HIV-1 Incidence, Adherence, and Drug Resistance in Individuals Taking Daily Emtricitabine/Tenofovir Disoproxil Fumarate for HIV-1 Pre-Exposure Prophylaxis: Pooled Analysis From 72 Global Studies.

BACKGROUND: Oral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (F/TDF) has high efficacy against HIV-1 acquisition. Seventy-two prospective studies of daily oral F/TDF PrEP were conducted to evaluate HIV-1 incidence, drug resistance, adherence, and bone and renal safety in diverse settings. METHODS: HIV-1 incidence was calculated from incident HIV-1 diagnoses after PrEP initiation and within 60 days of discontinuation. Tenofovir concentration in dried blood spots (DBS), drug resistance, and bone/renal safety indicators were evaluated in a subset of studies. RESULTS: Among 17,274 participants, there were 101 cases with new HIV-1 diagnosis (0.77 per 100 person-years; 95% CI 0.63-0.94). In 78 cases with resistance data, 18 (23%) had M184I or V, one (1.3%) had K65R, and three (3.8%) had both mutations. In 54 cases with tenofovir concentration data from DBS, 45 (83.3%), 2 (3.7%), 6 (11.1%), and 1 (1.9%) had average adherence of <2, 2-3, 4-6, and ≥7 doses/week, respectively, and the corresponding incidence was 3.9 (95% CI 2.9-5.3), 0.24 (0.060-0.95), 0.27 (0.12-0.60), and 0.054 (0.008-0.38) per 100 person-years. Adherence was low in younger participants, Hispanic/Latinx and Black participants, cisgender women, and transgender women. Bone and renal adverse event incidence rates were 0.69 and 11.8 per 100 person-years, respectively, consistent with previous reports. CONCLUSIONS: Leveraging the largest pooled analysis of global PrEP studies to date, we demonstrate that F/TDF is safe and highly effective, even with less than daily dosing, in diverse clinical settings, geographies, populations, and routes of HIV-1 exposure.

Freedom as Prevention: Mechanisms of Autonomy Support for Promoting HIV Pre-Exposure Prophylaxis Use and Condom Use among Black MSM in 3 US Cities-HPTN 073.

Healthcare providers who use controlling or coercive strategies may compel short-term enactment of HIV and sexually transmitted infection prevention behaviors but may inadvertently undermine their client's motivation to maintain those behaviors in the absence of external pressure. Autonomous motivation refers to the self-emanating and self-determined drive for engaging in health behaviors. It is associated with long-term maintenance of health behaviors. We used structural equation modeling to investigate whether autonomy support was associated with increased odds of therapeutic serum levels of pre-exposure prophylaxis, through a pathway that satisfies basic psychological needs for autonomous self-regulation and competence regarding pre-exposure prophylaxis use. We also investigated whether autonomy support was associated with decreased odds of condomless anal intercourse via the same psychological needs-satisfaction pathway of autonomous self-regulation and competence regarding condom use. We tested these two theorized pathways using secondary data from a longitudinal sample of Black men who have sex with men from across three cities in the US (N = 226). Data from the sample fit the theorized models regarding the pathways by which autonomy support leads to the presence of therapeutic PrEP levels in serum (χ2 = 0.56; RMSEA = 0.04; CFI = .99, TLI = 0.98) and how it also leads to decreased odds of condomless anal intercourse (χ2 = 0.58; RMSEA = 0.03; CFI = 0.99; TLI = 0.98). These findings provide scientific evidence for the utility of self-determination theory as a model to guide intervention approaches to optimize the implementation and impact of PrEP for Black men who have sex with men.

Risk compensation in HIV PrEP adherence among Black men who have sex with men in HPTN 073 study.

