The relationship between anti-LGBTQ+ legislation and HIV prevention among sexual and gender minoritized youth.

OBJECTIVE: Estimate the longitudinal associations of state-level anti-LGBTQ+ policies and county-level politics with individual HIV prevention outcomes among sexual and gender minoritized (SGM) youth. DESIGN: Keeping it LITE-1 prospectively enrolled 3,330 SGM youth and young adults (ages 13-34) at increased risk of HIV throughout the United States from 2017-2022. METHODS: Semiannual surveys collected self-reported HIV prevention measures (current PrEP use, weekly PrEP adherence, HIV/STI testing in the past 6 months). Geolocation was linked with state-level LGBTQ+ policy data and county-level election data. Generalized linear models with GEE estimated the single and joint longitudinal associations for 2 exposures [state-level policy climate (more discriminatory vs. less discriminatory) and county-level political majority (Democratic/swing vs. Republican)] with each outcome. RESULTS: Among participants living in a state with more discriminatory laws, those in a Democratic/swing county had a 6-percentage point increase in PrEP use (95% CI: 0.02, 0.09) compared to those in a Republican county. Those living in a Republican county but a state with less discriminatory laws saw a similar increase (0.05; -0.02,0.11). Residing in both a Democratic/swing county and a state with less discriminatory laws, relative to a Republican county and a state with more discriminatory laws, was associated with a 10-percentage point increase in PrEP use (0.10; 0.06,0.14) and a 5-percentage point increase in HIV/STI testing (0.05; 0.00,0.09). CONCLUSIONS: More progressive state and local policies were each associated with increased PrEP use, and together, doubled the magnitude of this association. PrEP is underutilized among SGM youth, and anti-LGBTQ+ policies may exacerbate this gap in coverage.

Discordance Between HIV Risk Perception, Sexual Behavior, and Pre-exposure Prophylaxis Adherence Among Young Sexual and Gender Minorities in the United States.

PURPOSE: In the United States, youth experience suboptimal HIV pre-exposure prophylaxis (PrEP) adherence. One common idea posits that this is due to their developing decision-making skills. However, quantitative evidence of this assumption is limited. We therefore examined whether individual decision-making factors, such as HIV risk perception and sexual behavior, predicted PrEP adherence in a national trial of young sexual and gender minorities (YSGMs). METHODS: In 2019-2021, the Adolescent Medicine Trials Network for HIV Interventions 142 study enrolled 225 PrEP users (ages 16-24) throughout the country. Regression models estimated the associations between HIV risk perception (using a modified Perceived HIV Risk Scale), sexual behavior (condomless anal sex in ≤ 3 months), and self-reported oral PrEP adherence (≥4 pills in the past week) at the same time point (baseline) and longitudinally (3 months). RESULTS: Baseline risk perception (risk ratio [RR]: 0.92, 95% confidence interval [CI]: 0.82, 1.04) and condomless anal sex (RR: 1.10, 95% CI: 0.97, 1.25) were not associated with PrEP adherence at the same time point and did not predict 3-month adherence (RR: 0.97, 95% CI: 0.85, 1.11; RR: 1.05, 95% CI: 0.93, 1.19, respectively). Baseline risk perception was not associated with condomless anal sex at either time point (baseline RR: 1.16, 95% CI: 0.94, 1.43; 3-month RR: 1.07, 95% CI: 0.90, 1.28). DISCUSSION: In this national trial of YSGM, HIV risk perception and condomless anal sex did not predict PrEP adherence. Targeting individual-level perceptions and behaviors will likely insufficiently address youth's suboptimal PrEP use. Future research should identify YSGM-specific adherence drivers and train providers to recognize such motivations.

Emotion regulation as a potential moderator of the association between HIV stigma and nonadherence to antiretroviral therapy among youth living with HIV.

