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A relationship-focused intervention to reduce intimate partner violence and increase PrEP uptake and adherence among adolescent girls and young women in Kenya

Award Number: R01MH125671
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/19/2021
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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A relationship-focused intervention to reduce intimate partner violence and increase PrEP uptake and adherence among adolescent girls and young women in Kenya - This R01 application, led by an Early Stage Investigator, aims to test the effectiveness of a multilevel community-based intervention to increase uptake and adherence to oral pre-exposure prophylaxis (PrEP) among adolescent girls and young women in Kenya. Young women in this setting live in a context of unhealthy relationship dynamics and high risk of intimate partner violence and represent a large subpopulation who are uniquely susceptible to HIV acquisition. In addition to having higher HIV incidence, women experiencing intimate partner violence are less likely to initiate and persist with PrEP, limiting the protective benefit of this efficacious biomedical prevention intervention. Challenges to PrEP uptake and adherence occur at multiple levels of the socioecological model, including low individual self-efficacy, partner opposition, and community stigma. We propose to test a multi-level, community-based intervention designed specifically to address these challenges among adolescent girls and young women in Siaya County, Kenya. Designed by our team using participatory methods engaging local young women (R34MH114519), the intervention includes three components delivered over 6 months: an eight-session support club for participants, community sensitization targeted toward male partners, and PrEP education events for couples. Activities are designed to be integrated into youth-focused programming to ensure efficiency and sustainability. Results from a pilot cluster-randomized controlled trial conducted with 100 adolescent girls and young women at six sites indicate high feasibility and acceptability, and preliminary effectiveness: intervention arm participants had 2-fold higher PrEP uptake and adherence (p<0.05), with less frequent or severe intimate partner violence than control arm participants. The proposed study builds on these promising results and aims to evaluate the intervention in a fully powered cluster-randomized controlled trial across 22 administrative wards in Siaya County, Kenya, enrolling 72 adolescent girls and young women per ward (total N=1,584). The primary objectives (Aim 1) will be to test the effectiveness of the intervention on PrEP uptake and adherence immediately post-delivery (month 6 post-enrollment) and 6 months later (month 12). As secondary objectives we will test the intervention effect on intimate partner violence (Aim 2). A rigorous process evaluation will explore mechanisms of change, contextual factors, and implementation considerations to inform future refinement and scale-up, using programmatic data, participant questionnaires, and qualitative interviews with participants and providers (Aim 3). The proposed study builds directly on our prior intervention development work to develop the evidence base for this youth-designed, multi-level HIV prevention intervention. If effective, the intervention will be ideally positioned for sustainable integration into existing youth-focused programming to expand and support PrEP use in this important population.


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 = $1,015,891 )
2025	2025	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Mental Health Research Grants	000	4	4/2/2025	SUPPLEMENT FOR EXPANSION	$106,162
2025	2025	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Mental Health Research Grants	001	5	9/4/2025	NON-COMPETING CONTINUATION	$909,729
														Subtotal = $1,015,891

Issue Date FY: 2024 ( Subtotal = $670,476 )
2024	2024	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Mental Health Research Grants	000	4	7/26/2024	NON-COMPETING CONTINUATION	$670,476
														Subtotal = $670,476

Issue Date FY: 2023 ( Subtotal = $651,257 )
2023	2023	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Mental Health Research Grants	000	3	7/20/2023	NON-COMPETING CONTINUATION	$651,257
														Subtotal = $651,257

Issue Date FY: 2022 ( Subtotal = $656,636 )
2022	2022	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Mental Health Research Grants	001	2	7/20/2022	NON-COMPETING CONTINUATION	$656,636
2022	2021	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Mental Health Research Grants	000	1	10/22/2021	NEW	$0
														Subtotal = $656,636

Issue Date FY: 2021 ( Subtotal = $773,884 )
2021	2021	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Mental Health Research Grants	002	1	9/21/2021	NEW	$0
2021	2021	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Mental Health Research Grants	001	1	9/1/2021	NEW	$0
2021	2021	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Mental Health Research Grants	000	1	8/19/2021	NEW	$773,884
														Subtotal = $773,884

Grand Total All Awards = $3,768,144

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A relationship-focused intervention to reduce intimate partner violence and increase PrEP uptake and adherence among adolescent girls and young women in Kenya

Award Number: R01MH125671

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/19/2021

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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