While HIV infections among men who have sex men (MSM) have started to decline in the United States, Black MSM continue to experience disproportionate rates of HIV infection. The purpose of this secondary analysis is to examine risk perception and its influence on PrEP adherence among Black MSM from HPTN 073. Risk perception was measured using the adapted Perceived Vulnerability to HIV Scale. The associations between risk perception and PrEP adherence were tested using generalized estimation equation model for time-variant repeated measures. Risk perception was not significantly associated with PrEP adherence. These findings suggest an there was no risk compensation among PrEP users, and inconsistency in perceived risk for HIV. Future studies should investigate the rationale for long term adherence to PrEP among Black MSM.

Sexual Risk Profiles Among Black Sexual Minority Men: Implications for Targeted PrEP Messaging.

Black gay, bisexual, and other Black sexual minority men (BSMM) continue to experience some of the largest sexual health disparities in the U.S. Engaging BSMM in PrEP is crucial to improving sexual health outcomes and reducing disparities. However, knowledge of the profiles of sexual risk and PrEP initiation among this group is limited. This study used latent class analysis to identify HIV risk and PrEP initiation patterns among BSMM in the HPTN 073 Study (n = 226). Guided by current Centers for Disease Control screening guidelines, latent class indicators included relationship status, condom use, number of sexual partners, substance use, sexually transmitted infection (STI) history, and partner HIV status. Age and PrEP initiation were used in a multinomial regression to identify correlates of class membership. Three latent classes were identified: Single, Condomless Partners, Single, Multiple Partners, and Serodiscordant Partners. Single, Condomless Partners had the highest conditional probabilities of having greater than three male partners, substance use before sex, and receiving an STI diagnosis. Serodiscordant Partners had a 100% conditional probability of condomless sex and having a male partner living with HIV. BSMM who initiated PrEP were less likely to be classified as Single, Condomless Partners than Serodiscordant Partners (AOR = 0.07, 95% CI = 0.02, 0.66). Findings support the need for culturally relevant tailored and targeted messaging for BSMM with multiple sexual risk indicators.

Development and Validation of the Personalized Sexual Health Promotion (SexPro) HIV Risk Prediction Model for Men Who Have Sex with Men in the United States.

Accurate HIV risk assessment among men who have sex with men (MSM) is important to help providers assess risk, and target HIV prevention interventions. We sought to develop an evidence-based HIV risk assessment tool for US MSM that is inclusive of Black MSM. Data from four large longitudinal cohorts of MSM were used to develop (EXPLORE), and validate (VAX004, HPTN061, and HVTN505). These data included visits in which participants self-reported HIV risk behavior and underwent HIV testing. We developed a pooled logistic model for incident HIV infection based on self-reported risk behaviors during the 6 months before each study visit. A total of 4069 MSM were used for the development cohort, and 8047 MSM in the three validation cohorts through 2013. The final model includes age (< 35, ≥ 35); Black race and Latino ethnicity; numbers of HIV-negative anal sex partners; number of insertive or receptive anal intercourse episodes; having 1 HIV-negative partner only; self-reported substance use; and bacterial sexually transmitted infection diagnosis. The model showed good discrimination in internal validation (C-statistic = 79.5). The external validation cohorts also showed good discrimination, with C-statistics of 73.1, 71.0, 71.9 in VAX004, HPTN061, and HVTN505 respectively, and acceptable calibration. We developed and validated an HIV risk assessment tool for MSM, which showed good predictive ability, including among the largest cohort of HIV-uninfected Black MSM in the US. This tool is available online (mysexpro.org) and can be used by providers to support targeting of HIV prevention interventions such as pre-exposure prophylaxis for MSM.

Incidence and Correlates of Sexually Transmitted Infections Among Black Men Who Have Sex With Men Participating in the HIV Prevention Trials Network 073 Preexposure Prophylaxis Study.

