral suppression less than 200 copies/mL. The secondary outcome measures included self-reported adherence on a visual analog scale and medication possession ratio, each dichotomized as ≥90% (good) or <90% (poor) adherence. The outcomes were analyzed using McNemar test. Retention in care, intervention feasibility and acceptability, and participants' satisfaction were also assessed., Results: Forty YWH (50% male participants) were enrolled: mean age 19.9 years (SD = 2.5), 55% perinatally infected, and 35% virologically suppressed at baseline. Compared with baseline, the odds of virologic suppression was higher at 24 weeks (odds ratio = 14.00, P < 0.001) and 48 weeks (odds ratio = 6.00, P = 0.013). Self-reported adherence (≥90%) increased from baseline at 24 weeks (63%, P = 0.008) and 48 weeks (68%, P = 0.031). Medication possession ratio ≥90% increased at weeks 24 and 48 (85% and 80%, respectively), achieving statistical significance at 24 weeks alone (P = 0.022). Retention in care at 48 weeks was 87.5%. All (37/37) participants at week 48 were fully or mostly satisfied with the intervention., Conclusion: Daily 2-way text message reminders plus peer navigation is a promising combination intervention to improve viral suppression among YWH in Nigeria., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

The TransLife Care (TLC) project was developed to address the structural factors that act as barriers to HIV care among transgender women of color. The purpose of this study was to evaluate the feasibility and initial efficacy of the TLC project; primary HIV care outcomes included linkage to HIV care, engagement in care, retention in care, use of ART and viral suppression among N = 120 participants. In multivariable analysis, receipt of the intervention (versus none), was associated with any HIV care visit (aOR 2.05; 95% CI 1.25-3.37; p = 0.005), more total HIV care visits (aRR 1.45; 95% CI 1.09-1.94; p = 0.011), being retained in care (aOR 1.58; 95% CI 1.03-2.44; p = 0.038), and having a viral load test done (aOR 1.95; 95% CI 1.23-3.09; p = 0.004). We conclude that a structural intervention, designed and delivered by the focus population, that directly addresses social determinants, is feasible and efficacious to promote HIV care engagement among transgender women of color.

Sexual agreements (SAs)-guidelines that outline what type of sexual behaviors are permissible with sexual partners outside of their primary relationship-are often negotiated within same-sex male relationships to reduce their risk for HIV infection. However, HIV risk is not only a function of sexual behavior, but is also affected by factors such as antiretroviral therapy (ART) adherence. We examined whether HIV-positive partners in serodiscordant male couples who have better communication about SAs and report concordant SAs with their partners have greater odds of being adherent to ART to not only improve their health, but to also reduce the risk of transmitting HIV to partners. We analyzed longitudinal data from 135 HIV-positive partners in serodiscordant male couples recruited from Atlanta, GA, Boston, MA, and Chicago, IL to examine the relationship between optimal ART adherence and two independent variables: communication about SAs and if the couples have discrepant SAs. HIV-positive male partners who reported high levels of communication regarding SAs had nearly three times the odds of optimal adherence to ART compared to those who reported lower levels. The HIV-positive partners with discrepant SAs with their male partner had approximately half the odds of optimal adherence to ART compared to those with concordant SAs. Our findings suggest that integrating communication skills training into dyad-level HIV interventions to improve communication regarding HIV may provide more opportunities for couples to discuss ways of reducing the risk of HIV transmission. Couples may benefit from interventions that assist them in composing SAs.

