RESTORE Study R61 Phase: Recovery and Engagement for Stimulant Users on Re-entry
Recruiting · NCT07136363 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Texas Southwestern Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed across 2 US states.
- Yale University - New Haven, Connecticut, United States
- Parkland County Hospital - Dallas, Texas, United States