NCT07136363 RESTORE Study R61 Phase: Recovery and Engagement for Stimulant Users on Re-entry
| NCT ID | NCT07136363 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-06-01 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Ank Nijhawan, MD
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT07136363 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07136363 currently recruiting?
Yes, NCT07136363 is actively recruiting participants. Contact the research team at Ank.Nijhawan@UTSouthwestern.edu for enrollment information.
Where is the NCT07136363 trial being conducted?
This trial is being conducted at New Haven, United States, Dallas, United States.
Who is sponsoring the NCT07136363 clinical trial?
NCT07136363 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Ank Nijhawan, MD at University of Texas Southwestern Medical Center. The trial plans to enroll 40 participants.
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