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Ending Tobacco Use through Interactive Tailored Messaging for Cambodian People Living with HIV/AIDS (EndIT)

Award Number: U01CA261598
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/17/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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Ending Tobacco Use through Interactive Tailored Messaging for Cambodian People Living with HIV/AIDS (EndIT) - Although the prevalence of tobacco use has declined in developed nations in recent decades, the prevalence of smoking remains strikingly high in many low-income countries. In Cambodia, recent national surveys have indicated that 33%–43% of adult men and 3% of adult women smoke cigarettes. Certain populations, such as people living with HIV (PLWH), are confronted with disproportionately high risks associated with tobacco use. Available estimates indicate that 43%–65% of male PLWH and 3%–5% of female PLWH smoke cigarettes. Although Cambodia has widespread coverage for antiretroviral treatment (ART), no known efforts have been made to provide tobacco treatment to ART recipients who smoke. Thus, complementing ART with efficacious tobacco cessation treatment offers tremendous potential to improve HIV care and to prolong life for PLWH. To address this need, we propose a randomized controlled trial with pharmacological and behavioral treatment components, including a fully automated, interactive smartphone-delivered intervention. Mobile health (mHealth) interventions are proliferating in the US, but efforts to utilize similar approaches in Cambodia are extremely limited. The World Health Organization acknowledges that mHealth is cost-effective, scalable, and sustainable, including for the least developed countries. We have already developed the mHealth platform and intervention approach proposed for this study, and we have completed a pilot study with 50 Cambodian PLWH who smoked and received care at an ART clinic. Results from this pilot indicated that the biochemically confirmed, 7-day point prevalence abstinence rates at 2-months follow-up were 40% in the group receiving the mHealth intervention vs. 8% in a standard care control group (relative risk: 5.0). In this proposed study, Cambodian PLWH will be recruited through the 6 largest ART clinics in Phnom Penh, which provide comprehensive care to more than 14,000 PLWH. Participants (n=800) will be randomized to one of 2 treatment groups: Standard Care (SC; n=400), or Automated Messaging (AM; n=400). SC consists of brief advice to quit smoking delivered by research staff, self-help written materials, and an 8-week supply of nicotine replacement therapy (NRT) in the form of transdermal patches. AM consists of the SC components plus a fully automated smartphone-based treatment program that involves interactive and tailored proactive messaging. The primary outcome is biochemically confirmed self-reported 7-day point prevalence abstinence at 12 months post-study enrollment. Secondary outcomes include abstinence at 3- and 6-months post-enrollment. The primary aims are to evaluate the efficacy of AM for Cambodian PLWH who smoke and to compare the cost-effectiveness of AM vs. SC. If our findings indicate that AM is efficacious and cost-effective, our collaboration with influential Cambodian governmental agencies will facilitate wide-scale implementation to HIV clinics across the country. Thus, the project has the potential to transform HIV care delivery throughout the country and to reduce tobacco-induced cancer morbidity and mortality significantly.


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: 2025 ( Subtotal = $656,491 )
2025	2025	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 USF MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Cancer Cause and Prevention Research	001	5	9/17/2025	SUPPLEMENT FOR EXPANSION	$189,132
2025	2025	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 USF MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Cancer Cause and Prevention Research	000	5	9/9/2025	NON-COMPETING CONTINUATION	$467,359
														Subtotal = $656,491

Issue Date FY: 2024 ( Subtotal = $203,060 )
2024	2024	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 USF MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Cancer Cause and Prevention Research	000	4	8/7/2024	NON-COMPETING CONTINUATION	$203,060
														Subtotal = $203,060

Issue Date FY: 2023 ( Subtotal = $699,359 )
2023	2023	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Cancer Cause and Prevention Research	001	3	8/23/2023	NON-COMPETING CONTINUATION	$699,359
2023	2022	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Cancer Cause and Prevention Research	000	2	3/3/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $699,359

Issue Date FY: 2022 ( Subtotal = $669,454 )
2022	2022	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Cancer Cause and Prevention Research	000	2	9/5/2022	NON-COMPETING CONTINUATION	$669,454
														Subtotal = $669,454

Issue Date FY: 2021 ( Subtotal = $751,427 )
2021	2021	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Cancer Cause and Prevention Research	000	1	9/17/2021	NEW	$751,427
														Subtotal = $751,427

Grand Total All Awards = $2,979,791

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Ending Tobacco Use through Interactive Tailored Messaging for Cambodian People Living with HIV/AIDS (EndIT)

Award Number: U01CA261598

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/17/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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