Background: Gender-based stigma contributes to increased HIV prevalence, but little is known about psychosocial mechanisms linking stigma and HIV risk among young transgender women (YTW)., Setting: This study uses data from Project LifeSkills, a randomized controlled efficacy trial of an empowerment-based HIV prevention intervention for YTW (N = 233). YTW were recruited in Boston, MA, and Chicago, IL, between 2012 and 2015 and completed study assessment visits at baseline and months 4 and 12., Methods: Using autoregressive structural equation modeling, we examined whether poor social support and psychological distress at 4 months mediate the prospective relationship between gender-based stigma at baseline and condomless anal and vaginal sex (CAVS) acts at 4 and 12 months; all models were adjusted for treatment arm, HIV serostatus, study site, and sociodemographics., Results: Gender-based stigma at baseline was directly associated with increased CAVS at 4 months [adjusted incidence rate ratio (aIRR) = 1.18, 95% confidence interval (CI): (1.05 to 1.33)] and 12 months [aIRR = 1.17, 95% CI: (1.02 to 1.34)]. Gender-based stigma was also associated with higher psychological distress at 4 months [b = 0.70, 95% CI: (0.13 to 1.27)], which in turn was marginally associated with increased CAVS at 12 months [aIRR = 1.03, 95% CI: (1.00 to 1.06)]. Contrary to expectations, poor social support at 4 months was associated with decreased CAVS at 12 months [aIRR = 0.40, 95% CI: (0.28 to 0.59)]., Conclusions: Future HIV prevention interventions with YTW should consider addressing experiences of gender-based stigma and the psychological distress that may ensue from gender-based stigma. More research is needed to understand the influence of poor social support on sexual behaviors in this population., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Because of stigmatization of and discrimination against lesbian, gay, bisexual, transgender, and other sexual and gender minority (SGM) people in East Africa, there is paucity of SGM-focused sexual health research. Technology-based outreach efforts may represent a feasible way to reach and engage this population. They also may be a way to deliver important yet sensitive sexual health information in a stigma-free, anonymous atmosphere. We explored the feasibility of recruiting and surveying East African SGM adults online, and examined their interest in technology-based sexual health programming. Over a 14-month period, 2451 respondents were surveyed. They were, on average, 26.7 years of age. Fifty-four percent identified as lesbian, gay, and/or bisexual (LGB); a similar percentage (49%) reported having sex with a same-sex partner. Sixteen percent identified as gender minority (i.e. transgender or non-binary); and 29% were assigned female at birth. Almost half (48%) of SGM adults expressed interest in an SGM-focused healthy sexuality program delivered online. Enthusiasm also was noted for email (43%) and text messaging (41%). Compared to face-to-face settings, technology-based settings were more commonly  appraised  as the safest mode through which one could engage in sexual health programming. People who had a same sex partner and those who identified as sexual minority were especially likely to want to engage in technology-based programs. Interest in technology-based programming was similar for adults across gender identities, sex assigned at birth, and age however. Findings suggest that technology may be an underutilized opportunity to reach and engage SGM East Africans in a safe and private manner. Given levels of acceptability indicated by SGM adults across age, sex assigned at birth, and gender and sexual identities in this study, it seems possible that technology-based sexual health and HIV prevention and intervention programs could have the potential to be transformative in East Africa.

Background: Young transgender women (YTW) are a key population for HIV-related risk reduction, yet very few interventions have been developed to meet their needs. Mobile health interventions with the potential for both efficacy and wide reach are a promising strategy to reduce HIV risk among YTW., Objective: This study aims to adapt an efficacious group-based intervention to a mobile app, Project LifeSkills, to reduce HIV risk among YTW, and to test its acceptability and usability., Methods: The group-based intervention was adapted to a mobile app, LifeSkills Mobile, with input from an expert advisory group and feedback from YTW collected during user-centered design sessions. A beta version of the app was then tested in a usability evaluation using a think-aloud protocol with debriefing interviews, recordings of screen activity, and assessments of usability via the Post-Study System Usability Questionnaire (PSSUQ) and the Health Information Technology Usability Evaluation Scale (Health-ITUES)., Results: YTW (n=8; age: mean 24 years, SD 3 years; racial or ethnic minority: 7/8, 88%) provided feedback on the app prototype in design sessions and then tested a beta version of the app in a usability trial (n=10; age: mean 24 years, SD 3 years; racial or ethnic minority: 8/10, 80%). Both usability ratings (Health-ITUES: mean 4.59, SD 0.86; scale range: 1-5) and ratings for satisfaction and accessibility (PSSUQ: mean 4.64, SD 0.90; scale range 1-5) were in the good to excellent range. No functional bugs were identified, and all mobile activities were deployed as expected. Participant feedback from the usability interviews indicated very good salience of the intervention content among the focal population. Participants' suggestions to further increase app engagement included adding animation, adding audio, and reducing the amount text., Conclusions: We conclude that the LifeSkills Mobile app is a highly usable and engaging mobile app for HIV prevention among YTW., (©Lisa M Kuhns, Jane Hereth, Robert Garofalo, Marco Hidalgo, Amy K Johnson, Rebecca Schnall, Sari L Reisner, Marvin Belzer, Matthew J Mimiaga. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 31.03.2021.)

