Practices and preferences for HIV testing and treatment services amongst partners of transgender women in Lima, Peru: An exploratory, mixed methods study.

BACKGROUND: In Peru, one-third of transgender women (TW) are estimated to be living with HIV. While TW are recognized as a priority population, their sexual partners are an at-risk hidden population with unmet needs for HIV services. We conducted a study examining the practices and preferences for HIV services among partners of transgender women (PTW), as compared to TW, to better understand the needs of PTW and inform HIV service delivery for them in Peru. METHODS: Between July-October 2022 we conducted a cross-sectional mixed methods study among PTW and TW in Lima, Peru. Using an explanatory sequential design, we administered online surveys to PTW (n = 165) and TW (n = 69), then interviewed a subset of participants (n = 20: 16 PTW, 4 TW). We quantitatively and qualitatively described PTW practices/perspectives on HIV testing and treatment and compared them to TW practices/preferences; we also compared practices/preferences among PTW based on their relationship with TW. RESULTS: Overall, PTW and TW shared similar experiences and preferences for HIV testing/treatment, but fewer PTW reported accessing non-traditional HIV testing options and PTW expressed less strong preferences for HIV services. PTW practices/preferences varied by type of relationship with TWs. Surveys and interviews highlighted a need to prioritize efficiency for HIV testing, eliminate gender/sexuality-based discrimination in healthcare settings, increase privacy when delivering HIV services, and increase awareness of pre-exposure prophylaxis. CONCLUSION: PTW identified many aspects related to the location, convenience, and privacy of HIV services as important. Next steps could include a discrete choice experiment to further clarify priorities for HIV services for PTW in Peru.

HIV Risk Behaviors and the Use of Geosocial Networking Dating Apps among Men Who have Sex with Men and Transgender Women in Lima, Peru: a Cross-Sectional Study.

Geosocial networking dating apps (GSN apps) are an increasingly widespread technology used by populations throughout the world to facilitate sexual encounters. Studies from a variety of settings suggest a possible association between GSN app use and HIV risk behaviors, including among sexual and gender minority populations such as men who have sex with men (MSM) and transgender women (TW). However, it remains unclear to what extent GSN apps play a causal role. We explored the relationship between GSN app use and sexual risk behaviors among MSM and TW in Lima, Peru by analyzing data from a multi-site cross-sectional survey assessing both general and partner-specific sexual behaviors. We performed bivariate analysis to estimate the association of GSN app use with different individual and partner-specific factors, then fit multivariable regression models adjusting for age and education. Among 741 total participants (698 MSM, 43 TW), 64% met at least one sex partner in the prior three months using a GSN app. GSN app users were significantly more likely to report engaging in HIV risk behaviors in general, including condomless receptive anal sex, group sex, transactional sex, and sex under the influence of alcohol or drugs. Having condomless anal sex with a given partner was not associated with meeting that partner via GSN app. These findings highlight GSN app users as a particularly vulnerable subpopulation among MSM and TW in Lima. GSN apps could provide a useful vehicle for targeted HIV prevention efforts for priority populations in Peru.

RESUMEN: Las aplicaciones de citas de redes geosociales (aplicaciones GSN) son una tecnología con creciente alcance en todo el mundo usadas para facilitar encuentros sexuales. Diferentes estudios sugieren una posible relación entre uso de aplicaciones GSN y comportamientos de riesgo para VIH entre hombres que tienen sexo con hombres (HSH) y mujeres transgénero (MT). No es claro hasta qué punto aplicaciones GSN tendrían un papel causal directo. Exploramos la relación entre uso de aplicaciones GSN y comportamientos sexuales de riesgo entre HSH y MT en Lima, Perú, analizando datos de una encuesta transversal que evaluó comportamientos sexuales en general y en parejas específicas. Realizamos análisis bivariable para estimar la asociación del uso de aplicaciones GSN con diferentes factores individuales y específicos de la pareja. También aplicamos modelos de regresión multivariables ajustados por edad y educación. Entre 741 participantes totales (698 HSH, 43 MT), 64% conoció al menos a una pareja sexual en los últimos tres meses mediante una aplicación GSN. Los usuarios de aplicaciones GSN fueron significativamente más propensos a reportar comportamientos de riesgo de VIH en general, incluyendo sexo anal receptivo sin condón, y sexo grupal, transaccional y bajo influencia de alcohol o drogas. Tener sexo anal sin condón con una pareja determinada no se asoció con conocer a esa pareja mediante aplicación GSN. Estos hallazgos muestran a usuarios de aplicaciones GSN como una subpoblación particularmente vulnerable entre HSH y MT en Lima. Aplicaciones GSN podrían ser útiles para iniciativas de prevención del VIH en poblaciones prioritarias en Perú.

