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The effect of non-injection substance use on HIV viral load (VL) is understudied in international settings. Data are from HPTN063, a longitudinal observational study of HIV-infected individuals in Brazil, Thailand, and Zambia, with focus on men with VL data (Brazil = 146; Thailand = 159). Generalized linear mixed models (GLMM) assessed whether non-injection substance use (stimulants, cannabis, alcohol, polysubstance) was associated with VL undetectability. ART adherence and depressive symptoms were examined as mediators of the association. In Thailand, substance use was not significantly associated with VL undetectability or ART adherence, but alcohol misuse among MSM was associated with increased odds of depression (AOR = 2.75; 95% CI 1.20, 6.32, p = 0.02). In Brazil, alcohol misuse by MSM was associated with decreased odds of undetectable VL (AOR = 0.34; 95% CI 0.13, 0.92, p = 0.03). Polysubstance use by heterosexual men in Brazil was associated with decreased odds of ART adherence (AOR = 0.25; 95% CI 0.08, 0.78, p = 0.02). VL suppression appears attainable among non-injection substance users. Substance use interventions among HIV-positive men should address depression, adherence, and VL undetectability.

BackgroundMen who have sex with men (MSM) in India are a key group at risk for HIV acquisition and transmission. They are also an extremely marginalized and stigmatized population, facing immense psychosocial stressors including, but not limited to, stigma, homophobia, discrimination, criminalization, low self-esteem, low self-acceptance, distress, and, as a result, high rates of mental health problems. Although these multi-level psychosocial problems may put MSM at high risk for HIV acquisition and transmission, currently HIV prevention interventions in India do not address them. This paper describes the design of a psychosocial intervention to reduce HIV risk for MSM in India.MethodsFunded by the National Institute of Mental Health, this study is a two-arm randomized clinical efficacy trial of a self-acceptance based psychosocial HIV prevention intervention, informed by the minority stress model and syndemic theory, that was developed with extensive community-based formative work and input from the Indian MSM community and key informants who are knowledgeable about the experiences faced by MSM in India. Participants are MSM in Chennai and Mumbai who endorsed recent sexual behaviors placing them at high risk for HIV/sexually transmitted infection (STI) acquisition and transmission. Enrolled participants are equally randomized to either 1) the experimental condition, which consists of four group and six individual counseling sessions and includes standard of care HIV/STI testing and counseling, or 2) the standard of care condition, which includes HIV/STI testing and counseling alone. The primary outcomes are changes in the frequency of condomless anal sex acts and STI incidence (syphilis seropositivity and urethral, rectal, and pharyngeal gonorrhea and chlamydia infection. Major study assessment visits occur at baseline, 4-, 8-, and 12-months.DiscussionHIV prevention interventions that address the psychosocial stressors faced by MSM in India are needed; this study will examine the efficacy of such an intervention. If the intervention is successful, it may be able to reduce the national HIV/AIDS burden in India while empowering a marginalized and highly stigmatized group.Trial registrationClinicalTrials.gov Identifier: NCT02556294 , registered 22 September 2015.

BackgroundIn the United States, problematic stimulant use is a prevalent and difficult to treat problem among men who have sex with men (MSM), as well as a major driver of HIV transmission through the large number of sexual partners and concomitant condomless anal sex (CAS). Evidence-based behavioral studies that address problematic stimulant use in MSM at risk for HIV infection are also lacking. In this paper, we describe the design of a behavioral intervention trial to reduce sexual risk behavior and stimulant use in HIV-uninfected MSM.MethodsThis study, funded by the National Institute on Drug Abuse (NIDA), is a randomized controlled trial (RCT) testing an integrated HIV risk reduction and behavioral activation counseling intervention (IMPACT) for HIV-uninfected, stimulant using MSM in Boston, MA, and Miami, FL. Participants are randomized (2:2:1) to either (1) the IMPACT intervention; (2) a relaxation condition, an active therapy time- and intensity-matched control; or (3) a standard of care risk reduction counseling comparison. At enrollment, all participants receive an HIV test and pre- and post-test counseling. The primary outcome is the difference in the rate of change in the number of self-reported condomless anal sex acts without the protection of consistent Pre-Exposure Prophylaxis (PrEP) use, as well as reductions in stimulant use during the prior 4-months. Major assessments are conducted at baseline, 4-, 8-, and 12-month follow-up visits.DiscussionEffective and sustainable behavioral interventions are sorely needed to reduce HIV acquisition in stimulant using MSM at risk for HIV infection. In this study, we will evaluate the evidence of efficacy of the IMPACT intervention to reduce HIV acquisition in HIV-uninfected, stimulant-using MSM. If found effective, the intervention tested here holds promise for being readily integrated into real-world clinical settings.Trial registrationClinicalTrials.gov number NCT03175159 , registered June 5, 2017.