Background: Men who have sex with men are disproportionately burdened by HIV/AIDS, and the advent of pre-exposure prophylaxis (PrEP) has provided an effective strategy to reduce the risk of HIV transmission. Research has shown that improving one partner's health-promoting behaviors increases the likelihood that their partner adopts healthier behaviors. We examined the longitudinal relationship between favorable HIV treatment outcomes with current PrEP use among HIV serodiscordant male partners., Setting: Data are from Project Stronger Together, a randomized controlled trial that recruited serodiscordant male couples from Atlanta, GA; Boston, MA; and Chicago, IL., Methods: Serodiscordant couples completed assessments at baseline, 6, 12, 18, and 24 months. We analyzed longitudinal data from 120 HIV serodiscordant male partners to assess the relationship between the HIV-negative partner's current PrEP use and their HIV-positive partner's current ART use, ART adherence, and viral load using generalized estimating equation models., Results: Fewer than half of the HIV-negative partners were on PrEP at baseline and nearly two-thirds of their HIV-positive partners were virally suppressed. HIV-negative male partners who had partners with an undetectable viral load had greater odds of being a current PrEP user than HIV-negative partners with partners with a detectable viral load., Conclusion: Our study highlights the need to develop dyad-level interventions to improve HIV medication use/adherence by HIV serodiscordant male couples. Our findings also suggest that dyad-level interventions may be able to leverage our understanding of how partners can influence each other's health-promoting behaviors to develop programs that improve health outcomes for both partners.

Transgender women are disproportionately affected by HIV and experiences of social adversity that may interfere with engagement in care and viral suppression. We used latent class analysis to examine patterns of social adversity and their impact on HIV care continuum outcomes in an urban sample of transgender women of color. Participants (n = 224) were median age 29 and 86% non-Hispanic Black. Lack of resources, unemployment, and housing instability were reported by over 50%, and 41% reported history of incarceration. Latent class analysis identified 2 distinct classes representing higher and lower levels of social adversity. In latent class regression, membership in the higher social adversity class was associated with statistically significantly lower odds of viral suppression and HIV care engagement in univariate analysis; when adjusted for age, race, and recruitment site the association remained statistically significant for viral suppression (aOR 0.38, 95% CI 0.18-0.79; chi-square = 6.681, d.f. = 1, p = 0.010), though not for HIV care engagement. Our findings highlight the impact of socio-structural barriers on engagement in the HIV care continuum among transgender women.

Sexual agreements are an important HIV risk reduction strategy enacted by men in male-male partnerships. Greater levels of relationship quality have been associated with sexual agreement formation and adherence. However, current evidence supporting the associations between relationship quality and sexual agreements for male dyads is based primarily on the responses of just one partner. Understanding that relationship quality and decisions about sexual agreements are inherently influenced by both partners, the present analysis uses dyadic-level data to examine the sexual agreements among 199 HIV serodiscordant and seroconcordant male dyads (n = 398 individuals). Specifically, the analysis examines measures of love, trust, and conflict style as they relate to (1) the type of agreement established, (2) concordance in agreement reporting, (3) satisfaction with the agreement, and (4) broken agreements. A discrepancy in love between partners was associated with the type of agreement established, whether they reported the same agreement type, and whether one of the partners reported a broken agreement, but it was not associated with either partner's satisfaction with the agreement. A discrepancy in trust was associated with agreement concordance and agreement breaks, but it was not associated with the type of agreement established or satisfaction with the agreement. Lastly, a discrepancy in conflict style was associated with each of the agreement outcomes. Future research and intervention efforts should focus on understanding the behavioral and communication skills necessary for couples to make successful sexual agreements.

Despite the approval of PrEP for adolescents by the FDA in 2018, little is known about the awareness and attitudes about PrEP use among adolescent sexual minority males, who are at the greatest risk for HIV. We analyzed baseline data from the MyPEEPS Mobile study, a multi-site randomized controlled trial evaluating the effectiveness of a mobile behavioral HIV prevention intervention. A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV. On the other hand, only about one third (34.6%) of participants indicated that taking a daily HIV pill would be "very" or "completely" effective in preventing HIV when having sex without a condom. These findings suggest that high awareness and willingness to use PrEP across various adolescent subgroups present opportunities for increased PrEP advocacy among this young age group.

