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

Recruiting now · Not applicable

Conditions studied: HIV, Stimulant Use Disorder, Justice Involved Populations, HIV Prevention

In brief

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.

Key facts

Study ID

NCT07136363

Run by

University of Texas Southwestern Medical Center

People needed

40

Starts

2026-06-01

Expected to finish

2027-07-31

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

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

Where it is running

• Yale University — New Haven, Connecticut, United States (enrolling)
• Parkland County Hospital — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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