RESTORE Study: Recovery and Engagement for Stimulant Users on Re-entry
The RESTORE study is looking at ways to help people who have been involved with the justice system and have stimulant use disorder (like using methamphetamine or cocaine) and HIV, or are at risk for HIV. This study tests two interventions: DynamiCare, a mobile app that offers incentives for healthy behaviors, and Patient Navigation (PN), where you work with a trained person to get support and connect with services. The goal is to see if combining these two approaches can help people start or continue taking HIV prevention medicine (PrEP) or HIV treatment (ART), and reduce stimulant use. We want to enroll 40 participants, but the current recruitment status is unclear. To join, you must be 18 or older, have a stimulant use disorder, be at risk for or living with HIV, be transitioning from a justice setting, and be able to use a smartphone app.
- Study design
- This is an interventional study with a planned enrollment of 40 participants. The study will compare DynamiCare (a device) with Patient Navigation (a behavioral intervention).
- What's involved
- Participants will use the DynamiCare app and/or work with a patient navigator. The patient navigator will meet with participants weekly during the first month and biweekly afterward.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main outcomes of the study will be measured at 6 months after starting the intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
RESTORE Study R61 Phase: Recovery and Engagement for Stimulant Users on Re-entry
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Ank Nijhawan, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
- Sandra Springer, MD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Proportion of participants without HIV taking HIV pre-exposure prophylaxis (PrEP) by validated self-report within 6-month intervention period6 months
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.
- Proportion of participants with HIV taking Antiretroviral therapy (ART) by validated self-report within 6-month intervention period6 months
Number of participants with HIV taking ART (initiating or re-initiating ART) within the 6-month intervention period, as measured by self-report and validated by medical record and pharmacy fill data, divided by all participants with HIV.
- Proportion of participants with HIV who achieve HIV viral suppression (VS) by blood assay at month 6 of the intervention.6 months
Number of participants with HIV who achieve (at month 6) an HIV viral load of \< 200 copies/mL as measured by real-time PCR (Polymerase Chain Reaction) blood test, divided by all participants with HIV.