We performed a pilot study among young African-American men who have sex with men (AAMSM) of real-time electronic adherence monitoring (EAM) in Chicago to explore acceptability and feasibility of EAM and to inform intervention development. We recruited 40 young AAMSM living with HIV on ART to participate in up to 3 months of monitoring with the Wisepill device. Participants were interviewed at baseline, in response to the first true adjudicated 1-dose, 3-day, and 7-day misses, and at the end of monitoring. Reasons for missing doses and the acceptability and feasibility of electronic monitoring were assessed using mixed methods. The median participant observation time was 90 days ( N  = 40). For 21 participants with 90 days of follow-up, <90% and <80% adherence occurred in 82% and 79%, respectively in at least one of their monitored months ( n  = 63 monitored months). The participants generally found the proposed intervention acceptable and useful. Although seven participants said the device attracted attention, none said it led to disclosure of their HIV status. This study found real-time EAM to be generally acceptable and feasible among YAAMSM living with HIV in Chicago. Future work will develop a triaged real-time EAM intervention including text alerts following detection of nonadherence.

Our study team developed the MyPEEPS Mobile App for improving HIV prevention behaviors in diverse young men. We conducted a randomized controlled trial and evaluated the preliminary outcomes in the first half (N=350) of our intended study sample. Higher self-efficacy for HIV prevention behaviors (p=0.0042) and more recent HIV tests in the past 3 months (p=0.0156) were reported by the intervention group compared to control. Numbers of condomless anal sex acts were lower among the intervention group for both insertive anal sex acts (p=0.0283) and receptive anal sex acts (p=0.0001). Preliminary results indicate that some sexual risk behaviors were reduced among the intervention group in the preliminary analytic sample.

Introduction: In the USA, transgender women are among the most vulnerable to HIV. In particular, transgender women of colour face high rates of infection and low uptake of important HIV prevention tools, including pre-exposure prophylaxis (PrEP). This paper describes the design, sampling methods, data collection and analyses of the TURNNT ('Trying to Understand Relationships, Networks and Neighbourhoods among Transgender women of colour') study. In collaboration with communities of transgender women of colour, TURNNT aims to explore the complex social and environmental (ie, neighbourhood) structures that affect HIV prevention and other aspects of health in order to identify avenues for intervention., Methods and Analyses: TURNNT is a prospective cohort study, which will recruit 300 transgender women of colour (150 Black/African American, 100 Latina and 50 Asian/Pacific Islander participants) in New York City. There will be three waves of data collection separated by 6 months. At each wave, participants will provide information on their relationships, social and sexual networks, and neighbourhoods. Global position system technology will be used to generate individual daily path areas in order to estimate neighbourhood-level exposures. Multivariate analyses will be conducted to assess cross-sectional and longitudinal, independent and synergistic associations of personal relationships (notably individual social capital), social and sexual networks, and neighbourhood factors (notably neighbourhood-level social cohesion) with PrEP uptake and discontinuation., Ethics and Dissemination: The TURNNT protocol was approved by the Columbia University Institutional Review Board (reference no. AAAS8164). This study will provide novel insights into the relationship, network and neighbourhood factors that influence HIV prevention behaviours among transgender women of colour and facilitate exploration of this population's health and well-being more broadly. Through community-based dissemination events and consultation with policy makers, this foundational work will be used to guide the development and implementation of future interventions with and for transgender women of colour., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Among men who have sex with men, there is now clear evidence that the risk of HIV transmission through condomless sex when the HIV-positive partner is virally suppressed is effectively zero. However, an understanding of the accuracy of reporting of viral load among serodiscordant same-sex male couples is missing from the literature., Setting: This analysis uses data from the baseline sample of Stronger Together, a randomized controlled efficacy trial of an innovative dyadic intervention to enhance antiretroviral therapy adherence for HIV serodiscordant male couples in 3 US cities (Atlanta, Boston, and Chicago)., Methods: Biomarker-confirmed and self-reported measures of viral load were used to assess the accuracy of self-report of viral suppression. In this descriptive analysis, the percentage of men who inaccurately reported being virally suppressed is compared across demographic, relationship, and HIV care characteristics., Results: Results confirm those of other recent studies that have shown relatively high levels of inaccuracy in reporting of viral suppression. Although 72.5% of men could accurately report their viral load status, 20% reported that they were virally suppressed when they did not have a biomarker-confirmed measure of viral suppression., Conclusion: These results highlight the need to provide interventions to men who have sex with men living with HIV to support access to care and ensure current knowledge of viral load and to continue to support primary prevention of HIV through condom use and pre-exposure prophylaxis. For couples, particularly serodiscordant male couples, interventions that can teach the couple how to collaborate to achieve and maintain viral suppression for the positive partner are an urgent and pragmatic programmatic priority that can equip couples with the knowledge required to correctly implement U = U strategies.

