Improving Choice, Use, and Equitable Implementation of Biomedical HIV Prevention for Women (R34 Clinical Trial Optional) | RFA MH 24 332

FAQs: NIH Funding Opportunity RFA-MH-24-332 (R34, Clinical Trial Optional)

What is this funding opportunity?

This NIH funding opportunity (RFA-MH-24-332) supports planning-stage research projects focused on improving how women access, choose, and successfully use biomedical HIV prevention options, with a strong emphasis on the vaginal ring in real-world settings.

What is the main goal of the grant?

The main goal is to close practical knowledge gaps about real-world vaginal ring adoption and use, including why women do or do not adopt the ring, what supports consistent use over time, and how health systems and community delivery models can make ring access more feasible, acceptable, and equitable.

What grant mechanism is being used?

The opportunity uses the NIH R34 mechanism (Clinical Trial Optional). This mechanism typically supports early-stage or pilot work designed to refine interventions, establish feasibility, and generate evidence needed for larger effectiveness or implementation trials later.

Are clinical trials allowed under this opportunity?

Yes. The mechanism is listed as “Clinical Trial Optional,” which indicates applicants may propose a clinical trial if it fits the project aims, but a clinical trial is not required.

What prevention method is emphasized in this opportunity?

While the opportunity is framed around biomedical HIV prevention options for women, it places a strong emphasis on the vaginal ring, particularly how it is taken up and used in everyday, real-world settings.

What does “real-world settings” mean in this context?

It refers to environments outside tightly controlled research conditions, such as routine clinical care, community-based service settings, and the everyday circumstances that shape prevention decisions (for example, privacy concerns, transportation barriers, clinic workflows, stigma, and competing life demands).

What kinds of research questions is NIH trying to answer?

The opportunity prioritizes questions like: why the ring is or is not adopted; what helps women use it consistently; what influences persistence over time; what common reasons lead to discontinuation; and how delivery systems can make access more feasible, acceptable, scalable, sustainable, and equitable.

What levels of influence can projects examine?

Projects can examine multi-level influences, including individual, interpersonal, and structural factors that affect uptake, adherence, and persistence.

What are examples of individual-level factors mentioned?

Examples include knowledge, attitudes, risk perception, side effects, comfort, stigma, and personal preferences related to HIV prevention and vaginal ring use.

What are examples of interpersonal factors mentioned?

Examples include partner dynamics, disclosure concerns, social support, and peer norms that may influence whether someone starts and continues using the ring.

What are examples of structural factors mentioned?

Examples include clinic workflows, cost and coverage, transportation, privacy protections, provider bias, supply chain issues, policy constraints, and broader social determinants that affect access and sustained use.

What is meant by “uptake,” “adherence,” and “persistence”?

In this opportunity’s framing, uptake refers to starting or adopting the vaginal ring; adherence refers to using it consistently as intended over time; and persistence refers to continuing use over longer periods, recognizing that prevention needs and preferences may change.

What types of interventions are supported?

A major supported category is developing and testing behavioral or support interventions that improve uptake and sustained use of the ring in real-world conditions.

What are examples of behavioral or support interventions mentioned?

Examples include counseling approaches, peer navigation, partner-inclusive strategies (when appropriate and safe), reminder and support systems, interventions aimed at reducing stigma or misinformation, and approaches that address common reasons for discontinuation.

Is the focus only on getting women to start using the ring?

No. The focus includes both initial adoption and consistent use and persistence over time, with an emphasis on supports that help align prevention with someone’s evolving life circumstances and relationships.

What is the role of implementation science in this opportunity?

Implementation science is a major focus area. Studies may examine how to deliver the vaginal ring effectively through health services and community programs, identify barriers and facilitators to delivery, and test strategies to optimize delivery models and reach.

What delivery factors can implementation-focused projects address?

Examples include staffing and training needs, provider readiness, integration into sexual and reproductive health services, youth-friendly care, confidentiality protections, and culturally responsive delivery approaches.

What types of service delivery models might be studied?

The opportunity describes testing or comparing different service models, distribution channels, clinic-community partnerships, or other approaches that improve reach and real-world access, particularly for women facing the greatest barriers.

How is equity addressed in this funding opportunity?

Equity is described as central. The intent is to help ensure vaginal ring delivery does not primarily benefit only those already well served by healthcare systems, and to build evidence for feasible and equitable delivery across diverse communities.

What is the award ceiling for this opportunity?

The award ceiling listed for the opportunity is $450,000.

What was the original closing date?

The original closing date listed in the provided information is November 22, 2023.

Is this a discretionary grant?

Yes. The opportunity is described as a discretionary grant offered by the National Institutes of Health (NIH).

What CFDA numbers are associated with this funding opportunity?

The CFDA numbers associated with the opportunity are 93.242, 93.310, and 93.313.

How many awards will NIH make?

The provided information does not specify an expected number of awards.

Who is eligible to apply?

Eligibility is broad and includes many public and private entities, including various levels of government, institutions of higher education, tribal entities, nonprofits, for-profit organizations (other than small businesses), and small businesses.

What types of government entities are eligible?

Eligible government entities include state governments; county governments; city or township governments; and special district governments.

Are schools and universities eligible?

Yes. Eligibility includes independent school districts, public and state-controlled institutions of higher education, and private institutions of higher education.

Are tribal governments and tribal organizations eligible?

Yes. Federally recognized Native American tribal governments are eligible, as well as tribal organizations that are not federally recognized.

Are nonprofits eligible, including those without 501(c)(3) status?

Yes. Nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status are both included as eligible entities.

Are for-profit entities eligible?

Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed as eligible.

Are public housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities are included in the eligibility list.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are explicitly mentioned among eligible applicants.

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

Yes. The provided information indicates that non-U.S. entities (foreign organizations) are included among eligible applicants.

Does the opportunity encourage applications from certain institution types?

Yes. It explicitly encourages participation from institutions and organizations often important for equitable health research and service delivery, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, eligible federal agencies, regional organizations, and others listed in the eligibility description.

What is the overall research emphasis of this grant (efficacy vs. real-world use)?

The grant is designed to move beyond efficacy questions and focus on practical, on-the-ground realities of HIV prevention for women, especially how ring use and delivery function in real-life contexts and systems.

What outcomes or evidence is this planning-stage work intended to support later?

The R34 mechanism is described as supporting early-stage work that refines interventions and establishes feasibility, producing evidence that can inform larger effectiveness or implementation trials later.