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Development and Pilot RCT of a ‘Healthy Welcome’ Intervention to Increase PrEP Uptake and Adherence

Award Number: K23MH134771
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 07/15/2024
PERIOD OF PERFORMANCE END DATE: 06/30/2029

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Development and Pilot RCT of a ‘Healthy Welcome’ Intervention to Increase PrEP Uptake and Adherence - Background: RSA has one of the highest rates of human mobility on the continent, and mobile men are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) is effective at preventing HIV. Mobile men face barriers to PrEP use, including lack of PrEP knowledge, stigma at clinics, and unfamiliarity about health services in new settings. To decrease the incidence of HIV, new interventions are needed to promote PrEP use. The goal of this proposal is to develop and pilot test a “Healthy Welcome” intervention to support mobile men in starting and adhering to PrEP by linking them to community pharmacies. Candidate: I am an Internal Medicine physician and an Associate Scientist at Brigham and Women’s Hospital (Harvard Medical School). I am applying for a five-year K23 Career Development Award to obtain the training and research experience that will allow me to become an independent investigator at the R01 level and an expert in developing interventions to promote engagement in HIV services. Mentoring: Drs. Ingrid Katz and Jessica Haberer will serve as my co-primary mentors. Dr. Katz brings expertise in behavioral components of intervention development and strategies to track hard-to-reach populations. Dr. Haberer brings expertise in PrEP clinical trials, including implementation science, the concept of “Prevention-Effective” (P-E) adherence to PrEP, and mobile health strategies. Co-mentor Prof. Terris-Prestholt will provide mentorship on discrete choice experiment (DCE) methodology. Profs. Pascoe and Setswe, RSA-based co-mentors, will provide mentorship on local application of DCE methods and behavioral economics (BE) strategies for intervention development (Pascoe) and community engagement and local implementation (Setswe). Profs. Miot and Venter, RSA-based members of my Scientific Advisory Board (SAB), will offer guidance on integrating my proposed study within an existing Gates-funded project to offer PrEP through community pharmacies and on policy implications of study findings. SAB member Prof. Lurie will offer guidance on engaging mobile men. SAB member Prof. Thirumurthy will guide me on BE theoretical frameworks. SAB member Smeaton will provide statistical expertise to guide the pilot randomized controlled trial (RCT). Training: Training in DCE methodology, BE strategies, and pilot RCTs for PrEP will be achieved through intensive direct mentorship and coursework. Research: The specific aims are to 1) elicit preferences for PrEP services among mobile men through a DCE; 2) design a “Healthy Welcome” intervention for mobile men to promote linkage to pharmacies for PrEP uptake and adherence; and 3) evaluate the feasibility, acceptability, appropriateness, and fidelity of the intervention through a pilot RCT. I will use this formative research to apply for an R01-level grant to evaluate the efficacy and effectiveness of the intervention.


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 = $197,022 )
2025	2025	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Mental Health Research Grants	001	2	9/19/2025	SUPPLEMENT FOR EXPANSION	$31,208
2025	2025	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Mental Health Research Grants	000	2	9/15/2025	NON-COMPETING CONTINUATION	$165,814
														Subtotal = $197,022

Issue Date FY: 2024 ( Subtotal = $201,006 )
2024	2024	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Mental Health Research Grants	000	1	7/12/2024	NEW	$201,006
														Subtotal = $201,006

Grand Total All Awards = $398,028

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Development and Pilot RCT of a ‘Healthy Welcome’ Intervention to Increase PrEP Uptake and Adherence

Award Number: K23MH134771

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 07/15/2024

PERIOD OF PERFORMANCE END DATE: 06/30/2029

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