Background: Young sexual minority men in the United States have a high incidence rate of HIV infection. Early intervention among this group, that is timed to precede or coincide with sexual initiation, is of critical importance to prevent HIV infection. Despite this, there are very few published randomized controlled efficacy trials testing interventions to reduce sexual vulnerability for HIV acquisition among racially/ethnically diverse, very young, sexual minority men (aged ≤18 years). This paper describes the design of a mobile app-based intervention trial to reduce sexual risk for HIV acquisition and promote health protection in this group., Methods: This study is a randomized controlled trial of an mHealth-based HIV prevention intervention, MyPEEPS Mobile, among diverse sexual minority cisgender young men, aged 13-18 years. The mobile intervention was adapted from a prior group-based intervention curriculum with evidence of efficacy, designed to be specific to the risk contexts and realities of young sexual minority men, and to include psychoeducational and skill-building components with interactive games and activities. Participants are recruited locally within four regional hubs (Birmingham, AL, Chicago, IL, New York City, NY, Seattle, WA) and nationwide via the Internet, enrolled in-person or remotely (via videoconference), and randomized (1:1) to either the MyPEEPS Mobile intervention or delayed intervention condition. Post-hoc stratification by age, race/ethnicity, and urban/suburban vs. rural statuses is used to ensure diversity in the sample. The primary outcomes are number of male anal sex partners and frequency of sexual acts with male partners (with and without condoms), sex under the influence of substances, and uptake of pre-and post-exposure prophylaxis, as well as testing for HIV and other sexually transmitted infections at 3-, 6- and 9-month follow-up., Discussion: Behavioral interventions for very young sexual minority men are needed to prevent sexual risk early in their sexual development and maturation. This study will provide evidence to determine feasibility and efficacy of a mobile app-based HIV prevention intervention to reduce sexual risk among this very young group., Trial Registration: ClinicalTrials.gov number, NCT03167606, registered May 30, 2017.

Background: Young people account for more than a quarter of new HIV infections in the US, with the majority of cases among young men who have sex with men; young transgender women are also vulnerable to infection. Substance use, particularly alcohol misuse, is a driver of sexual transmission and a potential barrier to engagement in the HIV prevention and care continuum, however vulnerable youth are difficult to reach for substance use services due, in part, to complex social and structural factors and limited access to health care. The Community Prevention Services Task Force recommends electronic screening and brief intervention as an evidence-based intervention for the prevention of excessive alcohol consumption; however, no prior studies have extended this model to community-based populations of youth that are susceptible to HIV infection. This paper describes the study protocol for an electronic screening and brief intervention to reduce alcohol misuse among adolescents and young adults vulnerable to HIV infection in community-based settings., Methods: This study, Step Up, Test Up, is a randomized controlled trial of an electronic alcohol screening and brief intervention among youth, ages 16-25, who are vulnerable to HIV infection. Individuals who present for HIV testing at one of three community-based locations are recruited for study participation. Eligibility includes those aged 16-25 years, HIV-negative or unknown HIV status, male or trans female with a history of sex with men, and English-speaking. Participants who screen at moderate to high risk for alcohol misuse on the Alcohol Use Disorders Identification Test (AUDIT) are randomized (1:1) to either an electronic brief intervention to reduce alcohol misuse or a time-and attention-matched control. The primary outcome is change in the frequency/quantity of recent alcohol use at 1, 3, 6 and 12-month follow-up., Discussion: Testing of evidence-based interventions to reduce alcohol misuse among youth vulnerable to HIV infection are needed. This study will provide evidence to determine feasibility and efficacy of a brief electronically-delivered intervention to reduce alcohol misuse for this population., Trial Registration: ClinicalTrials.gov number, NCT02703116, registered March 9, 2016.

