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

NCT07136363 | Not Yet Recruiting FDA Device

• 1 other identifier: STU20251062
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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 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.

Conditions

HIV; Stimulant Use Disorder; Justice Involved Populations; HIV Prevention

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Arm 1: DynamiCare-plus

EXPERIMENTAL

Patient Navigation (PN) with a smartphone with the DynamiCare mobile contingency management app

Device: DynamiCare; Behavioral: Patient Navigation (PN)

Arm 2: Enhanced Treatment as Usual (ETAU)

ACTIVE COMPARATOR

Patient Navigation (PN) with a smartphone without the DynamiCare app

Behavioral: Patient Navigation (PN)

Interventions

DynamiCare DEVICE

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.

Arm 1: DynamiCare-plus

Patient Navigation (PN) BEHAVIORAL

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.

Arm 1: DynamiCare-plus; Arm 2: Enhanced Treatment as Usual (ETAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

Yale University

New Haven, Connecticut, 06520, United States

Location

Parkland County Hospital

Dallas, Texas, 75235, United States

Location

MeSH Terms

Interventions

Patient Navigation

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Ank Nijhawan, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Sandra Springer, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ank Nijhawan, MD

CONTACT

2146482777; Ank.Nijhawan@UTSouthwestern.edu

Laura Hansen, MA

CONTACT

7133057882

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 22, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)