Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

DynamiCare-based program to support re-entry for stimulant users at risk for HIV

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

Run by University of Texas Southwestern Medical Center · NCT07136363 · Data updated 2026-11-12

This study tests whether adding the DynamiCare mobile app plus patient navigation helps people released from justice settings who use stimulants to start HIV care (ART/PrEP) and reduce stimulant use.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorUniversity of Texas Southwestern Medical Center
Academic / other
Locations2 sites (New Haven, Connecticut and 1 other locations)
StatusRecruiting
StartedJune 1, 2026
Main results expectedApril 1, 2027
Study endsJuly 31, 2027
Registry record updatedJune 15, 2026
Trial IDNCT07136363 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) with stimulant use disorder (methamphetamine and/or cocaine) who are transitioning from a justice setting and are at risk for or living with HIV, willing to use a smartphone app.

Probably not a fit

Participants without access to a smartphone or who have unsafe medical or psychiatric conditions may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The RESTORE study will evaluate a package that combines DynamiCare, a mobile contingency management tool, with patient navigation to help individuals transitioning from jail or other justice settings. In phase R61, researchers will assess feasibility, acceptability, and preliminary effectiveness in about 40 participants, focusing on stimulant use and HIV-related outcomes. If milestones are met, the study may progress to a larger randomized phase (R33) to compare the DynamiCare-plus approach against standard supports. Participants are adults with stimulant use disorder who are at risk for or living with HIV and who are transitioning back into the community. The intervention addresses barriers such as transportation, housing, and access to HIV services by delivering behavioral incentives and support through mobile technology and navigation.

Why it matters

Potential benefit: If successful, this approach could improve uptake of ART/PrEP and reduce stimulant use among justice-involved individuals.

How similar studies have gone: Contingency management and mobile health tools have shown promise in reducing stimulant use, with some evidence of behavioral benefits, though HIV-related outcomes in justice populations remain less established.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Yale University
    New Haven, Connecticut, United States
    Recruiting
  • Parkland County Hospital
    Dallas, Texas, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.