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Background: In Vietnam and other global settings, men who have sex with men (MSM) have become the population at greatest risk of HIV infection. Although HIV pre-exposure prophylaxis (PrEP) has been implemented as a prevention strategy, PrEP outcomes may be affected by low persistence and adherence among MSM with unhealthy alcohol use. MSM have a high prevalence of unhealthy alcohol use in Vietnam, which may affect PrEP outcomes., Methods: Design: We will conduct a two-arm hybrid type 1 effectiveness-implementation randomized controlled trial of a brief alcohol intervention (BAI) compared to the standard of care (SOC) at the Sexual Health Promotion (SHP) clinic Hanoi, Vietnam., Participants: Sexually active MSM (n=564) who are newly initiating PrEP or re-initiating PrEP and have unhealthy alcohol use will be recruited and randomized 1:1 to the SOC or BAI arm. A subgroup of participants (n=20) in each arm will be selected for longitudinal qualitative interviews; an additional subset (n=48) in the BAI arm will complete brief quantitative and qualitative interviews after completion of the BAI to assess the acceptability of the intervention. Additional implementation outcomes will be assessed through interviews with clinic staff and stakeholders (n=35)., Intervention: Study participants in both arms will receive standard care for PrEP clients. In the BAI arm, each participant will receive two face-to-face intervention sessions and two brief booster phone sessions, based on cognitive behavioral therapy and delivered in motivational interviewing informed style, to address their unhealthy alcohol use., Outcomes: Effectiveness (PrEP and alcohol use) and cost-effectiveness outcomes will be compared between the two arms. Intervention implementation outcomes (acceptability, feasibility, adoption) will be assessed among MSM participants, clinic staff, and stakeholders., Discussion: This proposed trial will assess an alcohol intervention for MSM with unhealthy alcohol use who initiate or re-initiate PrEP, while simultaneously preparing for subsequent implementation. The study will measure the effectiveness of the BAI for increasing PrEP persistence through reducing unhealthy alcohol use in a setting where excessive alcohol consumption is a normative behavior. If effective, implementation-focused results will inform future scale-up of the BAI in similar settings., Trial Registration: NCT06094634 on clinicaltrials.gov. Registered 16 October 2023., (© 2024. The Author(s).)

Stigma affects adversely the HIV prevention continuum and care cascade. Our population-based, mixed-methods study aimed to assess women's perceived HIV stigma and discriminatory attitudes, and their relation with HIV testing in a high-prevalence area in Belize. This population-representing household survey in the mixed urban-rural setting of Stann Creek District, Belize, collected data from 236 women age 15 to 49 years. We analyzed HIV testing rates, HIV prevention and transmission knowledge, perceived stigma manifestations, and participant attitudes. Concurrently, a nested qualitative component of study cognitive interviews with a purposive sample of 23 women explored HIV stigma in their community. A vast majority of women (96%) perceived HIV stigma manifestations in their communities as pervasive and a deterrent to people from testing. Discriminatory attitudes (16% believe children with HIV should not attend school) and HIV misconceptions (53% fear acquiring HIV through saliva) tended to be more common in nonurban areas and among women with less formal education. Stigma persisted even with high HIV testing rates among women. Qualitative findings triangulated survey results and, taken together, suggest that prejudices held against people with HIV led to avoidance of HIV preventive measures such as testing and status disclosure, fueled by a strong distrust of the medical care system regarding confidentiality of HIV test results. Misconceptions about HIV and stigmatizing attitudes remain pervasive among women in Stann Creek, Belize. Health literacy, stigma interventions, and expansion of routine confidential testing to include men are needed to address the HIV and stigma syndemic in Belize.

Background: Evidence-based interventions (EBIs) often address normative behaviors. If a behavior is also common among clinicians, they may be skeptical about the necessity or effectiveness of an EBI. Alternatively, clinicians' attitudes and behaviors may be misaligned, or they may lack the knowledge and self-efficacy to deliver the EBI. Several EBIs address unhealthy alcohol use, a common and often culturally acceptable behavior. But unhealthy alcohol use may be particularly harmful to people with HIV (PWH). Here, we present an implementation trial using an experiential implementation strategy to address clinicians' knowledge, attitudes, and behaviors. Clinicians receive the experiential intervention before they begin delivering an evidence-based brief alcohol intervention (BAI) to PWH with unhealthy alcohol use., Methods: Design: In this hybrid type 3 implementation-effectiveness cluster randomized controlled trial, ART clinics (n = 30) will be randomized 1:1 to facilitation, a flexible strategy to address implementation barriers, or facilitation plus the experiential brief alcohol intervention (EBAI). In the EBAI arm, clinicians, irrespective of their alcohol use, will be offered the BAI as experiential learning. EBAI will address clinicians' alcohol-related attitudes and behaviors and increase their knowledge and confidence to deliver the BAI., Participants: ART clinic staff will be enrolled and assessed at pre-BAI training, post-BAI training, 3, 12, and 24 months. All PWH at the ART clinics who screen positive for unhealthy alcohol use will be offered the BAI. A subset of PWH (n = 810) will be enrolled and assessed at baseline, 3, and 12 months., Outcomes: We will compare implementation outcomes (acceptability, fidelity, penetration, costs, and sustainability) and effectiveness outcomes (viral suppression and alcohol use) between the two arms. We will assess the impact of site-level characteristics on scaling-up the BAI. We will also evaluate how experiencing the BAI affected clinical staff's alcohol use and clinic-level alcohol expectations in the EBAI arm., Discussion: This trial contributes to implementation science by testing a novel strategy to implement a behavior change intervention in a setting in which clinicians themselves may engage in the behavior. Experiential learning may be useful to address normative and difficult to change lifestyle behaviors that contribute to chronic diseases., Trial Registration: NCT06358885 (04/10/2024), https://clinicaltrials.gov/study/NCT06358885 ., (© 2024. The Author(s).)

