Safe Injection Self-Efficacy is associated with HCV and HIV seropositivity among people who inject drugs in the San Diego-Tijuana border region.

Background: Safe injection self-efficacy (SISE) is negatively associated with injection risk behaviors among people who inject drugs (PWID) but has not been examined in differing risk environments. We compared responses to a validated SISE scale between PWID in San Diego, California and Tijuana, Mexico, and examine correlates of SISE among PWID in Tijuana. Methods: PWID were recruited via street outreach for a longitudinal cohort study from October 2020 - September 2021. We compared SISE scale items by city. Due to low variability in SISE scores among San Diego residents, we restricted analysis of factors associated with SISE to Tijuana residents and identified correlates of SISE scores (low, medium, high) using ordinal logistic regression. Results: Of 474 participants, most were male (74%), Latinx (78%) and Tijuana residents (73%). Mean age was 44. Mean SISE scores among San Diego residents were high (3.46 of 4 maximum) relative to Tijuana residents (mean: 1.93). Among Tijuana residents, White race and having previously resided in San Diego were associated with higher SISE scores. HCV and HIV seropositivity, homelessness, fentanyl use, polysubstance co-injection, and greater injection frequency were associated with lower SISE scores. Conclusions: We found profound inequalities between Tijuana and San Diego SISE, likely attributable to differential risk environments. Associations with fentanyl and polysubstance co-injection, injection frequency, and both HIV and HCV seropositivity suggest that SISE contribute to blood-borne infection transmission risks in Tijuana. SISE reflects an actionable intervention target to reduce injection risk behaviors, but structural interventions are required to intervene upon the risk environment.

Implications and Lessons Learned While Using Social Media Advertisements to Promote Longitudinal Social Network Study Participation in Latino Men Who Have Sex with Men (LMSM): A Brief Report.

We assess the effectiveness of paid ads on social media platforms as a research recruitment tool with Latino men who have sex with men (LMSM). We deployed four paid ad campaigns July-September 2022 in English and Spanish on Meta and Grindr featuring happy or risqué images of LMSM, documenting engagement and cost metrics. The four campaigns generated a total of 1,893,738 impressions and 1078 clicks (0.057 click-through rate) with a total cost of $7,989.39. Of the 58 people who accessed the study screener, 31 completed it (53.4%), 13 were eligible (22.4%), but none enrolled. Comparing platforms, Meta had higher engagement metrics than Grindr, while Grindr had higher proportions of those who completed the screener (57.9%) and were eligible (26.3%) than Meta (52.6% and 21.0%, respectively). Challenges to using paid ads as an LMSM recruitment tool included intersecting pandemics (Mpox, COVID-19), and limited connection between platforms and staff for study enrollment.

Peers plus mobile app for treatment in HIV (PATH): protocol for a randomized controlled trial to test a community-based integrated peer support and mHealth intervention to improve viral suppression among Hispanic and Black people living with HIV.

BACKGROUND: Significant disparities continue to exist in the HIV care continuum, whereby Hispanic and Black people living with HIV (PLWH) are less likely to achieve viral suppression compared to their White counterparts. Studies have shown that intervention approaches that involve peer navigation may play an important role in supporting patients to stay engaged in HIV care. However, implementation may be challenging in real-world settings where there are limited resources to support peer navigators. Combining a peer navigation approach with scalable mobile health (mHealth) technology may improve impact and implementation outcomes. METHODS: We combined a peer navigation intervention with a mHealth application and are conducting a randomized controlled trial (RCT) to test the efficacy of this integrated "Peers plus mobile App for Treatment in HIV" (PATH) intervention to improve HIV care engagement, and ultimately sustained viral suppression, among Hispanic and Black PLWH. We will enroll up to 375 PLWH into a two-arm prospective RCT, conducting follow-up assessments every 3 months up to 12 months post-baseline. Participants randomized to the control arm will continue to receive usual care Ryan White Program case management services. Individuals randomized to receive the PATH intervention will receive usual care plus access to two main intervention components: (1) a peer navigation program and (2) a mHealth web application. The primary outcome is sustained HIV viral suppression (undetectable viral load observed at 6- and 12-month follow-up). Secondary outcomes are retention in HIV care, gaps in HIV medical visits, and self-reported ART adherence. Recruitment for the RCT began in November 2021 and will continue until June 2024. Follow-up assessments and medical chart abstractions will be conducted to collect measurements of outcome variables. DISCUSSION: The efficacy trial of PATH will help to fill gaps in our scientific understanding of how a combined peer navigation and mHealth approach may produce effects on HIV care outcomes while addressing potential implementation challenges of peer navigation in Ryan White-funded clinics. TRIAL REGISTRATION: The PATH trial is registered at the United States National Institutes of Health National Library of Medicine (ClinicalTrials.gov) under ID # NCT05427318 . Registered on 22 June 2022.

