Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT07136363 (RESTORE) for HIV, Stimulant Use Disorder, Justice Involved Populations, HIV Prevention is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Back to Search
University of Texas Southwestern Medical CenterRESTORE Study R61 Phase: Recovery and Engagement for Stimulant Users on Re-entry 40 Randomized Mobile App Prevention
Clinical Trial NCT07136363 (RESTORE) is an interventional study for HIV, Stimulant Use Disorder, Justice Involved Populations, HIV Prevention and is currently not yet recruiting. Enrollment is planned to begin on 6 April 2026 and continue until the study accrues 40 participants. Led by University of Texas Southwestern Medical Center, this study is expected to complete by 5 January 2027. The latest data from ClinicalTrials.gov was last updated on 11 February 2026.
Brief 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 deliv...Show More
Detailed Description
Stimulant use (cocaine/ methamphetamine) has a major impact on HIV transmission and acquisition. Justice-involved individuals are more likely to have stimulant use disorders and be at risk or living with HIV than the general population, face interruptions in HIV treatment (antiretroviral therapy (ART)) and have limited access to HIV pre-exposure prophylaxis (PrEP). There is thus a critical need for effective interven...Show More
Official Title
RESTORE Study R61 Pilot Phase: Recovery and Engagement for Stimulant Users on Re-entry
Conditions
HIVStimulant Use DisorderJustice Involved PopulationsHIV PreventionOther Study IDs
- RESTORE
- STU20251062
NCT ID Number
Start Date (Actual)
2026-04-06
Last Update Posted
2026-02-11
Completion Date (Estimated)
2027-01-05
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalArm 1: DynamiCare-plus Patient Navigation (PN) with a smartphone with the DynamiCare mobile contingency management app | 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 ...Show More 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, tra...Show More |
Active ComparatorArm 2: Enhanced Treatment as Usual (ETAU) Patient Navigation (PN) with a smartphone without the DynamiCare app | 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, tra...Show More |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Proportion of participants without HIV taking HIV pre-exposure prophylaxis (PrEP) by validated self-report within 6-month intervention period | 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. | 6 months |
Proportion of participants with HIV taking Antiretroviral therapy (ART) by validated self-report within 6-month intervention period | 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. | 6 months |
Proportion of participants with HIV who achieve HIV viral suppression (VS) by blood assay at month 6 of the intervention. | 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. | 6 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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)
- Severe medical or psychiatric disability making participation unsafe
- Unable to provide consent or engage with the intervention
University of Texas Southwestern Medical CenterStudy Responsible Party
Ank Nijhawan, Principal Investigator, Professor, University of Texas Southwestern Medical Center
Study Central Contact
Contact: Ank Nijhawan, MD, 2146482777, [email protected]
Contact: Laura Hansen, MA, 7133057882
2 Study Locations in 1 Countries
Connecticut
Yale University, New Haven, Connecticut, 06520, United States
Sandra Springer, MD, Contact, 2036876680, [email protected]
Sandra Springer, MD, Principal Investigator
Texas
Parkland County Hospital, Dallas, Texas, 75235, United States
Ank Nijhawan, MD, Contact, 2146482777, [email protected]
Laura Hansen, MA, Contact, 7133057882, [email protected]
Ank Nijhawan, MD, Principal Investigator