Background: Worldwide, young transgender women (YTW) contend with exceptionally high risks of HIV infection. Cross-sectional studies have suggested that co-occurring epidemics or "syndemics" of psychosocial problems may accelerate HIV acquisition and transmission through elevated sexual risk behavior among transgender women. We aimed to examine how a syndemic of 7 psychosocial problems potentiates HIV sexual risk behavior among a multicity, longitudinal cohort of sexually active YTW in the United States., Methods: Between 2012 and 2015, 233 YTW from Boston, MA, and Chicago, IL, completed behavioral surveys at baseline, 4, 8, and 12 months. We used generalized estimating equations to examine the prospective relationship of overlapping psychosocial problems and HIV sexual risk behavior (ie, condomless anal or vaginal sex) among YTW., Results: The prevalence of 7 psychosocial syndemic problems was substantial at baseline and remained high at each time point: 6.4% reported polydrug use in the past 4 months (excluding stimulants); 7.7% reported heavy alcohol use in the past 4 months; 10% reported a history of childhood sexual abuse; 15.9% reported stimulant use in the past 4 months; 41.7% reported experiencing lifetime intimate partner violence; 42.1% reported clinically significant depressive symptoms; and 68.6% reported lifetime transgender-specific victimization. We identified a statistically significant positive "dose-response" relationship between the number of psychosocial syndemic problems and condomless anal or vaginal sex over time., Conclusions: The accumulation of "syndemic" psychosocial problems predicted HIV sexual risk behavior in a prospective cohort of YTW. Given the high prevalence of psychosocial problems and HIV sexual risk behavior, as well as having the highest HIV incidence among any risk group, the HIV prevention agenda requires a shift toward improved assessment of psychosocial comorbidities and stronger integration with gender-affirming and supportive mental health, violence recovery, and addiction treatment services for this population.

Background: Among persons living with HIV, poorer antiretroviral therapy adherence has been reported in African Americans and disproportionate mortality reported in young African American men who have sex with men (AAMSM) compared to whites. We report the results of focus groups with young AAMSM living with HIV that explore their opinions about the acceptability and feasibility of a triaged real-time missed dose alert intervention to improve treatment adherence. The purpose of this study is to develop a theory-driven triaged real-time adherence monitoring intervention to promote HIV medication adherence in young AAMSM., Methods: We performed five focus groups and two individual interviews among young HIV-positive AAMSM (n = 25) in Chicago guided by the Technology Acceptance Model and explored perceptions regarding the monitoring concept including device issues and concerns about inclusion of support persons whose involvement is triggered by sustained missed doses. The purpose was to inform the development of this intervention in this population., Results: Generally, the participants found the proposed intervention acceptable and useful. Privacy was a major concern for participants especially with attention to possible disclosure of their HIV status by receiving a medication-related text that someone else might view and could lead to unwanted attention. There was concern that the device could be confused with a taser. Approximately half of the men already had a close personal contact that helped them with medication taking. Some participants acknowledged that the notification might lead to friction., Conclusions: A triaged real-time alert intervention to improve treatment adherence is acceptable and feasible among young AAMSM living with HIV.

An embodied conversational agent can serve as a relational agent and provide information, motivation, and behavioral skills. To evaluate the feasibility, acceptability, and preliminary efficacy of My Personal Health Guide, a theory-based mobile-delivered embodied conversational agent intervention to improve adherence to antiretroviral therapy in young African American men who have sex with men, we conducted this prospective pilot study using a 3-month pre-post design. Outcome measures included adherence, acceptability, feasibility, pre versus post health literacy, and pre versus post self-efficacy. There were 43 participants. Pill count adherence > 80% improved from 62% at baseline to 88% at follow-up (p = .05). The acceptability of the app was high. Feasibility issues identified included loss of usage data from unplanned participant app deletion. Health literacy improved whereas self-efficacy was high at baseline and follow-up. This pilot study of My Personal Health Guide demonstrated acceptability and preliminary efficacy in improving adherence in this important population.

Young transgender women (YTW) are disproportionately affected by HIV, however, little is known about the factors associated with HIV infection and treatment engagement. We examined correlates of HIV infection and the steps of the HIV treatment cascade, specifically, being aware of their HIV infection, linked to care, on ART, and adherent to ART. We analyzed the baseline data of Project LifeSkills, a randomized control trial of sexually active YTW recruited from Chicago, Illinois and Boston, Massachusetts. We conducted multivariable Poisson regressions to evaluate correlates of HIV infection and the steps of the HIV treatment cascade. Nearly a quarter (24.7%) of YTW were HIV-infected. Among HIV-infected YTW, 86.2% were aware of their HIV status, 72.3% were linked to care, 56.9% were on ART, and 46.2% were adherent to ART. Having avoided healthcare due to cost in the past 12 months and not having a primary care provider were associated with suboptimal engagement in HIV care. Our results suggest that improving linkage and retention in care by addressing financial barriers and improving access to primary care providers could significantly improve health outcomes of YTW as well as reduce forward transmission of HIV.