Depression mediates the relationship between adverse childhood experiences and risky drinking among Hispanic young adults.

BACKGROUND AND OBJECTIVES: Hispanic young adults in the United States have consistently high rates of risky drinking, adverse childhood experiences (ACEs), depression, and anxiety. There is a positive association between ACEs and alcohol use among Hispanic populations; it is unknown if mental health symptomatology mediates this relationship. The purpose of this study was to test whether depression and anxiety mediated the relationship between ACEs and risky drinking among Hispanic young adults who engage in risky drinking. METHODS: Data from 264 Hispanic young adults, ages 19 to 30, were collected via an online questionnaire. Participants were recruited via social media, emails/listservs across colleges, the community, and web-panels. The questionnaire assessed ACEs, risky drinking, depression, and anxiety. We conducted a mediational analysis to test whether depression and anxiety mediated the relationship between ACEs and risky drinking. RESULTS: Of the sample, 59.8% identified as female and 40.2% as male. The average age was 24.37 (SD = 3.069). Participants (61%) identified as Mexican, Mexican American, or Chicano, and 84.1% identified as second-generation. ACEs were positively associated with risky drinking, depression, and anxiety. Depression mediated the relationship between ACEs and risky drinking. CONCLUSION AND SCIENTIFIC SIGNIFICANCE: Depression explained the association between ACEs and risky drinking among Hispanic young adults, adding to our understanding of how mediators can illustrate pathways that lead from ACEs to risky drinking. Practitioners and interventionists should continue supporting Hispanic youth by integrating them into early prevention programs to mitigate the mental health consequences of ACEs that could lead to risky drinking.

The Gender Minority Stress and Resilience Measure: Psychometric Validity for Use in Spanish.

Purpose: Stigma is a fundamental driver of HIV disparities among transgender women (TW). The gender minority stress and resilience (GMSR) measure has not been validated in Spanish-speaking, resource-limited settings. We examined the psychometric properties of a translated and abbreviated GMSR among TW in Tijuana, Mexico. Methods: From 2020 to 2021, 152 participants were recruited through social media and venue-based sampling. We collected information on the abbreviated GMSR, psychosocial factors (e.g., depressive symptoms), and sociodemographics. The abbreviated GMSR assessed 7 factors (Discrimination, Rejection, Internalized Transphobia, Negative Expectations, Nondisclosure, Pride, and Community Connectedness). Confirmatory factor analysis, Cronbach's alphas, and McDonald's omegas assessed structural validity. Pearson's partial correlations assessed criterion, convergent, and discriminant validities. Results: The 7-factor structure solution had acceptable fit (root mean square error of approximation [95% confidence interval]=0.05 [0.05-0.06]; comparative fit index/Tucker-Lewis index=0.92/0.91); and internal reliability (α=0.62-0.89; ω=0.62-0.89). Depressive (r=0.22-0.43; p<0.001-0.007), post-traumatic stress disorder (PTSD; r=0.20-0.34; p<0.001-0.017) symptoms, and perceived stress (r=0.19-0.41; p≤0.001-0.030) were all positively associated with all stress factors (e.g., Discrimination, Rejection, Internalized Transphobia, Negative Expectations, and Nondisclosure). The resilience factor Pride was associated with fewer PTSD symptoms (r=-0.18; p=0.027), lower perceived life stress (r=-0.21; p=0.012), and greater general resilience (r=0.26; p=0.002). The Community Connectedness resilience factor was associated with fewer depressive symptoms (r=-0.22; p=0.007). Constructs were conceptually distinct with factor correlations below 0.60. Conclusion: Findings suggest that the Spanish-translated, abbreviated GMSR is a reliable and valid measure. These data expand the usability of the GMSR to TW in a Latin American, Spanish-speaking context.

Promoting HIV care continuum outcomes among people who use drugs and alcohol: a systematic review of randomized trials evaluating behavioral HIV care interventions published from 2011 to 2023.

BACKGROUND: Substance use remains a robust predictor of HIV infection and a serious impediment to HIV care continuum progression for people living with HIV. The primary research question of this systematic review is focused on understanding the extent to which behavioral HIV care interventions have been efficacious in helping people who live with HIV and who use substances along the HIV care continuum. METHODS: Using PubMed and ProQuest databases, we performed a systematic review of randomized trials of behavioral HIV care continuum interventions among people who use substances published from 2011 to August 2023, since the beginning of the treatment-as-prevention era. RESULTS: We identified 11 studies (total participants: N = 5635), ten intentionally targeting substance-using populations. Four studies involved samples using ≥ 1 substance (e.g., alcohol, opioids, stimulants, marijuana); four involved injection drug use; one involved methamphetamine use; and one involved alcohol use. One study targeted a population with incidental substance use (i.e., alcohol, injection drug use, non-injection drug use reported in most participants). Each study defined one or more HIV care outcomes of interest. Viral suppression was an outcome targeted in 9/11 studies, followed by uptake of antiretroviral therapy (ART; 7/11), ART adherence (6/11), retention in care (5/11), and linkage to care (3/11). While most (nine) of the studies found significant effects on at least one HIV care outcome, findings were mostly mixed. Mediated (2/11) and moderated (2/11) effects were minimally examined. CONCLUSIONS: The results from this systematic review demonstrate mixed findings concerning the efficacy of previous HIV care interventions to improve HIV care continuum outcomes among people who use substances. However, heterogeneity of study components (e.g., diversity of substances used/assessed, self-report vs. objective measures, attrition) prevent broad deductions or conclusions about the amenability of specific substance-using populations to HIV care intervention. More coordinated, comprehensive, and targeted efforts are needed to promote and disentangle intervention effects on HIV care continuum outcomes among substance-using populations.

Effects of a social network intervention on HIV seroconversion among people who inject drugs in Ukraine: moderation by network gender composition.

BACKGROUND: Women who inject drugs in Ukraine are disproportionately burdened by HIV. To help address the needs of this population, a greater understanding of how interventions may uniquely benefit women who inject drugs is needed. METHODS: Data come from a randomized controlled trial of a social network intervention targeting people who inject drugs in Ukraine (N = 1195). Indexes, plus two of their injection network members, received HIV testing and counseling (control arm) or HIV testing and counseling plus a social network intervention (intervention arm), in which indexes were trained to influence network members' risk behaviors. We used Cox regressions with interaction terms to assess differences in time to HIV seroconversion between arms by network gender composition and gender of the index. For significant interaction terms, we calculated simple effects, generated survival functions using Kaplan-Meier methods, and compared survival curves using log-rank tests. RESULTS: At 12 months, there were 45 seroconversions among women (40.0 [28.3, 51.7] per 100 person years) and 111 among men (28.4 [23.1, 33.6] per 100 person years) in the control arm; there were 27 seroconversions among women (17.1 [10.7, 23.6] per 100 person years) and 77 among men (18.7 [14.5, 22.9] per 100 person years) in the intervention arm. Network gender composition (but not gender of the index) moderated the intervention effect on HIV incidence (p < 0.05). Specifically, the intervention appeared to be even more protective against HIV acquisition as female gender composition increased. In the intervention arm, the HIV seroconversion hazard rate was 44% lower with 1 network female; 61% lower with 2 network females; and 72% lower with 3 network females. CONCLUSIONS: A greater number of women in an injection network, coupled with the provision of risk-reduction strategies, is associated with HIV risk-mitigation, though the mechanisms through which this occurs remain unclear. Findings can support new research and practice directions that prioritize women who inject drugs and more thoughtfully support their health and wellbeing.

Supporting and Uplifting New and Diverse Scientists in HIV Research (San Diego SUN): A Research Education and Training Program to Promote the Success of Black, Indigenous, and People of Color Predoctoral and Postdoctoral Fellows.