BACKGROUND: The HIV Prevention Trials Network (HPTN) Study 073 (HPTN 073) assessed the feasibility, acceptability, and safety of preexposure prophylaxis (PrEP) for black men who have sex with men (BMSM). The purpose of this analysis was to characterize the relationship between PrEP uptake and use and incident sexually transmitted infections (STIs) among participants enrolled in HPTN 073. METHODS: A total of 226 human immunodeficiency virus (HIV)-uninfected BMSM were enrolled in 3 US cities; all participants received client-centered care coordination (C4) and were offered daily oral PrEP. Participants were followed for 12 months with STI testing (rectal and urine nucleic acid amplification test for gonorrhea and chlamydia, rapid plasma reagin for syphilis) conducted at baseline, week 26, and week 52. Logistic regression was used to examine associations between STI incidence and PrEP uptake. Generalized estimating equations were used to evaluate associations between age, PrEP acceptance, sexual behaviors, and incident STIs. RESULTS: Baseline STI prevalence was 14.2%. Men aged <25 years were more likely to have a baseline STI (25.3% vs 6.7%; odds ratio [OR], 4.39; 95% confidence interval [CI:, 1.91, 10.11). Sixty participants (26.5%) acquired ≥1 STI during follow-up; the incidence rate was 34.2 cases per 100 person-years (95% CI, 27.4, 42.9). In adjusted analyses, baseline STI diagnosis (OR, 4.23; 95% CI, 1.82, 9.87; P < .001) and additional C4 time (OR, 1.03; 95% CI, 1.00, 1.06; P = .027) were associated with having an incident STI. STI incidence was not associated with PrEP acceptance or adherence. CONCLUSIONS: While we found higher rates of STIs in younger BMSM, overall rates of STI were lower than in prior PrEP trials, with no increase over time. BMSM with STIs at PrEP initiation may require additional interventions that target STI acquisition risk. CLINICAL TRIALS REGISTRATION: NCT01808352.

Evaluation of a Multidrug Assay for Monitoring Adherence to a Regimen for HIV Preexposure Prophylaxis in a Clinical Study, HIV Prevention Trials Network 073.

Daily oral tenofovir disoproxil fumarate (TDF)-emtricitabine (FTC) is a safe and effective intervention for HIV preexposure prophylaxis (PrEP). We evaluated the performance of a qualitative assay that detects 20 antiretroviral (ARV) drugs (multidrug assay) in assessing recent PrEP exposure (detection limit, 2 to 20 ng/ml). Samples were obtained from 216 Black men who have sex with men (208 HIV-uninfected men and 8 seroconverters) who were enrolled in a study in the United States evaluating the acceptability of TDF-FTC PrEP (165 of the uninfected men and 5 of the seroconverters accepted PrEP). Samples from 163 of the 165 HIV-uninfected men who accepted PrEP and samples from all 8 seroconverters were also tested for tenofovir (TFV) and FTC using a quantitative assay (detection limit for both drugs, 0.31 ng/ml). HIV drug resistance was assessed in seroconverter samples. The multidrug assay detected TFV and/or FTC in 3 (1.4%) of the 208 uninfected men at enrollment, 84 (40.4%) of the 208 uninfected men at the last study visit, and 1 (12.5%) of the 8 seroconverters. No other ARV drugs were detected. The quantitative assay confirmed all positive results from the multidrug assay and detected TFV and/or FTC in 9 additional samples (TFV range, 0.65 to 16.5 ng/ml; FTC range, 0.33 to 14.6 ng/ml). Resistance mutations were detected in 4 of the 8 seroconverter samples. The multidrug assay had 100% sensitivity and specificity for detecting TFV and FTC at drug concentrations consistent with daily PrEP use. The quantitative assay detected TFV and FTC at lower levels, which also might have provided protection against HIV infection.

Embedding HIV Mentoring Programs in HIV Research Networks.