There is a dearth of evidence-based HIV prevention interventions for very young men who have sex with men (YMSM) ages 13-18 years, at high risk for HIV. We adapted the MyPEEPS intervention-an evidence-based, group-level intervention-to individual-level delivery by a mobile application. We used an expert panel review, in-depth interviews with YMSM (n = 40), and weekly meetings with the investigative team and the software development company to develop the mobile app. The expert panel recommended changes to the intervention in the following areas: (1) biomedical interventions, (2) salience of intervention content, (3) age group relevance, (4) technical components, and (5) stigma content. Interview findings reflected current areas of focus for the intervention and recommendations of the expert panel for new content. In regular meetings with the software development firm, guiding principles included development of dynamic content, while maintaining fidelity of the original curriculum and shortening intervention content for mobile delivery.

Emtricitabine/tenofovir disoproxil fumarate as pre-exposure prophylaxis (PrEP) can prevent HIV infection among at-risk individuals, including young transgender women (YTW). We used baseline data from 230 HIV-uninfected YTW (ages 16-29 years) who were enrolled in Project LifeSkills during 2012-2015. We examined factors associated with perceived acceptability of PrEP use (mean score = 23.4, range 10.0-30.0). Participants were largely transgender women of color (67%) and had a mean age of 23 years (SD = 3.5). In an adjusted multiple linear regression model, PrEP interest (β = 3.7, 95% CI 2.2-5.2) and having a medical provider who meets their health needs (β = 2.9, 95% CI 1.3-4.4) was associated with higher PrEP acceptability scores, whereas younger age (21-25 vs 26-29 years) (β = -2.0, 95% CI - 3.6 to - 0.4) and reporting transactional sex in the past 4 months (β = - 1.5, 95% CI - 3.0 to - 0.1) was associated with lower PrEP acceptability scores (all p values < 0.05). Enhancing PrEP-related interventions by addressing the unique barriers to uptake among YTW of younger age or those with history of transactional sex could bolster PrEP acceptability for this population.

Determining the barriers and facilitators of antiretroviral adherence among former and current substance users may be useful in the creation of successful interventions that target this hard-to-reach population. We performed a cross-sectional study of HIV-infected patients (N = 123) prescribed antiretroviral therapy at four Chicago healthcare venues. Bivariate and multivariable analyses were performed to determine factors associated with non-adherence based on definitions of non-adherence (any missed doses) within the past 4-day, 14-day, and 1-month time periods. Factors consistently associated with non-adherence in bivariate and multivariate analyses, regardless of duration of non-adherence definition, were lower confidence in taking medication consistently and less self-reported ability to read. These data reveal the importance of self-efficacy and ability to read (rather than specific knowledge of CD4 and viral load definitions) in the design of interventions in a population of HIV-infected persons with significant substance use.

Importance: The incidence of HIV infection among transgender women in the United States is extremely high, with young transgender women (YTW) at highest risk; condomless sex is the primary risk behavior for transmission. However, there are no published randomized clinical trials to date examining interventions to reduce sexual risk for HIV acquisition and transmission within this group., Objective: To determine the efficacy of a culturally specific, empowerment-based, and group-delivered behavioral prevention intervention to reduce sexual risk for HIV acquisition and transmission in sexually active YTW aged 16 to 29 years., Design, Setting, and Participants: Randomized clinical efficacy trial of Project LifeSkills, a group-delivered, behavioral HIV prevention intervention, vs standard of care conducted among 190 sexually active YTW between March 26, 2012, and August 15, 2016, at community-based locations in Boston, Massachusetts, and Chicago, Illinois, to reduce sexual risk for HIV acquisition or transmission. Data analysis was by a modified intention-to-treat approach., Interventions: Participants were randomized (approximately 2:2:1) to the LifeSkills intervention (n = 116), standard of care only (n = 74), or a diet and nutrition time- and attention-matched control (attention control) arm (n = 43). The attention control arm was dropped during active enrollment per the Data Safety and Monitoring Board's recommendation. The LifeSkills intervention was delivered in six 2-hour sessions spanning a 3-week period., Main Outcomes and Measures: Primary outcome was change in the number of self-reported condomless anal or vaginal sex acts in the 4 months before the baseline assessment and that reported at the 4-, 8-, and 12-month visits., Results: Of the 190 study participants, the mean (SD) age was 23.4 (3.4) years (range, 16-29 years); 47 (24.7%) were white, 83 (43.7%) were black or African American, 25 (13.2%) were Hispanic or Latina, and 35 (18.4%) were another race/ethnicity. From baseline to 4 months, the LifeSkills group had a 30.8% greater mean (SE) reduction in condomless sex acts (2.26 [0.40] at baseline vs 1.22 [0.22] at 4 months) compared with the standard of care group (2.69 [0.59] at baseline vs 2.10 [0.47] at 4 months) (risk ratio [RR], 0.69; 95% CI, 0.60-0.80; P < .001). Similarly, the LifeSkills group had a 39.8% greater mean (SE) reduction in condomless sex acts at the 12-month follow-up visit compared with the standard of care group (0.71 [0.13] vs 1.40 [0.32]; RR, 0.60; 95% CI, 0.50-0.72; P < .001)., Conclusions and Relevance: Among YTW at sexual risk of HIV acquisition or transmission, the LifeSkills intervention resulted in a 39.8% greater mean reduction in condomless sex acts during the 12-month follow-up in comparison to the standard of care group. This trial is the first to date to demonstrate evidence of efficacy for a behavioral intervention to reduce sexual risk in YTW., Trial Registration: ClinicalTrials.gov Identifier: NCT01575938.