BACKGROUND: We implemented a mentored research education and training program for underrepresented minorities (URMs) and Black, Indigenous, and People of Color (BIPOC) predoctoral and postdoctoral fellows called San Diego SUN (SD SUN): Supporting and Uplifting New and Diverse Scientists in HIV Research. The SD SUN program aimed to prepare fellows for an academic career trajectory in HIV science focused on ameliorating HIV-related disparities in communities of color. SETTING: The program leveraged a strong interinstitutional collaboration between San Diego State University and the University of California, San Diego, that share commitments to diversity, equity, and inclusion and an established history of training programs for URM/BIPOC investigators. METHODS: During a 9-month training period, launched in February 2022, fellows supported by a mentoring team completed ten 3-hour training sessions (core curriculum) and a mentored research project. The curriculum included seminars on building skills for a productive academic research career and reflective discussions around issues uniquely faced by URM/BIPOC investigators. Standardized measures developed for Center for AIDS Research Diversity, Equity, and Inclusion Pipeline Initiative (eg, around benefits gained) were used to evaluate the program. RESULTS: Six fellows participated in the SD SUN program. The results demonstrated a successful first year. Fellows were highly engaged and reported positive experiences, satisfaction with their mentor(s), various benefits gained from the program, and gains in numerous skillsets. CONCLUSIONS: Challenges were faced during implementation (eg, teaching grant writing to fellows at different skill levels). Time constraints were reported by some faculty mentors with limited bandwidth. We describe insights and solutions to the major challenges to sustaining the successful SD SUN program.

Adolescent alcohol use: use of social network analysis and cross-classified multilevel modeling to examine peer group, school, and neighborhood-level influences.

Background: Neighborhood-, school-, and peer-contexts play an important role in adolescent alcohol use behaviors. Methodological advances permit simultaneous modeling of these contexts to understand their relative and joint importance. Few empirical studies include these contexts, and studies that do typically: examine each context separately; include contexts for the sole purpose of accounting for clustering in the data; or do not disaggregate by sex.Objectives: This study takes an eco-epidemiologic approach to examine the role of socio-contextual contributions to variance in adolescent alcohol use. The primary parameters of interest are therefore variance rather than beta parameters (i.e. random rather than fixed effects). Sex-stratified models are also used to understand how each context may matter differently for male and female adolescents.Method: Data come from the National Longitudinal Study of Adolescent to Adult Health (n = 8,534 females, n = 8,102 males). We conduct social network analysis and traditional and cross-classified multilevel models (CCMM) in the full and sex-disaggregated samples.Results: In final CCMM, peer groups, schools, and neighborhoods contributed 10.5%, 10.8%, and 0.4%, respectively, to total variation in adolescent alcohol use. Results do not differ widely by gender.Conclusions: Peer groups and schools emerge as more salient contributing contexts relative to neighborhoods in adolescent alcohol use for males and females. These findings have both methodological and practical implications. Multilevel modeling can model contexts simultaneously to prevent the overestimation of variance in youth alcohol use explained by each context. Primary prevention strategies addressing youth alcohol use should focus on schools and peer networks.

Intersections between syndemic conditions and stages along the continuum of overdose risk among women who inject drugs in Mexicali, Mexico.

BACKGROUND: Research on women who inject drugs is scarce in low- and middle-income countries. Women experience unique harms such as sexism and sexual violence which translate into negative health outcomes. The present work aims to provide insight into the experiences of women who inject drugs at the US-Mexico border to identify social and health-related risk factors for overdose to guide harm reduction interventions across the Global South. METHODS: We recruited 25 women ≥ 18 years of age accessing harm reduction and sexual health services at a non-governmental harm reduction organization, "Verter", in Mexicali, Mexico. We employed purposeful sampling to recruit women who inject drugs who met eligibility criteria. We collected quantitative survey data and in-depth interview data. Analyses of both data sources involved the examination of descriptive statistics and thematic analysis, respectively, and were guided by the syndemic and continuum of overdose risk frameworks. RESULTS: Survey data demonstrated reports of initiating injection drug use at a young age, experiencing homelessness, engaging in sex work, being rejected by family members, experiencing physical violence, injecting in public spaces, and experiencing repeated overdose events. Interview data provided evidence of stigma and discrimination toward women, a lack of safe spaces and support systems, risk of overdose-related harms, sexual violence, and the overall need for harm reduction services. CONCLUSION: Women who inject drugs in Mexicali describe experiences of violence, overdose, and public injecting. Women are particularly vulnerable in the Mexicali context, as this area faces a noticeable lack of health and social services. Evidenced-based harm reduction strategies such as safe consumption sites and overdose prevention strategies (e.g., naloxone distribution and training) may benefit this population. Evidence from local organizations could help close the gap in service provision in low-resource settings like Mexico, where government action is almost nonexistent.

