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U01CA261620

Cooperative Agreement

Overview

Grant Description
Integrating Tobacco Use Cessation into Family AIDS Care and Education Services (FACES) in Kisumu, Kenya - Abstract

People living with HIV (PLHIV) are more likely to use tobacco than the general population. PLHIV who use tobacco have higher mortality rates and risk for co-morbidities, including diseases caused by tobacco, when compared to PLHIV who do not use tobacco.

Sub-Saharan Africa continues to be the epicenter of HIV infection while experiencing an increase in tobacco consumption. There is evidence that PLHIV in Africa are more likely to use tobacco than the general population. Kenya is an example of a country coping with the dual epidemic of HIV and tobacco, with an estimated 1.5 million PLHIV and 2.5 million tobacco users.

HIV remains one of the country's leading causes of morbidity and mortality, with an estimated 46,000 adults acquiring HIV and 25,000 persons dying of HIV in 2018. Tobacco use among the general population is estimated to be 11.6% (19.1% among men and 4.5% among women). The impact of tobacco use among PLHIV in Kenya has yet to be fully understood. There have been no research or initiatives in Kenya to support PLHIV to quit tobacco use in a primary care setting, a gap that this proposal seeks to address.

In 2017, Kenya's Ministry of Health launched the National Guidelines for Tobacco Dependence Treatment and Cessation. This project will evaluate the integration of the guidelines' interventions into HIV care clinics through the Family AIDS Care & Education Services (FACES). FACES is a 16-year partnership between the Kenya Medical Research Institute, the University of California San Francisco, and the Kisumu County Ministry of Health. FACES has tested over 1.5 million people for HIV, diagnosing over 21,000 people, and currently serves over 51,000 PLHIV on ART in 61 sites in Kisumu County.

We will conduct a cluster randomized controlled trial at 20 FACES-supported clinics, recruiting 580 patients to compare the effectiveness and cost-effectiveness of an intensive intervention (nicotine replacement therapy and bupropion, 12 sessions of behavioral counseling through in-person and telemedicine approaches, and provision of a quitline number) versus a brief intervention (one-time counseling plus the quitline number). We hypothesize that 15% of intensive intervention group participants will achieve biochemically verified 7-day point prevalence abstinence at 12 months compared to the brief intervention group quit rate of 5%. We will offer the intensive intervention to brief intervention group participants who continue to use tobacco at 12 months.

Prior to the trial, we will conduct a formative evaluation to tailor the guidelines to PLHIV. After the trial, we will assess barriers to and facilitators of adoption, implementation, and factors associated with scalability/sustainability of the intervention.

The proposed study will determine the most cost-effective strategy to integrate tobacco use cessation within HIV care in a community health setting. The project's results will inform policies to scale up tobacco dependence treatment within HIV primary care centers across the country and serve as a model for the region.
Funding Goals
NOT APPLICABLE
Place of Performance
San Francisco, California 941432510 United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the total obligations have increased 314% from $734,496 to $3,041,859.
San Francisco Regents Of The University Of California was awarded Integrating Tobacco Cessation in HIV Care: A FACES Initiative in Kenya Cooperative Agreement U01CA261620 worth $3,041,859 from National Cancer Institute in September 2021 with work to be completed primarily in San Francisco California United States. The grant has a duration of 5 years and was awarded through assistance program 93.393 Cancer Cause and Prevention Research. The Cooperative Agreement was awarded through grant opportunity Tobacco Use and HIV in Low and Middle-Income Countries (U01 Clinical Trial Optional).

Status
(Ongoing)

Last Modified 9/5/24

Period of Performance
9/16/21
Start Date
8/31/26
End Date
79.0% Complete

Funding Split
$3.0M
Federal Obligation
$0.0
Non-Federal Obligation
$3.0M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to U01CA261620

Subgrant Awards

Disclosed subgrants for U01CA261620

Transaction History

Modifications to U01CA261620

Additional Detail

Award ID FAIN
U01CA261620
SAI Number
U01CA261620-317191892
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Public/State Controlled Institution Of Higher Education
Awarding Office
75NC00 NIH NATIONAL CANCER INSTITUTE
Funding Office
75NC00 NIH NATIONAL CANCER INSTITUTE
Awardee UEI
KMH5K9V7S518
Awardee CAGE
4B560
Performance District
CA-11
Senators
Dianne Feinstein
Alejandro Padilla

Budget Funding

Federal Account Budget Subfunction Object Class Total Percentage
National Cancer Institute, National Institutes of Health, Health and Human Services (075-0849) Health research and training Grants, subsidies, and contributions (41.0) $1,588,242 100%
Modified: 9/5/24