INTRODUCTION: Human immunodeficiency virus (HIV)-related stigma affects adherence to antiretroviral therapy (ART) for youth living with HIV. Emotion regulation strategies such as cognitive reappraisal (reinterpreting adversity to mitigate emotional impact) and expressive suppression (inhibiting emotion-expressive behavior activated by adversity) may moderate the HIV stigma-ART adherence relationship in this group. METHODS: Using baseline data from 208 youth living with HIV aged 15-24 years enrolled in an mHealth ART-adherence intervention, we performed modified Poisson regressions with robust variance between HIV stigma (internalized, anticipated, enacted) and ART nonadherence. We tested for multiplicative interaction via product terms between HIV stigma and emotion regulation scores, and additive interaction via relative excess risk due to interaction and attributable proportion using dichotomous HIV stigma and emotion regulation variables. RESULTS: Mean age was 21 years; ≥50% of participants were cisgender male, non-Hispanic Black, and gay-identifying; 18% reported ART nonadherence. Confounder-adjusted regressions showed positive associations between each HIV stigma variable and ART nonadherence. Internalized HIV stigma and cognitive reappraisal negatively, multiplicatively interacted (as internalized HIV stigma increased, ART nonadherence increased for those with low cognitive reappraisal). High internalized HIV stigma positively, additively interacted with low cognitive reappraisal and low expressive suppression (when high internalized HIV stigma and low levels of either emotion regulation strategy were present, ART nonadherence increased dramatically). CONCLUSION: Cognitive reappraisal and expressive suppression may protect against internalized HIV stigma's harmful association with ART nonadherence. These modifiable emotion regulation strategies may be targeted to potentially buffer the effects of internalized HIV stigma and support ART adherence for youth living with HIV.

Exploring mobility data for enhancing HIV care engagement in Black/African American and Hispanic/Latinx individuals: a longitudinal observational study protocol.

INTRODUCTION: Increasing engagement in HIV care among people living with HIV, especially those from Black/African American and Hispanic/Latinx communities, is an urgent need. Mobility data that measure individuals' movements over time in combination with sociostructural data (eg, crime, census) can potentially identify barriers and facilitators to HIV care engagement and can enhance public health surveillance and inform interventions. METHODS AND ANALYSIS: The proposed work is a longitudinal observational cohort study aiming to enrol 400 Black/African American and Hispanic/Latinx individuals living with HIV in areas of the USA with high prevalence rates of HIV. Each participant will be asked to share at least 14 consecutive days of mobility data per month through the study app for 1 year and complete surveys at five time points (baseline, 3, 6, 9 and 12 months). The study app will collect Global Positioning System (GPS) data. These GPS data will be merged with other data sets containing information related to HIV care facilities, other healthcare, business and service locations, and sociostructural data. Machine learning and deep learning models will be used for data analysis to identify contextual predictors of HIV care engagement. The study includes interviews with stakeholders to evaluate the implementation and ethical concerns of using mobility data to increase engagement in HIV care. We seek to study the relationship between mobility patterns and HIV care engagement. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Institutional Review Board of the University of California, Irvine (#20205923). Collected data will be deidentified and securely stored. Dissemination of findings will be done through presentations, posters and research papers while collaborating with other research teams.

Psychosocial and structural stressors and engagement in medical care among young sexual minority men across racial identities.

Psychosocial and structural stressors and low engagement in medical care likely contribute to the disproportionate burden of chronic disease among sexual minority men (SMM) across the life course. However, how these stressors impact engagement in medical care among young SMM (YSMM) across racial identities remains understudied. The association of psychosocial and structural stressors with forgoing care among YSMM across racial identities was examined using race-stratified adjusted logistic regression of cross-sectional data. Among 737 HIV-negative SMM aged 16-24 years, nearly all (93%) experienced discrimination in their daily lives. Non-Hispanic/Latinx Black participants reported significantly higher levels of discrimination, exposure to community violence, and food insecurity. Medical mistrust and mental health were not significantly different across racial groups. In the full sample model, education, food insecurity, and discrimination were associated with forgoing care. Among the non-Hispanic/Latinx White sample, medical mistrust and discrimination were associated with forgoing care. Among the non-Hispanic/Latinx Black sample, discrimination was associated with forgoing care. Among the Hispanic/Latinx sample, food insecurity was associated with forgoing care. Psychosocial and structural stressors were common in this YSMM cohort, and significantly different across racial/ethnic identities. Race-stratified analysis revealed differences in the association of stressors with forgoing care among YSMM across racial identities, not appreciated in the analysis limited to the total study population. Our findings may support efforts to address health inequity and improve engagement in medical care among SMM.

Paradata: Measuring Engagement in Digital HIV Interventions for Sexual and Gender Minorities.

