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

HIV pre-exposure prophylaxis (PrEP) use is limited among male sex workers, who are at exceptionally high-risk for HIV infection. We developed a theory-informed, two-pronged intervention (PrEPare-for-Work) to optimize PrEP initiation and adherence among male sex workers, which was preliminarily evaluated in a two-stage pilot randomized controlled trial of 110 male sex workers in the US Northeast. Individuals randomized to the Stage 1 PrEPare-for-Work Case Management arm were three times as likely as those in the standard of care (SOC) arm to initiate PrEP (RR = 2.95, 95% CI = 1.57-5.57). Participants who initiated PrEP and were randomized to the Stage 2 PrEPare-for-Work Adherence Counseling arm had higher rates of prevention-effective adherence (measured via tenofovir in hair) compared to those in the SOC arm (RR = 1.7, 95% CI 0.64-4.77; 55.6% vs. 28.6%, respectively); though not statistically significant. Given the need and the promise of this pilot RCT, further efficacy testing is warranted and should be prioritized.

People who inject drugs (PWID) have extraordinarily low uptake of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) despite high levels of need. Long-acting PrEP modalities hold promise for HIV prevention among PWID, but product preferences remain poorly understood. From September to November 2021, we conducted qualitative interviews with 28 HIV-negative, adult (≥18 years) PWID in San Diego County, CA, to explore their perspectives on daily oral PrEP pills and long-acting PrEP modalities (i.e., injections, implants, intravaginal rings, and broadly neutralizing antibodies), which we explained using standard scripts. Thematic analysis identified variations in PrEP modality interest and acceptability. We identified three key factors across the 28 interviews that appeared to influence PrEP modality preferences: perceived convenience of use, invasiveness, and familiarity (based on past experience). Overall, most participants preferred injectable PrEP over other modalities because they viewed injectable medications as convenient, noninvasive, and familiar. While injectable PrEP was recently approved for use in the United States and was most the acceptable PrEP modality in this sample, our findings suggest that intervention and implementation research is urgently needed to improve our understanding of strategies that could support access, uptake, and sustained adherence to longer-acting PrEP for PWID.

Purpose of reviewRecent HIV outbreaks among people who use drugs (PWUD) necessitate additional HIV prevention tools. Pre-exposure prophylaxis (PrEP) is highly efficacious yet uptake among PWUD remains exceedingly low. To address multilevel, complex barriers to PrEP use among PWUD, a range of intervention strategies are needed.Recent findingsThe literature on interventions to optimize PrEP use among PWUD is nascent, comprising small pilots and demonstration projects in early phases of intervention development. Initial studies suggest that structural, healthcare, interpersonal, and individual-level interventions can improve PrEP use for PWUD, and a number of efficacy trials are underway. Future studies are needed to optimize the use of new PrEP modalities (e.g., injectable PrEP), simultaneously target multilevel challenges to PrEP use, and evaluate the integration of PrEP into other service settings and substance use treatment modalities.

Multilevel barriers to pre-exposure prophylaxis (PrEP) care among male sex workers (MSW) include aspects of interactions with health services and providers. We examined relationships between health service- and provider-level factors and PrEP care among MSW. Between 2017 and 2019, we enrolled 111 MSW in the Northeast United States who were not on PrEP, but expressed interest in potentially using PrEP, in a behavioral intervention to promote PrEP uptake and adherence. Using baseline data, we examined whether having a primary care provider, past year frequency of medical visits, comfort discussing sexual practices with providers, and transportation difficulties to accessing general health care were associated with PrEP use self-efficacy, anticipated barriers to PrEP uptake, adherence, and retention (linear regression), and intention to initiate PrEP (logistic regression). Models adjusted for age, race/ethnicity, sexual identity, education, and income. Participants' mean age was 34.2 [standard deviation (SD) = 8.5], and 47% were non-White. Three-quarters (76%) intended to initiate PrEP within the next month. Comfort discussing sexual practices with providers was associated with PrEP use self-efficacy (b = 0.41, p = 0.008). Comfort discussing sexual practices with providers was negatively associated with anticipated barriers to PrEP uptake (b = -0.29, p = 0.006). Transportation difficulties to accessing general health care were associated with barriers to PrEP uptake (b = 0.30, p = 0.007) and barriers to PrEP adherence and retention (b = 0.57, p