In the era of universal test and treat in Uganda, recent intimate partner violence is not associated with subsequent ART use or viral suppression.

Intimate partner violence (IPV) has been associated with delays throughout the HIV care continuum. This study explored prospective associations between experiences of past-year IPV and two HIV care outcomes in the context of current universal test and treat guidelines using two consecutive rounds of an ongoing HIV surveillance study conducted in the Rakai region of Uganda. Longitudinal logistic regression models examined associations between IPV, use of antiretroviral therapy (ART) and viral load suppression (VS), adjusting for outcome variables at baseline. To address differences in ART retention by IPV, propensity scores were used to create inverse-probability-of-treatment-and-censoring-weighted (IPTCW) models. At baseline, of 1923 women with HIV (WWH), 34.6%, 26.5%, 13.5% reported past-year verbal, physical and sexual IPV; a lower proportion of persons who experienced physical IPV (79.4%) were VS than those who did not (84.3%; p = 0.01). The proportion VS at baseline also significantly differed by exposure to verbal IPV (p = 0.03). However, in adjusted longitudinal models, IPV was not associated with lower odds of ART use or VS at follow-up. Among WWH in the Rakai region, IPV does not appear to be a barrier to subsequent ART use or VS. However, given the prevalence of IPV in this population, interventions are needed.

Injection Drug Use and Sexual Risk Behaviors Among People who Inject Drugs in Ukraine: A Random-Intercept Latent Transition Analysis.

HIV transmission in Ukraine is driven in part by unsafe injection drug use and sexual risk behaviors among people who inject drugs. We performed a random-intercept latent transition analysis on responses to 9 binary injection drug use and sexual behavior items from 1195 people who inject drugs with negative HIV status enrolled in a clustered randomized clinical trial of a social network intervention in Odessa, Donetsk, and Nikolayev, Ukraine. We identified 5 baseline classes: "Social injection/equipment-sharing" (11.7%), "Social injection" (25.9%), "High-risk collective preparation/splitting" (17.0%), "Collective preparation/splitting" (11.3%), and "Dealer-facilitated injection" (34.1%). After 12 months, intervention participants were more likely to transition to the "Collective preparation/splitting" class, which featured the fewest risk behaviors. Transitioning from the "Collective preparation/splitting" to the "Social injection/equipment-sharing" class was associated with HIV acquisition for control participants. Research to illuminate the stability of these patterns and how they may benefit from uniquely tailored programming to reduce unsafe behaviors is needed.

Correlates of impulsivity among female sex workers in Mexico.

Impulsivity is a trait characteristic that is associated with sexual risk behavior. We examined correlates of impulsivity among 602 female sex workers (FSWs) enrolled in a sexual risk reduction intervention in Mexico (2016-2020). Impulsivity was positively associated with condomless sex with clients. Higher levels of impulsivity were associated with greater use of alcohol and heavy drugs, use of illicit drugs with clients, sexual/physical abuse history, and clinical depression. Global public health policy that supports free substance abuse treatment in combination with psychotherapeutic treatments (e.g. regulation management skills) and behavioral-focused therapy may help to reduce HIV/STI incidence in this vulnerable population.

Behavior change after fentanyl testing at a safe consumption space for women in Northern Mexico: A pilot study.

