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Stigma-Treatment Enhanced Incentivized Directly Observed Therapy for People with HIV who Inject Drugs

Award Number: R34DA053686
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2021
PERIOD OF PERFORMANCE END DATE: 07/31/2025

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Stigma-Treatment Enhanced Incentivized Directly Observed Therapy for People with HIV who Inject Drugs - PROJECT ABSTRACT People who inject drugs (PWID) are less likely to maintain viral suppression, perpetuating HIV transmission among PWID over the past two years in Massachusetts. While resource intensive intervention strategies (i.e., incentive-based interventions and directly observed therapy (DOT)) have demonstrated effectiveness for improving ART adherence in the short-term, they do not address underlying barriers to engagement in HIV care for PWID, such internalized and anticipated stigma. Acceptable, feasible, and scalable intervention strategies that combine these intervention strategies with an evidence-based cognitive behavioral therapy (CBT) intervention designed to address internalized and anticipated stigma related to substance use, as well as other related stigmas (e.g., HIV) and their sequelae (e.g., avoidance behaviors) optimized for PWID may result in sustained adherence and viral suppression over time. We hypothesize that combining an app-based video-delivered optimized stigma-focused CBT intervention coupled with app-based video-delivered short-term incentivized DOT will have longer lasting effects than short-term incentivized DOT alone. To test this hypothesis, data on the feasibility, acceptability, and scalability of a combined intervention, optimized for PWID, is needed. In this R34 we will leverage the multiphase optimization strategy (MOST) to facilitate the optimization of an evidence-based video-delivered stigma-focused CBT intervention for PWID living with HIV in Massachusetts who are not virally suppressed (aim 1). We will then utilize implementation science strategies in a Hybrid Type 1 design to simultaneously conduct a pilot randomized controlled trial (RCT) to test the feasibility and acceptability of the optimized stigma-focused CBT intervention paired with incentivized DOT compared to incentivized DOT alone, both implemented through a tailored mobile app (emocha®; n=70; aim 2), while rigorously testing the implementation strategy, including scalability (aim 3). By accomplishing these aims, we will develop and refine critical components of the intervention, including optimizing the stigma-focused CBT intervention and assessing the acceptability, feasibility, and preliminary scalability of combined intervention. This R34 will enable the development and refinement of the infrastructure for a fully powered RCT, which will be submitted as a subsequent R01 to test the effectiveness of the intervention and scalability. Throughout this R34 and the subsequent R01, we will work closely with the Massachusetts Department of Public Health, given their interest in implementing this intervention strategy and platform should it be identified as effective and scalable.


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 = -$2,054 )
2026	2023	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	000	3	1/8/2026	NON-COMPETING CONTINUATION	-$2,054
														Subtotal = -$2,054

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	000	3	3/18/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $253,407 )
2023	2023	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	000	3	7/19/2023	NON-COMPETING CONTINUATION	$253,407
														Subtotal = $253,407

Issue Date FY: 2022 ( Subtotal = $295,870 )
2022	2022	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	000	2	7/19/2022	NON-COMPETING CONTINUATION	$295,870
														Subtotal = $295,870

Issue Date FY: 2021 ( Subtotal = $228,383 )
2021	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	000	1	8/20/2021	NEW	$228,383
														Subtotal = $228,383

Grand Total All Awards = $775,606

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Stigma-Treatment Enhanced Incentivized Directly Observed Therapy for People with HIV who Inject Drugs

Award Number: R34DA053686

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2021

PERIOD OF PERFORMANCE END DATE: 07/31/2025

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