BackgroundYoung men who have sex with men (YMSM) are disproportionately impacted by HIV and other sexually transmitted infections (STIs) in the United States (US) and have low rates of HIV/STI testing. Provision of HIV self-testing and STI self-collection can increase testing rates, and access to these kits through mobile applications (apps) could help facilitate YMSM using HIV self-testing and STI self-collection.MethodsData for this study comes from two pilot randomized controlled trials (RCTs) of mobile apps within the Adolescent Trials Network-LYNX and MyChoices-aimed to increase HIV/STI testing among YMSM (age 15-24) who had not recently tested for HIV and were at high risk for HIV acquisition across five US cities. Both apps include the ability to order a HIV self-test with rapid results and a kit for STI self-collection and mailing of samples for syphilis, gonorrhea and chlamydia to a lab for testing. Using assessments of app users (n=80) at pre-randomization and at 3- and 6-months post-randomization and online interview data from a purposive sample of app users (n=37), we report on experiences and lessons learned with HIV self-testing and STI self-collection kits ordered via the apps.ResultsParticipants were on average 20.7 years of age (SD =2.4), and 49% were non-White or multiple race/ethnicity. Sixty-three percent had a prior HIV test. Over half (58%) had a prior STI test, but only 3% had tested within the past 3 months. Nearly two-thirds ordered an HIV self-testing kit; of whom, 75% reported using at least one self-test kit over the study period. STI self-collection kit ordering rates were also high (54%); however, STI self-collection kit return rates were lower (13%), but with a high positivity rate (5.3%). Both HIV self-testing and STI self-collection kits were highly acceptable, and 87% reported that it was extremely/very helpful to be able to order these kits through the apps. The most common reason for not ordering the HIV/STI kits was preferring to test at a clinic. In interviews, participants expressed feeling empowered by being able to test at home; however, they also raised concerns around STI sample collection.ConclusionsHIV self-testing and STI self-collection kit ordering via mobile apps is feasible, acceptable and may show promise in increasing testing rates among YMSM. The LYNX and MyChoices apps are currently being tested in a full-scale efficacy trial, and if successful, these innovative mobile apps could be scaled up to efficiently increase HIV/STI testing among youth across the US.

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.

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.

To examine readiness to provide oral and injectable pre-exposure prophylaxis (PrEP) for sexual and gender minority youth (SGMY) and to explore decision-making for HIV prevention strategies (e.g., condom use, daily and event-driven oral PrEP, and injectable PrEP) among healthcare providers. Between February and April 2022, we recruited 31 prescribing providers (M.Ds, D.Os, P.As, and N.Ps) practicing in primary care and specialized clinics in the U.S. Northeast for focus groups or individual interviews. Focus groups and interview transcripts were analyzed using thematic analysis. Most providers specialized in Pediatrics (42%) or Adolescent Medicine (23%) and 58% had previously prescribed PrEP. Main barriers to PrEP readiness were low PrEP knowledge, limited time for visits, and competing clinical priorities. Organizational factors such as routine HIV/STI testing, PrEP-specific electronic health records templates, and specialized staff (e.g., PrEP navigators) promoted PrEP readiness. Providers held positive attitudes toward injectable PrEP to promote adherence among SGMY, yet barriers to implementation of this modality were identified (e.g., patient anxiety about needles, additional staffing needs). Providers described event-driven oral PrEP as an option for SGMY with episodic HIV risk. Assurances of conditional confidentiality, including preventing disclosure of sensitive information through insurance forms, and shared decision-making facilitated conversations about HIV prevention with SGMY. Future PrEP implementation efforts for SGMY should consider combined efforts targeting provider knowledge about PrEP modalities (e.g., decision aids) and clinic organizational factors (e.g., routine HIV/STI testing, resources to assist providers and patients in navigating the multiple steps between prescription and adherence to PrEP). [ABSTRACT FROM AUTHOR]

Background: HIV incidence has recently increased among people who inject drugs (PWID) across the United States, with outbreaks occurring in states with long-standing syringe service programs (SSPs) including Massachusetts (MA). Antiretroviral pre-exposure prophylaxis (PrEP) is an evidence-based HIV prevention strategy recommended for PWID, but uptake in this marginalized population is extraordinarily low. Methods: We describe the design and procedures for a National Institute on Drug Abuse (NIDA)-funded (R01) randomized controlled trial (RCT) testing the efficacy of "PrEP for Health," a multicomponent behavioral intervention to increase PrEP uptake, adherence, and persistence among HIV-negative PWID attending SSPs in two areas of the U.S. Northeast that are heavily affected by injection-related HIV transmission. Participants are equally randomized to receive the "PrEP for Health" intervention (involving individually tailored HIV and PrEP education, motivational interviewing, problem-solving skills and planning, and ongoing navigation support) or an enhanced standard of care (eSOC) control condition involving a brief educational video on the utility of PrEP for HIV prevention. Co-primary outcomes are PrEP uptake (using medical/pharmacy records) and adherence (using tenofovir quantification in hair samples); a secondary outcome is PrEP persistence (using medical/pharmacy records) over 12 months. Major assessments occur at baseline, 1-, 3-, 6-, and 12-month follow-up visits. Planned analyses will examine intervention efficacy, specific hypothesized conceptual mediators of the intervention effect (e.g., self-perceived HIV risk; PrEP knowledge, interest in use, motivation, and behavioral skills) and epidemiologically linked moderators (e.g., age; gender; condomless vaginal or anal sex). Discussion: Findings from our extensive preliminary research with the study population revealed that a multicomponent, theory-based intervention targeting PrEP knowledge, motivation, self-efficacy, behavioral skills, and structural barriers to PrEP access is urgently needed for PWID who are at risk of HIV acquisition. We also learned that SSPs represent a highly acceptable service setting for delivering such interventions. In this study, we are evaluating the efficacy of the "PrEP for Health" intervention. If efficacious, findings from our implementation evaluation could help guide its dissemination to diverse SSPs and possibly other community-based settings accessed by this population. Trial registration: ClinicalTrials.gov number NCT04430257, registered June 12, 2020. [ABSTRACT FROM AUTHOR]