Acceptability of venue-based HIV testing and prevention interventions for men who have sex with transgender women and transgender women in Lima, Perú: a formative, qualitative study.

BACKGROUND: Despite being at elevated risk for HIV, men who have sex with transgender women (MSTW) are an overlooked population in the global HIV response. Venue-based HIV interventions have previously had success reaching other HIV priority populations, including transgender women (TW). Similar approaches could be applied for MSTW. OBJECTIVE: To evaluate the prospective acceptability of venue-based HIV testing and prevention interventions for MSTW and TW in Lima, Peru. METHODS: In this exploratory qualitative study, we conducted in-depth interviews (IDI) and focus group discussions (FGD) with three types of participants: MSTW (7 IDIs, 1 FGD), TW (1 FGD), and owners of social venues frequented by MSTW/TW in Lima (2 IDIs). We elicited participants' attitudes and perceptions related to the following four hypothetical interventions delivered at social venues in Lima: rapid HIV testing; HIV self-test distribution; condom/lubricant distribution; and enrolment in a mobile app supporting HIV prevention. We performed a mixed deductive-inductive thematic analysis using the framework method, then applied the Theoretical Framework of Acceptability to classify the overall acceptability of each intervention. RESULTS: Condom/lubricant distribution and app-based HIV prevention information were highly acceptable among all participant types. The two HIV testing interventions had relatively lower acceptability; however, participants suggested this could be overcome if such interventions focused on ensuring discretion, providing access to healthcare professionals, and offering appropriate incentives. CONCLUSIONS: Overall, MSTW and TW shared similar favourable attitudes towards venue-based HIV interventions. Venue-based outreach warrants further exploration as a strategy for engaging MSTW and TW in HIV prevention activities.

Correlates of condomless anal intercourse with different types of sexual partners among men who have sex with men and transgender women in Lima, Peru.

CLINICAL TRIAL REGISTRATION: The Sabes study was registered in March 2013 with the National Institutes of Health at ClinicalTrials.gov (identifier: NCT01815580).

HIV transmission patterns among transgender women, their cisgender male partners, and cisgender MSM in Lima, Peru: A molecular epidemiologic and phylodynamic analysis.

BACKGROUND: Transgender women (TW) in Peru are disproportionately affected by HIV. The role that cisgender men who have sex with TW (MSTW) and their sexual networks play in TW's risk of acquiring HIV is not well understood. We used HIV sequences from TW, MSTW, and cisgender men who have sex with men (MSM) to examine transmission dynamics between these groups. METHODS: We used HIV-1 pol sequences and epidemiologic data collected through three Lima-based studies from 2013 to 2018 (n = 139 TW, n = 25 MSTW, n = 303 MSM). We identified molecular clusters based on pairwise genetic distance and used structured coalescent phylodynamic modeling to estimate transmission patterns between groups. FINDINGS: Among 200 participants (43%) found in 62 clusters, the probability of clustering did not differ by group. Both MSM and TW were more likely to cluster with members of their own group than would be expected based on random mixing. Phylodynamic modeling estimated that there was frequent transmission from MSTW to TW (67·9% of transmission from MSTW; 95%CI = 52·8-83·2%) and from TW to MSTW (76·5% of transmissions from TW; 95%CI = 65·5-90·3%). HIV transmission between MSM and TW was estimated to comprise a small proportion of overall transmissions (4·9% of transmissions from MSM, and 11·8% of transmissions from TW), as were transmissions between MSM and MSTW (7·2% of transmissions from MSM, and 32·0% of transmissions from MSTW). INTERPRETATION: These results provide quantitative evidence that MSTW play an important role in TW's HIV vulnerability and that MSTW have an HIV transmission network that is largely distinct from MSM.