PURPOSE OF REVIEW: The goal of this review was to examine online engagement using paradata (i.e., intervention usage metrics) as part of the reporting of online behavioral HIV prevention and care interventions' findings. We underscore the importance of these data in examining intervention engagement and effectiveness. RECENT FINDINGS: We focused on studies indexed in PubMed and published between April 1, 2017, and June 30, 2023, that reported the development and testing of online behavioral interventions for HIV prevention and/or care. Of the 689 extracted citations, 19 met the study criteria and provided engagement data - only six studies tested the association between engagement and intervention outcomes. Of these, four studies found a positive association between participants' engagement and improvements in HIV-related outcomes. Increasing attention is being paid to the collection and reporting of paradata within HIV online behavioral interventions. While the current evidence suggests a dose-response relationship due to user engagement on HIV outcomes, greater efforts to systematically collect, report, and analyze paradata are warranted.

A qualitative exploration of how to support PrEP adherence among young men who have sex with men.

New HIV infections disproportionately affect young men who have sex with men (YMSM). PrEP is effective in preventing HIV acquisition; however, adherence is critical and is often suboptimal among YMSM. Interventions addressing the unique PrEP adherence challenges faced by YMSM are needed. We conducted qualitative interviews with 20 HIV-negative, YMSM (ages 15-24) with a PrEP indication and 11 healthcare professionals to inform adaption of a PrEP adherence intervention (Life-Steps for PrEP) for YMSM. We explored environmental, healthcare, and individual factors influencing uptake, adherence, attitudes, and perspectives (including desired modifications) on the Life-Steps intervention. Interviews were analyzed using content analysis. Of YMSM study participants (mean age 21.6) 55% were White, 15% Hispanic, and 5% Black. Most YMSM were PrEP-experienced (70%). Healthcare professionals (6 prescribers, 1 nurse, 2 health educators, 2 other/unspecified) averaged 6.9 years of experience caring for YMSM. All described stigma as a barrier to PrEP; YMSM expressed concern around being perceived as "risky" and concern about inadvertent PrEP disclosure if family/friends found their medication, or if parental insurance was used. Difficulty with planning for potential adherence challenges were identified by both groups. YMSM highlighted benefits of a nurse-led intervention (i.e., adding "legitimacy"), but stressed need for nonjudgmental, "savvy" interventionists. YMSM expressed a desire for comprehensive YMSM-specific sexual health information. These findings informed modification and expansion of Life-Steps content. Results highlight key potential barriers, many of which center around privacy. Content that addresses PrEP stigma, disclosing PrEP use, navigating insurance, and planning ahead in a nonjudgmental environment by trusted providers emerged as important components of a YMSM-focused delivery of Life-Steps for PrEP.

Evaluating the Feasibility and Acceptability of a Digital Pre-Exposure Prophylaxis Navigation and Activation Intervention for Racially and Ethnically Diverse Sexual and Gender Minority Youth (PrEPresent): Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: To end the HIV epidemic by 2030, we must double down on efforts to tailor prevention interventions to both young men who have sex with men and transgender and nonbinary youth. There is an urgent need for interventions that specifically focus on pre-exposure prophylaxis (PrEP) uptake in sexual and gender minority youth (SGMY) populations. There are several factors that impact the ability of SGMY to successfully engage in the HIV prevention continuum, including uptake of PrEP. Patient activation, having the knowledge, skills, and self-efficacy to manage one's health, is an important indicator of willingness and ability to manage one's own health and care autonomously. Patient navigation also plays an important role in helping SGMY access PrEP and PrEP care, as navigators help guide patients through the health care system, set up medical appointments, and get financial, legal, and social support. OBJECTIVE: This study aims to evaluate the feasibility and acceptability of a digital PrEP navigation and activation intervention among a racially and ethnically diverse sample of SGMY living in the Los Angeles area. METHODS: In phase 1, we will conduct formative research to inform the development of PrEPresent using qualitative data from key informant interviews involving PrEP care providers and navigators and working groups with SGMY. In phase 2, we will complete 2 rounds of usability testing of PrEPresent with 8-10 SGMY assessing both the intervention content and mobile health delivery platform to ensure features are usable and content is understood. In phase 3, we will conduct a pilot randomized controlled trial to evaluate the feasibility and acceptability of PrEPresent. We will randomize, 1:1, a racially and ethnically diverse sample of 150 SGMY aged 16-26 years living in the Los Angeles area and follow participants for 6 months. RESULTS: Phase 1 (formative work) was completed in April 2021. Usability testing was completed in December 2021. As of June 2023, 148 participants have been enrolled into the PrEPresent pilot randomized controlled trial (phase 3). Enrollment is expected to be completed in July 2023, with final results anticipated in December 2023. CONCLUSIONS: The PrEPresent intervention aims to bridge the gaps in PrEP eligibility and PrEP uptake among racially and ethnically diverse SGMY. By facilitating the delivery of PrEP navigation and focusing on improving patient activation, the PrEPresent intervention has the potential to positively impact the PrEP uptake cascade in the HIV care continuum as well as serve as a model for the tailoring of PrEP interventions based on behavior-based qualifications for PrEP instead of generalized gender-based eligibility. TRIAL REGISTRATION: ClinicalTrials.gov NCT05281393; https://clinicaltrials.gov/ct2/show/NCT05281393. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/50866.

MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Adolescents and young adults with HIV repeatedly demonstrate low rates of antiretroviral therapy (ART) adherence as well as low rates of viral suppression. Digital health interventions are a promising way to engage adolescents and young adults with HIV to support ART adherence. However, few digital health interventions have been developed and tested with adolescents and young adults in countries like South Africa, where the HIV burden among adolescents and young adults is greatest. Masakhane Siphucule Impilo Yethu (MASI; Xhosa for "Let's empower each other and improve our health") is a comprehensive ART adherence-supporting app for South African adolescents and young adults with HIV. It was culturally adapted using the HealthMpowerment platform. OBJECTIVE: The aim of this paper is to describe the protocol for a pilot randomized controlled trial examining the feasibility, acceptability, and preliminary efficacy of MASI on self-reported ART adherence and social support. METHODS: We will enroll 50 adolescents and young adults with HIV ages 15-21 years. Participants will be recruited from public ART clinics linked to a large government-funded teaching hospital in Cape Town, South Africa. Participants will be randomized 1:1 into either the intervention arm receiving a full version of MASI or the control arm receiving an information-only version of the app (n=25 per arm). Participants will be asked to engage with MASI daily for 6 months. All participants will complete baseline and follow-up assessments at 3 and 6 months. RESULTS: Study screening began in May 2022 and the first participant was enrolled on June 21, 2022. As of June 12, 2023, 81 participants have completed screeners, and 36 eligible participants have been enrolled in the pilot randomized controlled trial. Recruitment is anticipated to last through August 31, 2023, with study activities anticipated through February 29, 2024. CONCLUSIONS: There is an urgent need for innovative interventions to improve ART adherence among adolescents and young adults in settings like South Africa. If found to be feasible and acceptable, MASI could be implemented with adolescents and young adults with HIV in other parts of the country. TRIAL REGISTRATION: ClinicalTrials.gov NCT04661878; https://clinicaltrials.gov/ct2/show/study/NCT04661878. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47137.

Structural-Level Racial-, Sexual Orientation-, and HIV-Related Discrimination and Subsequent Criminal Justice Involvement Among Young, Black, Men Who Have Sex With Men in North Carolina.

Multiple aspects of Black young men who have sex with men's (YMSM) identities cause them to be differentially targeted for arrest and incarceration. However, limited research has explored structural drivers of Black YMSM' criminal justice involvement, particularly co-occurring forms of discrimination. This article examines the temporal relationship between perceived racial discrimination, perceived sexual orientation discrimination, and community-level HIV discrimination and criminal justice involvement among Black YMSM in North Carolina. The study followed 465 Black YMSM from November 2013 to October 2016 who were recruited for a randomized controlled trial to test an internet-based intervention for Black YMSM living with, and at risk for HIV; participants completed online surveys at baseline, 3, 6, and 12 months. Logistic regression was used to explore the relationship between the three predictors at baseline (i.e., perceived racism and sexual orientation discrimination and community-level HIV discrimination) and criminal justice involvement at follow-up. All three predictor variables were significantly associated with subsequent criminal justice involvement in separate regression models that adjusted for other covariates: HIV discrimination (aOR = 1.06 [1.01-1.11]), perceived sexual orientation discrimination (aOR = 1.12 [1.00-1.27]), and perceived racism (aOR = 1.26 [1.12-1.42]). Perceived racism remained significant in the model with all three predictors (aOR = 1.29 [1.07-1.55]). Racism did not modify the relationship between HIV discrimination and perceived sexual orientation discrimination and criminal justice involvement. This study expands existing research by exploring racism as a structural driver of criminal justice involvement; we subsequently examined whether racism modified the effect of the two other predictors. It also contributes to research on co-occurring discrimination by examining their impact on an underrepresented population.

