NCT07136363 · University of Texas Southwestern Medical Center
RESTORE Study R61 Phase: Recovery and Engagement for Stimulant Users on Re-entry
(RESTORE)
What this study 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.
View original scientific description
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
DEVICE
DynamiCare
DynamiCare is a mobile contingency management (CM) platform. Participants randomized to this intervention receive access to the DynamiCare app, an FDA-approved mobile application that delivers CM through features such as at-home saliva drug testing, appointment check-ins, and incentives for healthy behaviors. The app is designed to promote substance use reduction and engagement in care by providing financial rewards for meeting health-related goals. The intervention aims to improve initiation and retention in HIV prevention or treatment (PrEP or ART), reduce stimulant use, and enhance overall health outcomes among justice-involved individuals.
BEHAVIORAL
Patient Navigation (PN)
Participants work with a trained patient navigator (PN) who provides individualized support, assists with linkage to medical and social services, and helps address barriers to care. The PN meets with participants weekly during the first month and biweekly thereafter to conduct a comprehensive needs assessment and provide tailored support. This includes assistance with obtaining housing, identification, insurance, transportation, and linkage to health and social services such as HIV prevention or treatment (PrEP/ART), substance use disorder treatment, and other community-based care. The navigation protocol follows established procedures from prior studies (e.g., ACTION). All participants receive a smartphone to support communication and appointment coordination.
Primary outcome measures
Proportion of participants without HIV taking HIV pre-exposure prophylaxis (PrEP) by validated self-report within 6-month intervention period
Time frame: 6 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 period
Time frame: 6 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.
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New Haven, Connecticut
- Dallas, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations