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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Jun 1, 2026

Status verified

Feb 2026

Primary completion

Apr 1, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Proportion of participants without HIV taking HIV pre-exposure prophylaxis (PrEP) by validated self-report within 6-month intervention period [ Time Frame: 6 months ]

Central Contacts

• Ank Nijhawan, MD
  2146482777
  [email protected]
• Laura Hansen, MA
  7133057882

Locations (2)

Find similar trials in New Haven, CT

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