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Supporting Treatment Adherence for Resilience and Thriving (START): A mHealth intervention to improve ART adherence for HIV-positive stimulant-using men

Award Number: R01DA049843
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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There is a strong resurgence of methamphetamine and other stimulant use in the United States (US). HIV- positive stimulant-using men who have sex with men (HIV+ SUMSM) may have greater difficulties navigating the HIV care continuum as well as display substantially elevated viral load (VL), amplified HIV transmission risk, and faster clinical HIV progression. While behavioral interventions show promise for achieving durable reductions in unsuppressed VL over time among HIV+ SUMSM, those residing outside of urban centers experience difficulties accessing services for HIV and substance use. For these reasons we propose a two-arm RCT of a 6-month mHealth intervention for HIV+ SUMSM, called Supporting Treatment Adherence for Resilience and Thriving (START). We will test the efficacy of START to improve VL suppression at 6 months (primary outcome) and determine whether any gains are maintained at month 12 (secondary outcome). START integrates two theoretically-grounded, evidence-based interventions (APP+ and ARTEMIS) with the goal of optimizing the effectiveness of treatment as prevention (TasP). HIV+ SUMSM (n=350) will be recruited and randomized to START or control to assess the following aims: Aim 1a. Test the efficacy of START for achieving a higher proportion of SUMSM who are virally suppressed at 6 months (primary outcome) compared to a website with referrals to HIV treatment information and substance use treatment resources (control condition). Aim 1b. Test the efficacy of START for maintaining viral suppression gains at 12 months, decreasing stimulant use and sexual risk, and increasing theory-based psychological processes (e.g., behavioral skills, positive affect). Aim 2. To assess the cost and cost-effectiveness of START, relative to the control condition, in achieving and/or maintaining viral suppression, including net savings with respect to averted healthcare utilization. During Phase I, we will integrate APP+ and ARTEMIS into a single START intervention platform using an iterative integration process that includes feedback through online focus groups with SUMSM. Phase I will conclude with usability testing among 10 HIV+ SUMSM to ensure a smooth transition to Phase II where we will conduct an RCT to test the efficacy of START. We will use home-based dried blood spot (DBS) collection to assess lab-quantified VL. All men will receive their respective condition for 6 months, with quarterly assessments until month 12. DBS specimens to measure VL will be collected at baseline, 6 and 12 months. The cost analysis will be framed from the provider perspective to estimate “real world” costs of providing START to give stakeholders a sense of feasibility for broader implementation, given existing resources and reimbursement mechanisms. The proposed project is highly significant since optimizing TasP with HIV+ SUMSM is among the highest NIH and National HIV/AIDS Strategy priorities. START is innovative because it is scalable to reach a broader population of HIV+ SUMSM and may be adapted to clinic- and community-based settings.


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: 2024 ( Subtotal = $0 )
2024	2023	FLORIDA INTERNATIONAL UNIVERSITY	11200 SW 8TH ST	MIAMI	FL	33199	MIAMI-DADE	USA	Drug Abuse and Addiction Research Programs	002	5	2/7/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$255,277
2024	2022	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Drug Abuse and Addiction Research Programs	001	4	2/7/2024	SUPPLEMENT FOR EXPANSION	-$24,000
2024	2022	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Drug Abuse and Addiction Research Programs	000	4	2/7/2024	NON-COMPETING CONTINUATION	-$231,277
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $762,759 )
2023	2023	FLORIDA INTERNATIONAL UNIVERSITY	11200 SW 8TH ST	MIAMI	FL	33199	MIAMI-DADE	USA	Drug Abuse and Addiction Research Programs	001	5	8/15/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$653,211
2023	2023	FLORIDA INTERNATIONAL UNIVERSITY	11200 SW 8TH ST	MIAMI	FL	33199	MIAMI-DADE	USA	Drug Abuse and Addiction Research Programs	002	5	8/28/2023	SUPPLEMENT FOR EXPANSION	$109,548
2023	2023	FLORIDA INTERNATIONAL UNIVERSITY	11200 SW 8TH ST	MIAMI	FL	33199	MIAMI-DADE	USA	Drug Abuse and Addiction Research Programs	003	5	9/28/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2023	2022	UNIVERSITY OF MIAMI	1400 NW 10TH AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Drug Abuse and Addiction Research Programs	000	4	8/15/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $762,759

Issue Date FY: 2022 ( Subtotal = $690,627 )
2022	2022	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Drug Abuse and Addiction Research Programs	001	4	8/1/2022	SUPPLEMENT FOR EXPANSION	$64,930
2022	2022	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Drug Abuse and Addiction Research Programs	000	4	7/28/2022	NON-COMPETING CONTINUATION	$625,697
														Subtotal = $690,627

Issue Date FY: 2021 ( Subtotal = $864,452 )
2021	2021	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Drug Abuse and Addiction Research Programs	001	3	7/20/2021	SUPPLEMENT FOR EXPANSION	$64,930
2021	2021	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Drug Abuse and Addiction Research Programs	000	3	7/16/2021	NON-COMPETING CONTINUATION	$799,522
														Subtotal = $864,452

Issue Date FY: 2020 ( Subtotal = $868,014 )
2020	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Drug Abuse and Addiction Research Programs	000	1	5/4/2020	SUPPLEMENT FOR EXPANSION	$152,977
2020	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Drug Abuse and Addiction Research Programs	002	2	7/17/2020	SUPPLEMENT FOR EXPANSION	$64,930
2020	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Drug Abuse and Addiction Research Programs	001	2	7/16/2020	NON-COMPETING CONTINUATION	$650,107
														Subtotal = $868,014

Issue Date FY: 2019 ( Subtotal = $718,290 )
2019	2019	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Drug Abuse and Addiction Research Programs	000	1	9/19/2019	NEW	$718,290
														Subtotal = $718,290

Grand Total All Awards = $3,904,142

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Supporting Treatment Adherence for Resilience and Thriving (START): A mHealth intervention to improve ART adherence for HIV-positive stimulant-using men

Award Number: R01DA049843

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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