PrEP for HIV Prevention among Substance Using Populations

Deadline: 12-Nov-21

The National Institutes of Health is seeking applications for its PrEP for HIV Prevention among Substance Using Populations to address gaps in their knowledge about PrEP among substance users that can ultimately inform clinical practice, including gaps related to basic clinical research, PrEP performance in PWUD, and research to improve implementation practice.

Purposes

NIDA seeks to address gaps in their knowledge about PrEP among PWUD that can ultimately inform clinical practice, including gaps related to basic clinical research, PrEP performance in PWUD, and research to improve implementation practice. This RFA is restricted to projects conducted in the United States (US), although foreign components are permitted where they support domestic research conducted in the US. Understanding PrEP use and ways to improve PrEP uptake and persistence address areas targeted by the US Government’s Ending the HIV Epidemic (EHE) initiative.
Projects should address demonstrable gaps in knowledge about clinical effects of PrEP or implementation of PrEP among PWUD rather than simply providing trial data on PrEP acceptability or demonstrations of PrEP uptake. Clinical trials are optional under this RFA and consideration should be given to whether a clinical trial is needed to answer key study questions as opposed to rigorous observational frameworks. Because available data suggest that PrEP use is relatively low among PWUD and PrEP implementation has received less attention among them, applicants should consider ways to aggregate sources of data such as cohort studies, clinical patient databases or PrEP implementation studies already underway, as well as to consider how to recruit new observational or intervention cohorts of sufficient size to address study hypotheses.
Examples of projects include (but are not restricted to):
- Using existing cohorts or clinical databases to evaluate longitudinal interplay between PrEP use and substance use with particular attention to substance use disorder and/or injection.
- Studies able to detect how PrEP persistence varies with what the literature has described as “seasons of risk”, including variations in substance use.
- Studies that include non-treatment seeking injectors to evaluate the impact of injection practices on the pharmacokinetics of PrEP and related biomarkers, with consideration of the possible contributory roles played by medical consequences of substance abuse or injection practices.
- Development and testing of strategies for optimizing PrEP engagement, uptake and monitoring among PWUD, particularly among those with polysubstance use and substance use disorders.
- Development and testing of strategies for optimizing PrEP engagement, uptake, monitoring and maintenance among PWUD recruited from settings such as drug treatment clinics or needle exchange sites. Opportunities to compare sub-populations attributable to setting and service delivery characteristics (e.g., buprenorphine versus methadone versus non-medical treatment settings) should be considered.
- Development and testing of strategies for optimizing PrEP engagement, uptake and monitoring among PWUD who present complex issues for clinical management such as marginal housing, comorbid psychiatric or infectious disease conditions, and stigmas attributable to self or health care and social service providers.
- Development and testing of intervention strategies that can address HIV risk reduction among PWUD who are not successful in their adherence to PrEP, including attention to their continued substance use as well as sexual risks. Use of adaptive or optimization designs is welcome.
- Development and testing of strategies that overcome the limitations of case management or navigation approaches among PWUD that have been observed in the past in HIV prevention and care.

Funding Information

NIDA intends to commit $2,000,000 in FY22 to fund 2-3 awards.
The maximum project period is 5 years.

Eligibility Criteria

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)
Federal Governments
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- 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