Who prefers what? Correlates of preferences for next-generation HIV prevention products among a national U.S. sample of young men who have sex with men.

INTRODUCTION: Pre-exposure prophylaxis (PrEP) has been available for young people for over a decade, yet only ∼15% of young people in the United States with indications for PrEP have a prescription for it. Next-generation PrEP modalities may address some of the challenges of daily oral PrEP. However, preferences for these products are unknown. METHODS: From October 2020 to June 2021, we conducted an online survey of 737 cisgender, young men who have sex with men (age 15-24 years) without HIV across the United States who reported same-sex attraction or consensual sex with another man in the past 6 months. Participants completed a conjoint experiment comparing daily oral pills, event-driven oral pills, event-driven rectal douches, intramuscular injections, intravenous broadly neutralizing antibody (bnAb) infusions and subcutaneous implants. Participants ranked the products from most to least preferred. Exploded logit models examined the association between ranked preferences of PrEP modalities and socio-demographic and behavioural characteristics. RESULTS: Participants' mean age was 21 years (SD = 2.3), and 56% identified as White. Nineteen percent were currently taking daily oral PrEP, and another 9% had previously taken it. Participants prioritized efficacy, absence of side effects and costs in the conjoint analyses. Daily oral PrEP had the highest preference ranking, followed by event-driven oral (OR = 0.89, p = 0.058), injectable (OR = 0.83, p = 0.005), implant (OR = 0.48, p < 0.0001), bnAb infusions (OR = 0.38, p < 0.0001) and rectal douches (OR = 0.24, p < 0.0001). There were differences in PrEP preferences across age, insurance status, sexual behaviour, PrEP use history, HIV and sexually transmitted infection (STI) testing history, and STI diagnoses (omnibus tests: p < 0.05). Participants also provided reasons for selecting their top product choice: ease of use for those who chose daily oral (99%) and daily event-driven (98.5%); feel more protected against HIV for those who chose injectable (95.4%) and implants (100%); not worrying about forgetting to take it for those who chose bnAbs (93.8%); and being able to stop taking it when they want for those who chose rectal douche (90.9%). CONCLUSIONS: Next-generation modalities were less likely to be preferred over daily oral PrEP, with differences in the magnitude by socio-demographic and behavioural characteristics. Given the low uptake of daily oral PrEP, end-users' preferences for and concerns about PrEP products must be understood to ensure high acceptability and penetration.

Cost of peer mystery shopping to increase cultural competency in community clinics offering HIV/STI testing to young men who have sex with men: results from the get connected trial.

INTRODUCTION: Cultural competency has been identified as a barrier to lesbian, gay, bisexual and transgender (LGBT) populations seeking care. Mystery shopping has been widely employed in the formal health care sector as a quality improvement (QI) tool to address specific client needs. The approach has had limited use in community-based organizations due in part to lack of knowledge and resource requirement concerns. Several mystery shopping initiatives are now being implemented which focus on the LGBT population with the goal of reducing barriers to accessing care. One subset targets men who have sex with men (MSM) to increase uptake of human immunodeficiency virus (HIV) testing. No study investigates the costs of these initiatives. Get Connected was a randomized control trial with the objective of increasing uptake of HIV-prevention services among young men who have sex with men (YMSM) through use of a resource-locator application (App). The initial phase of the trial employed peer-led mystery shopping to identify culturally competent HIV testing sites for inclusion in the App. The second phase of the trial randomized YMSM to test the efficacy of the App. Our objective was to determine the resource inputs and costs of peer-led mystery shopping to identify clinics for inclusion in the App as costs would be critical in informing possible adoption by organizations and sustainability of this model. METHODS: Through consultation with study staff, we created a resource inventory for undertaking the community-based, peer-led mystery shopping program. We used activity-based costing to price each of the inputs. We classified inputs as start-up and those for on-going implementation. We calculated costs for each category, total costs and cost per mystery shopper visit for the four-month trial and annually to reflect standard budgeting periods for data collected from September of 2019 through September of 2020. RESULTS: Recruitment and training of peer mystery shoppers were the most expensive tasks. Average start-up costs were $10,001 (SD $39.8). Four-month average implementation costs per visit were $228 (SD $1.97). Average annual implementation costs per visit were 33% lower at $151 (SD $5.60). CONCLUSIONS: Peer-led, mystery shopping of HIV-testing sites is feasible, and is likely affordable for medium to large public health departments.

