METHODS AND ANALYSIS CORE

Unhealthy alcohol use is a major unaddressed barrier to control of the HIV epidemic in the region south of the Sahara Desert and the United States. The Zambia Alabama HIV Alcohol Comorbidities (ZAMBAMA) program aims to address this barrier through the following overarching aims: (a) test the effectiveness of a transdiagnostic model (Common Elements Treatment Approach [CETA]) to reduce unhealthy alcohol use and improve HIV clinical outcomes; (b) evaluate the mechanisms through which CETA impacts HIV outcomes; (c) investigate whether the treatment effect of CETA varies by clinical (e.g., presence of mental health comorbidities), demographic and contextual (e.g., Zambia, Alabama) factors; and (d) examine implementation factors, including cost, related to integrated delivery of alcohol reduction interventions to people with HIV and unhealthy alcohol use at front-line HIV clinics. The Methods and Analysis Core (MAC) will support ZAMBAMA’s two clinical trials and promote integration and synergy within the program. The specific aims of MAC are (1) implement the scientific approach of both trials (e.g., overseeing randomization procedures, measurement tools, and data management); (2) conduct primary and secondary outcomes analyses evaluating CETA’s effectiveness (including moderator analyses); (3) conduct mediator/mechanisms analysis investigating the degree to which CETA’s impact on HIV outcomes are mediated by reductions in alcohol use, substance use, and mental health problems; (4) analyze and interpret alcohol biomarker (phosphatidylethanol) data used to confirm self-reported alcohol abstinence data; and (5) analyze implementation and cost effectiveness data to inform the scale-up and sustainability potential of CETA. MAC will be staffed by investigators with international and multidisciplinary expertise in research methods, including in substance use, HIV, clinical trials, and global health. MAC will leverage a wealth of information technology, statistical, and laboratory resources at participating institutions. Harmonized patient reported outcome measures and a centralized team to oversee the intervention (i.e., CETA core) for both trials will create unique opportunities to understand the interplay between unhealthy alcohol use and psychiatric comorbidities, whether and how comorbidities influence alcohol treatment outcomes, and how differences in delivery modality and contextual factors impact CETA’s effectiveness.