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RESTORE Study R61 Pilot Phase: Recovery and Engagement for Stimulant Users on Re-entry

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Connecticut
Yale University
RECRUITING
New Haven
Texas
Parkland County Hospital
RECRUITING
Dallas
Contact Information
Primary
Ank Nijhawan, MD
Ank.Nijhawan@UTSouthwestern.edu
2146482777
Backup
Laura Hansen, MA
7133057882
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 40
Treatments
Experimental: Arm 1: DynamiCare-plus
Patient Navigation (PN) with a smartphone with the DynamiCare mobile contingency management app
Active_comparator: Arm 2: Enhanced Treatment as Usual (ETAU)
Patient Navigation (PN) with a smartphone without the DynamiCare app
Related Therapeutic Areas
Sponsors
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov