Key Dates

NOT-MH-22-020 - Notice of Intent to Publish a Funding Opportunity Announcement for Improving Uptake and Use of the Dapivirine Vaginal Ring for HIV Prevention (R01 Clinical Trial Optional)

NOT-MH-22-022 - Notice of Intent to Publish a Funding Opportunity Announcement for Improving Uptake and Use of the Dapivirine Vaginal Ring for HIV Prevention (R34 Clinical Trial Optional)

National Institute of Mental Health (NIMH)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Research on Women's Health (ORWH)

The National Institute of Mental Health (NIMH) intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for research on the dapivirine vaginal ring for HIV prevention, including research to: advance understanding of multilevel facilitators and barriers to use of the dapivirine vaginal ring; develop interventions to support uptake and correct and persistent use of the vaginal ring; and test implementation strategies for optimal delivery of the vaginal ring.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in Winter 2022with an expected application due date in Summer 2022.

This FOA will utilize the R21 activity code, and companion FOAs will utilize the R01 (see NOT-MH-22-020) and the R34 (see NOT-MH-22-022) activity codes. Details of the planned FOA are provided below.

The dapivirine vaginal ring for women has been shown to reduce risk of HIV by approximately 30% in clinical trials, and risk may be reduced even further when used correctly and consistently. In July 2020, the European Medicines Agency (EMA) issued a positive opinion for the dapivirine vaginal ring to reduce the risk of HIV for women in high disease burden countries, and the ring is presently undergoing regulatory review in several countries.

This initiative will solicit behavioral and implementation science research to target gaps in scientific knowledge about barriers and facilitators to ring use, interventions to improve uptake, adherence, and persistence on the vaginal ring, and implementation science studies to improve access to and distribution of the ring.

Examples of research topics include, but are not limited to:

• Studies of individual, interpersonal, and structural factors associated with uptake of, adherence to, and persistence on the vaginal ring when the ring is delivered in real world settings (i.e., outside of clinical or open label extension trials), including cultural beliefs, stigma, gender-based violence, and partner support
• Studies to characterize and understand patterns of use of the ring, including switching between the ring and other HIV prevention options
• Studies to determine how to best communicate to potential ring users factors such as the effectiveness of the ring and the importance of correct and consistent ring use
• Development and testing of decision aids to assist with patient-provider discussions around HIV prevention options, to help women choose and initiate their preferred HIV prevention option
• Studies to understand the impact of HIV prevention product choice on uptake, adherence to, and persistence with HIV prevention options
• Development and testing of communication strategies and behavioral interventions to support uptake, consistent use, and persistence on the vaginal ring
• Intervention studies 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
• Intervention studies to engage partners or other key influencers to support women’s ring use
• Intervention studies to develop and test training programs for providers and clinics regarding ring delivery, which could be scaled to foster expanded access to and use of the ring
• Implementation science studies to understand implementation barriers and facilitators to delivery of the vaginal ring in healthcare settings and to optimize delivery of the ring in these settings, including integration of vaginal ring delivery into sexual and reproductive health and maternal/child health services
• Implementation science studies to determine optimal settings and venues for ring distribution, including community-based delivery