Brief Report: Self-Reported Knowledge of HIV Status Among Cisgender Male Sex Partners of Transgender Women in Lima, Peru.

BACKGROUND: Knowledge of HIV status is a critical first step in the HIV care cascade. Cisgender male sex partners of transgender women (MSTW) are at a disproportionately high risk of HIV, but little is known about their access to HIV testing or knowledge of HIV status. METHODS: We used cross-sectional data from a respondent-driven sampling study to analyze self-reported HIV status and predictors of knowledge of HIV status among MSTW in Lima, Peru. Mixed-effects models were used to generate crude and adjusted prevalence ratios (aPRs) and 95% confidence intervals (CIs) for the association between knowledge of HIV status and predictors of interest, including sociodemographics and recent sexual behavior. RESULTS: From February to July 2018, 196 eligible MSTW enrolled, of which 90 (46%) reported not knowing their HIV status. Recent casual or 1-time partners were reported by 84% of MSTW and 54% reported purchasing sex. In adjusted analyses, MSTW participants were less likely to know their HIV status if they reported buying sex (aPR 0.43, 95% CI: 0.32 to 0.59) or reported ≥16 recent sex partners compared with ≤5 partners [aPR 0.32, (0.20 to 0.50)]. Those who reported male sex partners were 80% more likely to know their status [aPR 1.80, (1.33 to 2.44)]. CONCLUSIONS: Reported knowledge of HIV status was low among MSTW in Lima, and unknown HIV status was associated with behaviors linked to HIV acquisition. MSTW who reported male partners were more likely to know their status, potentially indicating that HIV testing is more accessible to men who have sex with men.

Viral Suppression Levels in Men Who Have Sex With Men and Transgender Women With Newly Diagnosed HIV and Alcohol Use Disorder in Peru: Results From a Randomized, Double-Blind, Placebo-Controlled Trial Using Oral Naltrexone.

BACKGROUND: Alcohol use disorders (AUDs) are common in men who have sex with men (MSM) and transgender women (TGW) in Peru and undermine antiretroviral therapy (ART) adherence. Oral naltrexone (NTX) is an evidence-based treatment for AUD that has not been assessed in cotreating AUD in MSM/TGW with HIV. SETTING AND DESIGN: A multi-site, randomized, double-blind, placebo-controlled trial among MSM/TGW with AUD and newly diagnosed with HIV in Lima, Peru. METHODS: Newly diagnosed MSM/TGW with HIV and AUD were prescribed a single-treatment regimen of EFV/TDF/FTC from 2014 to 2015 and randomized 2:1 to oral NTX (N = 103) or placebo (N = 53) for 24 weeks. The primary and secondary outcomes were proportion achieving viral suppression (VS: HIV-1 RNA < 400 copies/mL) or maximal viral suppression (MVS: HIV-1 RNA < 40 copies/mL) at 24 weeks. RESULTS: There were no significant differences between the arms in VS (81.6% NTX arm vs 75.5% placebo arm; P = 0.37) or MVS (61.2% NTX arm vs 66.0% placebo arm; P = 0.48). Adherence to study medication was low (mean = 34.6%) overall with only 21.4% of participants meeting recommended adherence levels (≥80% daily doses/month). Participants allocated to NTX had significantly lower adherence compared with placebo for both the first and second 12-week study periods, respectively (44.0% vs 35.2%, P = 0.04; 31.4% vs 35.2%, P = 0.03). CONCLUSIONS: Findings are inconclusive regarding the use of NTX for treatment of AUD in MSM/TGW newly diagnosed with HIV. VS and MVS levels were high irrespective of allocation. Adherence to study medication was low, requiring further exploration of strategies to optimize adherence to NTX as AUD treatment.

