Feasibility and preliminary effectiveness of a transdiagnostic cognitive behavioral therapy treatment approach for alcohol misuse integrated within HIV care in Zambia

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Alcohol use is increasing in sub-Saharan Africa (SSA) where it commonly intersects with the HIV/AIDS epidemic. Hazardous alcohol use increases HIV transmission, impedes uptake and retention on antiretroviral therapy (ART), and ultimately reduces HIV viral suppression (VS). Approximately 20-50% of persons living with HIV (PLWH) on ART drink hazardously; however, most clinics in SSA offer only brief interventions (BIs) for alcohol reduction that are ineffective for many patients. BIs have limited ability to address more severe alcohol use disorders (AUDs) or comorbid mental health or substance use issues (hereafter called `comorbidities') that are common among PLWH. In preliminary studies, we found that 40% of male and 20% of female PLWH on ART in Zambia had hazardous alcohol use, that ~60% failed to respond to current BIs, and that >50% had comorbidities. We previously developed and demonstrated the effectiveness of a novel cognitive-behavioral therapy intervention, Common Elements Treatment Approach (CETA), which trains lay health workers to address both AUDs and comorbidities. Our central hypothesis is that a stepped care approach to alcohol use, where interventions ranging in time and resource intensity are provided according to symptom severity, can be utilized by HIV treatment programs in SSA to effectively and efficiently address hazardous alcohol use and improve HIV outcomes. In this application, we propose a Stage 1 hybrid effectiveness-implementation study to adapt and pilot test CETA at two Zambian HIV clinics for PLWH who report hazardous alcohol use and are less likely to respond to BIs (i.e., those with moderate-to-severe alcohol use disorders (AUDs) and/or comorbidities). This project leverages (a) our development of CETA, (b) a prospective cohort of HIV-infected individuals that was created by the NIAID-funded International Epidemiological Databases to Evaluate AIDS, and (c) >10 years of HIV and mental health research in Zambia. Aim 1 will adapt the current CETA manual for HIV-infected individuals and HIV clinics with input from PLWH, health workers, and key informants in the health system. In Aim 2, PLWH who screen positive for hazardous alcohol use will be enrolled and assessed for AUD and comorbidities. Those with moderate-to-severe AUD and/or comorbidities (n=160) will be randomized 1:1 to receive BI alone or BI+CETA. Participants with subthreshold/mild AUD and without comorbidities will also receive the BI. Changes in alcohol use, comorbidities, and HIV outcomes (ART retention and HIV viral suppression) will be measured over 6 months of follow-up and the impact of the interventions will be evaluated. Urine Ethyl glucuronide testing will be used to augment self-reported alcohol measures. Aim 3 will investigate feasibility, acceptability, and other implementation factors related to delivery of BI and CETA. This study will: (1) result in an HIV-adapted CETA manual, (2) generate preliminary effectiveness and implementation data on CETA and BI in PLWH drinkers with comorbidities, and (3) inform an R01 application to further test a stepped care approach to address hazardous drinking in HIV care settings.