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

Adolescents and young adults (young people) with HIV (YPWH) often struggle with treatment self-management. Many have symptoms due to HIV disease, medication side-effects, or comorbid conditions. Our study investigated the severity of HIV-related symptoms among YPWH aged 18–24 with detectable viral loads from an HIV clinic in Ghana (N = 60) and potential correlates of severity across a range of factors. Results indicated that YPWH currently experienced, on average, 13 symptoms (SD = 12.33). Six of the 10 most common symptoms were from two domains: fatigue and psychological. The most common symptoms were headaches (62%), weakness (53%), and fear/worries (52%). No differences were observed in number or severity of symptoms between youth based on HIV transmission status. Bivariate correlates of symptom severity were found with six that remained significant or approached significance in a multivariate model predicting severity: living with a parent/guardian, higher perceived access to HIV care, and higher treatment readiness were associated with lower severity while greater travel time to the HIV clinic, psychological distress, and more missed clinic appointments were associated with higher severity. Our findings suggest that interventions to address symptoms among YPWH should be multilevel and include strategies (e.g., telehealth, home care) to increase access to care. [ABSTRACT FROM AUTHOR]

People living with HIV (PLWH) are at higher risk of developing lymphoma. In this study, we performed cytometry by time-of-flight (CyTOF) on peripheral blood mononuclear cells of cART-naïve HIV+ individuals and cART-naïve HIV+ individuals prior to AIDS-associated non-Hodgkin lymphoma (pre-NHL) diagnosis. Participants were enrolled in the Los Angeles site of the MACS/WIHS Combined Cohort Study (MWCCS). Uniform Manifold Approximation and Projection (UMAP) and unsupervised clustering analysis were performed to identify differences in the expression of B-cell activation markers and/or oncogenic markers associated with lymphomagenesis. CD10+CD27- B cells, CD20+CD27- B cells, and B-cell populations with aberrant features (CD20+CD27+CXCR4+CD71+ B cells and CD20+CXCR4+cMYC+ B cells) were significantly elevated in HIV+ cART-naïve compared to HIV-negative samples. CD20+CD27+CD24+CXCR4+CXCR5+ B cells, CD20+CD27+CD10+CD24+CXCR4+cMYC+ B cells, and a cluster of CD20+CXCR4hiCD27-CD24+CXCR5+CD40+CD4+AICDA+ B cells were significantly elevated in HIV+ pre-NHL (cART-naïve) compared to HIV+ cARTnaïve samples. A potentially clonal cluster of CD20+CXCR4+CXCR5+cMYC+AICDA+ B cells and a cluster of germinal center B-cell-like cells (CD19-CD20+CXCR4+Bcl- 6+PD-L1+cMYC+) were also found in the circulation of HIV+ pre-NHL (cART-naïve) samples. Moreover, significantly elevated clusters of CD19+CD24hiCD38hi cMYC+ AICDA+ B regulatory cells were identified in HIV+ pre-NHL (cART-naïve) compared to HIV+ cART-naïve samples. The present study identifies unique B-cell subsets in PLWH with potential pre-malignant features that may contribute to the development of pre-tumor B cells in PLWH and that may play a role in lymphomagenesis. [ABSTRACT FROM AUTHOR]