Access to daily oral pre-exposure prophylaxis (PrEP) is suboptimal among young cisgender men who have sex with men (YMSM) in the United States. Next-generation modalities that do not involve daily oral regimens may mitigate some of the barriers to PrEP use. We identified latent classes of YMSM based on health care decision-making patterns and examined associations between latent classes and access to health care and PrEP modality preferences (i.e., daily and event-driven oral, rectal douches, broadly neutralizing antibodies, subcutaneous implants, and an injectable). Between October 2020 and June 2021, we administered an online survey to 737 YMSM. Latent class analysis (LCA) identified groups of YMSM based on communication with providers, stigma and mistrust in health care, and autonomy in sexual health decisions. Logistic regression examined associations between class membership and health care access, and exploded logit regression examined associations between class membership and ranked PrEP modality preferences. LCA identified three classes: shared decision-making (high communication with providers and high autonomy); provider-led decision-making (high communication and low autonomy); and patient-driven decision-making (low communication and high autonomy). Shared decision-making was associated with higher access to health care in comparison with the other classes. Across all classes, YMSM preferred daily oral PrEP over all next-generation PrEP modalities. Preferences for daily oral PrEP over next-generation PrEP modalities were particularly marked among the patient-driven decision-making class. Shared decision-making is associated with access to health care and HIV prevention and higher acceptability of next-generation PrEP modalities, and should be considered as part of future interventions to promote use of daily oral and next-generation PrEP. [ABSTRACT FROM AUTHOR]

Introduction: Coronavirus disease 2019 (COVID-19) has impacted researchers' ability to continue to deliver HIV prevention and treatment interventions face to face. Although telehealth has been an important strategy to maintain research operations during the current pandemic, participants at increased risk of or living with HIV are often at higher risk of also experiencing poverty, housing instability, and other challenges that may present obstacles to successful remote delivery. Methods: We provide descriptions of remote adaptations to two randomized controlled efficacy trials of behavioral interventions for primary and secondary HIV prevention with descriptive enrollment and retention data. Results and Conclusions: Best practices for implementing telemedicine and e-health procedures are discussed, including procedures for addressing remote participation barriers (economic, health literacy, etc.) and other challenges, such as building rapport and staff support (NCT03092531 and NCT03175159). [ABSTRACT FROM AUTHOR]

Gay, bisexual, and other men who have sex with men (GBMSM) in Nigeria bear a disproportionately higher burden of HIV. Meyer's minority stress theory posits that social stress due to the discrimination, violence, and stigma experienced by lesbian, gay, and bisexual men and women (LGBs)—due to their sexual orientation—may contribute to psychological problems, including mental health problems, substance use, and HIV sexual risk-taking. Between March and June 2019, we recruited 406 GBMSM from four states in Nigeria (Abuja, Delta, Lagos, and Plateau) to complete a cross-sectional survey at local community-based organizations. We utilized structural equation modeling to test whether psychological problems and substance use mediated the relationship between minority stress and HIV sexual risk-taking (condomless anal sex and number of sexual partners) among GBMSM in Nigeria. Minority stress (β = 0.60, 95% CI: 0.44–0.72, p ≤.001), substance use (β = 0.43, 95% CI: 0.27–0.59, p =.004), and psychological problems (β = 0.35, 95% CI: 0.28–0.45 p =.012) had moderate associations with HIV sexual risk-taking. We found that psychological problems mediated the relationship between minority stress and HIV sexual risk-taking. Interventions focused on addressing psychological problems may help mitigate the effects of minority stress on HIV sexual risk-taking among GBMSM in Nigeria. [ABSTRACT FROM AUTHOR]

