The purpose of this Funding Opportunity Announcement (FOA) is to provide support for research designed to optimize smoking cessation treatment among people living with HIV (PLWH) in the United States (U.S.). Responsive applications must propose research that will be conducted with PLWH and will inform efforts to reduce the incidence of tobacco-related morbidity and mortality among PLWH.
Research may address the behavioral and sociocultural factors and conditions that are associated with cigarette smoking among PLWH and may also address smoking-related health disparities among PLWH, considering the heterogeneity across the various subgroups of PLWH.
- The goal of this FOA is to provide support for studies that employ rigorous designs that seek to systematically test existing evidence-based tobacco cessation interventions (e.g., a combination of behavioral and pharmacological) and/or to develop and test adaptations of evidence-based tobacco cessation interventions for PLWH in the U.S.
- The principal focus of this initiative is on cigarette smoking cessation. Studies that address dual/poly tobacco use cessation as part of a cigarette smoking cessation intervention are also acceptable. Since the number of non-AIDS-defining cancers appears to be higher than expected by smoking alone, the inclusion of markers of HIV/AIDS immune status and related disease etiologies should be incorporated into proposed studies.
- Applicants should also include a detailed assessment of smoking history, as the current understanding of smoking behavior in this population is limited. Proposed projects must include prospective, comparative evaluation of the intervention(s) in terms of the rates of cigarette smoking cessation, including sustained abstinence, among current cigarette smokers.
All projects must include the following:
- Research strategies need to be consistent with the highest HIV/AIDS research priorities as identified by NIH (see NOT-OD-20-018); applicants are encouraged to address the health consequences of smoking that may be prevalent among PLWH;
- Research designed to estimate the effect of an intervention on cigarette smoking cessation outcomes with at least one control or comparison group;
- A detailed assessment of cigarette smoking and cigarette smoking history among study participants;
- The use of other tobacco products, including electronic cigarettes, should also be assessed.
- The following cessation endpoints/characteristics are required for all studies: rates of cessation, including quit attempts, and sustained abstinence among current smokers. Biological verification of tobacco abstinence is strongly encouraged. These include:
- Markers of HIV/AIDS immune status (e.g., CD4 cell count) must be assessed. If feasible, examination of HIV/AIDS-related co-infections (e.g., hepatitis B or C, Kaposi sarcoma-associated herpesvirus, human papillomavirus) and/or co-morbidities (e.g., non-AIDS-defining cancers such as lung, anal, or Hodgkin lymphoma) should be assessed.
- Studies should be designed for dissemination (e.g., feasibility/acceptability of the intervention for PLWH and providers) and suitable for the intended context. Applicants are encouraged to use an evaluation framework (e.g., RE-AIM) to assess the potential of the intervention to be scaled up.
Primary research questions that fall within the scope of this FOA include, but are not limited to the following:
- What evidence-based smoking cessation interventions are most effective in helping PLWH to achieve long-term tobacco abstinence?
- How can evidence-based smoking cessation interventions be adapted to improve smoking cessation outcomes among PLWH?
- Considering the diverse and unique needs of PLWH, including culture, country of origin, English language proficiency, socioeconomic status, and race/ethnicity, how can existing evidence-based smoking cessation interventions be adapted to best reach and be effective in specific groups?
- What smoking cessation interventions are most effective among subgroups of PLWH with disproportionately high smoking rates? These subgroups include African American men, American Indian/Alaska Natives, rural residents, sexual and gender minorities, individuals with mental illness, persons with other substance use disorders, those of low socioeconomic status (SES), and medically underserved or uninsured people.
Additional topics (e.g., secondary research questions) that fall within the scope of this FOA include but are not limited to the following:
- What barriers are identified when integrating evidence-based tobacco dependence treatment interventions into the existing HIV prevention and treatment context?
- How does the social and behavioral context of tobacco use among PLWH, including the use of alcohol and other drugs, influence tobacco use behaviors and cessation outcomes within the context of smoking cessation interventions?
- How is smoking cessation among PLWH influenced by the concurrent use of alcohol and drug use, particularly patterns of alcohol and drug use associated with increased behavioral risk for HIV transmission?
- How can relapse prevention strategies best be incorporated into existing evidence-based tobacco cessation interventions for PLWH?
- How does HIV treatment adherence influence the effects of smoking cessation interventions? Conversely, how do smoking cessation and/or smoking cessation interventions influence HIV treatment adherence?
- How can evidence-based smoking cessation interventions be adapted and implemented in the context of diverse HIV care settings?
- What smoking cessation services, such as telephone-based, web-based, text-based, and app-based interventions, influence tobacco use behaviors and cessation outcomes?
- Within health care delivery systems, what strategies are most effective to inform HIV treatment providers and PLWH about the health risks of smoking? Similarly, what strategies are most effective in increasing motivation for smoking cessation among PLWH?
- What strategies are effective to decrease barriers to the provision of evidence-based smoking cessation interventions for PLWH, including increasing motivation of providers?
- What healthcare systems-based approaches can facilitate the delivery of evidence-based smoking cessation interventions for PLWH?
The following types of projects are not responsive to this FOA (applications proposing non-responsive projects will not be reviewed):
- Applications or research projects focused on biological mechanisms or disease processes;
- Studies that do not test an intervention that is intended to reduce cigarette smoking among PLWH;
- Observational studies;
- Studies that lack a control or comparison group;
- Studies that employ non-evidence-based tobacco cessation interventions;
- Studies that do not provide a detailed assessment of cigarette smoking and cigarette smoking history.
- Application budgets are limited to $500,000 in direct costs in any one year
- The maximum project period is 5 years.
- Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
- The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
- Nonprofits Other than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
- Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
- Foreign Institutions
- Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
- Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
- Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
For more information, visit https://www.grants.gov/web/grants/view-opportunity.html?oppId=327624