Responding to the demands of the HIV/AIDS epidemic necessitates a diverse scientific and clinical workforce trained in applying interdisciplinary research approaches to address the epidemic domestically and internationally. Ensuring diversity in our workforce requires concerted efforts. Yet, the majority of graduate and post-graduate programs are ill-equipped to provide this type of training. Research networks, the HPTN, HVTN, CFAR and ATN, are uniquely positioned to implement interdisciplinary mentoring programs and all four have done so. We describe these programs, the nuts and bolts of program implementation and efforts to recruit and retain diversity scholars. We outline some inherent challenges such as competing demands for network resources or tension in aligning scholars' research agenda with that of the networks. We argue that the benefits to be gained from continuing these programs far outweigh their costs and that these programs are an essential component of a comprehensive strategy for developing the future HIV research workforce.

Economic, Legal, and Social Hardships Associated with HIV Risk among Black Men who have Sex with Men in Six US Cities.

We assessed whether economic, legal, and social hardships were associated with human immunodeficiency virus (HIV) risk among a sample of Black men who have sex with men (MSM) and whether associations were moderated by city of residence. The study analyzed baseline and follow-up data from HIV Prevention Trials Network 061 (N = 1553). Binary logistic regression assessed associations between hardships and HIV risk indicators. Multivariate regressions were used to test if city of residence had a moderating effect for hardships and HIV risks. Adjusted analyses showed that Black MSM with recent job loss were more likely to engage in condomless insertive anal intercourse (adjusted odds ratios (AOR) = 1.37, 95% CI 1.01-1.87) and that those with recent financial crisis were more likely to have had two or more male sexual partners in the past 6 months (AOR = 1.65; 95% CI 1.18-2.29). Black MSM with recent convictions were more likely to have a sexually transmitted infection at 6 months (AOR = 3.97; 95% CI 1.58-9.94), while those who were unstably housed were more likely to have a sexually transmitted infection at 12 months (AOR = 1.71; 95%CI 1.02 = 2.86). There were no city of residence and hardship interaction effects on HIV risks. Hardships are important factors that influence HIV risk for Black MSM. Integrating strategies that address structural factors that influence HIV risk may enhance HIV prevention interventions implementation efforts.

Respondent-Driven Sampling in a Multi-Site Study of Black and Latino Men Who Have Sex with Men.

PURPOSE: Respondent-driven sampling (RDS) was used to recruit four samples of Black and Latino men who have sex with men (MSM) in three metropolitan areas to measure HIV prevalence and sexual and drug use behaviors. We compared demographic and behavioral risk characteristics of participants across sites, assessed the extent to which the RDS statistical adjustment procedure provides estimates that differ from the crude results, and summarized our experiences using RDS. METHODS: From June 2005 to March 2006 a total of 2,235 MSM were recruited and interviewed: 614 Black MSM and 516 Latino MSM in New York City, 540 Black MSM in Philadelphia, and 565 Latino MSM in Los Angeles County. Crude point estimates for demographic characteristics, behavioral risk factors and HIV prevalence were calculated for each of the four samples. RDS Analysis Tool was used to obtain population-based estimates of each sampled population's characteristics. RESULTS: RDS adjusted estimates were similar to the crude estimates for each study sample on demographic characteristics such as age, income, education and employment status. Adjusted estimates of the prevalence of risk behaviors were lower than the crude estimates, and for three of the study samples, the adjusted HIV prevalence estimates were lower than the crude estimates. However, even the adjusted HIV prevalence estimates were higher than what has been previously estimated for these groups of MSM in these cities. Each site faced unique circumstances in implementing RDS. CONCLUSIONS: Our experience in using RDS among Black and Latino MSM resulted in diverse recruitment patterns and uncertainties in the estimated HIV prevalence and risk behaviors by study site.

A Comparison of Referred Sexual Partners to Their Community Recruited Counterparts in The BROTHERS Project (HPTN 061).

