Given multiple pathways through which alcohol impacts HIV morbidity, mortality and transmission, the Brown University ARCH provides an integrated, multifaceted, interdisciplinary approach to forward science on alcohol/HIV interactions and inform clinical approaches to caring for people living with HIV and efforts to prevent HIV transmission.
The ARCH has 5 integrated parts: an Administrative Core, a Research Methods Core, and three Research Components.
Research Component 1 ( Brief, Web-Based Intervention to Reduce Heavy Drinking and Encourage Prevention Among High-Rick Men Completing HIV/STI Self-Testing) In the United States, rates of new HIV infections have remained stable among men who have sex with men (MSM) in recent years despite declines among most other at-risk groups, highlighting the continued need for innovative approaches to prevention for MSM. Alcohol use is a major risk factor for HIV infection among MSM, in part due to the tendency for heavy drinking to increase the odds of engaging in sex that can transmit HIV. Our work has also shown that heavy drinkers are less likely to have tested for HIV within CDC-recommended intervals. This level of drinking is common among MSM, with up to 40% reporting heavy drinking in the past month. Home-based HIV and STI self-testing is a promising strategy for encouraging regular testing. Regular testing can help detect more new infections earlier, preventing onward infections and improving mortality. Despite self-testing’s promise, little is known about the best ways to provide support alongside HIV/STI self- testing programs. Although many current self-testing programs provide recipients with access to a 24-hour helpline they can call for counseling and referrals, few use this service. The counseling provided is also rarely informed by theory and often does not address key factors that maintain risk, like alcohol use. Web-based, brief interventions may be one approach that is well-suited to provide support alongside these programs and could help MSM participating in these programs to reduce their alcohol use and begin using HIV prevention methods that work. With previous support, we developed Game Plan, an interactive, responsive web application modeled after evidence-based brief motivational interventions. It is designed to help high-risk, heavy drinking MSM consider reducing their binge drinking and sexual risk behavior when they get tested for HIV. In a preliminary study of 40 heavy drinking, high-risk MSM, those who used Game Plan after HIV testing reported 24% fewer binge drinking days, 17% fewer alcohol problems, 50% fewer new anal sex partners, and 12% fewer high-risk condomless sex (CAS) acts compared to controls over a three-month follow-up period. The proposed study involves conducting a larger-scale study exploring Game Plan’s effects among MSM in the real-world, alongside innovative approaches for expanding HIV testing. Using a hybrid 1 effectiveness- implementation approach, we will recruit 360 high-risk, heavy drinking MSM online from several high-incidence areas in the US to participate in a program providing home-based HIV/STI self-tests in the mail at regular intervals over a year (baseline, 6 months, 12 months). Participants will be randomly assigned to receive access to either (1) a 24-hour helpline for counseling/referrals, or (2) the helpline plus Game Plan. We will test whether those who use Game Plan show lower rates of heavy drinking, any STIs, and high-risk CAS events compared to those receiving access to the helpline alone. Mixed-methods approaches will also be used with Game Plan users (N=30) and testing outreach program stakeholders (N=12) to begin understanding key implementation outcomes that can guide us in designing strategies for implementing Game Plan into HIV/STI testing programs.
Research Component 2 (Using Telehealth to Address Alcohol Misuse in HIV Care) 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. 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.
Research Component 3 (Advancing Integrated Alcohol-HIV Training of Frontline Providers in a Global Priority Setting). South Africa is at the epicenter of the global HIV pandemic with the largest country population of individuals living with HIV in the world. South Africa also has alarming rates of alcohol use, which pose a significant challenge to the HIV care cascade. Integrated alcohol-HIV care is the gold standard, but delivery of integrated care in South Africa is extremely rare. To promote treatment integration, the South Africa HIV ATTC (led by M- PIs Becker, Kuo, and Sibeko) was established in October 2017. The South Africa HIV ATTC is a national center, jointly funded by the Substance Abuse and Mental Health Services Administration (SAMHSA) and the President’s Emergency Plan for AIDS Relief (PEPFAR), dedicated to providing training to health professionals and lay workers who serve patients with HIV, alcohol use, and other mental health problems. On an annual basis, the South Africa HIV ATTC is charged with training 1,000 individuals as a means of driving the uptake of evidence-based approaches to address alcohol-HIV throughout the country. Recognizing the detrimental effects of heavy alcohol use and alcohol use disorders on the HIV care cascade, and in response to a needs assessment of national stakeholders and policy-makers, the South Africa HIV ATTC is preparing to roll out a national training initiative on Screening, Brief Intervention, and Referral to Treatment (SBIRT) for risky alcohol use. Using a novel task sharing approach, the South Africa HIV ATTC will provide SBIRT training and ongoing consultation to over 900 health professionals and lay workers embedded within HIV treatment organizations over a three-year period. Rollout of this national initiative presents unparalleled opportunities to advance implementation science for integrated alcohol-HIV treatment in a global priority site. However, research and data collected by the South Africa HIV ATTC is severely restricted under the SAMSHA and PEPFAR funded streams. Indeed, the only data currently collected by the South Africa HIV ATTC is a brief SAMHSA-required form called the Government Performance and Reporting Act (GPRA) tool, which measures satisfaction of training attendees. Thus, the current study proposes to first codify and then conduct comprehensive evaluation of training effectiveness on a range of key implementation science constructs. Study activities will occur across three phases. First, we will develop a SBIRT train-the-trainer manual consisting of a coding system to measure training fidelity, which will greatly enhance the rigor of the proposed training rollout. Second, we will evaluate the effectiveness of the SBIRT train-the-trainer model on key implementation science outcomes measured at the trainer (e.g., fidelity, knowledge), provider (e.g., attitudes, self-efficacy, acceptability), and patient levels (e.g., proportion of patients who receive each component of SBIRT – screening, brief intervention, and referral to treatment). Finally, we will examine the relationship among trainer-level, provider-level, and patient-level outcomes. Results of this study will advance knowledge of key implementation science questions, while promoting the integration of alcohol and HIV care, in a global priority setting.