Supporting Adolescents With HIV in South Africa Through an Adherence-Supporting App: Mixed Methods Beta-Testing Study.

BACKGROUND: Novel smartphone app-delivered interventions have the potential to improve HIV treatment adherence among adolescents with HIV, although such interventions are limited. Our team has developed Masakhane Siphucule Impilo Yethu (MASI; Xhosa for "Let's empower each other and improve our health"), a smartphone app-delivered intervention to improve treatment adherence among adolescents with HIV in South Africa. MASI was adapted to the South African cultural context using the HealthMpowerment platform, an evidence-based digital health intervention developed for and with youth in the United States. OBJECTIVE: We conducted this beta-testing study to (1) explore the initial usability of MASI, (2) examine engagement and experiences using MASI features, and (3) inform refinements to the app and intervention implementation plan prior to a subsequent pilot randomized controlled trial (RCT). METHODS: This study was conducted from August 2021 to December 2021 in Cape Town, South Africa. Beta-testing participants received access to MASI for 3 weeks. A mixed methods approach was used, with brief questionnaires and semistructured in-depth interviews conducted prior to app installation and after 1 week to 2 weeks of app testing. Engagement with MASI was measured through analysis of back-end app paradata, and follow-up in-depth interview guides were tailored to each participant based on their app use. RESULTS: Participants in the beta-testing study (6 male participants, 6 female participants; ages 16-19 years) collectively spent 4.3 hours in MASI, averaging 21.4 minutes per participant over the 3-week period (range 1-51.8 minutes). Participants logged into MASI an average of 24.1 (range 10-75) times during the study period. The mean System Usability Scale score was 69.5 (SD 18), which is considered slightly above average for digital health apps. Thematic analysis of qualitative results revealed generally positive experiences across MASI features, although opportunities to refine the app and intervention delivery were identified. CONCLUSIONS: Initial usability of MASI was high, and participants described having a generally positive experience across MASI features. Systematically analyzing paradata and using the interview findings to explore participant experiences allowed us to gain richer insights into patterns of participant engagement, enabling our team to further enhance MASI. The results from this study led to a few technological refinements to improve the user experience. Enhancements were also made to the intervention implementation plan in preparation for a pilot RCT. Lessons learned from the conduct of this beta-testing study may inform the development, implementation, and evaluation of similar app-delivered interventions in the future.

Prediction of Sex and the Potential Use of On-Demand PrEP Among Young Men Who Have Sex With Men in the United States.

BACKGROUND: On-demand dosing of preexposure prophylaxis (PrEP) requires accurate prediction of sex; however, prediction abilities among young men who have sex with men (YMSM) have not been characterized. SETTING: A nationally recruited prospective cohort of YMSM ages 16-24 years. METHODS: We followed 120 YMSM for 8 weeks using digital daily surveys (DDSs) to measure engagement in and prediction of anal sex over 24 hours, along with condom use and other encounter-level circumstances. Our main outcome, an "unpredicted spontaneous encounter," was defined as an anal sex encounter that occurred without sufficient prior knowledge to (hypothetically) enable protective on-demand PrEP use according to dosing guidelines. We operationalized this outcome as an anal sex encounter for which a participant indicated: (1) on the prior day's DDS that there was a low likelihood of sex occurring in the subsequent 24 hours (unpredicted) and (2) on the current day's DDS that he knew ≤2 hours in advance that the encounter would occur (spontaneous). RESULTS: Approximately one-third of all anal sex encounters during the study period were unpredicted and spontaneous and would not have been protected (hypothetically) by on-demand dosing. More than two-thirds of participants experienced such an encounter and almost three-quarters of all acts were condomless. CONCLUSIONS: On-demand PrEP to prevent HIV acquisition may be challenging for many YMSM. Clinical and public health approaches that account for patients' predictive abilities alongside their dosing preferences may help to optimize selection of and adherence to PrEP dosing strategies.

A Relationship-Focused HIV Prevention Intervention for Young Sexual Minority Men in the United States: A Pilot Randomized Controlled Trial of the We Prevent Intervention.