The BROTHERS Project (HPTN 061) was established to determine the feasibility and acceptability of a multi-component intervention among African American MSM to reduce HIV incidence. The goal of this analysis was to determine if the sexual partner referral approach used in HPTN 061 broadened the reach of recruitment with regards to characteristics associated with higher infection rates and barriers to quality health care. Overall, referred sexual partners had notable structural barrier differences in comparison to community-recruited participants: lower income, less education, higher unemployment, HIV positive diagnosis, incarceration history, and no health insurance. The study's findings pose implications for utilizing the sexual partner referral approach in reaching African American MSM who may not be accessed by traditional recruitment methods or who are well-integrated in health care systems.

Nondisclosure of HIV status in a clinical trial setting: antiretroviral drug screening can help distinguish between newly diagnosed and previously diagnosed HIV infection.

In The HIV Prevention Trials Network 061 study, 155 human immunodeficiency virus (HIV)-infected men reported no prior HIV diagnosis; 83 of those men had HIV RNA levels of <1000 copies/mL at enrollment. Antiretroviral drug testing revealed that 65 of the 83 (78.3%) men were on antiretroviral treatment. Antiretroviral drug testing can help distinguish between newly diagnosed and previously diagnosed HIV infection.

HIV diversity as a biomarker for HIV incidence estimation: including a high-resolution melting diversity assay in a multiassay algorithm.

Multiassay algorithms (MAAs) can be used to estimate cross-sectional HIV incidence. We previously identified a robust MAA that includes the BED capture enzyme immunoassay (BED-CEIA), the Bio-Rad Avidity assay, viral load, and CD4 cell count. In this report, we evaluated MAAs that include a high-resolution melting (HRM) diversity assay that does not require sequencing. HRM scores were determined for eight regions of the HIV genome (2 in gag, 1 in pol, and 5 in env). The MAAs that were evaluated included the BED-CEIA, the Bio-Rad Avidity assay, viral load, and the HRM diversity assay, using HRM scores from different regions and a range of region-specific HRM diversity assay cutoffs. The performance characteristics based on the proportion of samples that were classified as MAA positive by duration of infection were determined for each MAA, including the mean window period. The cross-sectional incidence estimates obtained using optimized MAAs were compared to longitudinal incidence estimates for three cohorts in the United States. The performance of the HRM-based MAA was nearly identical to that of the MAA that included CD4 cell count. The HRM-based MAA had a mean window period of 154 days and provided cross-sectional incidence estimates that were similar to those based on cohort follow-up. HIV diversity is a useful biomarker for estimating HIV incidence. MAAs that include the HRM diversity assay can provide accurate HIV incidence estimates using stored blood plasma or serum samples without a requirement for CD4 cell count data.

HIV prevention in clinical care settings: 2014 recommendations of the International Antiviral Society-USA Panel.

IMPORTANCE: Emerging data warrant the integration of biomedical and behavioral recommendations for human immunodeficiency virus (HIV) prevention in clinical care settings. OBJECTIVE: To provide current recommendations for the prevention of HIV infection in adults and adolescents for integration in clinical care settings. DATA SOURCES, STUDY SELECTION, AND DATA SYNTHESIS: Data published or presented as abstracts at scientific conferences (past 17 years) were systematically searched and reviewed by the International Antiviral (formerly AIDS) Society-USA HIV Prevention Recommendations Panel. Panel members supplied additional relevant publications, reviewed available data, and formed recommendations by full-panel consensus. RESULTS: Testing for HIV is recommended at least once for all adults and adolescents, with repeated testing for those at increased risk of acquiring HIV. Clinicians should be alert to the possibility of acute HIV infection and promptly pursue diagnostic testing if suspected. At diagnosis of HIV, all individuals should be linked to care for timely initiation of antiretroviral therapy (ART). Support for adherence and retention in care, individualized risk assessment and counseling, assistance with partner notification, and periodic screening for common sexually transmitted infections (STIs) is recommended for HIV-infected individuals as part of care. In HIV-uninfected patients, those persons at high risk of HIV infection should be prioritized for delivery of interventions such as preexposure prophylaxis and individualized counseling on risk reduction. Daily emtricitabine/tenofovir disoproxil fumarate is recommended as preexposure prophylaxis for persons at high risk for HIV based on background incidence or recent diagnosis of incident STIs, use of injection drugs or shared needles, or recent use of nonoccupational postexposure prophylaxis; ongoing use of preexposure prophylaxis should be guided by regular risk assessment. For persons who inject drugs, harm reduction services should be provided (needle and syringe exchange programs, supervised injection, and available medically assisted therapies, including opioid agonists and antagonists); low-threshold detoxification and drug cessation programs should be made available. Postexposure prophylaxis is recommended for all persons who have sustained a mucosal or parenteral exposure to HIV from a known infected source and should be initiated as soon as possible. CONCLUSIONS AND RELEVANCE: Data support the integration of biomedical and behavioral approaches for prevention of HIV infection in clinical care settings. A concerted effort to implement combination strategies for HIV prevention is needed to realize the goal of an AIDS-free generation.