Depressive symptoms vary in severity and chronicity. We used group-based trajectory models to describe trajectories of depressive symptoms (measured using the Patient Health Questionnaire-9) and predictors of trajectory group membership among 1493 HIV-infected men (84%) and 292 HIV-infected women (16%). At baseline, 29% of women and 26% of men had depressive symptoms. Over a median of 30 months of follow-up, we identified four depressive symptom trajectories for women (labeled "low" [experienced by 56% of women], "mild/moderate" [24%], "improving" [14%], and "severe" [6%]) and five for men ("low" [61%], "mild/moderate" [14%], "rebounding" [5%], "improving" [13%], and "severe" [7%]). Baseline antidepressant prescription, panic symptoms, and prior mental health diagnoses were associated with more severe or dynamic depressive symptom trajectories. Nearly a quarter of participants experienced some depressive symptoms, highlighting the need for improved depression management. Addressing more severe or dynamic depressive symptom trajectories may require interventions that additionally address mental health comorbidities.

Up to two-thirds of new cases of HIV transmission between gay, bisexual and other men who have sex with men in the USA are attributed to primary relationships. Understanding the relationship dynamics and sexual agreements of male-male couples can provide insight into HIV transmission patterns and prevention needs in this population. The daily use of antiretroviral pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV, but its negotiation and use within social and intimate relationship contexts remain understudied. We conducted semi-structured qualitative interviews with 20 male couples (n = 40 men) in which at least one partner was either using or in the process of initiating PrEP. Congruent with a theoretical focus on social theories of relationships and negotiated risk, couples were interviewed about relationship dynamics, trust, communication and sexual health practices, including their perception and use of PrEP. Overall, we found that couples showed heightened trust and communication when establishing open, sexual agreements and demonstrated high awareness of sexual risks and health practices in the context of PrEP use. This study demonstrates how understanding relationship dynamics can better inform HIV prevention and sexual health promotion efforts for male couples at risk of HIV.

Transgender women (TW) represent a vulnerable population at increased risk for HIV infection in Peru. A mixed-methods study with 48 TW and 19 healthcare professionals was conducted between January and February 2015 to explore barriers and facilitators to implementing a model of care that integrates HIV services with gender-affirmative medical care (i.e., hormone therapy) in Lima, Peru. Perceived acceptability of the integrated care model was high among TW and healthcare professionals alike. Barriers included stigma, lack of provider training or Peruvian guidelines regarding optimal TW care, and service delivery obstacles (e.g., legal documents, spatial placement of clinics, hours of operation). The hiring of TW staff was identified as a key facilitator for engagement in health care. Working in partnership with local TW and healthcare provider organizations is critical to overcoming existing barriers to successful implementation of an integrated HIV services and gender-affirmative medical care model for this key population in Peru.

ObjectiveThe aim of this study was to assess whether ever reporting depressive symptoms affects mortality in the modern HIV treatment era.DesignA cohort study of HIV-infected adults in routine clinical care at seven sites in the USA.MethodsWe examined the effect of ever reporting depressive symptoms on all-cause mortality using data from the Centers for AIDS Research Network of Integrated Clinical Systems cohort. We included individuals with at least one depression measure between 2005 and 2014. Depressive symptoms were measured with the Patient Health Questionnaire (PHQ)-9. We used weighted Kaplan-Meier curves and marginal structural Cox models with inverse probability weights to estimate the effect of ever reporting depressive symptoms (PHQ-9 ≥10) on all-cause mortality.ResultsA total of 10 895 individuals were included. Participants were followed for a median of 3.1 years (35 621 total person-years). There were 491 (4.5%) deaths during the follow-up period (crude incidence rate 13.8/1000 person-years). At baseline, 28% of the population reported depressive symptoms. In the weighted analysis, there was no evidence that ever reporting depressive symptoms increased the hazard of all-cause mortality (hazard ratio 0.82, 95% confidence interval 0.55-1.24).ConclusionIn a large cohort of HIV-infected adults in care in the modern treatment era, we observed no evidence that ever reporting depressive symptoms increased the likelihood of all-cause mortality, controlling for a range of time-varying factors. Antiretroviral therapy that is increasingly robust to moderate adherence and improved access to depression treatment may help to explain changes in the relationship between depressive symptoms and mortality in the modern treatment era.

