HIVRESTORENCT07136363
RESTORE Study R61 Phase: Recovery and Engagement for Stimulant Users on Re-entry
A study testing DynamiCare and Patient Navigation (PN) in people with HIV and Stimulant Use Disorder, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Stimulant Use Disorder, Justice Involved Populations
- What is being tested?
- DynamiCare and Patient Navigation (PN)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Severe medical or psychiatric disability making participation unsafe
- Unable to provide consent or engage with the intervention
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Laura Hansen, MA contact
United States2 sites, 2 recruiting
- Recruiting
Parkland County Hospital
Dallas, Texas, 75235
Ank Nijhawan, MD, 2146482777, Ank.Nijhawan@UTSouthwestern.edu
Laura Hansen, MA, 7133057882, laura.hansen@utsouthwestern.edu
- Recruiting
Yale University
New Haven, Connecticut, 06520
Sandra Springer, MD, 2036876680, Sandra.Springer@Yale.edu
Sandra Springer, MD
About this study
Official title: RESTORE Study R61 Pilot Phase: Recovery and Engagement for Stimulant Users on Re-entry
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.
Read the 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 interventions that reduce stimulant use and potentially improve HIV viral suppression (VS) and PrEP initiation and retention, particularly among justice-involved groups. The most successful treatment for stimulant use disorder to date is contingency management (CM), shown to reduce stimulant use and HIV risk behaviors, though implementation has been limited for justice-involved people due to competing priorities (transportation, housing, probation) and practical challenges of providing CM (frequent drug testing, trained staff, incentive management). DynamiCare is an FDA-approved mobile app that delivers patient-centered behavioral CM and has been shown to reduce biological and self-reported assessments of stimulant and other substance use, however it is unknown if it could improve PrEP/ART initiation for persons with stimulant use disorder at risk or living with HIV. Thus, in response to NIDA RFA-DA-23-008 [Request for Applications (RFA) from the National Institute on Drug Abuse (NIDA)]: Stimulants and HIV, we propose the RESTORE study: Recovery and Engagement for Stimulant Users on Re-entry. Guided by the Exploration Preparation Implementation Sustainment (EPIS) framework, we will assess if the addition of personalized CM via the DynamiCare app to a previously protocolized patient navigator (PN) ("DynamiCare-plus") intervention improves initiation of PrEP/ART and reduces stimulant use. The Specific Aims are: Aim 1 (R61): To conduct a pilot assessment of DynamiCare-plus for persons at risk or living with HIV with DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) stimulant use disorders (methamphetamine/cocaine) being released to the community from a closed justice setting (jail/ prison/ justice-mandated substance use program). N=40 adults in Dallas, TX (Texas) and CT (Connecticut) will be randomized 1:1 to DynamiCare-plus compared to enhanced treatment as usual (ETAU) (PN + smartphone) for 6 months to assess acceptability, feasibility and preliminary effectiveness: proportion who (1) initiate PrEP/ART; and (2) achieve/maintain VS (VL < 200 copies/mL) for those with HIV; Aim 2 (R33): The R61 pilot will inform a type 1 hybrid implementation effectiveness randomized controlled trial of DynamiCare-plus v. ETAU among 252 participants with the same eligibility as the R61 to assess the primary outcome of initiation/reinitiation of PrEP/ART followed for 15 months, with a 12 month intervention period. Secondary outcomes include stimulant and other substance use, overdose, PrEP/ART/SUD (Substance Use Disorder) retention, HIV risk behaviors, VS, Quality of life, and recidivism; Aim 2.1: Examine implementation of the intervention. Aim 2.2: Conduct cost analyses of the intervention compared to control. The Dynamicare app is mobile, adaptable and scalable, and combined with PN (DynamiCare-plus) has the potential to have a major impact on HIV treatment and prevention for justice-involved people with stimulant use disorder.