Geosocial networking applications (GSN apps) are widely utilized by gay, bisexual, and other men who have sex with men (GBMSM) to meet potential sexual/romantic partners, foster friendships, and build community. However, GSN apps usage has been linked to elevated levels of HIV sexual risk behavior among GBMSM. Little is known about how GSN apps can facilitate HIV sexual risk behaviors, especially among GBMSM in Africa. To fill this gap in research, the present study aimed to characterize the frequency of GSN apps usage and its association with sociodemographic characteristics, sexual health, healthcare access, psychosocial problems, and substance use in a large multicity sample of community-recruited GBMSM in Nigeria (N = 406). Bivariate and multivariable ordinal logistic regression procedures were used to examine factors associated with GSN apps usage. We found that 52.6% of participants reported recent (≤ 3 months) GSN apps use to meet sexual partners. Factors associated with increased odds of GSN apps usage included: being single, having a university degree or higher, reporting higher recent receptive anal sexual acts, being aware of PrEP, having a primary care provider, and reporting higher levels of identity concealment. HIV-related intervention delivered through GSN apps may help curb the spread of HIV among Nigerian GBMSM. [ABSTRACT FROM AUTHOR]

Little is known about the potential population-level impact of HIV pre-exposure prophylaxis (PrEP) use among cisgender male sex workers (MSWs), a high-risk subset of cisgender men who have sex with men (MSM). Using an agent-based model, we simulated HIV transmission among cisgender MSM in Rhode Island to determine the impacts of PrEP implementation where cisgender MSWs were equally ("standard expansion") or five times as likely ("focused expansion") to initiate PrEP compared to other cisgender MSM. Without PrEP, the model predicted 920 new HIV infections over a decade, or an average incidence of 0.39 per 100 person-years. In a focused expansion scenario where 15% of at-risk cisgender MSM used PrEP, the total number of new HIV infections was reduced by 58.1% at a cost of $57,180 per quality-adjusted life-year (QALY) gained. Focused expansion of PrEP use among cisgender MSWs may be an efficient and cost-effective strategy for reducing HIV incidence in the broader population of cisgender MSM. [ABSTRACT FROM AUTHOR]

Background: People who inject drugs (PWID) are at increased risk for HIV infection through sharing contaminated needles and injection equipment, and engaging in condomless sex. Objectives: To qualitatively examine the overlapping nature of these behaviors among PWID in the US Northeast. Methods: We recruited HIV-uninfected PWID and key informants through community-based organizations. Qualitative interviews explored sexual partnerships as they related to sharing contaminated needles and injection equipment, engaging in condomless sex, and associated indications for PrEP among PWID. Results: Among 33 PWID, 66% engaged in condomless vaginal or anal sex in the past 3 months, and 27% had three or more sexual partners in this same time period. Over half engaged in any past month distributive or receptive syringe sharing (64%). We identified three contexts through which overlapping sexual and injection-related HIV risks emerged, including (1) multiple concurrent sexual partnerships; (2) using and injecting drugs with sexual partners (including increase injecting of crystal methamphetamine); and (3) exchanging sex for money or drugs (including among male PWID). Condom use was inconsistent across these contexts. Limited interactions with healthcare providers often resulted in sexual risks being overlooked in light of competing health concerns. Conclusions: Sexual risk for HIV acquisition is complex and multi-faceted among PWID yet may be overlooked by prevention and healthcare providers. Comprehensive HIV prevention efforts must acknowledge the distinct contexts in which overlapping injection and sexual risk behaviors occur. Increased sexual health screening and risk reduction services including PrEP for PWID may help curtail transmission in this population. [ABSTRACT FROM AUTHOR]

Background: Male sex workers (MSWs) are at increased risk of HIV infection in the United States. Research is limited on sexual and drug use network characteristics of MSWs. Setting: Community-based organization and health center in 2 US Northeast cities. Methods: One hundred MSWs completed a behavioral assessment and sexual and drug network inventory. Using dyadic analyses, we assessed whether network characteristics, including sex worker-male client age, race, and HIV status homophily and risk multiplexity (ie, overlap in druguse and sex networks), were associated with condom use. Results: MSW participants' mean age was 33.6. Two-thirds identified as Black or Latino, 12% identified as heterosexual, and 90% reported recent drug use. Participants reported an average of 5.3 male clients in the past month (SD = 3.4), and having anal sex with 74% of these clients, at a rate of 2.2 times per month (SD = 4.6). Participants reported inconsistent condom use during anal sex with 53% of clients. In multivariable models, inconsistent condom use was more common in relationships with presumed HIV status homophily [odds ratio (OR): 1.25; 95% confidence interval (CI): 1.07 to 1.46] and sexual and drug network multiplexity (OR: 1.19; 95% CI: 1.09 to 1.30); and less common within relationships where the client is older than the MSW participant (OR: 0.83; 95% CI: 0.74 to 0.93). Number of multiplex relationships was positively associated with number of condomless anal sex acts with male clients (incidence rate ratio: 1.35; 95% CI: 1.19 to 1.54). Conclusions: Network characteristics may contribute to disproportionate HIV risk among MSWs. Modeling studies should include network characteristics when simulating HIV transmission, and future HIV interventions should address the role of networks. [ABSTRACT FROM AUTHOR]

