Recruiting

DynamiCare-plus

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07136363

Conditions

HIV

Stimulant Use Disorder

Justice Involved Populations

HIV Prevention

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DynamiCare

Patient Navigation (PN)

Study Details

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

Study ID

NCT07136363

Start date

Jun 1, 2026

Status verified date

Jun, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

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 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 ]
  • Proportion of participants with HIV taking Antiretroviral therapy (ART) by validated self-report within 6-month intervention period [ Time Frame: 6 months ]
  • Proportion of participants with HIV who achieve HIV viral suppression (VS) by blood assay at month 6 of the intervention. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Ank Nijhawan, MD

2146482777Ank.Nijhawan@UTSouthwestern.edu

Laura Hansen, MA

7133057882

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Sandra Springer, MD

2036876680Sandra.Springer@Yale.edu

Principal Investigator:

Sandra Springer, MD

Parkland County Hospital

Recruiting

Dallas, Texas, United States, 75235

Contacts

Ank Nijhawan, MD

2146482777Ank.Nijhawan@UTSouthwestern.edu

Laura Hansen, MA

7133057882laura.hansen@utsouthwestern.edu

Principal Investigator:

Ank Nijhawan, MD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-06-15.