Background: HIV infection among youth in the United States is on the rise. A high level of antiretroviral therapy (ART) adherence is crucial to treatment success and can minimize the population burden of the disease. However, the overall rate of ART adherence among youth is generally suboptimal and no published efficacious interventions exist to address the specific needs of this population. This paper describes the design of a stepped-care, "adaptive" ART adherence intervention protocol for HIV-infected adolescents and young adults., Methods: This is a randomized controlled trial (RCT) to establish the efficacy of "Positive STEPS," a behavioral and technology-based intervention to optimize ART adherence and viral suppression among HIV-infected youth, ages 16 to 29. Participants are equally randomized to 1) the Positive STEPS intervention, which begins with two-way daily text messaging as a reminder system to take their medications; participants progress to a more intensive in-person counseling intervention if text messaging is not sufficient to overcome barriers; or 2) or standard of care (SOC). At randomization, all participants receive standardized ART adherence education. During the 4 major study assessment visits (baseline, 4-, 8-, and 12-months), participants have their blood drawn to measure HIV viral load and complete a mix of computer-based self-administered and interviewer-administered behavioral and psychosocial measures. The primary outcomes are improvements in viral load and ART adherence measured via a medication-tracking device (i.e., Wisepill) and self-report., Discussion: Behavioral interventions are greatly needed to improve ART adherence among HIV-infected adolescents and young adults and prevent onward transmission. If effective, the intervention tested here will be one of the first rigorously-designed efficacy trials to promote ART adherence in this population, using an approach that holds promise for being readily integrated into real-world clinical settings., Trial Registration: ClinicalTrials.gov number NCT03092531 , registered March 28, 2017.

The MyPEEPS Mobile intervention is a novel evidence-driven intervention using mobile technology to deliver HIV prevention information. This is the first study to test the efficacy of a scaled-up, mobile version of an existing HIV prevention intervention originally developed, designed, and piloted for, a diverse group of YMSM. We used an iterative design process incorporating feedback from experts and end-users to update the user-interface and content of the MyPEEPS Mobile Intervention.

Background: Transgender women in the U.S. have an alarmingly high incidence rate of HIV infection; condomless anal and vaginal sex is the primary risk behavior driving transmission. Young transgender women are the subpopulation at the highest risk for HIV. Despite this, there are no published randomized controlled efficacy trials testing interventions to reduce sexual risk for HIV among this group. This paper describes the design of a group-based intervention trial to reduce sexual risk for HIV acquisition and transmission in young transgender women., Methods: This study, funded by the National Institutes of Health, is a randomized controlled trial of a culturally-specific, empowerment-based, and group-delivered six-session HIV prevention intervention, Project LifeSkills, among sexually active young transgender women, ages 16-29 years in Boston and Chicago. Participants are randomized (2:2:1) to either the LifeSkills intervention, standard of care only, or a diet and nutrition time- and attention-matched control. At enrollment, all participants receive standardized HIV pre- and post-test counseling and screening for HIV and urogenital gonorrhea and chlamydia infections. The primary outcome is difference in the rate of change in the number of self-reported condomless anal or vaginal sex acts during the prior 4-months, assessed at baseline, 4-, 8-, and 12-month follow-up visits., Discussion: Behavioral interventions to reduce sexual risk for HIV acquisition and transmission are sorely needed for young transgender women. This study will provide evidence to determine feasibility and efficacy in one of the first rigorously designed trials for this population., Trial Registration: ClinicalTrials.gov number, NCT01575938 , registered March 29, 2012.