Tuesday, December 16, 2025 12/16/2025

Strategies to Prevent HIV Acquisition for At-Risk Men in the US

Award Number: R01MH129175
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/15/2024
PERIOD OF PERFORMANCE END DATE: 10/31/2027

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Strategies to Prevent HIV Acquisition for At-Risk Men in the US - PROJECT SUMMARY In the US, men at-risk of HIV acquisition and require tailored biobehavioral HIV prevention strategies. The goal of the proposed study is to assess the ability of digitally delivered peer-based strategies to improve PrEP uptake in PrEP-indicated HIV-negative adult men. This study proposes a digital open-label randomized 2x2 factorial trial (1:1:1:1 randomization) of peer-delivered HIV prevention strategies designed to increase PrEP uptake for men residing in high HIV incidence geographic hotspots in the Eastern and Southern US. The specific aims are to: (1) Compare the efficacy of individual (PrEP4T: one-on-one peer navigation) and group-based (LS4M: small group-based behavioral intervention) peer-delivered HIV prevention strategies implemented over 6 mo to increase PrEP uptake (primary outcome) in 300 PrEP-indicated HIV-negative adult men; (2) Examine mechanisms by which peer-delivered interventions impact PrEP uptake focusing on healthcare empowerment, community support, and information, motivation, and behavioral skills; and (3) Explore PrEP decision-making and intervention experiences qualitatively. Biobehavioral assessments will be conducted every 3 mo for 21 mo with self-administered surveys; remote HIV self-testing (4th gen tests) and biologic measures of PrEP via emtricitabine triphosphate (FTC-TP) and tenofovir diphosphate (TFV-DP) using dried blood spots (DBS) to evaluate uptake of approved TFV-based PrEP regimens; and STIs (gonorrhea, chlamydia, syphilis) via electronic medical record (EMR) releases. The team will use a participatory population perspective to work “with” not “on” communities ensuring meaningful participation of at-risk men. The proposed study is significant by addressing HIV prevention in high HIV burdened population and will fill critical gaps in biobehavioral HIV prevention and peer-engaged approaches. The study is aligned with US national priorities to implement integrated strategies for HIV prevention in at-risk populations and high HIV incidence geographic hotspots and will advance the 2021-2025 National Strategic Plan to End the HIV epidemic.


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 = $0 )
2026	2025	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE STE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Mental Health Research Grants	000	4	12/10/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE STE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Mental Health Research Grants	004	3	7/9/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2025	2024	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE STE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Mental Health Research Grants	002	3	2/21/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$891,010
2025	2024	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE STE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Mental Health Research Grants	003	3	3/24/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2025	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Mental Health Research Grants	001	2	2/21/2025	NON-COMPETING CONTINUATION	-$749,203
2025	2022	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Mental Health Research Grants	000	1	2/21/2025	NEW	-$141,807
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $676,347 )
2024	2024	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Mental Health Research Grants	001	3	9/10/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$676,347
2024	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Mental Health Research Grants	000	2	9/10/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $676,347

Issue Date FY: 2023 ( Subtotal = $749,203 )
2023	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Mental Health Research Grants	000	2	7/7/2023	NON-COMPETING CONTINUATION	$749,203
2023	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Mental Health Research Grants	001	2	8/18/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $749,203

Issue Date FY: 2022 ( Subtotal = $818,862 )
2022	2022	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Mental Health Research Grants	000	1	8/19/2022	NEW	$818,862
														Subtotal = $818,862

Grand Total All Awards = $2,244,412

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Strategies to Prevent HIV Acquisition for At-Risk Men in the US

Award Number: R01MH129175

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/15/2024

PERIOD OF PERFORMANCE END DATE: 10/31/2027

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