Integrating tobacco and alcohol counseling and treatment into HIV care in kisumu county, kenya- intact study

The National Institutes of Health National Cancer Institute awarded Kenya Medical Research Institute $537,250 on September 1, 2026, under the Cancer Cause and Prevention Research program (CFDA 93.393) to conduct a cluster-randomized trial evaluating integrated tobacco and alcohol dependence treatment within HIV primary care in Kisumu County, Kenya.

The study will assess the effectiveness, implementation feasibility, acceptability, and cost-effectiveness of combining pharmacologic and behavioral interventions for tobacco and alcohol use alongside routine HIV care. The trial will evaluate bupropion (FDA-approved for tobacco dependence) and naltrexone (FDA-approved for alcohol use disorder) used together among people with HIV who have concurrent tobacco and heavy alcohol use. Kenya's integrated HIV and non-communicable disease infrastructure within primary healthcare provides an established platform for rigorous evaluation while generating implementation evidence applicable to U.S. HIV care settings, including federally qualified health centers and Ryan White HIV/AIDS Program clinics.

Work is performed in Kenya with a period of performance extending from September 1, 2026, through August 31, 2031. The award is a Project Grant, the primary assistance type for supporting research by a named principal investigator.

Abstract

Advances in HIV treatment have substantially increased life expectancy among people with HIV (PWH), but have also highlighted a growing burden of non-communicable diseases (ncds). Higher rates of tobacco and alcohol use among PWH increase the risk of cardiovascular disease, cancer, and other chronic conditions. This study will evaluate the effectiveness, implementation, and costeffectiveness of integrating pharmacologic and behavioral interventions for tobacco and alcohol use into routine HIV primary care. In the united states, HIV care remains fragmented, with limited integration of behavioral health, substance use treatment, alcohol use disorder services, and other NCD care. This fragmentation creates barriers to provider adoption, participant recruitment and retention, and evaluation of integrated interventions in real-world settings. Kenya provides a strong implementation setting because integrated HIV and NCD services are already embedded within primary healthcare, offering established infrastructure for integrating tobacco and alcohol dependence treatment. Leveraging this platform will enable efficient recruitment and rigorous evaluation of intervention effectiveness, cost-effectiveness, feasibility, acceptability, and scalability, while generating implementation evidence that would be more difficult and costly to obtain in the fragmented U.S. Healthcare system. Bupropion and naltrexone are FDA-approved treatments for tobacco dependence and alcohol use disorder, respectively, but evidence supporting their combined use among PWH with concurrent tobacco and heavy alcohol use remains limited. Findings from this study could inform integrated treatment approaches in U.S. HIV care settings, including federally qualified health centers and ryan white HIV/aids program clinics. We will conduct a 2×2 factorial cluster-randomized trial in 12 primary care clinics in kisumu, kenya, enrolling 600 PWH who use tobacco and alcohol. Aim 1: conduct formative research to develop and adapt interventions and online provider training for integrating medication management and motivational interviewing-based counseling into HIV primary care. Aim 2: evaluate the effectiveness of bupropion plus naltrexone and/or intensive counseling on biochemically verified tobacco cessation and alcohol reduction at 6 months. Aim 3: estimate the incremental cost-effectiveness of the intervention strategies. Aim 4: assess implementation outcomes and contextual determinants using the prism framework.