Women co-infected with HIV and HCV are at elevated risk for adverse health outcomes associated with alcohol use. Evidence-based alcohol reduction interventions for this vulnerable population are limited. To address this gap, the proposed study is an exciting opportunity to extend and deepen a longstanding partnership between Russian and U.S. investigators. We propose to harness the multidisciplinary expertise and experience of our collaborative Russian-U.S. research team to adapt an effective computer-based intervention, called CBT4CBT, to enhance its appropriateness for HIV/HCV co-infected women and evaluate its efficacy. The proposed study will be conducted in three sequential stages: (1) Adaptation, (2) Implementation, and (3) Evaluation. In Stage 1, Adaptation, we will use our ADAPT-ITT framework to systematically guide the adaptation process enhancing the linguistic-, gender- and HIV/HCV-appropriateness of the intervention. In Stage 2, Implementation, we will evaluate the efficacy of intervention in a Phase III randomized trial with 250 alcohol-using HIV/HCV co-infected women, 18-40 years of age, in clinical care. Women will be screened to assess eligibility and those willing to participate and identified as having laboratory- confirmed recent alcohol use, as assessed by a novel biomarker, phosphatidylethanol (PEth), will be eligible to participate. Eligible women will be asked to return to the AIDS Centre to complete a baseline assessment consisting of an audio-computer-assisted self-interview (ACASI) and specimen collection for PEth assay, and HIV (VL, CD4) and HCV (Fibroscan, serum markers) biomarkers. Following baseline assessment, women will be randomized, using a computer-generated algorithm and concealment of allocation techniques designed to minimize assignment bias, to one of two conditions: (1) adapted computer-based alcohol reduction intervention, or (2) standard-of-care control condition. Women complete the first session of the intervention immediately following assignment to the that condition and return to the AIDS Centre on consecutive weeks to complete two additional sessions (one session each week). All women will complete follow-up assessments consisting of an identical ACASI and specimen collection at 3-, 6- and 9-months post-baseline. In Stage 3, Evaluation, we will use an intent-to-treat analysis and logistic and linear generalized estimating equations to evaluate intervention efficacy, relative to the standard-of-care, in enhancing the proportion of women with a laboratory-confirmed negative PEth over the follow-up period. Other analyses will evaluate intervention effects on reducing viral load, HCV markers of disease progression, and improving CD4 levels. The proposed trial design and analysis provides an appropriate conceptual and methodological framework to assess the efficacy of the adapted computer-based intervention. The intervention, if effective, may be an efficient and cost- effective alcohol reduction strategy that is scalable and can be readily disseminated and integrated in clinical care at other AIDS Centres in Russia to enhance women?s health and reduce HIV/HCV transmission risk.
Women co-infected with HIV and HCV are at elevated risk for adverse health outcomes associated with alcohol use. We propose to adapt and test an innovative computer-based alcohol reduction intervention among HIV/HCV co-infected women in clinical care to assess intervention efficacy in reducing alcohol use and HIV and HCV biological markers of disease progression.