Engaging, recruiting, and retaining black men who have sex with men in research studies: don't underestimate the importance of staffing--lessons learned from HPTN 061, the BROTHERS study.

CONTEXT: HIV/AIDS in the United States continues to primarily impact men who have sex with men (MSM), with disproportionately high rates among black MSM. OBJECTIVE: The purpose of this study was to identify factors that may influence engagement and retention of black MSM in HIV research. DESIGN AND PARTICIPANTS: This was a qualitative evaluation of study implementation within a multisite, prospective, observational study (HIV Prevention Trials Network 061, BROTHERS) that enrolled 1553 black MSM in 6 cities throughout the United States. Data collection for this evaluation included a written, structured survey collected from each of the sites describing site characteristics including staff and organizational structure, reviews of site standard operating procedures, and work plans; semistructured key informant interviews were conducted with site coordinators to characterize staffing, site-level factors facilitating or impeding effective community engagement, study recruitment, and retention. Data from completed surveys and site standard operating procedures were collated, and notes from key informant interviews were thematically coded for content by 2 independent reviewers. RESULTS: Several key themes emerged from the data, including the importance of inclusion of members of the community being studied as staff, institutional hiring practices that support inclusive staffing, cultivating a supportive working environment for study implementation, and ongoing relationships between research institutions and community. CONCLUSIONS: This study underscores the importance of staffing in implementing research with black MSM. Investigators should consider how staffing and organizational structures affect implementation during study design and when preparing to initiate study activities. Ongoing monitoring of community engagement can inform and improve methods for engagement and ensure cultural relevance while removing barriers for participation.

Estimating the Effect of PrEP in Black Men Who Have Sex with Men: A Framework to Utilize Data from Multiple Non-Randomized Studies to Estimate Causal Effects.

Black men who have sex with men (MSM) are disproportionately burdened by the HIV epidemic in the US. The effectiveness of pre-exposure prophylaxis (PrEP) in preventing HIV infection has been demonstrated through randomized placebo-controlled clinical trials in several populations. Importantly, no such trial has been conducted exclusively among Black MSM in the US, and it would be unethical and infeasible to do so now. To estimate the causal effects of PrEP access, initiation, and adherence on HIV risk, we utilized causal inference methods to combine data from two non-randomized studies that exclusively enrolled Black MSM. The estimated relative risks of HIV were: (i) 0.52 (95% confidence interval: 0.21, 1.22) for individuals with versus without PrEP access, (ii) 0.48 (0.12, 0.89) for individuals who initiated PrEP but were not adherent versus those who did not initiate, and (iii) 0.23 (0.02, 0.80) for individuals who were adherent to PrEP versus those who did not initiate. Beyond addressing the knowledge gap around the effect of PrEP in Black MSM in the US, which may have ramifications for public health, we have provided a framework to combine data from multiple non-randomized studies to estimate causal effects, which has broad utility.

