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NCT07136363 · ClinicalTrials.gov registry record · NA
RESTORE Study R61 Phase: Recovery and Engagement for Stimulant Users on Re-entry
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT07136363 is a NA study that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 40 participants.
The verdict
NCT07136363, a NA study, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Patient Navigation (PN)
- DEVICE DynamiCare
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2027-07-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07136363
The ClinicalTrials.gov registry entry for NCT07136363 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Patient Navigation (PN) is the first listed.
NCT07136363 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07136363 about?
NCT07136363 is a clinical study titled "RESTORE Study R61 Phase: Recovery and Engagement for Stimulant Users on Re-entry". 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...
What is the current status of trial NCT07136363?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2026-06-01. Estimated completion is 2027-07-31.
What interventions are being tested in trial NCT07136363?
The interventions under investigation include: Patient Navigation (PN) (BEHAVIORAL), DynamiCare (DEVICE).
Who is sponsoring clinical trial NCT07136363?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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