In Mexico City, male sex workers (MSWs) are up to 126 times more likely to be living with HIV than the general public. We conducted interviews with 23 MSWs in Mexico City to examine their subjective understandings about their sexual risk behaviors and explore opportunities about HIV pre-exposure prophylaxis (PrEP) as a prevention approach in this group. Despite knowledge about sexual HIV risks, most participants reported condomless anal sex with clients. There was very little prior knowledge about PrEP, but very high interest in using a daily pill for prevention. Several participants expected an increase in condomless anal sex if taking PrEP, because of monetary incentives from clients or a perceived increase in pleasure. Additionally, seasonal sex workers expressed interest in using PrEP only during months when they were performing sex work. PrEP implementation efforts through Mexico's healthcare system should recognize the varying needs and sexual risk behaviors of MSWs. [ABSTRACT FROM AUTHOR]

In Latin America, men who have sex with men (MSM) remain disproportionately impacted by HIV. Pre-exposure prophylaxis (PrEP) is an effective HIV prevention tool and has been FDA approved in the United States since 2012, but no Latin American state, with the recent exception of Brazil, has implemented PrEP guidelines. We carried out a multinational online survey of MSM in Latin America (n = 22698) in 2012 to assess whether MSM at highest risk of HIV acquisition (i.e., those engaging in condomless anal sex [CAS; n = 2606] and transactional sex [n = 1488]) had higher levels of awareness of PrEP, PrEP use and interest in participating in a PrEP trial. After adjusting for demographic and psychosocial characteristics including depressive symptoms, hazardous alcohol use, childhood sexual abuse, and sexual compulsivity, transactional sex and CAS were associated with increased PrEP awareness (aOR = 1.29, 95% CI: 1.05-1.59, p < .001 and aOR = 1.22, 95% CI: 1.11-1.34, p < .001, respectively) and PrEP trial interest (aOR = 1.45, 95% CI: 1.25-1.71, p < .001 and aOR = 1.74, 95% CI: 1.57-1.95, p < .001, respectively). Findings demonstrate substantial awareness of and interest in PrEP among MSM with behavioral risk factors for HIV in Latin America, suggesting that this region is primed for PrEP implementation, which has been slow. [ABSTRACT FROM AUTHOR]

Brazil's comprehensive HIV treatment program does not specifically address ART adherence challenges for adolescents—a group accounting for the largest number of incident HIV infections in Brazil. We conducted three focus groups with 24 adolescents (age 15–24) living with HIV in Rio de Janeiro, separately for cisgender men who have sex with men, heterosexual-identified cisgender men and women, and transgender women of any sexual orientation, and key informant interviews (n = 7) with infectious disease specialists and HIV/AIDS service organization staff. Content analysis identified socioecological barriers and facilitators to adherence, including individual (e.g., low knowledge, side effects, and substance use), interpersonal (e.g., stigma from partners and health care providers) and structural (e.g., transportation and medication access) barriers. Overlapping and unique barriers emerged by sexual/gender identity. A community-informed, theory-driven ART adherence intervention for adolescents that is organized around identity and leverages social networks has the potential to improve HIV treatment and health outcomes for Brazilian adolescents. [ABSTRACT FROM AUTHOR]

Cisgender men (CM) who report transgender women (TW) as sexual partners are an understudied population in the HIV epidemic in Latin America. The current study sought to characterize this group in a 2012 cross-sectional online survey of Latin American CM who were members of a sexual networking website for men who have sex with men (N = 11,847). Multivariable logistic regression models were fit to estimate demographic, behavioral, and psychosocial correlates of having a TW sexual partner and engaging in condomless sex. Overall, 0.9% (n = 106) reported a TW sexual partner in the last 12 months; of these, 76.4% (n = 81) reported condomless sex in the last three months. Identifying as bisexual or heterosexual compared to gay, and specifying a versatile sexual role preference compared to insertive were associated with reporting a recent TW sex partner (all p < 0.05). HIV-negative serostatus, lifetime STI history, and alcohol dependence were associated with recent condomless sex (all p < 0.05). CM with TW sexual partners have distinct HIV-related vulnerabilities. Future research is needed to understand CM who report TW sexual partners, including their sexual preferences and practices, sexual networks, exposure to stigma, biomedical prevention interest and uptake, and acceptability of integrating alcohol abuse screening into sexual health services. [ABSTRACT FROM AUTHOR]

