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Peer Behavioral Activation Utilization to Improve Substance Use and HIV Outcomes in People Receiving Long Acting Injectable-PrEP/ART (PUSH).”

Award Number: R01DA061324
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2024
PERIOD OF PERFORMANCE END DATE: 05/31/2029

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Peer Behavioral Activation Utilization to Improve Substance Use and HIV Outcomes in People Receiving Long Acting Injectable-PrEP/ART (PUSH).” - Background. Substance use continues to be a major driver of HIV acquisition and has been associated with suboptimal ART adherence, treatment interruption, and inability to achieve or maintain viral suppression. Though PrEP is a key tool for HIV prevention, awareness, uptake, and adherence are disproportionately lower among people who use drugs. New long-acting injectable (LAI) formulations of PrEP/ART provide a potential biomedical intervention to overcome adherence challenges, however, due to the prolonged subtherapeutic period after LAI discontinuation, ensuring adherence is crucial. A peer-delivered reinforcement-based intervention may be a promising solution for improving LAI adherence. Our team has developed, through several rounds of stakeholder feedback, a peer-delivered behavioral activation and problem-solving intervention, Peer Activate. Peer Activate focuses on problem-solving skills to improve adherence to ART and/or PrEP at multiple levels and includes behavioral activation to promote engagement in rewarding, substance-free activities in one’s environment and structured daily activities to promote treatment adherence. However, Peer Activate has not been evaluated in the context of LAI PrEP/ART. Preliminary Studies. This proposal builds upon our team’s prior studies demonstrating 1) our ability to engage patients with and at risk for HIV and provide LAI PrEP/ART in community-based settings; 2) the feasibility and acceptability of Peer Activate and promise in improving HIV treatment adherence for people who use substances; and 3) promise for cost-effectiveness. Approach. We propose a randomized Type 1 hybrid effectiveness-implementation trial (N=186) to test the effectiveness and implementation of Peer Activate for LAI PrEP/ART (“Peer Activate-LAI”) vs. enhanced treatment as usual for a substance using population living with or at high risk for HIV, evaluating the following over 12 months: (1) Effectiveness: a) LAI PrEP/ART adherence (primary; receipt of all 6 maintenance injections within 7-day window); b) substance use (secondary; urine toxicology, self-report); c) moderators of effectiveness (exploratory); (2) Implementation of Peer Activate-LAI including feasibility, acceptability, fidelity, and adoption guided by RE-AIM and Proctor’s model, assessed using mixed methods, including a rapid ethnographic assessment of how life course factors may affect implementation; and (3) Economic viability of Peer Activate- LAI, including cost of implementation and sustainment and cost-effectiveness from multiple stakeholder perspectives. Implications. This study will inform a potentially scalable, cost-effective model for facilitating effective adherence to LAI formulations of ART/PrEP within substance using populations who to date have had limited support for improving LAI adherence for HIV ART/PrEP.


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 = $598,161 )
2026	2026	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	000	3	5/29/2026	NON-COMPETING CONTINUATION	$598,161
														Subtotal = $598,161

Issue Date FY: 2025 ( Subtotal = $605,950 )
2025	2025	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	003	2	7/23/2025	NON-COMPETING CONTINUATION	$605,950
2025	2025	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	004	2	9/25/2025	NON-COMPETING CONTINUATION	$0
2025	2024	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	001	1	6/2/2025	TERMINATION	$0
2025	2024	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	000	1	10/10/2024	NEW	$0
2025	2024	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	002	1	7/8/2025	OTHER REVISION	$0
														Subtotal = $605,950

Issue Date FY: 2024 ( Subtotal = $644,233 )
2024	2024	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	000	1	7/31/2024	NEW	$644,233
														Subtotal = $644,233

Grand Total All Awards = $1,848,344

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Peer Behavioral Activation Utilization to Improve Substance Use and HIV Outcomes in People Receiving Long Acting Injectable-PrEP/ART (PUSH).”

Award Number: R01DA061324

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/01/2024

PERIOD OF PERFORMANCE END DATE: 05/31/2029

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