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Socio-Structural Intervention to Improve Pre-Exposure Prophylaxis (PrEP) Services for Cisgender Women (CGW) (PrEP-CGW)

Award Number: R34MH128046
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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Socio-Structural Intervention to Improve Pre-Exposure Prophylaxis (PrEP) Services for Cisgender Women (CGW) (PrEP-CGW) - PROJECT SUMMARY Cisgender Women (CGW) account for nearly 20% of new HIV diagnoses in the United States (US) and both research and public health efforts in HIV prevention in this population have fallen short. Most CGW acquire HIV via heterosexual transmission, and Black CGW are disproportionately affected. Washington, D.C. (DC) is an epicenter of the HIV epidemic in the Southern US; HIV prevalence among CGW is seven-fold higher than the national average, and ten-fold higher among Black CGW. Given the severity and pervasiveness of the epidemic, DC is the model location to efficiently develop and pilot a HIV prevention intervention for CGW to be tested across the Southern US. HIV is highly preventable through consistent use of barrier contraception and HIV pre-exposure prophylaxis (PrEP), however there are significant socio-structural barriers to PrEP use among CGW, including medical mistrust, cost, stigma, and lack of access. Our preliminary research in reproductive-age CGW at high risk for HIV echoed the critical importance of medical provider and peer support in engagement and retention in the PrEP cascade reported in the literature. There is mounting evidence to support the importance of socio-structural interventions to address identified barriers to successful PrEP delivery and utilization. There are currently no evidenced-based interventions to improve PrEP initiation, adherence, and persistence among CGW in the US. This planning proposal builds upon the successful multi-pronged approach of Project Shikamana, a socio- structural intervention to prevent HIV among CGW in Tanzania (a NIMH R01 award, recognized by CDC as an evidence-based intervention (EBI) led by Dr. Kerrigan (co-I) and upon the PI’s formative research with reproductive-age CGW at high-risk for HIV in DC. In this proposal, we plan to adapt and tailor the Project Shikamana approach to address the culturally-specific, socio-structural barriers to HIV prevention. Our specific aims are: 1) Intervention Development: We will adapt the existing multi-pronged Project Shikamana Intervention for use with Southern US reproductive-age Black CGW. This intervention will integrate A) provider training to mitigate implicit biases and positively reframe HIV prevention as part of patient-centered care, and B) peer navigation to address socio-structural barriers to PrEP initiation, adherence, and persistence. 2) Feasibility & Acceptability Testing: We will evaluate the feasibility and acceptability of this HIV prevention intervention. Additionally, we will evaluate the feasibility of using a regression discontinuity design and the collection of associated outcome measures to inform a future trial. We will utilize the PRISM framework to assess patient and organizational perspectives, reach, adoption, and intervention acceptability and feasibility in preparation for our planned, multi-site trial to increase engagement and retention in the PrEP cascade.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = -$3,057 )
2026	2023	MEDSTAR HEALTH RESEARCH INSTITUTE INC.	10980 GRANTCHESTER WAY 7TH FL	COLUMBIA	MD	21044	HOWARD	USA	Mental Health Research Grants	000	3	1/9/2026	NON-COMPETING CONTINUATION	-$3,057
														Subtotal = -$3,057

Issue Date FY: 2023 ( Subtotal = $271,237 )
2023	2023	MEDSTAR HEALTH RESEARCH INSTITUTE INC	6525 BELCREST RD	HYATTSVILLE	MD	20782	PRINCE GEORGES	USA	Mental Health Research Grants	000	3	8/22/2023	NON-COMPETING CONTINUATION	$271,237
														Subtotal = $271,237

Issue Date FY: 2022 ( Subtotal = $195,105 )
2022	2022	MEDSTAR HEALTH RESEARCH INSTITUTE, INC.	6525 BELCREST RD STE 700	HYATTSVILLE	MD	20782	PRINCE GEORGES	USA	Mental Health Research Grants	001	2	8/18/2022	NON-COMPETING CONTINUATION	$195,105
2022	2021	MEDSTAR HEALTH RESEARCH INSTITUTE, INC.	6525 BELCREST RD STE 700	HYATTSVILLE	MD	20782	PRINCE GEORGES	USA	Mental Health Research Grants	000	1	1/5/2022	NEW	$0
														Subtotal = $195,105

Issue Date FY: 2021 ( Subtotal = $245,586 )
2021	2021	MEDSTAR HEALTH RESEARCH INSTITUTE, INC.	6525 BELCREST RD STE 700	HYATTSVILLE	MD	20782	PRINCE GEORGES	USA	Mental Health Research Grants	000	1	9/1/2021	NEW	$245,586
														Subtotal = $245,586

Grand Total All Awards = $708,871

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Socio-Structural Intervention to Improve Pre-Exposure Prophylaxis (PrEP) Services for Cisgender Women (CGW) (PrEP-CGW)

Award Number: R34MH128046

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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