Adolescent Trials Network for HIV-AIDS Scale It Up Program: Protocol for a Rational and Overview

Background: The past 30 years have witnessed such significant progress in the prevention and treatment of HIV/AIDS that an AIDS-free generation and the end to the global AIDS epidemic are ambitious, but achievable, national and global goals. Despite growing optimism, globally, youth living with HIV are markedly less likely to receive antiretroviral therapy than adults (23% vs 38%). Furthermore, marked health disparities exist regarding HIV infection risk, with young men of color who have sex with men disproportionately affected. A large body of research has identified highly impactful facilitators of and barriers to behavior change. Several efficacious interventions have been created that decrease the rate of new HIV infections among youth and reduce morbidity among youth living with HIV. However, full benefits that should be possible based on the tools and interventions currently available are yet to be realized in youth, in large part, because efficacious interventions have not been implemented in real-world settings. Scale It Up (SIU) primarily aims to assemble research teams that will ultimately bring to practice evidence-based interventions that positively impact the youth HIV prevention and care cascades, and in turn, advance the fields of implementation science and self-management science. Objective: This paper aims to describe the structure of the U19-SIU and the effectiveness-implementation hybrid trials, as well as other center-wide protocols and initiatives, implemented within SIU. Methods: SIU will achieve its aims through 4 individual primary protocols, 2 center-wide protocols, and 3 cross-project initiatives. Results: SIU was funded by National Institute for Child Health and Human Development (U19HD089875) and began in October 2016. As of November 2018, 6 SIU protocols have launched at least the first phase of work (ATN 144 SMART: Sequential Multiple Assignment Randomized Trial; ATN 145 YMHP: Young Men’s Health Project; ATN 146 TMI: Tailored Motivational Interviewing Intervention; ATN 153 EPIS: Exploration, Preparation, Implementation, Sustainment model; ATN 154 CM: Cascade Monitoring; ATN 156 We Test: Couples\u27 Communication and HIV Testing). Further details can be found in the individual protocol papers. Conclusions: To date, the youth HIV research portfolio has not adequately advanced the important care area of self-management. SIU protocols and initiatives address this broad issue by focusing on evaluating the effectiveness and implementation of self-management interventions. SIU is highly innovative for 5 primary reasons: (1) our research framework expands the application of “self-management”; (2) the 4 primary protocols utilize innovative hybrid designs; (3) our Analytic Core will conduct cost-effectiveness analyses of each intervention; (4) across all 4 primary protocols, our Implementation Science Core will apply implementation scales designed to assess inner and outer context factors; and (5) we shall advance understanding of the dynamics between provider and patient through analysis of recorded interactions

How different are men who do not know their HIV status from those who do? Results from an U.S. online study of gay and bisexual men

We compared self-described HIV-positive (31.6%, n=445), HIV-negative (56.8%, n=801), and HIV-unknown (11.6%, n=164) gay and bisexual men (GBM) on sociodemographic and behavioral characteristics. Participants from across the U.S. were enrolled via a popular sexual networking website to complete an online survey. In total, 44.8% of HIV-negative and HIV-unknown men said they had not been tested for HIV in the CDC-recommended last 6 months. HIV-unknown men significantly differed from HIV-negative and HIV-positive men in sexual behavior and HIV status disclosure patterns. HIV-unknown men were more willing than HIV-negative men to take PrEP; however, HIV-unknown men were significantly less likely than others to have health insurance or a primary care provider. Given the observed differences, researchers should consider analyzing men who are HIV-unknown distinctly from HIV-negative and HIV-positive men

Community Reactions to Campaigns Addressing Crystal Methamphetamine Use Among Gay and Bisexual Men In New York City

