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A Multi-Level Trauma-Informed Approach to Increase HIV Pre-exposure Prophylaxis Initiation among Black Women

Award Number: R01MD019178
ORGANIZATION: NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/21/2023
PERIOD OF PERFORMANCE END DATE: 03/12/2025

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A Multi-Level Trauma-Informed Approach to Increase HIV Pre-exposure Prophylaxis Initiation among Black Women - Project Summary Black cisgender women (hereafter, Black women) carry a disproportionate HIV burden than women in other racial and ethnic groups. Despite its promise, there is an unmet need for pre-exposure prophylaxis (PrEP) among Black women. Intimate partner violence (IPV) and gendered racism may exacerbate racial disparities in PrEP access and also curb potential real-world effectiveness. IPV reduces PrEP uptake among women. Black women also experience unfair treatment due to deeply ingrained stereotypes by healthcare systems. As such, Black women may feel uncomfortable discussing PrEP with a provider or provider biases may prevent PrEP access. Integrating trauma-informed care into community health centers that serve Black women may enhance PrEP adoption. Trauma-informed care can help providers understand IPV, medical mistrust and gendered racism within the context of Black women’s experiences. System policies can also be modified to be trauma-informed for both staff and Black women clients. In addition to changing health systems, peer navigation could be a successful model of care to improve PrEP engagement. Peer navigation can build self-efficacy in patient-provider communication and decrease medical mistrust offsetting the impact of socio-structural barriers. The proposed research aims to address this gap via the implementation and evaluation of a trauma-informed multilevel intervention designed to increase PrEP initiation among Black women. This intervention includes a trauma- informed PrEP Implementation Toolkit for staff in community healthcare clinics in addition to a trauma-informed peer navigation model. We propose a hybrid type 2 effectiveness-implementation study with clinical staff, peer navigators, and clients. Aim 1 includes adapting an existing trauma-informed peer navigation for PrEP-eligible Black women. Qualitative data from semi-structured interviews with 20 Black women clients will be used to adapt the peer navigation. Aim 2 includes assessing the effectiveness of the trauma-informed multilevel intervention. The toolkit will be employed in clinics using a stepped wedge design with monthly aggregated clinic data collected 8 months before and after toolkit implementation in each clinic. Toolkit effectiveness will be assessed using within- and between-clinic changes in PrEP initiation. Staff will complete baseline, immediate post, and 3-month post surveys to assess mechanisms of change. In a parallel two-arm trial, 300 Black women clients will be randomized to receive either peer navigation (intervention arm) or support group only (control arm) and will complete baseline, 1-, 3-, and 6- month post-randomization surveys. The primary client outcomes will be 1-, 3-, and 6-month PrEP initiation. Aim 3 includes assessing the implementation of the multilevel intervention. Adoption, acceptability, appropriateness, and sustainability will be assessed with 3-month post-toolkit staff surveys; and at 1-, 3-, and 6- month client post-randomization surveys. Intervention costs will be computed using an ingredients-based approach. Fidelity will be assessed with the fidelity-monitoring approach for multilevel trials.


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: 2025 ( Subtotal = $0 )
2025	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Minority Health and Health Disparities Research	001	2	3/20/2025	NON-COMPETING CONTINUATION	$0
2025	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Minority Health and Health Disparities Research	000	2	3/13/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $1,105,281 )
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Minority Health and Health Disparities Research	003	2	5/29/2024	NON-COMPETING CONTINUATION	$110,529
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Minority Health and Health Disparities Research	002	2	3/22/2024	NON-COMPETING CONTINUATION	$994,752
2024	2023	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Minority Health and Health Disparities Research	000	1	10/7/2023	NEW	$0
2024	2023	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Minority Health and Health Disparities Research	001	1	3/11/2024	NEW	$0
														Subtotal = $1,105,281

Issue Date FY: 2023 ( Subtotal = $1,087,723 )
2023	2023	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Minority Health and Health Disparities Research	000	1	9/21/2023	NEW	$1,087,723
														Subtotal = $1,087,723

Grand Total All Awards = $2,193,004

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A Multi-Level Trauma-Informed Approach to Increase HIV Pre-exposure Prophylaxis Initiation among Black Women

Award Number: R01MD019178

ORGANIZATION: NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/21/2023

PERIOD OF PERFORMANCE END DATE: 03/12/2025

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