RESTORE Study R61 Phase: Recovery and Engagement for Stimulant Users on Re-entry

Not Applicable

Not yet recruiting

• Conditions: HIV; Stimulant Use Disorder; Justice Involved Populations; HIV Prevention

• Registration Number: NCT07136363
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

Justice-involved individuals face disproportionately high rates of stimulant use disorder and HIV, along with disrupted access to HIV treatment and prevention services like ART and PrEP. Contingency management (CM) is the most effective intervention for stimulant use, but its use in justice-involved populations has been limited by logistical and structural barriers. DynamiCare is an FDA-approved mobile app that delivers behavioral CM and has shown promise in reducing stimulant use, but its impact on HIV-related outcomes remains unknown. The RESTORE study (Recovery and Engagement for Stimulant Users on Re-entry) will evaluate whether combining DynamiCare with patient navigation (DynamiCare-plus) improves PrEP/ART initiation and reduces stimulant use among individuals recently released from justice settings. The R61 phase will assess feasibility, acceptability, and preliminary effectiveness among 40 participants. If milestones are met, the R33 phase will scale to a randomized controlled trial with 252 participants to assess effectiveness, implementation, and cost. This scalable, mobile approach has the potential to address a critical gap in care for a highly vulnerable population.

Detailed Description

Stimulant use (cocaine/ methamphetamine) has a major impact on HIV transmission and acquisition. Justice-involved individuals are more likely to have stimulant use disorders and be at risk or living with HIV than the general population, face interruptions in HIV treatment (antiretroviral therapy (ART)) and have limited access to HIV pre-exposure prophylaxis (PrEP). There is thus a critical need for effective interventions that reduce stimulant use and potentially improve HIV viral suppression (VS) and PrEP initiation and retention, particularly among justice-involved groups. The most successful treatment for stimulant use disorder to date is contingency management (CM), shown to reduce stimulant use and HIV risk behaviors, though implementation has been limited for justice-involved people due to competing priorities (transportation, housing, probation) and practical challenges of providing CM (frequent drug testing, trained staff, incentive management). DynamiCare is an FDA-approved mobile app that delivers patient-centered behavioral CM and has been shown to reduce biological and self-reported assessments of stimulant and other substance use, however it is unknown if it could improve PrEP/ART initiation for persons with stimulant use disorder at risk or living with HIV. Thus, in response to NIDA RFA-DA-23-008 \[Request for Applications (RFA) from the National Institute on Drug Abuse (NIDA)\]: Stimulants and HIV, we propose the RESTORE study: Recovery and Engagement for Stimulant Users on Re-entry. Guided by the Exploration Preparation Implementation Sustainment (EPIS) framework, we will assess if the addition of personalized CM via the DynamiCare app to a previously protocolized patient navigator (PN) ("DynamiCare-plus") intervention improves initiation of PrEP/ART and reduces stimulant use. The Specific Aims are: Aim 1 (R61): To conduct a pilot assessment of DynamiCare-plus for persons at risk or living with HIV with DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) stimulant use disorders (methamphetamine/cocaine) being released to the community from a closed justice setting (jail/ prison/ justice-mandated substance use program). N=40 adults in Dallas, TX (Texas) and CT (Connecticut) will be randomized 1:1 to DynamiCare-plus compared to enhanced treatment as usual (ETAU) (PN + smartphone) for 6 months to assess acceptability, feasibility and preliminary effectiveness: proportion who (1) initiate PrEP/ART; and (2) achieve/maintain VS (VL \< 200 copies/mL) for those with HIV; Aim 2 (R33): The R61 pilot will inform a type 1 hybrid implementation effectiveness randomized controlled trial of DynamiCare-plus v. ETAU among 252 participants with the same eligibility as the R61 to assess the primary outcome of initiation/reinitiation of PrEP/ART followed for 15 months, with a 12 month intervention period. Secondary outcomes include stimulant and other substance use, overdose, PrEP/ART/SUD (Substance Use Disorder) retention, HIV risk behaviors, VS, Quality of life, and recidivism; Aim 2.1: Examine implementation of the intervention. Aim 2.2: Conduct cost analyses of the intervention compared to control. The Dynamicare app is mobile, adaptable and scalable, and combined with PN (DynamiCare-plus) has the potential to have a major impact on HIV treatment and prevention for justice-involved people with stimulant use disorder.

Study Timeline

• Study First Submitted: 2025-07-09
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Study Start: 2025-11-01
• Primary Completion: 2026-05-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Be 18 years of age or older
• Have a DSM-5 diagnosis of stimulant use disorder (methamphetamine and/or cocaine)
• Be at risk for or living with HIV
• Be transitioning to the community from a closed justice setting, such as:

Jail Prison Justice-mandated residential substance use program

• Be able to provide informed consent
• Be willing and able to use a smartphone app (DynamiCare)

Exclusion Criteria

• Severe medical or psychiatric disability making participation unsafe
• Unable to provide consent or engage with the intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of participants without HIV taking HIV pre-exposure prophylaxis (PrEP) by validated self-report within 6-month intervention period	6 months	Number of participants without HIV who report taking PrEP (initiating or re-initiating PrEP) within the 6-month intervention period, as measured by self-report and validated by medical record and pharmacy fill data, divided by all participants without HIV.
Proportion of participants with HIV taking Antiretroviral therapy (ART) by validated self-report within 6-month intervention period	6 months	Number of participants with HIV taking ART (initiating or re-initiating ART) within the 6-month intervention period, as measured by self-report and validated by medical record and pharmacy fill data, divided by all participants with HIV.
Proportion of participants with HIV who achieve HIV viral suppression (VS) by blood assay at month 6 of the intervention.	6 months	Number of participants with HIV who achieve (at month 6) an HIV viral load of \< 200 copies/mL as measured by real-time PCR (Polymerase Chain Reaction) blood test, divided by all participants with HIV.

Trial Locations

Locations (2)

Yale University; 🇺🇸 New Haven, Connecticut, United States

Parkland County Hospital; 🇺🇸 Dallas, Texas, United States