Finding and treating early-stage HIV infections: A cost-effectiveness analysis of the Sabes study in Lima, Peru.

Background: Sabes, a treatment-as-prevention intervention among men who have sex with men and transgender women in Lima, Peru, was developed to identify HIV during early primary infection (<3 months from acquisition) through monthly serologic assays and HIV RNA tests. Newly diagnosed individuals were rapidly linked to care and offered to initiate ART. In this study we sought to study the cost-effectiveness of Sabes compared to the standard of care (SOC) for HIV testing and initiation of treatment. Methods: We adapted a compartmental model of HIV transmission to evaluate the cost-effectiveness of the Sabes approach compared to the SOC using a government health care perspective, 20-year time horizon, and 3% annual discounting. We estimated the proportion of cases of HIV detected during early primary infection, reduction in HIV incidence and prevalence, incremental cost-effectiveness ratio (ICER), and net monetary benefit. We analyzed costs using data from the Sabes study, the Peruvian Ministry of Health, published literature, and expert consultation. Findings: The Sabes intervention is projected to identify 9294 early primary HIV infections in Lima, Peru over 20 years. The intervention costs $6,896 per early primary infection diagnosed and by 2038 is expected to decrease the fraction of early infections among prevalent infections by 62%. Sabes is expected to improve health, resulting in greater total discounted QALYs per person than the SOC (16·7 vs 16·4, respectively). Sabes had an ICER of $1431 (22% per capita GDP in Peru) per QALY compared to SOC. Interpretation: Our analysis suggests that in Lima, Peru the Sabes intervention could be a cost-effective approach to reduce the burden of HIV even under stringent cost-effectiveness criteria. This finding suggests that programs that use frequent HIV testing, rapid linkage to care and initiation of ART should be considered as part of a comprehensive HIV prevention strategy. Funding: National Institutes of Health.

HIV Disease Dynamics and Markers of Inflammation and CNS Injury During Primary HIV Infection and Their Relationship to Cognitive Performance.

INTRODUCTION: Early systemic and central nervous system viral replication and inflammation may affect brain integrity in people with HIV, leading to chronic cognitive symptoms not fully reversed by antiretroviral therapy (ART). This study examined associations between cognitive performance and markers of CNS injury associated with acute HIV infection and ART. METHODS: HIV-infected MSM and transgender women (average age: 27 years and education: 13 years) enrolled within 100 days from the estimated date of detectable infection (EDDI). A cognitive performance (NP) protocol was administered at enrollment (before ART initiation) and every 24 weeks until week 192. An overall index of cognitive performance (NPZ) was created using local normative data. Blood (n = 87) and cerebrospinal fluid (CSF; n = 29) biomarkers of inflammation and neuronal injury were examined before ART initiation. Regression analyses assessed relationships between time since EDDI, pre-ART biomarkers, and NPZ. RESULTS: Adjusting for multiple comparisons, shorter time since EDDI was associated with higher pre-ART VL and multiple biomarkers in plasma and CSF. NPZ scores were within the normative range at baseline (NPZ = 0.52) and at each follow-up visit, with a modest increase through week 192. Plasma or CSF biomarkers were not correlated with NP scores at baseline or after ART. CONCLUSIONS: Biomarkers of CNS inflammation, immune activation, and neuronal injury peak early and then decline during acute HIV infection, confirming and extending results of other studies. Neither plasma nor CSF biomarkers during acute infection corresponded to NP scores before or after sustained ART in this cohort with few psychosocial risk factors for cognitive impairment.

Exploring HIV risk behavior and sexual/gender identities among transgender women and their sexual partners in Peru using respondent-driven sampling.

