Tobacco and HIV

Over 1.2 million people in the US are living with human immunodeficiency virus (HIV), and an estimated 34-47% smoke cigarettes. Lung cancer is the leading cause of cancer death among people with HIV (PWH) on antiretroviral therapy. It is estimated that life expectancy among HIV-positive smokers is reduced by at least 16 years compared with HIV-positive nonsmokers, and that 94% of lung cancer diagnoses among PWH could potentially be prevented by eliminating cigarette smoking in this population.

While tobacco use has been slowly declining in most high-income countries, including the US, this is not necessarily the case in many low- and middle- income countries (LMICs), including those where the HIV burden is also high. Already, a disproportionate share of the global tobacco burden falls on LMICs, where 84% of the world’s 1.3 billion current smokers reside. While advances in HIV treatment have contributed to longer lifespans in PWH, many LMICs are now facing a “double burden” of disease - a rise in the prevalence of non-communicable diseases (NCDs), such as cancer and heart disease, alongside a persistent burden of infectious diseases such as HIV.

The high prevalence of cigarette smoking and the high incidence of tobacco-related cancer and other smoking-related diseases among PWH call for swift action to intervene with this population to drive down tobacco use rates. However, evidence to guide the care of HIV-positive smokers is lacking. Few randomized clinical trials have rigorously and systematically tested evidence-based tobacco cessation interventions among PWH, and few studies have addressed patient-level, provider-level, and systems- or contextual-level barriers to successful smoking cessation among PWH.

Funding Opportunities

Improving Smoking Cessation Interventions among People Living with HIV (PWH)

To reach the long-term goal of reducing cigarette smoking rates among PWH, NCI is funding research to assess existing evidence-based smoking cessation interventions and/or to develop and test adaptations of evidence-based smoking cessation interventions, focusing on the unique barriers to cessation in this population.

In 2019, NCI began by awarding six grants under the RFAs (R01R21Improving Smoking Cessation Interventions among People Living with HIV. A second issuance of the RFAs was released in 2021 and an additional four grants were awarded. In addition, meritorious investigator-initiated applications have been awarded. These awards support research to systematically test existing evidence-based smoking cessation interventions and/or develop and evaluate adaptations of evidence-based smoking cessation interventions for PWH in the US. The funded research will address crosscutting areas of health disparities, behavioral, and social sciences research, and inform dissemination efforts to reduce the incidence of tobacco-related disease and death among PWH, in accordance with the highest HIV/AIDS research priorities identified by NIH.

Tobacco Use and HIV in Low- and Middle-Income Countries (LMICs)

NCI also supports research to develop and evaluate tobacco cessation interventions tailored to HIV-positive populations, including those with comorbidities such as tuberculosis, in low-resource settings in LMICs.

NCI has awarded grants through multiple mechanisms, including two PARs, Tobacco Use and HIV in Low- and Middle-Income Countries (R01, R21). In 2020, NCI published an RFA on Tobacco Use and HIV in Low- and Middle-Income Countries (U01). The goal of the RFA is to bring together transdisciplinary teams of investigators to adapt interventions developed and tested in other challenging settings or low-resource populations and to test their robustness among PWH in LMICs. The RFA uses a U01 cooperative agreement mechanism to facilitate coordination and collaboration across funded projects.

These are high-priority research areas for NCI, and we welcome new applications using the omnibus and parent funding opportunity announcements.

Selected Grants

Project Title

Project Number

Expiration Date Contact

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

1U01CA261620-01

August 31, 2026 Stella Aguinaga Bialous, DrPH, FAAN

A Peer Navigator Model to Improve Quit Attempts, Quitline Use, and Smoking Cessation Rates among HIV-Positive Smokers

1R21CA243906-01

August 31, 2020 Patricia Cioe, PhD

Preloading with Nicotine Replacement Therapy in HIV-positive Smokers to Improve Self-Efficacy and Quit Attempts

1R21CA261233-01

April 20, 2023 Patricia Cioe, PhD

Improving the Reach and Effectiveness of Smoking Cessation Services Targeted to Veterans Living with HIV

1R01CA243907-01

August 31, 2024 Kristina Crothers, MD
Sheryl Catz, PhD
Jennifer McClure, PhD

A SMART Approach to Treating Tobacco Use Disorder in Persons Living with HIV

1R01CA243910-01

August 31, 2024 Jennifer Edelman, MD, MHS
Steven Bernstein, MD

Evaluating Smoking Cessation Interventions for PWH in South Africa: Efficacy, Implementation, and Cost-Effectiveness

1U01CA261626-01

August 31, 2026 Jonathan E Golub, PhD, MPH
Neil Martinson, MD, MPH

Testing the Combination of Behavioral Activation and Problem Solving as a Novel Behavioral Smoking Cessation Intervention for Smokers with HIV in Botswana

1R01DA045604-01A1

March 31, 2025 Robert Gross, MD, MSCE
Robert Schnoll, PhD

Optimizing Smoking Cessation Interventions for PLWH in Nairobi, Kenya

5R01CA225419-02

August 31, 2023 Seth Himelhoch, MD
Jonathan Shuter, MD

Development of an Integrated mHealth App-Based Intervention to Support Smoking Cessation in People Living with HIV

1R21CA261458-01

June 30, 2023 Bettina Hoeppner, PhD, MS
Conall O'Cleirigh, PhD

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

1U01CA261614-01

August 31, 2026 Gina Kruse, MD, MPH

The Positively Quit Trial: Addressing Disproportionate Smoking Rates among People Living with HIV

1R01CA243800-01

July 31, 2024 Stephanie Marhefka, PhD

Design and Testing of a mHealth App for Ambivalent Smokers Living with HIV: A Randomized Pilot Study

1R21CA261199-01

April 30, 2023 Jennifer McClure, PhD

Early-phase Studies of a Tailored Evidence-Based Smoking Cessation mHealth App for Persons Living with HIV

1R21CA243911-01

August 31, 2021 Lauren Pacek, PhD
Roger Vilardaga, PhD

Quit for Life (QFL): Smoking Cessation Among Chinese Smokers Living with HIV

R21CA243835-01

April 30, 2022 Lisa Quintiliani, PhD

Optimizing Tobacco Treatment Delivery for People Living with HIV

1R01CA261232-01

February 26, 2026 Alana Rojewski, PhD

mHealth Messaging to Motivate Quitline use and Quitting among Persons Living with HIV in Vietnam (M2Q2-HIV)

1U01CA261604-01

August 31, 2026 Rajani Sadasivam, PhD
Hoa Nguyen, MD, PhD, MS

Development and Pilot Testing of a Just in Time Mobile Smoking Cessation Intervention for Persons Living with HIV

1R21CA265961-01

August 31, 2023 Rebecca Schnall, PhD, MPH
Ming-Chun Huang, PhD, MS

Testing Novel Pharmacogenetic and Adherence Optimization Treatments to Improve the Effectiveness of Smoking Cessation Treatments for Smokers with HIV

1R01CA243914-01

August 31, 2024 Robert Schnoll, PhD
Robert Gross, MD, MSCE

Implementing Tobacco Use Treatment in HIV Clinics in Vietnam

1R01CA240481-01A1

April 30, 2025 Donna Shelley, MD, MPH
Nam Truong Nguyen, MD, DrPH

RCT of an Internet Cessation Program Plus Online Social Network for HIV + Smokers

5R01CA192954-07

July 31, 2022 Jonathan Shuter, MD
Cassandra Stanton, PhD

Randomized Trial of Automated Video-Assisted Smoking Treatment for People Living with HIV

