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The study brings together researchers from the University of California, San Francisco and St. John’s National Academy of Health Sciences in Bangalore, India. The overall goal of this study is to evaluate the impact of a promising Antiretroviral Therapy (ART) adherence-enhancing intervention grounded in Social Cognitive Theory (SCT) that addresses the needs of people living with HIV (PLHIV). This intervention targets not only medication adherence, but also other culturally-relevant topics designed to enhance physical and mental health among PLHIV, including yoga/meditation, nutrition, legal services, and assistance accessing local resources. We are testing this promising intervention in a Randomized Controlled Trial (RCT) among 500 sub-optimally adherent patients, comparing it to a time-matched active control condition, consisting of the non-adherence specific components of the intervention. Specifically, we propose:

1. To evaluate the impact of the Chetana intervention on antiretroviral medication adherence and treatment outcome, as measured by self-report, viral load, Wisepill wireless monitoring, and medical chart review. We hypothesize that participants in the intervention arm will show a significant reduction in missed pills as well as a reduced number of treatment interruptions and improved viral suppression, compared to participants in the time-matched active control group.
2. To evaluate the impact of the Chetana intervention on reported adherence barriers. We hypothesize that participants in the intervention arm will report a significant reduction in number of adherence barriers, compared to participants in the time-matched active control group.
3. To examine wireless adherence monitoring as a predictor of treatment outcome. We hypothesize that this ongoing, objective real-time measure of adherence will better predict subsequent viral load than our self-reported Optimal Adherence measure that combines past month adherence and treatment interruptions.

In the era of HIV treatment as prevention (TasP), efforts are needed to identify evidence-based combination prevention approaches that achieve greater decreases HIV viral load among populations that are more likely to engage in HIV transmission risk behavior. Because methamphetamine-using men who have sex with men (MSM) are at greater risk for acquiring and transmitting medication-resistant strains of HIV, interventions targeting stimulant use in this population of high-risk men could boost the effectiveness of TasP. At present, only conditional cash transfer approaches such as contingency management (CM) have demonstrated short-term efficacy in reducing stimulant use among substance-using MSM who are not actively seeking formal treatment. The proposed RCT will examine the efficacy of a positive affect intervention that is designed to optimize the effectiveness of CM to achieve long-term reductions in stimulant use and HIV viral load in this population. Our team will examine the efficacy of this integrative intervention in a randomized controlled trial (RCT) with 230 HIV-positive, methamphetamine-using MSM. After enrolling in CM, participants will be randomized to receive either: 1) the positive affect intervention; or 2) an attention-matched control condition. Follow-up data will be collected at 2, 3, 6, and 12 months post-randomization. This RCT will provide an opportunity to examine the efficacy of an integrative intervention designed to promote long-term reductions in HIV viral load as the primary outcome. Secondary outcomes that will be examined include: increases positive affect, reductions in stimulant use, improvements in T-helper (CD4+) count, and decreases HIV transmission risk behavior. Identifying an efficacious intervention approach to decrease HIV viral load among methamphetamine-using MSM would substantially support the goals of the National HIV/AIDS Strategy to reduce HIV incidence and mitigate HIV-related health disparities

The STAR study will develop and pilot test a multi-component intervention to promote affect regulation among HIV+ methamphetamine-using MSM. In Phase 1a of this study, the intervention will be pilot tested with 10 HIV+ methamphetamine-using MSM to obtain initial feedback that will assist with refining the protocol. In Phase 1b, we will conduct a pilot randomized controlled trial to examine the feasibility, acceptability and potential clinical utility of this affect regulation intervention with 70 HIV+ methamphetamine-using MSM.

Young injection drug users (IDU) constitute a distinctive high risk and understudied group with high rates of hepatitis C virus (HCV) infection. The Acute UFO study has identified 135 incident HCV infections, 95 of which are being followed prospectively. In this study we are: Studying the epidemiology of acute HCV infection. Assessing immunological responses to acute HCV (the spectrum of cytotoxic T lymphocyte (CTL) responses and evolution within CTL targets (“epitopes”) to identify early correlates of viral resolution. Examining HCV transmission and risk behavior among injecting partnerships using epidemiological and molecular virology methods. Assessing candidacy and factors to facilitate access to early antiviral treatment for acute HCV