IntroductionIn Peru, transgender women (TW) experience unique vulnerabilities for HIV infection due to factors that limit access to, and quality of, HIV prevention, treatment and care services. Yet, despite recent advances in understanding factors associated with HIV vulnerability among TW globally, limited scholarship has examined how Peruvian TW cope with this reality and how existing community-level resilience strategies are enacted despite pervasive social and economic exclusion facing the community. Addressing this need, our study applies the understanding of social capital as a social determinant of health and examines its relationship to HIV vulnerabilities to TW in Peru.MethodsUsing qualitative methodology to provide an in-depth portrait, we assessed (1) intersections between social marginalization, social capital and HIV vulnerabilities; and (2) community-level resilience strategies employed by TW to buffer against social marginalization and to link to needed HIV-related services in Peru. Between January and February 2015, 48 TW participated (mean age = 29, range = 18-44) in this study that included focus group discussions and demographic surveys. Analyses were guided by an immersion crystallization approach and all coding was conducted using Dedoose Version 6.1.18.ResultsThemes associated with HIV vulnerability included experiences of multilevel stigma and limited occupational opportunities that placed TW at risk for, and limited their engagement with, existing HIV services. Emergent resiliency-based strategies included peer-to-peer and intergenerational knowledge sharing, supportive clinical services (e.g. group-based clinic attendance) and emotional support through social cohesion (i.e. feeling part of a community).ConclusionThis study highlights the importance of TW communities as support structures that create and deploy social resiliency-based strategies aimed at deterring and mitigating the impact of social vulnerabilities to discrimination, marginalization and HIV risk for individual TW in Peru. Public health strategies seeking to provide HIV prevention, treatment and care for this population will benefit from recognizing existing social capital within TW communities and incorporating its strengths within HIV prevention interventions. At the intersection of HIV vulnerabilities and collective agency, dimensions of bridging and bonding social capital emerged as resiliency strategies used by TW to access needed healthcare services in Peru. Fostering TW solidarity and peer support are key components to ensure acceptability and sustainability of HIV prevention and promotion efforts.

BackgroundDepression affects 20-30% of HIV-infected patients and is associated with worse HIV outcomes. Although effective depression treatment is available, depression is largely untreated or undertreated in this population.MethodsWe quantified gaps in antidepressant treatment, treatment adjustments, and outcomes among US patients in routine HIV care in the nationally distributed CNICS observational clinical cohort. This cohort combines detailed clinical data with regular, self-reported depressive severity assessments (Patient Health Questionnaire-9, PHQ-9). We considered whether participants with likely depression received antidepressants, whether participants on antidepressants with persistently high depressive symptoms received timely dose adjustments, and whether participants achieved depression remission. We considered a cross-sectional analysis (6,219 participants in care in 2011-2012) and a prospective analysis (2,936 participants newly initiating CNICS care when PHQ-9 screening was active).ResultsThe cross-sectional sample was 87% male, 53% Caucasian, 25% African American, and 18% Hispanic; the prospective sample was similar. In both samples, 39-44% had likely depression, with 44-60% of those receiving antidepressants. Of participants receiving antidepressants, 20-26% experienced persistently high depressive symptoms; only a small minority of those received antidepressant dose adjustments. Overall, 35-40% of participants on antidepressants achieved full depression remission. Remission among participants with persistently high depressive symptoms was rare regardless of dose adjustments.ConclusionsIn this large, diverse cohort of US patients engaged in routine HIV care, we observed large gaps in antidepressant treatment, timely dose adjustment to address persistently high depressive symptoms, and antidepressant treatment outcomes. These results highlight the importance of more effective pharmacologic depression treatment models for HIV-infected patients.

