Strengthening HIV Prevention Efforts for Women in the Southern U.S. (R01 Clinical Trial Optional) | RFA MH 21 151

Frequently Asked Questions (FAQs)

What is the official title of this NIH funding opportunity?

The funding opportunity is titled "Strengthening HIV Prevention Efforts for Women in the Southern U.S. (R01 Clinical Trial Optional)."

What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is RFA-MH-21-151.

What is the overall goal of this grant opportunity?

The goal is to support research that strengthens HIV prevention for women living in the Southern United States by addressing real-world factors that affect the uptake and sustained use of HIV prevention strategies.

What are the two main purposes of the initiative?

The initiative has two central purposes: (1) to clarify barriers and facilitators affecting whether women in the Southern U.S. can access and consistently use HIV prevention strategies, and (2) to develop and test new or improved interventions that increase uptake and adherence to HIV prevention options among women in the region.

Who is the focus population for this opportunity?

The focus population is women living in the Southern United States, particularly in the context of persistent HIV disparities and social determinants of health that influence prevention outcomes in the region.

What kinds of research does this opportunity encourage?

It encourages research that goes beyond single-level solutions and instead uses multi-level approaches that reflect the combined influence of individual, interpersonal, community, clinical, and structural factors on HIV prevention.

What does "multi-level approaches" mean in the context of this opportunity?

"Multi-level approaches" refers to research and interventions that address more than just individual knowledge or behavior. Competitive projects are generally expected to consider multiple layers of influence, such as patient-facing supports combined with clinic-level changes and community or structural strategies that address real-world barriers.

What are examples of barriers this opportunity is interested in studying?

Examples include barriers related to awareness, stigma, risk perception, healthcare access, provider practices, social and relationship dynamics, economic constraints, transportation, insurance coverage, housing instability, local policies, and broader inequities that shape health outcomes in the Southern U.S.

What are examples of facilitators this opportunity is interested in studying?

Facilitators include factors that help women access and use HIV prevention strategies consistently, such as supportive healthcare practices, improved access to services, reduced stigma, helpful social supports, and systems that reduce logistical obstacles.

Does this funding opportunity require a clinical trial?

No. The opportunity is designated "clinical trial optional," meaning applicants may propose research that includes a clinical trial, but a clinical trial is not required if the research aims can be achieved through other rigorous study designs.

If a clinical trial is optional, what does that imply for study design?

It implies flexibility: applicants can propose studies with or without a clinical trial, as long as the design is rigorous and appropriate for the proposed aims (for example, to understand barriers/facilitators or to develop and evaluate interventions).

What grant mechanism is used for this opportunity?

This opportunity uses the NIH R01 grant mechanism.

What types of interventions are considered responsive or competitive?

Interventions that do more than education-only approaches and address multiple levels of influence are generally aligned with the emphasis of the announcement. Examples described include combining patient-facing support (counseling, navigation, reminders, peer support) with clinic-level changes (provider training, streamlined workflows, integration into routine care) and community or structural components (partnerships with trusted organizations, stigma reduction, reducing transportation or childcare barriers).

Is the funding opportunity specifically limited to the Southern United States?

Yes. The initiative is specifically aimed at improving HIV prevention for women in the Southern U.S., reflecting regional HIV disparities and contextual factors that affect prevention.

What types of organizations are eligible to apply?

Eligibility is broad and includes many U.S.-based organizations and government entities, including state, county, city or township governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and private institutions of higher education; tribal entities; nonprofits with or without 501(c)(3) status (with the noted exclusion in the nonprofit category for institutions of higher education); for-profit organizations other than small businesses; and small businesses.

Are tribal entities eligible?

Yes. Eligible applicants include federally recognized Native American tribal governments and Native American tribal organizations other than federally recognized tribal governments.

Are higher education institutions eligible?

Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education.

Are nonprofits eligible to apply?

Yes. Nonprofit organizations with and without 501(c)(3) status are eligible (excluding those that are institutions of higher education under the nonprofit category, as stated in the provided information).

Are for-profit organizations eligible?

Yes. For-profit organizations other than small businesses are eligible, and small businesses are also eligible.

Does the announcement highlight any additional eligible applicant types?

Yes. It explicitly highlights eligibility for entities 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 (AANAPISI), faith-based or community-based organizations, eligible federal agencies, regional organizations, tribal governments other than federally recognized, and U.S. territories or possessions.

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

No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply.

Can a U.S. organization include non-domestic components in the project?

No. Non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed. Projects must be fully domestic in terms of applicant organization and supported components.

What is the funding instrument type?

The funding instrument is a grant.

How is this opportunity categorized in the source data?

In the provided source data, the opportunity is categorized as discretionary funding, with activity categories in education and health.

What CFDA numbers are associated with this opportunity?

The CFDA numbers listed are 93.242, 93.279, 93.307, and 93.313.

When was this opportunity created and when was it originally due?

The opportunity was created on 2020-11-17, with an original closing date of 2021-01-11.

Is the award ceiling provided in the information shared here?

No. An award ceiling is not specified in the provided fields.

Is the expected number of awards provided in the information shared here?

No. The expected number of awards is not specified in the provided fields.

What is the practical emphasis of the research supported by this opportunity?

The practical emphasis is on work that not only introduces HIV prevention tools, but also addresses the conditions that determine whether women can start them, stay on them, and benefit over time within the contexts where they live and receive care.

Why does this opportunity emphasize real-world context?

Because HIV prevention outcomes for women in the Southern U.S. are influenced by a real-world mix of factors across multiple levels, including social determinants of health and healthcare access gaps. The opportunity is designed to stimulate research that reflects those combined influences rather than relying on single-level solutions.