We Prevent is a virtual counseling intervention designed to improve communication as a mechanism for reducing HIV risk among young sexual minority men (SMM) in relationships. We evaluated the feasibility, acceptability, and preliminary efficacy of We Prevent in comparison to standard Counseling, Testing, and Referral among a national sample of 318 SMM ages 15-24 in a pilot randomized control trial. We found significant differences in condomless sex with outside partners; however, there were no differences in other sexual behaviors, sexual agreements, intimate partner violence (IPV), or communication between the conditions across the 9-month follow-ups. Stratified analyses found non-significant trends suggestive that We Prevent may reduce condomless sex for those ages 15-17 and for relationships over 1-year and may reduce IPV in relationships over 1-year. Though study retention was adequate, session attendance was low. Exit interviews participants reported benefits of We Prevent and provided insights into how to increase uptake.

Adolescents Living With or at Risk for HIV: A Pooled Descriptive Analysis of Studies From the Adolescent Medicine Trials Network for HIV/AIDS Interventions.

PURPOSE: This study aims to describe the cohort of Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) research program participants and evaluate whether the ATN's recently completed 5-year cycle recruited study participants who parallel the populations most impacted by HIV in the United States. METHODS: Harmonized measures across ATN studies collected at baseline were aggregated for participants aged 13-24 years. Pooled means and proportions stratified by HIV status (at risk for or living with HIV) were calculated using unweighted averages of study-specific aggregate data. Medians were estimated using a weighted median of medians method. Public use 2019 Centers for Disease Control and Prevention surveillance data for state-level new HIV diagnoses and HIV prevalence among US youth aged 13-24 years were obtained for use as reference populations for ATN at-risk youth and youth living with HIV (YLWH), respectively. RESULTS: Data from 3,185 youth at-risk for HIV and 542 YLWH were pooled from 21 ATN study phases conducted across the United States. Among ATN studies tailored to at-risk youth, a higher proportion of participants were White and a lower proportion were Black/African American and Hispanic/Latinx compared to youth newly diagnosed with HIV in the United States in 2019. Participants in ATN studies tailored to YLWH were demographically similar to YLWH in the United States. DISCUSSION: The development of data harmonization guidelines for ATN research activities facilitated this cross-network pooled analysis. These findings suggest the ATN's YLWH are representative, but that future studies of at-risk youth should prioritize recruitment strategies to enroll more participants from African American and Hispanic/Latinx populations.

Engaging Black or African American and Hispanic or Latino Men Who Have Sex With Men for HIV Testing and Prevention Services Through Technology: Protocol for the iSTAMP Comparative Effectiveness Trial.

BACKGROUND: Gay, bisexual, and other men who have sex with men (MSM), particularly Black or African American MSM (BMSM) and Hispanic or Latino MSM (HLMSM), continue to be disproportionately affected by the HIV epidemic in the United States. Previous HIV self-testing programs have yielded high testing rates, although these studies predominantly enrolled White, non-Hispanic MSM. Mobile health tools can support HIV prevention, testing, and treatment. This protocol details an implementation study of mailing free HIV self-tests (HIVSTs) nested within a randomized controlled trial designed to assess the benefit of a mobile phone app for increasing the uptake of HIV prevention and other social services. OBJECTIVE: This study was a comparative effectiveness trial of innovative recruitment and testing promotion strategies intended to effectively reach cisgender BMSM and HLMSM. We evaluated the use of a mobile app for increasing access to care. METHODS: Study development began with individual and group consultations that elicited feedback from 3 core groups: HIV care practitioners and researchers, HIV service organization leaders from study states, and BMSM and HLMSM living in the study states. Upon completion of the formative qualitative work, participants from 11 states, based on the observed areas of highest rate of new HIV diagnoses among Black and Hispanic MSM, were recruited through social networking websites and smartphone apps. After eligibility was verified, participants consented and were randomized to the intervention arm (access to the Know@Home mobile app) or the control arm (referral to web resources). We provided all participants with HIVSTs. The evaluation of the efficacy of a mobile phone app to support linkage to posttest prevention services that included sexually transmitted infection testing, pre-exposure prophylaxis initiation, antiretroviral treatment, and acquisition of condoms and compatible lubricants has been planned. Data on these outcomes were obtained from several sources, including HIVST-reporting surveys, the 4-month follow-up survey, laboratory analyses of dried blood spot cards returned by the participant, and data obtained from the state health department surveillance systems. Where possible, relevant subgroup analyses were performed. RESULTS: During the formative development phase, 9 consultations were conducted: 6 in-depth individual discussions and 3 group consultations. From February 2020 through February 2021, we enrolled 2093 MSM in the randomized controlled trial from 11 states, 1149 BMSM and 944 HLMSM. CONCLUSIONS: This study was designed and implemented to evaluate the effectiveness of recruitment strategies to reach BMSM and HMSM and of a mobile app with regard to linkage to HIV prevention or treatment services. Data were also obtained to allow for the analyses of cost and cost-effectiveness related to study enrollment, HIV testing uptake, identification of previously undiagnosed HIV, sexually transmitted infection testing and treatment, and linkage to HIV prevention or treatment services. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04219878); https://clinicaltrials.gov/ct2/show/NCT04219878. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43414.

