U01CA261614

Title: Varenicline and Mobile Behavioral Assistance for Tobacco Cessation in HIV Care in India

Abstract:
There is an urgent need to implement effective tobacco cessation interventions in HIV care programs in low- and middle-income countries (LMICs) where most tobacco users and people with HIV live. India, with an estimated 275 million tobacco users and 2 million people living with HIV (PWH), is an important setting to test tobacco cessation interventions. However, effective medications and behavioral interventions have not been well tested in HIV care settings in LMICs. In high-income settings, Positively Smoke Free (PSF), a theory-based behavioral intervention, has demonstrated efficacy among PWH and has been adapted for mobile phone delivery (PSF-M). Mobile health interventions offer scalability and may be more effective among PWH than face-to-face interventions. Varenicline is the cessation medication with the strongest evidence of efficacy in PWH, but achieving sufficient adherence for long-term success is a challenge.

We propose to combine the two most promising cessation interventions among PWH, varenicline and PSF-M, enhanced with varenicline adherence support. These interventions will be tested at the Voluntary Health Services (VHS) Infectious Disease Medical Center, Chennai Antiviral Research and Treatment Clinical Research Site, where 24% of patients new to HIV care are current smokers or dual users of smoked and smokeless tobacco, and 83% own mobile phones. In this setting, we propose the following specific aims:

1. To demonstrate the effectiveness of an integrated intervention combining varenicline plus mobile behavioral treatment among tobacco users in HIV care on biochemically verified tobacco abstinence at 24 weeks compared to a standard care control.
2. To evaluate the implementation processes of the integrated intervention in an LMIC HIV practice.
3. To measure the costs and cost-effectiveness of an integrated intervention with varenicline and PSF-M.

To accomplish these aims, PSF-M will be adapted to the VHS context, and novel content about smokeless tobacco and medication adherence self-efficacy will be added. A randomized two-arm trial will compare the combination of varenicline and PSF-M to a standard care control. We will evaluate implementation processes within HIV care workflows, including acceptability, appropriateness, feasibility, and costs, and conduct a cost-effectiveness analysis to assess the clinical impact and value of the integrated intervention if scaled-up.

The work proposed is responsive to the specific interests in RFA-CA-20-037 by testing the effectiveness of tobacco cessation interventions with demonstrated efficacy in other settings and adapted for an LMIC context, evaluating the implementation process from multiple stakeholder perspectives in an HIV care practice, and assessing the clinical impact and value of the integrated intervention if implemented at scale. The successful completion of this work will move the field forward by advancing our understanding of the effectiveness of an integrated tobacco cessation intervention in HIV care settings and projecting the population-level impacts of implementing the integrated intervention for PWH in India or other LMICs.

The Regents Of The Univ. Of Colorado

TO IDENTIFY CANCER RISKS AND RISK REDUCTION STRATEGIES, TO IDENTIFY FACTORS THAT CAUSE CANCER IN HUMANS, AND TO DISCOVER AND DEVELOP MECHANISMS FOR CANCER PREVENTION AND PREVENTIVE INTERVENTIONS IN HUMANS. RESEARCH PROGRAMS INCLUDE: (1) CHEMICAL, PHYSICAL AND MOLECULAR CARCINOGENESIS, (2) SCREENING, EARLY DETECTION AND RISK ASSESSMENT, INCLUDING BIOMARKER DISCOVERY, DEVELOPMENT AND VALIDATION, (3) EPIDEMIOLOGY, (4) NUTRITION AND BIOACTIVE FOOD COMPONENTS, (5) IMMUNOLOGY AND VACCINES, (6) FIELD STUDIES AND STATISTICS, (7) CANCER CHEMOPREVENTION AND INTERCEPTION, (8) PRE-CLINICAL AND CLINICAL AGENT DEVELOPMENT, (9) ORGAN SITE STUDIES AND CLINICAL TRIALS, (10) HEALTH-RELATED QUALITY OF LIFE AND PATIENT-CENTERED OUTCOMES, AND (11) SUPPORTIVE CARE AND MANAGEMENT OF SYMPTOMS AND TOXICITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO STIMULATE TECHNICAL INNOVATION, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, AND FOSTER PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS.

93.393 - Cancer Cause and Prevention Research

National Cancer Institute (NCI) [HHS - NIH]

Aurora, Colorado 800452527 United States

Single Zip Code

Tobacco Use and HIV in Low and Middle-Income Countries (U01 Clinical Trial Optional) (RFA-CA-20-037)

Amendment Since initial award the total obligations have increased 320% from $804,169 to $3,375,322.