Crystal methamphetamine (aka “crystal meth”) use with high-risk sex has become an emerging health problem for gay and bisexual men in New York City since the late 1990s. Public health campaigns were eventually developed to encourage gay and bisexual men to avoid or reconsider using crystal meth. Reactions to three campaigns were measured with a cross-sectional survey administered in 2004. Among an ethnically-diverse sample of 971 gay and bisexual men, 61.8% reported seeing the campaigns. Those who reported ever using crystal meth, recent use, and recent use with sex were significantly more likely to have seen the campaigns. In general, white men, HIV-negative men, and men not currently using crystal meth responded more positively to the campaigns than their counterparts; yet, more men of color reported having discussions with partners and friends about their crystal use as a result of these campaigns. Implications for researchers and practitioners are discussed

Familiarity with and preferences for oral and long-acting injectable HIV pre-exposure prophylaxis (PrEP) in a national sample of gay and bisexual men in the U.S.

Objectives: We sought to determine preferences for oral versus long-acting injectable (LAI) PrEP among gay and bisexual men (GBM). Methods: We surveyed a national U.S. sample of 1,071 GBM about forms of PrEP. Results: Overall, 46.0% preferred LAI, 14.3% oral, 21.7% whichever was most effective, 10.1% had no preference, and 7.8% would not take PrEP. There were no differences in PrEP preferences by race/ethnicity, income, region of residence, or relationship status. Those unwilling to take PrEP were significantly older than those who preferred LAI PrEP and those who would take either. Those who preferred the most effective form were younger, had less education, and reported more recent club drug use. Those who reported condomless anal sex and those who thought they were good PrEP candidates were more willing to take PrEP. Long-term health and side effects were of the greatest concern for both LAI and oral PrEP. Conclusions: The availability of LAI PrEP has the potential to increase uptake among GBM. The results of ongoing clinical trials of LAI PrEP will need to demonstrate similar or greater efficacy as daily Truvada for uptake to be maximized

Sexual behavior varies between same-race and different-race partnerships: A daily diary study of highly sexually active Black, Latino, and White gay and bisexual men

Background. Gay and bisexual men (GBM) are at elevated risk for gonorrhea and chlamydia trachomatis (GC/CT). Rectal GC/CT symptoms may be less obvious than urethral, increasing opportunities for undiagnosed rectal GC/CT. Method. A U.S. national sample of 1,071 GBM completed urethral and rectal GC/CT testing and an online survey. Results. In total, 6.2% were GC/CT positive (5.3% rectal, 1.7% urethral). We calculated adjusted (for education, race, age, relationship status, having health insurance, and income) odds ratios for factors associated with rectal and urethral GC/CT diagnoses. Age was inversely associated with urethral and rectal GC/CT. Compared to White men, Latinos had significantly greater odds of rectal GC/CT. Among men who reported anal sex, those reporting only insertive sex had lower odds of rectal GC/CT than men who reported both insertive and receptive. There was a positive association between rectal GC/CT and number of male partners (\u3c12 \u3emonths), the number of anal receptive acts, receptive condomless anal sex (CAS) acts, and insertive CAS acts. Compared to those who had engaged in both insertive and receptive anal sex, those who engaged in only receptive anal sex had lower odds of urethral GC/CT. The number of male partners (\u3c12 \u3emonths) was associated with increased odds of urethral GC/CT. Conclusion. Rectal GC/CT was more common than urethral and associated with some demographic and behavioral characteristics. Our finding that insertive CAS acts was associated with rectal GC/CT highlights that providers should screen patients for GC/CT via a full range of transmission routes, lest GC/CT go undiagnosed

Social Media Use and HIV Transmission Risk Behavior Among Ethnically Diverse HIV-Positive Gay Men: Results of an Online Study in Three U.S. States