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

Adolescents are disproportionately impacted by HIV in the United States. Optimal effects from antiretroviral therapy (ART) can be achieved through stringent adherence to a daily medication regimen; for adolescents, this may be interrupted due to complex barriers unique to this age group. We previously conducted formative qualitative interviews with HIV-infected adolescents to identify key barriers facing adolescents regarding ART adherence and potential strategies to address these barriers. These data were used to inform an ART adherence intervention designed to overcome difficulties unique to HIV-infected adolescents (e.g., internalized stigma and HIV-related shame, disclosure to sexual partners, social life, and extracurricular activities at school, etc.). The resulting intervention—"Positive Strategies To Enhance Problem-solving Skills (Positive STEPS)"—combines five individual counseling sessions with daily text message reminders. We conducted a pilot randomized controlled trial of the intervention against a standard of care control and report on the feasibility of procedures and participant acceptability of the intervention in terms of content, structure, and format. ART adherence was measured in both arms through Medication Event Monitoring System pill caps and self-report. Feasibility and acceptability of the Positive STEPS intervention was evidenced by 90% retention for the intervention sessions; 100% completion of the four-month assessment; and positive responses on postintervention evaluation forms (all intervention participants rated Positive STEPS as "acceptable" or "very acceptable") and brief exit interviews. At the 4-month assessment visit, the change in ART adherence among the intervention group [mean change score = 13%, standard deviation (SD) = 29.5] was significantly higher compared with the standard of care group (mean change score = −26%, SD = 26.0; Cohen's d effect size = 1.43, confidence interval = 0.17–2.49, p = 0.02). Future testing of the intervention in a fully powered randomized controlled trial to determine efficacy is warranted. [ABSTRACT FROM AUTHOR]

In India men who have sex with men and engage in sex work (i.e., male sex workers; MSW) have a high risk of transmitting HIV. Globally, sex workers have become more spatially mobile due to advances in mobile-phone technology. In 2012 in-depth qualitative feedback was garnered from 40 interviews with MSW and four focus groups with 35 key informants (KIs) who had expert knowledge of the local MSW community to inform the design of an HIV-prevention intervention among MSW in Chennai, India. All MSW were recruited during outreach by employees of a Chennai-based organization for MSM (men who have sex with men). The data were analyzed using a descriptive qualitative approach. MSW and KIs discussed the need for intervention content that went beyond basic HIV psychoeducation. They emphasized the importance of addressing psychological distress, alcohol-related risk, and sexual communication skills. Concerns were raised about confidentiality, privacy, and scheduling. Participants endorsed a combination of in-person and mobile-phone-delivered sessions as well as the integration of mobile-phone messaging. These findings served as the basis for the development of a theoretically driven, manual-based intervention incorporating mobile phones. An open pilot assessed the feasibility and acceptability of the intervention with eight MSW. Assessments and HIV testing were administered at baseline, 3, and 6 months post-baseline. Exit interviews were conducted at the conclusion of the intervention. Retention for session attendance and assessment follow-up was 100 %. There was a high level of acceptability for the format, structure, and content. These data show initial promise, feasibility, and acceptability of the intervention. [ABSTRACT FROM AUTHOR]

Black and Latino gay, bisexual, and other men who have sex with men (MSM) have higher rates of HIV and other sexually transmitted infections (STIs) than their White counterparts. Differences in sexual networks have been hypothesized to play an important role in the observed racial/ethnic disparities in risk. However, concerns about the acceptability and feasibility of conducting sociocentric sexual network studies have left a dearth of data on the structure of sexual networks of MSM. If certain network research procedures are unacceptable among target populations, biases may be introduced. We conducted qualitative interviews and brief surveys with 30 self-identified Black (n = 12), Hispanic/Latino, (n = 9) and White (n = 9) sexually active MSM in the Greater Boston area to assess the acceptability and feasibility of potential procedures for a sociocentric sexual network study. We found that referring recent sexual partners as part of a sociocentric network study was generally acceptable, but racial/ethnic differences emerged regarding specific preferences for how to recruit sexual partners. While the majority of Black participants (7/12) explained that they would not want their name disclosed to sexual partners approached for study participation, most Latino participants (7/9) preferred having the opportunity to inform referrals themselves about the study prior to researchers contacting them, and White participants (8/9) favored having researchers disclose their names when recruiting referrals, emphasizing the importance of transparency. In order to reduce differential rates of research participation, increase scientific validity, and reduce risks of social harm, researchers studying sexual networks among MSM should be aware of these potential differences, engage communities in study design, and provide participants with a variety of options for recruiting their sexual partners. [ABSTRACT FROM PUBLISHER]