BACKGROUND: Fentanyl has led to an increased number of overdose deaths in North America. Testing substances for fentanyl may be a harm reduction strategy to prevent overdose. Little is known about behavior change after fentanyl testing and the attitudes around fentanyl knowledge and testing along the US-Mexico border in the context of a safe consumption site. METHODS: This was a pilot quantitative and qualitative study with 30 women who use drugs at an unsanctioned safe consumption site in Mexicali, Mexico. Women participated in a quantitative survey, a semi-structured interview, and fentanyl testing of substances. Injection behavior was observed after fentanyl testing results were provided. Qualitative data were collected to explore the meanings participants attributed to fentanyl and fentanyl testing. RESULTS: Half of the substances tested positive for fentanyl (n=15, 50%), and all of them were in samples of black tar heroin. Among those participants who tested positive for fentanyl, 7 (47%) subsequently used less of the intended substance, 1 did not use the intended substance, and 7 (47%) did not change their behavior (i.e., used as originally intended). In qualitative interviews, a predominant theme was a description of fentanyl as dangerous and deadly and fentanyl testing as being helpful for modifying drug use behaviors. However, participants recognized that there could be no change in behavior following a positive fentanyl test in the context of not being able to find substances free of fentanyl. CONCLUSION: We observed mixed results related to behavior change after women's intended substance for use tested positive for fentanyl. Fentanyl testing was acceptable to women, but behavior change was hampered by the inability to find substances free of fentanyl. Further research is needed to maximize the potential of fentanyl testing as a harm reduction tool especially in the context of a changing drug supply.

Comparison of factor analysis models applied to the NCANDA neuropsychological test battery.

The factor structure of neuropsychological functioning among a large sample (N = 831) of American youth (ages 12-21 at baseline) was investigated in order to identify an optimal model. Candidate models were selected based on their potential to provide service to the study of adolescent development and the effects of heavy episodic alcohol consumption. Data on neuropsychological functioning were obtained from the NCANDA study. This is a longitudinal community study of the effects of alcohol exposure on neurodevelopment. Three conceptually motivated and one empirically motivated factor analysis model of neuropsychological domains were compared based on penalized-likelihood selection criteria and model fit statistics. Two conceptually-motivated models were found to have adequate fit and pattern invariance to function as a measurement model for the Penn Computerized Neurocognitive Battery (Penn CNB) anchored neuropsychological battery in NCANDA. Corroboration of previous factor analysis models was obtained, in addition to the identification of an alternative factor model that has higher discriminant capacity for neuropsychological domains hypothesized to be most sensitive to alcohol exposure in human adolescents. The findings support the use of a factor model developed originally for the Penn CNB and a model developed specifically for the NCANDA project. The NCANDA 8-Factor Model has conceptual and empirical advantages that were identified in the current and prior studies. These advantages are particularly valuable when applied in alcohol research settings.

"He is the Same as Me": Key Populations' Acceptability and Experience of a Community-Based Peer Navigator Intervention to Support Engagement in HIV Care in Tijuana, Mexico.

Engagement in the HIV care continuum among people living with HIV is essential to prevent ongoing transmission. Although there is evidence for the need for comprehensive approaches (e.g., peer navigation) to improve the HIV care continuum, there is limited knowledge of how the peer navigation model might work to improve the HIV care continuum in low resource settings among Latinx key populations (e.g., persons who inject drugs, female sex workers, men who have sex with men, and transgender women). Therefore, this article aims to qualitatively assess members of key populations' acceptability of Conexiones Saludables (Healthy Connections), a community-based peer navigation intervention implemented in Tijuana, Mexico. This analysis draws upon the postintervention survey data from 34 participants and data from qualitative interviews with 10 participants. Participants found the intervention to be acceptable and discussed the ways in which peer navigators were influential in educating participants about HIV, antiretroviral therapy (ART), linking participants to existing HIV care and ancillary services in Tijuana, and in providing emotional and instrumental support to facilitate engagement in HIV treatment and ART adherence. The intervention emphasized the use of peer navigators who had a deep understanding of the sociostructural barriers (e.g., substance use, homelessness) that HIV-positive key populations face in Tijuana. Findings from this study may inform programs with highly vulnerable populations in similar settings.

Alcohol use and alcohol-related consequences are associated with not being virally suppressed among persons living with HIV in the Rakai region of Uganda.