HIV prevalence is high among transgender women, but little is known about cisgender men who have sex with transgender women (MSTW). The objective of this study was to investigate characteristics and behavior of MSTW compared to transgender women and men who have sex with men (MSM) using a modified respondent-driven sampling design. Seed participants completed a survey and invited up to three sex partners. Forward recruitment continued in waves through the referral of sex partners. Cross-sectional data were assessed using mixed effects models. From February to July 2018, 479 participants in Lima, Peru enrolled (n = 199 transgender women, n = 196 MSTW, and n = 45 MSM). MSTW behavior and identity differed significantly from that of transgender women and MSM. MSTW primarily identified as bisexual (69%) or heterosexual (15%) and only 6% reported male partners. Insertive condomless anal intercourse was reported by 61% of MSTW; 46% did not know their HIV serostatus. Compared to MSTW without male partners, those with recent male partners were more likely to sell sex (OR 15.7, 95% CI 4.1-60.5), and report condomless receptive anal intercourse (OR 89.0, 95% CI 19.1-414.8). This evidence suggests that MSTW are a distinct population from MSM, and highlights the critical need to include MSTW in HIV research and interventions.

Linkage to care after HIV diagnosis among men who have sex with men and transgender women in Lima, Peru.

In Lima, Perú, HIV prevalence is estimated to be 15% among men who have sex with men (MSM) and 30% among transgender women (TW). We investigated timely linkage of MSM and TW to HIV care, as linkage to antiretroviral therapy (ART) is critical to protect the health of those living with HIV and to prevent onward transmission. We investigated linkage within 90 days of HIV diagnosis by matching data from two studies conducted in Lima between 2013 and 2015 to national ART program records. We used generalized linear modeling to assess predictors of timely linkage and late presentation to care. Of 487 newly-diagnosed MSM and TW, only 44% presented for care at an HIV clinic within 90 days. Timely linkage was less common among TW (aPR 0.7, 95% CI 0.5-1.0), those younger than 24 (aPR 0.8, 95% CI 0.6-1.0), and those reporting a history of sex work (aPR 0.7, 95% CI 0.6-0.9). Proximity to an ART program clinic was not associated with linkage; most participants linked to clinics offering "LGBTQ-friendly" care. The pattern of clinics selected by participants suggests the importance of concerns about confidentiality and stigma in decision-making about where to link to care.

Clinical and Immunologic Outcomes After Immediate or Deferred Antiretroviral Therapy Initiation During Primary Human Immunodeficiency Virus Infection: The Sabes Randomized Clinical Study.

BACKGROUND: In addition to demonstrated public health benefits on reducing transmission, it remains unclear how early antiretroviral therapy (ART) must be started after acquisition of human immunodeficiency virus (HIV) to maximize individual benefits. METHODS: We conducted an open-label randomized clinical study in Lima, Peru among adult men who have sex with men and transgender women with acute (HIV-antibody negative/HIV-1 RNA positive) or recent (confirmed negative HIV-antibody or RNA test within 3 months) HIV infection, who were randomized to start ART immediately versus defer by 24 weeks. We evaluated outcomes by treatment arm and immunologic markers by days since estimated date of detectible infection (EDDI). RESULTS: Of 216 participants, 105 were assigned to immediate arm and 111 to deferred arm (median age 26.8 years, 37% with acute HIV). The incidence of non-ART-related adverse events was lower in immediate versus deferred arm (83 vs 123/100 person-years, IRR 0.67 (95% confidence interval [CI] .47, .95; P = .02), the difference dominated by fewer infections in those treated immediately. After 24 weeks of ART, between-group differences in CD4/CD8 cell ratio lessened (P = .09 overall), but differences between those initiating ART ≤ 30 days from EDDI (median 1.03, interquartile range [IQR] 0.84, 1.37), and those initiating > 90 days (0.88, IQR 0.61, 1.11) remained, P = .02. Principal components analysis of 20 immune biomarkers demonstrated distinct patterns between those starting ART > 90 days from EDDI versus those starting within 30 or 90 days (both P < .001). CONCLUSIONS: To our knowledge, this is the only evaluation of randomized ART initiation during primary HIV and provides evidence to explicitly consider acute HIV in World Health Organization recommendations for universal ART. CLINICAL TRIALS REGISTRATION: NCT01815580.

Sexual Behavior Among Men Who Have Sex With Men: The Need for More Targeted Outreach to Men Who Also Have Sex With Cisgender Women.