Though Black and Hispanic men who have sex with men (MSM) are at an increased risk for HIV, few HIV risk reduction interventions that target HIV-positive MSM, and even fewer that use technology, have been designed to target these groups. Despite similar rates of social media and technology use across racial/ethnic groups, online engagement of minority MSM for HIV prevention efforts is low. Since minority MSM tend to have less representation in online HIV prevention studies, the goals of this online anonymous study of HIV-positive gay-identified men were to test the feasibility of conducting targeted recruitment by race/ethnicity and sexual orientation, to assess technology and social media use,and to assess global HIV transmission risk. In 2011,an anonymous online survey was conducted among 463 members of an HIV-positive personals website. Emails were sent to a subset of HIV-positive male members who self- identified as gay. While 57% were White, substantial proportions of participants were Black (20%) or Hispanic (18 %). Median age was 46 (range 18–79). Men who reported using 3 or more websites or apps to meet sex partners were significantly more likely to report anal intercourse (AOR 4.43, p\.001) and condomless anal sex (CAS) (AOR 2.70, p\.05) in the past 3 months. The only predictor of CAS with HIV-negative or unknown status partners was being under age 30 (AOR3.38, p\ .01). This study helped to inform online targeted recruitment techniques, access to technology and social media use, and sexual risk among a diverse sample of HIV-positive gay men. Efficacy trials of technology-based HIV prevention interventions targeting high-risk minority HIV-positive MSM are warranted

Changes in familiarity with and willingness to take PrEP in a longitudinal study of highly sexually active gay and bisexual men

PURPOSE: For gay and bisexual men (GBM), research suggests that familiarity with Pre-Exposure Prophylaxis (PrEP) has been increasing since being approved by the U.S. FDA in 2012. However, it is less clear how willingness to start using PrEP has changed over time. Likewise, some have expressed concerns regarding the potential for risk compensation (i.e., reduced condom use) were one to start PrEP; however, again, it is unclear how these may have been changing over time. METHODS: We conducted baseline and 12 month assessments with 158 highly sexually active HIV-negative GBM in NYC who were assessed between 2011 and 2014. We examined change over time both between participants (based on when they entered the study), as well as within each participant (over the 12 months of his involvement). RESULTS: Familiarity with PrEP increased over time (both between and within participants); however, willingness to take PrEP did not change (neither between nor within participants). Few men believed taking PrEP would cause their condomless anal sex (CAS) to increase and this did not change over time. However, a majority believed PrEP would increase temptation for CAS, and this did not change over time within participants. Sexual compulsivity (SC) symptomology was associated with higher willingness to take PrEP and perceiving that PrEP would increase one’s temptations for CAS. Furthermore, recent CAS was associated with greater willingness to take PrEP, a perception that PrEP would increase one’s likelihood to engage in CAS, and a perception that being on PrEP would increase one’s temptation for CAS. CONCLUSIONS: Participants became more familiar with PrEP over time; however, willingness to start PrEP did not change, and this may serve as an opportunity for providers to 3 discuss PrEP with their patients. Higher risk men were interested in PrEP and pre-existing patterns of sexual behavior may be the primary determinant of CAS while on PrEP

Daily Minority Stress and Affect among Gay and Bisexual Men: A 30-day Diary Study

Background. This study examined the time-variant association between daily minority stress and daily affect among gay and bisexual men. Tests of time-lagged associations allow for a stronger causal examination of minority stress-affect associations compared with static assessments. Multilevel modeling allows for comparison of associations between minority stress and daily affect when minority stress is modeled as a between-person factor and a within-person time-fluctuating state. Methods. 371 gay and bisexual men in New York City completed a 30-day daily diary, recording daily experiences of minority stress and positive affect (PA), negative affect (NA), and anxious affect (AA). Multilevel analyses examined associations between minority stress and affect in both same-day and time-lagged analyses, with minority stress assessed as both a between-person factor and a within-person state. Results. Daily minority stress, modeled as both a between-person and within-person construct, significantly predicted lower PA and higher NA and AA. Daily minority stress also predicted lower subsequent-day PA and higher subsequent-day NA and AA. Limitations. Self-report assessments and the unique sample may limit generalizability of this study. Conclusions. The time-variant association between sexual minority stress and affect found here substantiates the basic tenet of minority stress theory with a fine-grained analysis of gay and bisexual men’s daily experience. Time-lagged effects suggest a potentially causal pathway between minority stress as a social determinant of mood and anxiety disorder symptoms among gay and bisexual men. When modeled as both a between-person factor and within-person state, minority stress demonstrated expected patterns with affect