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. [ABSTRACT FROM AUTHOR]

BackgroundCross-sectional studies have suggested that co-occurring epidemics or "syndemics" of psychosocial health problems may accelerate HIV transmission among men who have sex with men (MSM) in the United States. We aimed to assess how 5 syndemic conditions (depressive symptoms, heavy alcohol use, stimulant use, polydrug use, and childhood sexual abuse) affected HIV incidence and sexual risk behavior over time.MethodsEligible men in a large prospective cohort of sexually active HIV-uninfected MSM completed HIV testing and behavioral surveys at baseline and every 6 months for 48 months. We examined interrelationships between psychosocial problems and whether these interactions increased the odds of HIV risk behaviors and risk of seroconversion over study follow-up.ResultsAmong 4295 men, prevalence of psychosocial conditions was substantial at baseline and was positively associated with each other. We identified a statistically significant positive dose-response relationship between numbers of syndemic conditions and HIV seroconversion for all comparisons (with the greatest hazard among those with 4-5 conditions, adjusted hazard ratio = 8.69; 95% confidence interval: 4.78 to 15.44). The number of syndemic conditions also predicted increased HIV-related risk behaviors over time, which mediated the syndemic-HIV seroconversion association.ConclusionsThe accumulation of syndemic psychosocial problems predicted HIV-related sexual risk behaviors and seroconversion in a large sample of US MSM. Given the high prevalence of syndemic conditions among MSM and the moderate effect sizes attained by traditional brief behavioral interventions to date, the HIV prevention agenda requires a shift toward improved assessment of psychosocial comorbidities and stronger integration with mental health and substance abuse treatment services.

BackgroundHIV disproportionately affects young men who have sex with men (YMSM) in the United States. Uptake of evidence-based prevention strategies, including routine HIV testing and use of pre-exposure prophylaxis (PrEP), is suboptimal in this population. Novel methods for reaching YMSM are required. ObjectiveThe aim of this study is to describe the development and evaluate the feasibility and acceptability of the MyChoices app, a mobile app designed to increase HIV testing and PrEP use among YMSM in the United States. MethodsInformed by the social cognitive theory, the MyChoices app was developed using an iterative process to increase HIV testing and PrEP uptake among YMSM. In 2017, beta theater testing was conducted in two US cities to garner feedback (n=4 groups; n=28 YMSM). These findings were used to refine MyChoices, which was then tested for initial acceptability and usability in a technical pilot (N=11 YMSM). Baseline and 2-month postbaseline assessments and exit interviews were completed. Transcripts were coded using a deductive approach, and thematic analysis was used to synthesize data; app acceptability and use data were also reported. ResultsThe MyChoices app includes personalized recommendations for HIV testing frequency and PrEP use; information on types of HIV tests and PrEP; ability to search for nearby HIV testing and PrEP care sites; and ability to order free home HIV and sexually transmitted infection test kits, condoms, and lube. In theater testing, YMSM described that MyChoices appears useful and that they would recommend it to peers. Participants liked the look and feel of the app and believed that the ability to search for and be pinged when near an HIV testing site would be beneficial. Some suggested that portions of the app felt repetitive and preferred using casual language rather than formal or medicalized terms. Following theater testing, the MyChoices app was refined, and participants in the technical pilot used the app, on average, 8 (SD 5.0; range 2-18) times over 2 months, with an average duration of 28 (SD 38.9) minutes per session. At the 2-month follow-up, the mean System Usability Scale (0-100) score was 71 (ie, above average; SD 11.8). Over 80% (9/11) of the participants reported that MyChoices was useful and 91% (10/11) said that they would recommend it to a friend. In exit interviews, there was a high level of acceptability for the content, interface, and features. ConclusionsThese data show the initial acceptability and user engagement of the MyChoices app. If future studies demonstrate efficacy in increasing HIV testing and PrEP uptake, the app is scalable to reach YMSM across the United States. Trial RegistrationClinicaltrials.gov NCT03179319; https://clinicaltrials.gov/ct2/show/NCT03179319 International Registered Report Identifier (IRRID)RR2-10.2196/10694