BACKGROUND: In Peru, as in the Americas overall, men who have sex with men (MSM) are disproportionately affected by HIV. Most research focuses on practices between cisgender men, whereas many MSM report male and female partners, cisgender, transgender, or both. METHODS: Data for these analyses were from a treatment-as-prevention study in Lima (the Sabes study). We compared demographics and behaviors of MSM who reported cisgender women partners in the past 3 months (MSMW) and MSM who reported both cisgender and transgender women partners (MSMW-T) to MSM who reported only male partners (MSMO). We calculated HIV incidence in each group during 2-year follow-up. RESULTS: Compared with MSMO, MSMW and MSMW-T more often self-identify as heterosexual or bisexual and report insertive sex practices. MSMW reported condomless sex with cisgender women: vaginal (72%), anal sex (18%). One-third of MSMW reported condomless receptive anal sex with men in the past 3 months, with 24% of MSMW overall who reported both condomless receptive sex with men and condomless insertive vaginal or anal sex with cisgender women. Of these, 17% were HIV infected. HIV incidence did not differ significantly between groups. CONCLUSION: Most MSMW and MSMW-T report bisexual or heterosexual orientation and prefer insertive sex. MSMW and MSMW-T (47% and 29%, respectively) engage in receptive anal intercourse. In both groups, the majority who engaged in condomless receptive sex with men (76% MSMW, 85% MSMW-T) also engaged in condomless vaginal and/or anal sex with women, indicating need for intervention.

Sexual Behavior and Sexually Transmitted Infection Outcomes Among Men Who Have Sex With Men and Transgender Women Participating in a Study of the Timing of Antiretroviral Therapy in Lima, Peru.

BACKGROUND: We assessed sexual behavior and incidence of sexually transmitted infections (STIs) among men who have sex with men and transgender women participating in Sabes, a study of an expanded treatment as prevention strategy focused on early diagnosis and treatment of HIV infection in Lima, Peru (2013-2017). METHODS: Sabes participants were tested monthly for HIV to identify acute or early infections, and HIV-positive participants were randomized to receive antiretroviral therapy immediately (immediate arm) or after 24 weeks (deferred arm) during a 48-week follow-up period. Sexual behavior was assessed at randomization (baseline) and every 12 weeks thereafter. Participants were tested for urethral and rectal chlamydia and gonorrhea and for syphilis at baseline, 12, 24, and 48 weeks. We describe patterns of sexual behavior during the 48-week follow-up period and compare sexual behavior and STI incidence between study arms. RESULTS: After randomization, 207 HIV-positive participants completed questionnaires and STI testing at 2 or more visits. After HIV diagnosis, participants in both arms reported increases in condom use with main and casual partners and decreased drug and alcohol use before or during anal sex. We observed no between-arm differences in sexual behavior. Deferred arm participants had higher incidence of chlamydia (incidence rate ratio, 2.33; 95% confidence interval, 1.14-4.77) but not gonorrhea or syphilis. CONCLUSIONS: Despite reported increases in condom use, the overall high incidence of STIs reflects some ongoing condomless sex among HIV-positive men who have sex with men and transgender women, highlighting the importance of regular STI screening and counseling to support consistent condom use among HIV-positive individuals at risk for STIs.

Sex-on-premise venues, associated risk behaviors, and attitudes toward venue-based HIV testing among men who have sex with men in Lima, Perú.