Implementation Science Research Examining the Integration of Evidence-Based Practices Into HIV Prevention and Clinical Care: Protocol for a Mixed-Methods Study Using the Exploration, Preparation, Implementation, and Sustainment (EPIS) Model

BACKGROUND: The Exploration, Preparation, Implementation, and Sustainment (EPIS) model is an implementation framework for studying the integration of evidence-based practices (EBPs) into real-world settings. The EPIS model conceptualizes implementation as a process starting with the earliest stages of problem recognition (Exploration) through the continued use of an EBP in a given clinical context (Sustainment). This is the first implementation science (IS) study of the integration of EBPs into adolescent HIV prevention and care settings. OBJECTIVE: This protocol (ATN 153 EPIS) is part of the Scale It Up program, a research program administered by the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN), described in this issue by Naar et al. The EPIS study is a descriptive study of the uptake of 4 EBPs within the Scale It Up program. The goal of EPIS is to understand the barriers and facilitators associated with the Preparation, Implementation, and Sustainment of EBPs into HIV prevention and clinical care settings. METHODS: The EPIS study is a convergent parallel mixed-methods IS study. Key implementation stakeholders, that is, clinical care providers and leaders, located within 13 ATN sites across the United States will complete a qualitative interview conducted by telephone and Web-based surveys at 3 key implementation stages. The Preparation assessment occurs before EBP implementation, Implementation occurs immediately after sites finish implementation activities and prepare for sustainment, and Sustainment occurs 1 year postimplementation. Assessments will examine stakeholders\u27 perceptions of the barriers and facilitators to EBP implementation within their clinical site as outlined by the EPIS framework. RESULTS: The EPIS baseline period began in June 2017 and concluded in May 2018; analysis of the baseline data is underway. To date, 153 stakeholders have completed qualitative interviews, and 91.5% (140/153) completed the quantitative survey. CONCLUSIONS: The knowledge gained from the EPIS study will strengthen the implementation and sustainment of EBPs in adolescent prevention and clinical care contexts by offering insights into the barriers and facilitators of successful EBP implementation and sustainment in real-world clinical contexts

Home-based pre-exposure prophylaxis (PrEP) services for gay and bisexual men: An opportunity to address barriers to PrEP uptake and persistence

Gay, bisexual, and other men who have sex with men (GBM) are disproportionately affected by the HIV epidemic. Despite the promise of pre-exposure prophylaxis (PrEP) in reducing HIV transmission risk, barriers for uptake and persistence exist. We sought to identify whether GBM in a nationwide cohort who have not yet initiated PrEP (n = 906) would prefer to get PrEP-related care from a primary care provider (PCP) compared to a specialist clinic or provider. We then sought to identify their level of interest and factors associated with preference for using home-based PrEP services (i.e., HB-PrEP), defined to participants as conducting HIV/STI self-testing from home with PrEP prescription mailing after an initial inperson clinic visit. We examined the associations of demographics, sexual HIV transmission risk, concern about frequent medical checkups associated with PrEP, health care access, and PrEP intentions with preferences for healthcare provider type and HB-PrEP. Concern about frequent medical checkups were associated with preferring a PCP for PrEP-related care, but men who perceived a barrier to bringing up the topic of PrEP with a doctor preferred a specialist clinic or provider more than a PCP. HB-PrEP was more appealing for younger men and those engaged in sexual HIV transmission risk, suggesting HB-PrEP could help reach GBM most vulnerable to HIV and in need of PrEP. HB-PrEP expansion has potential to increase PrEP uptake and persistence among GBM, particularly for men with barriers to clinic-based care and higher intentions to initiate PrEP. Clinical guidelines regarding HB-PrEP are needed to expand its use