Background: To estimate the effects on pain of two medications (low-dose naltrexone and gabapentin) compared to placebo among people with HIV (PWH) with heavy alcohol use and chronic pain., Methods: We conducted a pilot, randomized, double-blinded, 3-arm study of PWH with chronic pain and past-year heavy alcohol use in 2021. Participants were recruited in St. Petersburg, Russia, and randomized to receive daily low-dose naltrexone (4.5mg), gabapentin (up to 1800mg), or placebo. The two primary outcomes were change in self-reported pain severity and pain interference measured with the Brief Pain Inventory from baseline to 8 weeks., Results: Participants (N = 45, 15 in each arm) had the following baseline characteristics: 64% male; age 41 years (SD±7); mean 2 (SD±4) heavy drinking days in the past month and mean pain severity and interference were 3.2 (SD±1) and 3.0 (SD±2), respectively. Pain severity decreased for all three arms. Mean differences in change in pain severity for gabapentin vs. placebo, and naltrexone vs. placebo were -0.27 (95% confidence interval [CI] -1.76, 1.23; p = 0.73) and 0.88 (95% CI -0.7, 2.46; p = 0.55), respectively. Pain interference decreased for all three arms. Mean differences in change in pain interference for gabapentin vs. placebo, and naltrexone vs. placebo was 0.16 (95% CI -1.38, 1.71; p = 0.83) and 0.40 (95% CI -1.18, 1.99; p = 0.83), respectively., Conclusion: Neither gabapentin nor low-dose naltrexone appeared to improve pain more than placebo among PWH with chronic pain and past-year heavy alcohol use., Clinical Trial Registration: ClinicalTrials.gov (NCT4052139)., Competing Interests: Employees of the funder NIH (K. Bryant and M. Backonja) are co-authors on this manuscript and helped guide analysis, interpretation and presentation of data and participated in the decision to submit the manuscript for publication. The funder provided support in the form of salaries for authors [K. Bryant, M. Backonja], but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section. D. Cheng serves on Data Safety Monitoring Boards for Janssen Research & Development. This does not alter our adherence to PLOS ONE policies on sharing data and materials. The remaining authors report no conflicts of interest., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Stigma that people with HIV who inject drugs experience negatively impacts HIV and substance use care, but stigma's association with sharing injection equipment is not known. This is a cross-sectional analysis of data from two studies of people with HIV reporting drug injection ( N  = 319) in St. Petersburg, Russia (September 2018-December 2020). We used logistic regression to examine associations between HIV stigma and substance use stigma scores (categorised into quartiles) and past 30-day equipment sharing, adjusting for demographic and clinical characteristics. Secondary analyses examined associations of arrest history and social support with sharing equipment. Almost half (48.6%) of participants reported sharing injection equipment. Among groups who did and did not share, mean HIV stigma (2.3 vs 2.2) and substance use stigma (32 vs 31) scores were similar. Adjusted analyses detected no significant associations between HIV stigma quartiles (global p -value = 0.85) or substance use stigma quartiles (global p -value = 0.51) and sharing equipment. Neither arrest history nor social support were significantly associated with sharing equipment. In this cohort, sharing injection equipment was common and did not vary based on stigma, arrest history, or social support. To reduce equipment sharing, investments in sterile injection equipment access in Russia should be prioritised over interventions to address stigma.