Implementation of Client-Centered Care Coordination for HIV Prevention with Black Men Who Have Sex with Men: Activities, Personnel Costs, and Outcomes-HPTN 073.

BACKGROUND: Black men who have sex with men (MSM) experience disproportionate rates of HIV infection in the USA, despite being no more likely to engage in sexual risk behaviors than other MSM racial/ethnic groups. HIV pre-exposure prophylaxis (PrEP) has been shown to reduce risk of HIV acquisition; however, rates of PrEP use among Black MSM remain low. Clinical, psychosocial, and structural factors have been shown to impact PrEP use and adherence among Black MSM. Care coordination of HIV prevention services has the potential to improve PrEP use and adherence for Black MSM, as it has been shown to improve HIV-related care outcomes among people living with HIV. METHODS: Client-centered care coordination (C4) is a multi-level intervention designed to address clinical, psychosocial, and structural barriers to HIV prevention services for Black MSM within HPTN 073, a PrEP demonstration project among Black MSM in three cities in the USA. The current study examined the implementation process of C4, specifically investigating the activities, cost, time, and outcomes associated with the C4 intervention. RESULTS: On average, participants engaged in five care coordination encounters. The vast majority of care coordination activities were conducted by counselors, averaging 30 min per encounter. The cost of care coordination was relatively low with a mean cost of $8.70 per client encounter. CONCLUSION: Although client-centered care coordination was initially implemented in well-resourced communities with robust HIV research and service infrastructure, our findings suggest that C4 can be successfully implemented in resource constrained communities.

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.

Modeling the impact of social discrimination and financial hardship on the sexual risk of HIV among Latino and Black men who have sex with men.

OBJECTIVES: We examined the impact of social discrimination and financial hardship on unprotected anal intercourse with a male sex partner of serodiscordant or unknown HIV status in the past 3 months among 1081 Latino and 1154 Black men who have sex with men (MSM; n = 2235) residing in Los Angeles County, California; New York, New York; and Philadelphia, Pennsylvania. METHODS: We administered HIV testing and a questionnaire assessing 6 explanatory variables. We combined traditional mediation analysis with the results of a path analysis to simultaneously examine the direct, indirect, and total effects of these variables on the outcome variable. RESULTS: Bivariate analysis showed that homophobia, racism, financial hardship, and lack of social support were associated with unprotected anal intercourse with a serodiscordant or sero-unknown partner. Path analysis determined that these relations were mediated by participation in risky sexual situations and lack of social support. However, paths between the explanatory variable and 2 mediating variables varied by participants' serostatus. CONCLUSIONS: Future prevention research and program designs should specifically address the differential impact of social discrimination and financial hardship on lack of social support and risky sexual situations among Latino and Black MSM.

Optimizing PrEP Continuance: A Secondary Analysis Examining Perceived Autonomy Support and Care Coordination Quality among Black MSM in HPTN 073.

At the end of year 2018, it was estimated that in the United States over 1 million people were living with HIV. Although Black/African American individuals comprise an estimated 13.4% of the US population, as of 2019, they represented an estimated 42% of all new HIV diagnoses in 2018. PrEP use among Black men who have sex with men has not reached levels sufficient to have a population impact on HIV incidence. The purpose of this study was to examine whether high perceived autonomy support and care coordination quality were associated with PrEP continuation. Secondary analyses were conducted on data with 226 Black MSM in three US cities. Participants who were PrEP users and scored higher on autonomy support at week 8 were significantly more likely to continue PrEP (OR 1.48; 95% CI 1.04-2.11). Perception of coordination quality did not differ between PrEP users and non-users at any of the visits. Although coordination quality was not statistically significant, greater than half of PrEP users and non-PrEP users utilized the C4 services. Addressing social, individual, and structural barriers to PrEP may benefit Black MSM irrespective of their PrEP use.