Among people living with HIV (PLWH), alcohol misuse has been associated with reduced adherence to antiretroviral therapy and decreased odds of HIV viral suppression, as well as liver and neurocognitive dysfunction, cardiovascular disease, cancer, systemic inflammation, and decreased survival. Behavioral interventions can significantly reduce drinking in PLWH as well as increase condom use, increase ART adherence, and decrease HIV viral load. We recently found that motivational interviewing (MI) with booster sessions through 6 months, compared to HIV care as usual, results in particularly large reductions in drinking that are well-maintained over a 12-month follow-up and have been validated biochemically. However, delivering MI requires trained staff to conduct repeated sessions of counseling, a resource that is unlikely to be available at most community health centers caring for PLWH. In our recent work, we have found that it is feasible to deliver MI by videoconferencing and telephone with high fidelity using a resource-efficient centralized core of counselors. We further have found that a combination of both extended counseling by video or telephone and interactive text messaging shows promise in further reducing drinking and in increasing the odds of HIV viral suppression.
ReACH (Reducing Alcohol use and related Comorbidities in HIV care)
The purpose of the proposed study is to test the real-world effectiveness of the ReACH (Reducing Alcohol use and related Comorbidities in HIV care) telehealth counseling protocol in a pragmatic Hybrid Type 1 effectiveness-implementation randomized trial. We will recruit 600 heavy-drinking PLWH from four federally-qualified health centers in geographically distinct regions across the U.S, which provide services to over 14,000 PLWH. Upon completing enrollment, participants will be randomized to receive either single-session brief intervention (BI) by phone with referral to local treatment when appropriate or BI plus referral to ReACH telehealth counseling (TC). Participants will complete follow-ups through 24 months after baseline to assess longer-term changes in drinking and health outcomes. We will test the hypothesis that TC compared to BI will result in (a) reduced number of drinks consumed per week and frequency of heavy drinking and (b) increased odds of having an undetectable viral load at 12- and 24-month follow-ups. Secondary outcomes include self-reported ART adherence, engagement in condomless sex with non-exclusive partners, frequency of other substance use, phosphatidylethanol levels (a biomarker of recent alcohol use), and Veterans Aging Cohort Study index scores. We also will examine potential moderators of TC effectiveness.
As a secondary aim, we will assess implementation measures corresponding to aspects of the Dynamic Sustainability Framework and examine implementation outcomes of acceptability, appropriateness, and feasibility guided by Proctor’s Implementation Outcomes Framework. Thus, this pragmatic Hybrid Type 1 trial will help establish the real-world effectiveness of the ReACH TC intervention while also providing key implementation-related measures and outcomes that will inform future ReACH TC scale up and sustainability.