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.

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NCT07136363

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

Recruiting
NAAges 18+InterventionalTreatment
University of Texas Southwestern Medical Center
~40 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:DynamiCarePatient Navigation (PN)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants without HIV taking HIV pre-exposure prophylaxis (PrEP) by validated self-report within 6-month intervention period
Measured over 6 months
+2 more outcomes measured
HIV
Stimulant Use Disorder
Justice Involved Populations
HIV Prevention
2 sites across 2 states
Connecticut1
Texas1
  • Ank Nijhawan, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
  • Sandra Springer, MD · PRINCIPAL_INVESTIGATOR · Yale University

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Eligibility criteria

Inclusion

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:
Be able to provide informed consent
Be willing and able to use a smartphone app (DynamiCare)

Exclusion

Severe medical or psychiatric disability making participation unsafe
Unable to provide consent or engage with the intervention
  • 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.