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 (R01, R21) Improving 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 notices of funding opportunities.
Selected Grants
| Project Title | Project Number | Contact |
| Optimizing Tobacco Treatment Delivery for People Living with HIV | 1R01CA261232-01 | Alana Rojewski, PhD Featured Grantee profile |
| mHealth Messaging to Motivate Quitline use and Quitting among Persons Living with HIV in Vietnam (M2Q2-HIV) | 1U01CA261604-01 | Rajani Sadasivam, PhD Hoa Nguyen, MD, PhD, MS |
| Testing Novel Pharmacogenetic and Adherence Optimization Treatments to Improve the Effectiveness of Smoking Cessation Treatments for Smokers with HIV | 1R01CA243914-01 | Robert Schnoll, PhD Robert Gross, MD, MSCE |
| Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes | 1R01CA275521-01 | Jonathan Shuter, MD |
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)
Cioe, P.A., Schnoll, R., Hoeppner, B.B., Gross, R., Hitsman, B.L., Leone, F.T., Ashare, R., Vilardaga, R., Tashima, K., Pinkston, M., Kahler, C.W. (2023). The Impact of the COVID-19 Pandemic on Stress, Isolation, Smoking Behaviors, and Motivation to Quit in People with HIV Who Smoke. AIDS Behav. 2023 Jun;27(6):1862-1869. doi: 10.1007/s10461-022-03917-w. PMID: 36357808; PMCID: PMC9649403.
Sanford, B. T., Toll, B. A., Eckard, A. R., Sterba, K. R., Cummings, K. M., Baker, N. L., & Rojewski, A. M. (2022). Optimizing tobacco treatment delivery for people with HIV: trial protocol for a randomized controlled trial Addict Scientist Clinical Practice. 2022 Nov 5;17(1):61. doi: 10.1186/s13722-022-00341-2. PMID: 36335376; PMCID: PMC9636678.
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.
Contacts