In Venezuela, members of a social and sexual partner networking site for men who have sex with men (MSM) completed an online survey regarding sexual behaviours and HIV medical care. Among the 2851 respondents, self-reported HIV prevalence was 6.6%. Of participants living with HIV, 73.2% reported taking antiretroviral medication and 56.6% reported complete adherence within the past month. Participants living with HIV were more likely to be older (aOR = 1.04 per one-year increase in age, 95% CI: 1.02, 1.06) and diagnosed with a sexually transmitted infection in the previous year (aOR 3.26, 95% CI: 2.11, 5.04). These data provide further understanding of the HIV epidemic among MSM in Venezuela, and potential targets for HIV prevention interventions. [ABSTRACT FROM AUTHOR]

Objective: To examine whether latent class indicators of negative affect and substance use emerged as distinct psychosocial risk profiles among HIV-infected men, and if these latent classes were associated with high-risk sexual behaviors that may transmit HIV. Methods: Data were from HIV-infected men who reported having anal intercourse in the past 6 months and received routine clinical care at 4 U.S. sites in the Centers for AIDS Research Network of Integrated Clinical Systems cohort (n = 1,210). Latent class membership was estimated using binary indicators for anxiety, depression, alcohol and/or drug use during sex, and polydrug use. Generalized estimating equations modeled whether latent class membership was associated with HIV sexual transmission risk in the past 6 months. Results: Three latent classes of psychosocial indicators emerged: (a) internalizing (15.3%; high probability of anxiety and major depression); (b) externalizing (17.8%; high probability of alcohol and/or drug use during sex and polydrug use); (c) low psychosocial distress (67.0%; low probability of all psychosocial factors examined). Internalizing and externalizing latent class membership were associated with HIV sexual transmission risk, compared to low psychosocial class membership; externalizing class membership was also associated with higher sexual transmission risk compared to internalizing class membership. Conclusions: Distinct patterns of psychosocial health characterize this sexually active HIV-infected male patient population and are strongly associated with HIV sexual transmission risk. Public Health intervention efforts targeting HIV sexual risk transmission may benefit from considering symptom clusters that share internalizing or externalizing properties. [ABSTRACT FROM AUTHOR]

In Vietnam, there is an emerging HIV epidemic among men who have sex with men (MSM). Male sex workers engage in high-risk sexual behaviours that make them particularly vulnerable to HIV infection. In 2010, 23 MSM in Ho Chi Minh City (HCMC) who recently received payment for sex with another man completed in-depth qualitative interviews exploring motivations for sex work, patterns of sex work disclosure and experiences of social stigma. Interviews were recorded, transcribed and translated into English and analysed using a qualitative descriptive approach. Low wages, unstable employment and family remittances were motivating factors for MSM in HCMC to sell sex. Participants described experiences of enacted and felt social stigma related to their involvement in sex work. In response, they utilised stigma management techniques aimed at concealment of involvement in sex work. Such strategies restricted sexual communication with non-paying sex partners and potentially limited their ability to seek social support from family and friends. Departing from decontextualized depictions of sex work disclosure, our findings describe how decisions to reveal involvement in sex work are shaped by social and structural factors such as social stigma, techniques to minimise exposure to stigma, economic imperatives and familial responsibilities. [ABSTRACT FROM PUBLISHER]

Background: PEARLS, a large scale trial of antiretroviral therapy (ART) for HIV (n = 1,571, 9 countries, 4 continents), found that a once-daily protease inhibitor (PI) based regimen (ATV+DDI+FTC), but not a once-daily non-nucleoside reverse transcriptase inhibitor/nucleoside reverse transcriptase inhibitor (NNRTI/NRTI) regimen (EFV+FTC/TDF), had inferior efficacy compared to a standard of care twice-daily NNRTI/NRTI regimen (EFV+3TC/ZDV). The present study examined non-adherence in PEARLS. Methods: Outcomes: non-adherence assessed by pill count and by self-report, and time to treatment failure. Longitudinal predictors: regimen, quality of life (general health perceptions  =  QOL-health, mental health  =  QOL-mental health), social support, substance use, binge drinking, and sexual behaviors. “Life-Steps” adherence counseling was provided. Results: In both pill-count and self-report multivariable models, both once-a-day regimens had lower levels of non-adherence than the twice-a-day standard of care regimen; although these associations attenuated with time in the self-report model. In both multivariable models, hard-drug use was associated with non-adherence, living in Africa and better QOL-health were associated with less non-adherence. According to pill-count, unprotected sex was associated with non-adherence. According to self-report, soft-drug use was associated with non-adherence and living in Asia was associated with less non-adherence. Both pill-count (HR = 1.55, 95% CI: 1.15, 2.09, p<.01) and self-report (HR = 1.13, 95% CI: 1.08, 1.13, p<.01) non-adherence were significant predictors of treatment failure over 72 weeks. In multivariable models (including pill-count or self-report nonadherence), worse QOL-health, age group (younger), and region were also significant predictors of treatment failure. Conclusion: In the context of a large, multi-national, multi-continent, clinical trial there were variations in adherence over time, with more simplified regimens generally being associated with better adherence. Additionally, variables such as QOL-health, regimen, drug-use, and region play a role. Self-report and pill-count adherence, as well as additional psychosocial variables, such QOL-health, age, and region, were, in turn, associated with treatment failure. [ABSTRACT FROM AUTHOR]

