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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: Recruiting NA study, sponsored by University of Texas Southwestern Medical Center.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants without HIV who report taking PrEP (initiating or re-initiating PrEP) within the 6-month intervention period, as measured by self-report and validated by medical record and pharmacy fill data, divided by all participants without HIV.
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 |
What NCT07136363 shows while recruiting
NCT07136363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Patient Navigation (PN) is the first listed.
NCT07136363 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07136363's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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