- Being tested
- DynamiCare, Patient Navigation (PN)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DynamiCareDevice
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)Behavioural
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 group | Role | What they receive |
|---|---|---|
| Arm 1: DynamiCare-plus | Experimental | Patient Navigation (PN) with a smartphone with the DynamiCare mobile contingency management app Receives: 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 Receives: Behavioral: Patient Navigation (PN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Jun 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ank Nijhawan, University of Texas Southwestern Medical Center
- Investigators
- Ank Nijhawan, MD, Principal investigator, University of Texas Southwestern Medical CenterSandra Springer, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136363
- Sponsor's protocol ID
- STU20251062
- Acronym
- RESTORE
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: MPIs (Multiple Principle Investigators) will consider de-identified data sharing upon reasonable request from other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESTORE Study R61 Pilot Phase: Recovery and Engagement for Stimulant Users on Re-entry
- ClinicalTrials.gov ID
- NCT07136363
- Acronym / sponsor ID
- RESTORE / STU20251062
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 interventions that reduce stimulant use and potentially improve HIV viral suppression (VS) and PrEP initiation and retention, particularly among justice-involved groups. The most successful treatment for stimulant use disorder to date is contingency management (CM), shown to reduce stimulant use and HIV risk behaviors, though implementation has been limited for justice-involved people due to competing priorities (transportation, housing, probation) and practical challenges of providing CM (frequent drug testing, trained staff, incentive management). DynamiCare is an FDA-approved mobile app that delivers patient-centered behavioral CM and has been shown to reduce biological and self-reported assessments of stimulant and other substance use, however it is unknown if it could improve PrEP/ART initiation for persons with stimulant use disorder at risk or living with HIV. Thus, in response to NIDA RFA-DA-23-008 [Request for Applications (RFA) from the National Institute on Drug Abuse (NIDA)]: Stimulants and HIV, we propose the RESTORE study: Recovery and Engagement for Stimulant Users on Re-entry. Guided by the Exploration Preparation Implementation Sustainment (EPIS) framework, we will assess if the addition of personalized CM via the DynamiCare app to a previously protocolized patient navigator (PN) ("DynamiCare-plus") intervention improves initiation of PrEP/ART and reduces stimulant use. The Specific Aims are: Aim 1 (R61): To conduct a pilot assessment of DynamiCare-plus for persons at risk or living with HIV with DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) stimulant use disorders (methamphetamine/cocaine) being released to the community from a closed justice setting (jail/ prison/ justice-mandated substance use program). N=40 adults in Dallas, TX (Texas) and CT (Connecticut) will be randomized 1:1 to DynamiCare-plus compared to enhanced treatment as usual (ETAU) (PN + smartphone) for 6 months to assess acceptability, feasibility and preliminary effectiveness: proportion who (1) initiate PrEP/ART; and (2) achieve/maintain VS (VL < 200 copies/mL) for those with HIV; Aim 2 (R33): The R61 pilot will inform a type 1 hybrid implementation effectiveness randomized controlled trial of DynamiCare-plus v. ETAU among 252 participants with the same eligibility as the R61 to assess the primary outcome of initiation/reinitiation of PrEP/ART followed for 15 months, with a 12 month intervention period. Secondary outcomes include stimulant and other substance use, overdose, PrEP/ART/SUD (Substance Use Disorder) retention, HIV risk behaviors, VS, Quality of life, and recidivism; Aim 2.1: Examine implementation of the intervention. Aim 2.2: Conduct cost analyses of the intervention compared to control. The Dynamicare app is mobile, adaptable and scalable, and combined with PN (DynamiCare-plus) has the potential to have a major impact on HIV treatment and prevention for justice-involved people with stimulant use disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: DynamiCare-plus | Experimental | Device: DynamiCare, Behavioral: Patient Navigation (PN)Patient Navigation (PN) with a smartphone with the DynamiCare mobile contingency management app |
| Arm 2: Enhanced Treatment as Usual (ETAU) | Active comparator | Behavioral: Patient Navigation (PN)Patient Navigation (PN) with a smartphone without the DynamiCare app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Severe medical or psychiatric disability making participation unsafe
- Unable to provide consent or engage with the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DynamiCareDynamiCare 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. | Device | Arm 1: DynamiCare-plus |
| 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. | Behavioural | Arm 1: DynamiCare-plus, Arm 2: Enhanced Treatment as Usual (ETAU) |
Primary outcome
Proportion of participants without HIV taking HIV pre-exposure prophylaxis (PrEP) by validated self-report within 6-month intervention period
Time frame: 6 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 period
Time frame: 6 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.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No. MPIs (Multiple Principle Investigators) will consider de-identified data sharing upon reasonable request from other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Hansen, MA contact
Ank Nijhawan, MD principal investigator
University of Texas Southwestern Medical Center
Sandra Springer, MD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DynamiCare and Patient Navigation (PN) in people with HIV and Stimulant Use Disorder, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ank Nijhawan, MD (2146482777, Ank.Nijhawan@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.