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reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)

Award Number: R01DA055563
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2022
PERIOD OF PERFORMANCE END DATE: 07/31/2028

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reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA) - In 2019, there were approximately 1.2 million people living with HIV in the United States. Stimulant use is a major barrier to achieving viral load control, necessary for reducing HIV transmission and improving long term health outcomes. Additionally, having HIV and substance use disorder diagnoses exacerbate the barriers to accessing and completing in-person drug treatment services. reSET is the first FDA approved prescription digital therapeutic designed to treat substance use disorders in adults. In patients with a primary diagnosis of stimulant use disorder, reSET has been found efficacious in reducing stimulant use, both for patients who are already in substance use treatment and as a standalone substance use treatment for incarcerated persons. However, reSET has not been tested in any medical settings, including HIV care settings, as an all-virtual standalone stimulant use disorder treatment for patients living with HIV. To effectively mitigate the HIV epidemic among persons living with HIV, we propose a two-arm RCT of an all-virtual 12-week stimulant disorder treatment for persons living with HIV who are on antiretroviral therapy (ART). The study will randomize 426 participants who are patients of participating HIV healthcare centers in US metro areas with the highest rates of HIV cases with stimulant use. The participants will be randomized to one of two conditions: (1) referral to outpatient substance use disorder treatment (treatment as usual/ control condition) or (2) reSET (experimental condition) to: (Aim 1a, primary outcome) Investigate the effectiveness of reSET in achieving lower stimulant use and (Aim 1b, secondary outcome) higher proportion of viral suppression at 3-, 9 and 15-months compared to treatment as usual; (Aim 2) Test for differentiators of reSET’s effectiveness on stimulant use and viral load suppression; and (Aim 3) In the context of the RE-AIM framework, evaluate the reach, effectiveness, adoption, implementation (including cost-effectiveness), and maintenance of reSET. If effective, reSET implemented in conjunction with antiretroviral therapy among people living with HIV and stimulant use disorder, could present a major scalable advancement in improving HIV treatment as prevention.


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	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Drug Use and Addiction Research Programs	000	3	12/5/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $1,056,408 )
2025	2025	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Drug Use and Addiction Research Programs	000	3	8/7/2025	NON-COMPETING CONTINUATION	$1,056,408
														Subtotal = $1,056,408

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Drug Use and Addiction Research Programs	001	2	8/7/2024	NON-COMPETING CONTINUATION	$0
2024	2023	UNIVERSITY OF MIAMI	1400 NW 10TH AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Drug Use and Addiction Research Programs	000	2	10/24/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $990,189 )
2023	2023	UNIVERSITY OF MIAMI	1400 NW 10TH AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Drug Use and Addiction Research Programs	000	2	8/1/2023	NON-COMPETING CONTINUATION	$990,189
														Subtotal = $990,189

Issue Date FY: 2022 ( Subtotal = $932,305 )
2022	2022	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Drug Use and Addiction Research Programs	000	1	8/24/2022	NEW	$932,305
														Subtotal = $932,305

Grand Total All Awards = $2,978,902

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reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)

Award Number: R01DA055563

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2022

PERIOD OF PERFORMANCE END DATE: 07/31/2028

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