Background: People who inject drugs (PWID) living with HIV may be disproportionately impacted by pandemic restrictions. This study qualitatively explored the impacts of the SARS-CoV-2 pandemic on PWID with HIV in St. Petersburg, Russia., Methods: In March and April 2021, we conducted remote, semi-structured interviews with PWID with HIV, health care providers, and harm reductionists., Results: We interviewed 25 PWID with HIV (aged 28-56 years, 46% female) and 11 providers. The pandemic exacerbated economic and psychological challenges experienced by PWID with HIV. Simultaneously, barriers to HIV care access, ART prescription refill and dispensing and police violence, which hindered the health and safety of PWID with HIV, were themselves hindered from normal operations by the pandemic, significantly reducing these burdens., Conclusion: Pandemic responses should account for the unique vulnerabilities of PWID with HIV to avoid worsening the structural violence they already experience. Wherever the pandemic decreased structural barriers, such as institutional, administrative, and bureaucratic challenges and state violence enacted by police and other elements of the criminal justice system, such changes should be protected., Competing Interests: Declarations of Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Food insecurity (FI) impacts people with HIV (PWH) and those who use substances (i.e. drugs and alcohol). We evaluated the longitudinal association between FI and HIV transmission risks (unprotected sexual contacts and shared needles/syringes). Among 351 PWH who use substances in Russia, 51.6% reported FI and 37.0% past month injection drug use. The mean number of unprotected sexual contacts in the past 90 days was 13.4 (SD 30.1); 9.7% reported sharing needles/syringes in the past month. We did not find a significant association between mild/moderate FI (adjusted IRR = 0.87, 95% CI 0.47, 1.61) or severe FI (aIRR = 0.84, 95% CI 0.46, 1.54; global p = 0.85) and unprotected sexual contacts. We observed a significant association between severe FI and sharing needles/syringes in the past month (adjusted OR = 3.27, 95% CI 1.45, 7.39; p = 0.004), but not between mild/moderate FI and sharing needles/syringes in the past month (aOR = 1.40,95% CI 0.58, 3.38; p = 0.45). These findings suggest that severe FI could be a potential target for interventions to lower HIV transmission., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

HIV stigma is associated with negative physical and mental health outcomes. Intersectional stigma among persons living with HIV (PLHIV) results from interrelated, synergistic impacts of experiencing multiple stigma forms. Its relation with mental health outcomes is still an emerging area of study in this key population. This study aimed to evaluate associations of intersectional stigma, defined as endorsing high levels of HIV and substance use stigmas, with depressive and anxiety symptoms in a cohort of 111 PLHIV who inject drugs in St. Petersburg, Russia. Over a third of participants (37%) reported experiencing intersectional stigma (i.e., both stigma scores above the median). In adjusted analysis, lower Patient Health Questionnaire depression scale (PHQ-9) scores (beta (β=-4.31, 95% CI: -7.11 - -1.51, p = 0.003) and Generalized Anxiety Disorders Scale (GAD-7) scores (β=-3.64, 95% CI: -5.57 - -1.71, p < 0.001) were associated with having low scores for both HIV and substance use stigmas. Lower PHQ-9 scores (β=-3.46, 95% CI: -5.72 - -1.19, p = 0.003) and GAD-7 scores (β=-3.06, 95% CI: -4.62 - -1.50, p < 0.001) were also associated with high stigma on either HIV or substance use stigma scales. Controlling for demographics, depressive symptoms approximately linearly increased from both forms of stigma low to experiencing either form of stigma high to experiencing intersectional stigma, while levels of anxiety symptoms were comparable among participants with both types of stigma low and one stigma high. Participants who experienced intersectional stigma reported the greatest severity of both depressive and anxiety symptoms, as compared to individuals who endorsed low stigma scores (i.e., low stigma on both HIV and substance use stigma scales) or high scores of only one form of stigma. This suggests that intersectional stigma in this population of PLHIV who inject drugs in Russia is linked with worsened mental health outcomes, exceeding the effects of experiencing one form of stigma alone. Interventions to help people cope with intersectional stigma need to consider affective symptoms and tailor coping strategies to address impacts of multiple forms of mental health distress., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Of the 12 million people who inject drugs worldwide, 13% live with HIV. Whether opioid use impacts HIV pathogenesis and latency is an outstanding question. To gain insight into whether opioid use influences the proviral landscape and latent HIV reservoir, we performed intact proviral DNA assays (IPDA) on peripheral blood mononuclear cells (PBMCs) from antiretroviral therapy (ART)-suppressed people living with HIV (PWH) with or without current opioid use. No differences were observed between PWH with and without opioid use in the frequency of HIV intact and defective proviral genomes. To evaluate the latent reservoir, we activated PBMCs from ART-suppressed PWH with or without opioid use and assessed the induction of HIV RNA. PWH using opioids had diminished responses to ex vivo HIV reactivation, suggesting a smaller reversible reservoir of HIV-1 latently infected cells. However, in vitro studies using primary CD4+ T cells treated with morphine showed no effect of opioids on HIV-1 infection, replication or latency establishment. The discrepancy in our results from in vitro and clinical samples suggests that while opioids may not directly impact HIV replication, latency and reactivation in CD4+ T cells, opioid use may indirectly shape the HIV reservoir in vivo by modulating general immune functions.

People with HIV (PWH) who inject drugs often experience coexisting HIV- and substance use-related stigma manifestations. We assessed correlates of HIV stigma (Berger HIV stigma scale), substance use stigma (Substance Abuse Self-stigma scale) and intersectional HIV and substance use stigma in a cohort of PWH with a lifetime history of drug use in St. Petersburg, Russia. Intersectional stigma was defined as having a score greater than the median for both forms of stigma. Of the 208 participants, 56 (27%) had intersectional stigma. Depressive symptoms and alcohol dependence were significantly associated with a higher HIV and substance stigma score, but not with intersectional stigma. Individual and community interventions to reduce the impact of HIV stigma and substance use stigma affecting PWH who inject drugs should consider assessing and addressing mental health and unhealthy substance use. Further work with longitudinal data is needed to understand mechanisms leading to intersectional stigma., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)