BACKGROUND: Alcohol use is common among persons living with HIV (PWH) in Uganda and associated with poor HIV care outcomes; findings regarding the relationship between alcohol use and viral suppression (VS) have been inconclusive. METHODS: Data from two rounds (2017-2020) of the Rakai Community Cohort Study, an open population-based cohort study in the Rakai region, Uganda, were analyzed. Two alcohol exposures were explored: past year alcohol use and alcohol-related consequences. Multivariable models (GEE) were used to estimate associations between alcohol exposures and VS for the overall sample and stratified by sex, adjusting for repeated measurement. Causal mediation by ART use was explored. RESULTS: Over half (55 %) of participants (n = 3823 PWH) reported alcohol use at baseline; 37.8 % of those reporting alcohol use reported alcohol-related consequences. ART use and VS at baseline significantly differed by alcohol use with person reporting alcohol use being less likely to be on ART or VS. Alcohol use was significantly associated with decreased odds of VS among women but not men (adj. OR 0.72 95 % CI 0.58-0.89, p = 0.0031). However, among males who use alcohol, experiencing alcohol-related consequences was significantly associated with decreased odds of VS (adj. OR 0.69 95 % CI 0.54-0.88, p = 0.0034). The relationships between both alcohol exposures and VS were not significant in models restricted to persons on ART. CONCLUSIONS: We provide sex-stratified estimates of associations between two alcohol measures and VS in the context of current HIV treatment guidelines. This study confirms that alcohol use is adversely associated with VS but ART use mediates this pathway, suggesting that initiation and retention on ART are critical steps to addressing alcohol-related disparities in VS.

Using Novel Approaches to Evaluate Behavioral Interventions: Overlooked Significant HIV Prevention Effects in the HPTN 015 Project EXPLORE.

BACKGROUND: Mediated and moderated processes that lead to intervention efficacy may underlie results of trials ruled as nonefficacious. The overall purpose of this study was to examine such processes to explain the findings of one of the largest, rigorously conducted behavioral intervention randomized controlled trials, EXPLORE. METHODS: Four thousand two hundred ninety-five HIV-negative men who have sex with men (MSM) in the United States were randomized in a 2-armed trial. Participants completed follow-up and an HIV test every 6 months up to 48 months. We used multiple and causal mediation analyses to test 5 mediators, including safer sex self-efficacy and condomless receptive anal sex with HIV-positive or status-unknown partners on our primary outcome (HIV seroconversion). We also examined whether intervention effects on the mediators would be moderated by robust correlates of HIV among MSM, including stimulant use. RESULTS: There were significant effects of the intervention on all hypothesized mediators. Stimulant use moderated the effect on condomless receptive anal sex In stratified multiple mediation models, we found that among MSM with low stimulant use, the intervention significantly prevented HIV by reducing condomless receptive anal sex with HIV-positive or status-unknown partners. Among MSM with higher stimulant use, there were no indirect effects of the intervention on HIV through any of the hypothesized mediators. CONCLUSION: The results suggest that the null effect found in the original EXPLORE trial might have occurred as a function of previously unexplored mediated and moderated processes. This study illustrates the value of testing mediated and moderated pathways in randomized trials, even in trials ruled out as nonefficacious.

Assessing Potential Outcomes Mediation in HIV Interventions.

Knowledge of causal processes through mediation analysis can help improve the effectiveness and reduce costs of public health programs, like HIV prevention and treatment interventions. Advancements in mediation using the potential outcomes framework provide a method for estimating the causal effect of interventions on outcomes via a mediating variable. The purpose of this paper is to provide practical information about mediation and the potential outcomes framework that can enhance data analysis and causal inference for intervention studies. Causal mediation effects are defined and then estimated using data from an HIV intervention randomized trial among people who inject drugs (PWID) in Ukraine. Results from a potential outcomes mediation analysis show that the intervention had a total causal effect on incident HIV infection such that participants in the experimental group were 36% less likely to become infected during the 12-month study than those in the control arm, but that neither self-efficacy nor network communication mediated this effect. Because neither putative mediator was significant, measurement and confounding issues should be investigated to rule out these mediators. Other putative mediators, such as injection frequency, route of administration, or HIV knowledge can be considered. Future research is underway to examine additional, multiple mediators explaining efficacy of the current intervention and sensitivity to confounding effects.