Tough Talks COVID-19 Digital Health Intervention for Vaccine Hesitancy Among Black Young Adults: Protocol for a Hybrid Type 1 Effectiveness Implementation Randomized Controlled Trial.

BACKGROUND: Interventions for increasing the uptake of COVID-19 vaccination among Black young adults are central to ending the pandemic. Black young adults experience harms from structural forces, such as racism and stigma, that reduce receptivity to traditional public health messaging due to skepticism and distrust. As such, Black young adults continue to represent a priority population on which to focus efforts for promoting COVID-19 vaccine uptake. OBJECTIVE: In aims 1 and 2, the Tough Talks digital health intervention for HIV disclosure will be adapted to address COVID-19 vaccine hesitancy and tailored to the experiences of Black young adults in the southern United States (Tough Talks for COVID-19). In aim 3, the newly adapted Tough Talks for COVID-19 digital health intervention will be tested across the following three southern states: Alabama, Georgia, and North Carolina. METHODS: Our innovative digital health intervention study will include qualitative and quantitative assessments. A unique combination of methodological techniques, including web-based surveys, choose-your-own-adventures, digital storytelling, user acceptability testing, and community-based participatory approaches, will culminate in a 2-arm hybrid type 1 effectiveness implementation randomized controlled trial, wherein participants will be randomized to the Tough Talks for COVID-19 intervention arm or a standard-of-care control condition (N=360). Logistic regression will be used to determine the effect of the treatment arm on the probability of vaccination uptake (primary COVID-19 vaccine series or recommended boosters). Concurrently, the inner and outer contexts of implementation will be ascertained and catalogued to inform future scale-up. Florida State University's institutional review board approved the study (STUDY00003617). RESULTS: Our study was funded at the end of April 2021. Aim 1 data collection concluded in early 2022. The entire study is expected to conclude in January 2025. CONCLUSIONS: If effective, our digital health intervention will be poised for broad, rapid dissemination to reduce COVID-19 mortality among unvaccinated Black young adults in the southern United States. Our findings will have the potential to inform efforts that seek to address medical mistrust through participatory approaches. The lessons learned from the conduct of our study could be instrumental in improving health care engagement among Black young adults for several critical areas that disproportionately harm this community, such as tobacco control and diabetes prevention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05490329; https://clinicaltrials.gov/ct2/show/NCT05490329. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41240.

Examining the Role of Autonomy Support, Goal Setting, and Care Coordination Quality on HIV PrEP Adherence in Black Men Who Have Sex with Men: HPTN 073.

Autonomy support is a concept that is derived from self-determination theory. Autonomy refers to the freedom to act as one chooses. The current study aimed to examine if autonomy support was associated with dried blood spot validated pre-exposure prophylaxis (PrEP) adherence, and whether the association was mediated by PrEP adherence goal setting and progress toward PrEP adherence goals. Our sample was drawn from Black men who have sex with men (MSM) from across three cities (Chapel Hill, NC; Los Angeles, CA; and Washington, DC) in the United States between February 2013 and September 2014. We used logistic regression to evaluate associations between study variables and path analysis to test mediation effects. Participants were, on average, 28 [standard deviation (SD) = 1.12] years old and 25% were unemployed. We found that MSM who experienced high autonomy support were more likely to adhere to PrEP [odds ratio (OR) = 1.17; 95% confidence interval: 1.00-1.38]. MSM who set PrEP adherence goals were more likely to adhere to PrEP. Moreover, MSM who reported making progress toward their goals were also more likely to adhere to PrEP. Finally, client perception of coordination quality enhanced the magnitude of the association between goal setting and goal progress and the effect size of goal progress on PrEP adherence. Autonomy support, goal setting, goal monitoring/evaluation, and care coordination quality influenced PrEP adherence among Black MSM. Our findings indicate that while it is important to set goals for PrEP adherence, goal setting may need to be accompanied by progress monitoring to achieve the maximal effect.