Deadline: 22-Nov-23
National Institutes of Health invites applications to understand factors that impact uptake and adherent and persistent use of biomedical HIV prevention options, to inform and advance approaches to support choice and use among these options, and to understand and advance equitable delivery of biomedical HIV prevention options for cisgender and transgender women in settings where multiple prevention options are available.
The biomedical HIV prevention landscape for cisgender and transgender women is rapidly expanding. In addition to daily oral pre-exposure prophylaxis (PrEP), the dapivirine vaginal ring and long-acting injectable cabotegravir are approved for use or undergoing regulatory review in several countries. The expanding number of options for women brings important opportunities. Additional options may lead to greater uptake of HIV prevention, paralleling increases in contraceptive uptake as more contraceptive options became available. Expanded choices that allow women to select the HIV prevention option that best fits their preferences and routines may also help to improve adherence and persistence. Expanding HIV prevention options may be particularly important for adolescent girls and young women, who may struggle with adhering to daily oral PrEP.
Grant Purpose
- Understanding and exploring factors associated with choice, use, and implementation of biomedical HIV prevention.
- Evaluating interventions to encourage and support women’s choice of an HIV prevention product, and/or to improve uptake, adherence, and persistence on the chosen product.
- Evaluating strategies to optimize implementation and to improve equitable access to biomedical HIV prevention for cisgender and transgender women.
Research Objectives/Scope
New advances in biomedical HIV prevention may help to reduce disparities in HIV incidence. However, a thoughtful evidence-based approach is needed to ensure that these innovations are delivered in a way that reduces, rather than exacerbates, health disparities.
- Key Considerations:
- Applications must propose research with a primary aim to understand and/or improve choice, use, or equitable implementation of biomedical HIV prevention for cisgender and/or transgender women.
- Applications must include at least two of the following biomedical HIV prevention options: oral PrEP, vaginal ring, and long-acting injectable PrEP.
- If HIV prevention product(s) will be provided to participants, the application must provide details on the status of regulatory approval of the product(s) being studied. In case the prevention option(s) has not received in-country regulatory approval by the time human subjects research with the product is proposed to start, the application must propose alternative strategies (including partnerships with Ministries of Health on formative research or demonstration projects).
- Studies are expected to include a plan for a Community Advisory Board (CAB). The CAB should reflect the target population of the grant. For clinical trials, the CAB should be involved prior to the launch of the trial, throughout the trial, and following the completion of the project to assist with data interpretation.
- Applicants are encouraged to leverage ongoing demonstration and implementation projects in the country in which they propose to conduct research.
- Applicants are encouraged to partner with organizations involved in the roll-out of novel biomedical HIV prevention options; applications should address how these partnerships will be mutually beneficial.
- Applicants should complement any self-report measures of product use with other objective measures of use, including in studies that use secondary data.
- For research that does not include an intervention or implementation strategy, there should be a clear plan for how the proposed research will inform future intervention or implementation research.
- For intervention and implementation science research, applicants should articulate a clear plan for how the study findings will be implemented into practice and/or scaled up in the country where the research is being conducted.
- Studies that provide biomedical HIV prevention should provide a plan for how women will continue to have access to HIV prevention product(s) after study completion.
- Research is encouraged across the lifespan. Consideration should be given the unique developmental context, especially for adolescents and young women.
- Specific Areas of Research Interest:
- Studies of individual, interpersonal, and structural factors associated with uptake of, adherence to, and persistence on biomedical HIV prevention when delivered in real-world settings with multiple prevention options, including factors such as cultural beliefs, stigma, gender-based violence, and partner support
- Studies to characterize and understand patterns of use of HIV prevention options, including switching between products or planned breaks
- Clinical trials to test the effectiveness of decision aids or other innovative approaches to assist with patient-provider discussions around HIV prevention options, as well as implementation or hybrid design studies to understand how and where to implement decision aids
- Clinical trials to test the effectiveness of promoting choice of biomedical HIV prevention products on uptake, adherence to, and persistence with HIV prevention options
- Studies to test the effectiveness and/or implementation of communication strategies and behavioral interventions to support uptake, consistent use, and persistence on a woman’s chosen biomedical HIV prevention option
- Studies to test the effectiveness and/or implementation of interventions to support women who want to switch from their initial choice of an HIV prevention product to a different HIV prevention product, or to facilitate change to a different HIV prevention product if use of a product is discontinued
- Studies to test the effectiveness and/or implementation of interventions to address the unique HIV prevention needs among transgender women
- Studies to test the effectiveness and/or implementation of interventions to engage partners, family members, or other key influencers to support women’s HIV prevention use
- Clinical trials to test the effectiveness of training programs for providers and clinics regarding biomedical HIV prevention delivery, and implementation science to evaluate strategies to implement and scale these programs, to foster equitable access to and use of biomedical HIV prevention
- Studies to optimize and test implementation strategies for delivering biomedical HIV prevention in healthcare settings, including integration of HIV prevention for women into sexual and reproductive health and maternal/child health services
- Implementation science studies to test delivery of biomedical HIV prevention options in different settings and venues
- Implementation science studies to determine which implementation strategies lead to equitable access and use
- Non-responsive Areas of Research:
- Applications proposing any of the following areas of study will be deemed to be non-responsive and will not proceed to review and will be withdrawn.
- Studies that are not focused on understanding and/or improving choice, use, or equitable implementation of biomedical HIV prevention for cisgender and/or transgender women.
- Studies that do not include at least two biomedical HIV prevention options, including oral PrEP, the vaginal ring, and long-acting injectable PrEP.
- Studies that are only focused on HIV treatment as prevention, post-exposure prophylaxis (PEP), medical male circumcision, and/or male and female condoms, although these strategies may be offered to participants alongside the other biomedical prevention options that are the focus of the research.
- Studies that include biomedical HIV prevention options that have not received regulatory approval or are not undergoing regulatory review in the country(ies) where the research is planned.
- Studies with a primary focuson cisgender and/or transgender men.
- Studies that do not include a CAB.
- Studies that propose to use grant funds to purchase a product that has not received U.S. Food and Drug Administration (FDA) approval, where the submitting institution is not in a country where the product has received in-country regulatory approval, or is anticipated to receive in-country regulatory approval by the time the product is provided to participants.
- Applications proposing any of the following areas of study will be deemed to be non-responsive and will not proceed to review and will be withdrawn.
Funding Information
- NIMH intends to commit a total of $2,000,000 in FY 2024 to fund 3-5 awards in response to this NOFO
- The maximum project period is 5 years.
Eligibility Criteria
- Eligible Organizations
- 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)
- The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- 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 Government
- 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
- Non-domestic (non-U.S.) Entities (Organizations)
- Higher Education Institutions
- Eligible Individuals (Program Director/Principal Investigator)
- Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.
For more information, visit Grants.gov.