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Integrating Tobacco and Alcohol Counseling and Treatment into HIV Care in Kisumu County, Kenya- INTACT Study

Award Number: R01CA318829
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2031

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Integrating Tobacco and Alcohol Counseling and Treatment into HIV Care in Kisumu County, Kenya- INTACT Study - PROJECT SUMMARY / 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $537,250 )
2026	2026	KENYA MEDICAL RESEARCH INSTITUTE	OFF MBAGATHI ROAD	NAIROBI CITY				KEN	Cancer Cause and Prevention Research	000	1	8/31/2026	NEW	$537,250
														Subtotal = $537,250

Grand Total All Awards = $537,250

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Integrating Tobacco and Alcohol Counseling and Treatment into HIV Care in Kisumu County, Kenya- INTACT Study

Award Number: R01CA318829

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2031

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