1R01CA243552-01

August 31, 2024 Damon Vidrine, DrPH, MS

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

1U01CA261598-01

August 31, 2026 Damon Vidrine, DrPH, MS
Thanh Bui, MD, DrPH

Quit4Life+: Adapting and Evaluating a Phone-Based Tobacco Use Cessation Program for People Living with HIV in Uganda and Zambia

1U01CA261624-01

August 31, 2026 Heather Wipfli, PhD

RFA-CA-18-027 (R01 Clinical Trial Optional), reissued as RFA-CA-20-035 
RFA-CA-18-028 (R21 Clinical Trial Optional), reissued as RFA-CA-20-036

PAR-17-086 (R21 Clinical Trial Optional), reissued as PAR-18-022
PAR-17-087 (R01 Clinical Trial Optional), reissued as PAR-18-023

PAR-18-023 (U01 Research Project – Cooperative Agreements)

Helpful Resources

Schnoll R, Bernstein SL, Kaufman A, et al. COVID-19 Challenges Confronted by Smoking Cessation Clinical Trials for People Living with HIV: The Experience of Grantees of the United States National Cancer Institute. Nicotine & Tobacco Research, 2021, Aug 18;23(9):1629-1632. doi: 10.1093/ntr/ntab035.

Ashare RL, Bernstein SL, Schnoll R, et al. The United States National Cancer Institute's Coordinated Research Effort on Tobacco Use as a Major Cause of Morbidity and Mortality among People with HIV. Nicotine & Tobacco Research. 2021, Jan 22;23(2):407-410. doi: 10.1093/ntr/ntaa155.

Contemporary Clinical Trials Collection

Preface:

Kaufman A, Ciccolo JT, Berzon RA, Edelman EJ. Preface to special collection of articles on interventions for promoting smoking cessation among individuals with HIV [published online ahead of print, 2021 Aug 13]. Contemporary Clinical Trials. 2021;106518. doi:10.1016/j.cct.2021.106518

Articles:

McClure JB, Catz SL, Chalal C, Ciuffetelli R, Coggshall S, DeFaccio RJ, Fleehart S, Heffner JL, Thompson E, Williams EC, Crothers K. Design and methods of a randomized trial testing the novel Wellness Intervention for Smokers Living with HIV (WISH). Contemporary Clinical Trials. 2021. Epub ahead of print.

Marhefka S, Lockhart E, Chen H, Meng H, Reina Ortiz M, Powell B, Shuter J. A tailored telehealth group tobacco cessation treatment program for people with HIV: Study protocol for a randomized controlled trial. Contemporary Clinical Trials. 2021 Jun 8:106475. doi: 10.1016/j.cct.2021.106475. Epub ahead of print. PMID: 34116206.

Cioe PA, Pinkston M, Tashima KT, Kahler CW. Peer navigation for smoking cessation in smokers with HIV: Protocol for a randomized clinical trial. Contemporary Clinical Trials. 2021 May 14:106435. doi: 10.1016/j.cct.2021.106435. Epub ahead of print. PMID: 33992767.

Quinn MH, Bauer AM, Fox EN, Hatzell J, Randle T, Purnell J, Rogers T, Stevens N, Leone F, Achenbach C, Wileyto EP, Josephson S, Gollan J, Ashare R, Hitsman B, Schnoll R, Gross R. Rationale and design of a randomized factorial clinical trial of pharmacogenetic and adherence optimization strategies to promote tobacco cessation among persons with HIV. Contemporary Clinical Trials. 2021 Apr 24:106410. doi: 10.1016/j.cct.2021.106410. Epub ahead of print. PMID: 33901574.

Edelman EJ, Dziura J, Deng Y, Bold KW, Murphy SM, Porter E, Sigel KM, Yager JE, Ledgerwood DM, Bernstein SL. A SMART approach to treating tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study. Contemporary Clinical Trials. 2021 Mar 29:106379. doi: 10.1016/j.cct.2021.106379. Epub ahead of print. PMID: 33794354.

Last Updated
September 24, 2020