Improving Choice, Use, and Equitable Implementation of Biomedical HIV Prevention for Women (R01 Clinical Trial Optional) | RFA MH 24 330

Frequently Asked Questions (FAQs)

1) What is the name and number of this NIH funding opportunity?

This is NIH discretionary grant opportunity RFA-MH-24-330, titled "Improving Choice, Use, and Equitable Implementation of Biomedical HIV Prevention for Women (R01 Clinical Trial Optional)."

2) What is the main purpose of this grant?

The purpose is to support research that strengthens real-world use and delivery of the HIV prevention vaginal ring for women. The focus is on closing practical knowledge gaps around uptake (starting use), adherence (how consistently it is used), and persistence (staying on it over time) when the ring is offered through routine services rather than tightly controlled trials.

3) What prevention product is the opportunity focused on?

The opportunity is focused on the HIV prevention vaginal ring for women, with an emphasis on how women experience the product and how systems deliver it in everyday settings.

4) What does "real-world" or "everyday settings" mean in this announcement?

It means research should examine ring use and delivery outside tightly controlled clinical trials or open-label extension studies. The announcement emphasizes that barriers and facilitators can look different in routine care contexts, such as typical clinics and community health settings.

5) What does "equitable implementation" mean here?

"Equitable implementation" signals that studies should look closely at who is reached by ring delivery efforts, who is not reached, why gaps exist, and how strategies can reduce disparities rather than unintentionally widen them.

6) What are the main research directions encouraged by the notice?

The notice highlights three broad directions: (1) studies identifying barriers and facilitators to uptake and continued use at multiple levels; (2) development and rigorous testing of behavioral interventions to improve uptake, adherence, and persistence; and (3) implementation science studies to improve access, distribution, and quality of ring delivery.

7) What kinds of barriers and facilitators are of interest?

The opportunity invites multi-level research, including:

• Individual factors such as comfort, perceived HIV risk, side effect concerns, stigma, knowledge, and preferences.
• Interpersonal factors such as partner dynamics, disclosure concerns, family influence, and social support.
• Structural factors such as access to clinics, pharmacy distribution pathways, cost and coverage issues, transportation, clinic wait times, health system capacity, provider bias, and broader social stigma.

8) Is the goal only to document obstacles?

No. The announcement emphasizes generating actionable insights, including understanding what predicts successful adoption and sustained use when the ring is delivered through routine services.

9) What types of behavioral interventions does NIH seem to encourage under this RFA?

The opportunity encourages behavioral interventions designed to improve uptake, consistent use, and persistence. Examples described include interventions that support decision-making and product choice, build skills and confidence for correct and ongoing use, address stigma or misinformation, strengthen communication with partners or providers, and support habit formation and adherence over time.

10) What does the R01 mechanism imply about expected study scope?

Because this is an R01, the notice suggests applicants typically propose well-powered, theory-informed studies capable of producing generalizable evidence and clear next steps for broader dissemination.

11) Are clinical trials required?

No. Clinical trials are listed as optional. Applicants may propose studies with or without a clinical trial component depending on the research question and design.

12) What implementation science topics fit this opportunity?

Implementation science studies are encouraged that improve access, distribution, and quality of ring delivery and that map and address real-world barriers and facilitators within health systems and communities.

13) What are examples of implementation strategies mentioned in the notice?

Examples include evaluating service delivery models (such as integrating ring delivery into family planning, maternal health, HIV prevention, or primary care), provider training and workflow redesign, community-based distribution approaches, demand creation strategies, patient navigation, telehealth-supported follow-up, and strategies intended to improve reach and equity.

14) Does the RFA prioritize any particular populations?

The notice emphasizes equity and improving reach for populations who face disproportionate HIV risk or barriers to prevention services, and it encourages applicants to examine who is being reached and who is not.

15) What kinds of settings can be studied?

The announcement points toward routine service settings and real-world delivery contexts, including integration into common health service areas like family planning, maternal health, HIV prevention services, and primary care, as well as community-based approaches.

16) What is the funding agency and grant type?

The funding agency is the National Institutes of Health (NIH), and the mechanism is an R01 research project grant.

17) Which CFDA numbers are associated with this opportunity?

The opportunity is associated with CFDA numbers 93.242, 93.310, 93.313, and 93.865.

18) When was this opportunity posted, and what is the listed closing date?

The posting (creation) date provided is 2023-09-20, and the original closing date listed is 2023-11-22.

19) Is an award ceiling or number of expected awards provided?

No. The provided information does not specify an award ceiling or the expected number of awards. The notice indicates applicants may need to rely on standard NIH budget expectations for R01s and details in the full funding announcement.

20) Who is eligible to apply?

Eligibility is broad and includes many organization types, including: state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations (including those other than federally recognized governments); public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other entities.

21) Are specific institution types explicitly encouraged or listed as eligible?

Yes. The announcement specifically notes eligibility for groups such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and non-U.S. (foreign) organizations.

22) Are non-U.S. (foreign) organizations eligible?

Yes. The provided information explicitly includes non-U.S. (foreign) organizations among eligible applicants.

23) What kinds of partnerships align with the intent of the RFA?

The opportunity is designed for real-world implementation, so it aligns with teams and partnerships that combine biomedical HIV prevention knowledge with behavioral science and implementation science, often involving academic, clinical, community, and public health systems.

24) What is the central set of outcomes this RFA is trying to improve?

The RFA is centered on improving uptake (starting the ring), adherence (consistent use), and persistence (staying on the ring over time), along with improving the delivery systems that support equitable access and sustained use.

25) What is the broader category for this opportunity?

The opportunity is categorized under Health, Income Security and Social Services.