BackgroundYoung transgender women (YTW) are a key population for HIV-related risk reduction, yet very few interventions have been developed to meet their needs. Mobile health interventions with the potential for both efficacy and wide reach are a promising strategy to reduce HIV risk among YTW. ObjectiveThis study aims to adapt an efficacious group-based intervention to a mobile app, Project LifeSkills, to reduce HIV risk among YTW, and to test its acceptability and usability. MethodsThe group-based intervention was adapted to a mobile app, LifeSkills Mobile, with input from an expert advisory group and feedback from YTW collected during user-centered design sessions. A beta version of the app was then tested in a usability evaluation using a think-aloud protocol with debriefing interviews, recordings of screen activity, and assessments of usability via the Post-Study System Usability Questionnaire (PSSUQ) and the Health Information Technology Usability Evaluation Scale (Health-ITUES). ResultsYTW (n=8; age: mean 24 years, SD 3 years; racial or ethnic minority: 7/8, 88%) provided feedback on the app prototype in design sessions and then tested a beta version of the app in a usability trial (n=10; age: mean 24 years, SD 3 years; racial or ethnic minority: 8/10, 80%). Both usability ratings (Health-ITUES: mean 4.59, SD 0.86; scale range: 1-5) and ratings for satisfaction and accessibility (PSSUQ: mean 4.64, SD 0.90; scale range 1-5) were in the good to excellent range. No functional bugs were identified, and all mobile activities were deployed as expected. Participant feedback from the usability interviews indicated very good salience of the intervention content among the focal population. Participants’ suggestions to further increase app engagement included adding animation, adding audio, and reducing the amount text. ConclusionsWe conclude that the LifeSkills Mobile app is a highly usable and engaging mobile app for HIV prevention among YTW.

Depressed mood has been associated with HIV transmission risk behavior. To determine whether effective depression treatment could reduce the frequency of sexual risk behavior, we analyzed secondary outcome data from a 36-week, two-arm, parallel-design, randomized controlled trial, in which homeless and marginally housed, HIV-infected persons with comorbid depressive disorders were randomized to receive either: (a) directly observed treatment with the antidepressant medication fluoxetine, or (b) referral to a local public mental health clinic. Self-reported sexual risk outcomes, which were measured at 3, 6, and 9 months, included: total number of sexual partners, unprotected sexual intercourse, unprotected sexual intercourse with an HIV-uninfected partner or a partner of unknown serostatus, and transactional sex. Estimates from generalized estimating equations regression models did not suggest consistent reductions in sexual risk behaviors resulting from treatment. Mental health interventions may need to combine depression treatment with specific skills training in order to achieve durable impacts on HIV prevention outcomes.

Non-occupational post-exposure prophylaxis (nPEP) use is an HIV prevention strategy that has been recommended by the CDC to prevent HIV infection after a high risk sexual exposure since 1997. In a behavioral intervention trial of 4,295 MSM we assessed perceptions and use of nPEP over 4 years in six cities across the United States. Overall, 1.9% of MSM reported use of nPEP prior to enrollment, and 6.3% at least once during the trial. Awareness of nPEP was reported by 47.5%, with higher awareness in two sites with funded nPEP programs. Three seroconversions occurred in the 384 visits where nPEP courses were reported, with no effect of nPEP on risk of HIV acquisition in this cohort (hazard ratio = 0.91, 95% confidence interval [0.29, 2.86]). NPEP users were a riskier group: increased odds of nPEP use were observed in association with multiple partners and unprotected receptive and insertive anal sex with HIV infected partners and partners with unknown HIV status. NPEP use was also associated with use of illicit drugs (injection drugs, crack cocaine, hallucinogens, and amphetamines). Importantly, willingness to use nPEP after high risk sex was associated with lower odds of high risk sex. After an episode of nPEP use, nPEP users remained more likely to report high risk sex than those in this cohort who had not previously used nPEP. However, within the subset of people who had previously reported high risk sex, previous nPEP use was not associated with higher odds of high risk sex, thus allaying fears that availability of nPEP would lead to an increase in high risk sex.