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

RecruitingNAAges 18 Years - anyAllUniversity of Texas Southwestern Medical Center
NCT07136363 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 effectivenes

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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
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What it tests

  • DynamiCare
  • Patient Navigation (PN)
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Where

2 sites
Yale University
New Haven, United States
Parkland County Hospital
Dallas, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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