In 2010, the centre for the AIDS Programme of Research in South Africa (CAPRISA)004 and iPrEx trials (microbicide gel containing tenofovir and oral pill containing tenofovir–emtricitabine, respectively) demonstrated that antiretroviral preexposure prophylaxis (PrEP) reduced the risk of HIV acquisition among high-risk individuals. To determine the facilitators and barriers to PrEP provision by health-care providers, we conducted an online, quantitative survey of Massachusetts-area physicians following the publication of the CAPRISA and iPrEx results. We assessed awareness and comprehension of efficacy data, prescribing experience, and anticipated provision of oral and topical PrEP among physicians, as well as demographic and behavioral factors associated with PrEP awareness and prescribing intentions. The majority of HIV specialists and generalist physicians were aware of data from these PrEP trials and able to correctly interpret the results, however, correct interpretation of findings tended to vary according to specialty (i.e., HIV specialists had greater awareness than generalists). In addition, provider concerns regarding PrEP efficacy and safety, as well its ability to divert funds from other HIV prevention resources, were associated with decreased intentions to prescribe both oral and topical PrEP. Findings suggest that a substantial proportion of physicians who may have contact with at-risk individuals may benefit from interventions that provide accurate data on the risks and benefits of PrEP in order to facilitate effective PrEP discussions with their patients. Future studies to develop and test interventions aimed at health-care providers should be prioritized to optimize implementation of PrEP in clinical settings. [ABSTRACT FROM AUTHOR]

Indian men who have sex with men (MSM) are at increased risk for HIV compared to the general Indian population. Psychosocial factors may be uniquely associated with HIV risk among Indian MSM and may moderate the beneficial impact of standard HIV prevention approaches. Psychiatric diagnostic interviews and psychosocial and sexual risk assessments were conducted among 150 MSM in Mumbai, India. Logistic regression was employed to examine the association of psychiatric disorders and psychosocial problems to recent sexual risk behavior. Twenty-five percent of participants reported engaging in unprotected anal sex (UAS) during their last sexual contact with a man. Men who were married to a woman were more likely to have engaged in UAS during their last sexual contact with a man (35% vs. 17%,p=0.018). In multivariable models, significant predictors of engaging in UAS were current major depression (adjusted odds ratio [AOR]=2.61; 95% confidence interval [CI] 1.07, 6.39) and number of stressful life events (AOR=0.91; 95% CI 0.83, 0.99). Alcohol dependence, anxiety, and self-esteem were not associated with engaging in UAS. Indian MSM with depression are at higher odds of engaging in UAS compared to MSM without depression. HIV prevention programs for Indian MSM may benefit from incorporating treatment or triage for mental health problems. [ABSTRACT FROM AUTHOR]

In the USA, sexual intercourse is the leading route of human immunodeficiency virus transmission among women, primarily through their main partner. Because male condom use is not directly under a woman's control, gender inequalities may help shape this sexual risk behavior. To examine this association, data came from follow-up interviews of young, primarily minority, pregnant women enrolled in a prospective, randomized controlled trial. Specifically, we aimed to determine the relationship between economic dependence on a male partner and condom use, and to establish whether this relationship was mediated by sexual assertiveness. Overall, 28% of women reported being economically dependent on a male partner. Young women dependent on a male partner were 1.6 times more likely to report not using a condom at last sex than women not dependent on their partner (95% confidence interval = 1.11–2.32; p = 0.01). Sexual assertiveness mediated the relationship between economic dependence and condom use (Sobel = 2.05, p = 0.04). Coupled with past research, this study supports the premise that sexual behaviors may be rooted in a complex web of social determinants. Addressing gender inequalities in contextual factors may promote healthier decisions within sexual relationships. [ABSTRACT FROM AUTHOR]

Background: HIV 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.Objective: The 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.Methods: Informed 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.Results: The 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.Conclusions: These 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 Registration: Clinicaltrials.gov NCT03179319; https://clinicaltrials.gov/ct2/show/NCT03179319.International Registered Report Identifier (irrid): RR2-10.2196/10694. [ABSTRACT FROM AUTHOR]

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