BACKGROUND: In Perú, HIV disproportionately affects men who have sex with men (MSM). Despite widespread access to treatment, the high rate of new HIV infections has remained unchanged over the last decade. Low knowledge of HIV status associated with late diagnosis is a key factor underlying the high HIV incidence observed in this setting, creating conditions for efficient onward transmission. Improving access to HIV testing and prevention services for those at highest risk is an important public health priority. Sex-on-premise venues (SOPVs) - saunas, sex clubs, pornographic movie theaters, hourly hotels, and bars/discos with areas where sex is permitted - may be opportune sites for outreach; however, further research on SOPVs and the populations who frequent them is needed to inform such efforts. METHODS: We conducted a cross-sectional online survey of adult MSM in Lima, Perú to evaluate patterns of SOPV attendance, associated sexual risk behaviors, and attitudes toward SOPV-based interventions. Participants were recruited through outreach to social media networks affiliated with local LGBTQ-aligned community groups. Our primary analytic objective was to estimate the association of HIV-related sexual risk behaviors and SOPV attendance. Additionally, we performed exploratory analyses to describe risk behavior stratified by SOPV category and to examine the relationship between SOPV attendance and the use of online platforms to meet sex partners. RESULTS: Overall, 389 MSM completed the survey from November 2018 through May 2019, of whom 68% reported attending an SOPV in the last 3 months. SOPV attendance was associated with multiple sexual risk behaviors, including transactional sex, group sex, substance use around the time of sex, and higher number of partners. Over two thirds of SOPV attendees indicated they would accept HIV testing if offered at SOPVs. CONCLUSIONS: SOPV attendance was common among MSM in Lima who participated in our survey, and SOPV attendees reported significantly greater engagement in sexual risk behaviors related to HIV transmission. Attitudes toward hypothetical SOPV-based interventions were generally favorable. These findings suggest that outreach at SOPVs may be an effective mechanism for reaching a particularly high-risk sub-population of MSM in Perú to deliver targeted HIV testing and prevention interventions.

Safety of oral naltrexone in HIV-positive men who have sex with men and transgender women with alcohol use disorder and initiating antiretroviral therapy.

HIV disproportionately affects men who have sex with men (MSM) and transgender women (TW). These populations use alcohol more heavily than the general population, and alcohol use disorders (AUDs) are more prevalent among them. Naltrexone (NTX) has documented efficacy and safety as a medication-assisted therapy for AUD. Its use has not been well-examined in persons with HIV (PWH) newly initiating antiretroviral therapy (ART) where the possibility of hepatotoxicity may be increased when initating multiple new medications. This study assessed the safety of oral NTX treatment (50 mg daily) initiated concomitantly with antiretroviral therapy (ART) in a double-blind randomized placebo-controlled trial of NTX in MSM/TW in Lima, Peru among MSM and TW with AUD (AUDIT score ≥ 8). We analyzed adverse event data from ART-naïve participants (N = 155) who were randomized (2:1) to initiate ART plus NTX (N = 103) or ART plus placebo (N = 52). Participants were monitored for 24 weeks while taking ART plus NTX/placebo, followed by 24 weeks receiving ART alone. Over 48 weeks, 135 grade 2 or 3 adverse events were reported, resulting in 1.3 clinical adverse events per participant equally represented in both treatment and placebo arms. Two serious adverse events occurred among two participants receiving NTX; neither was attributed to the study medication. No significant differences were found in the proportion of subjects reporting any adverse events between treatment arms across all time-points. These results suggest NTX is safe in MSM/TW PWH with AUD newly initiating ART, as no excess of clinical adverse events or transaminase elevation was associated with NTX use.

Increasing PrEP uptake and adherence among MSM and TW sex workers in Lima, Perú: what and whom do different patients trust?

In Perú, men who have sex with men (MSM) and transgender women (TW) suffer rates of HIV 50 times greater than the general population. MSM or TW sex workers (SWs) are at especially high risk. Daily oral pre-exposure prophylaxis (PrEP) effectively prevents HIV infection if patients adhere to a daily or on-demand regimen. Necessary levels of adoption and adherence require data-driven intervention strategies for these marginalized groups. We conducted qualitative content analysis of data obtained from focus groups (FGs) with MSM and TW SWs. Both groups expressed strong skepticism about the motives behind international drug trials, and the safety of participating in them. Important differences between MSM and TW groups' beliefs about trustworthy information as well as community and public institutions also emerged. MSM SWs were less trusting of information from other MSM SWs, and preferred to receive information from institutional medical sources, while TGW SWs preferred to receive information from other TGW SWs. Successful strategies to encourage PrEP uptake and adherence must address the distrust patients feel towards international and institutional actors by providing patients with tailored, reliable information from local and community sources that they trust.