Behavioral InterventionreSTARTNCT07125235
Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) Clinical Trial
A study testing reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention and urine tenofovir point-of-care self-test in people with Behavioral Intervention and Viral Suppression of HIV Infection, run by University of California, San Francisco at 1 site in United States.
Trial summary
Men who are living with HIV and use stimulants face many challenges and barriers that may interfere with remembering to take their HIV medication. Forgetting to take HIV medication puts men living with HIV at a greater risk of becoming virally unsuppressed. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Behavioral Intervention, Viral Suppression of HIV Infection, ART Adherence
- What is being tested?
- reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention and urine tenofovir point-of-care self-test
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2026to 30 Jul 2028
- 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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prescribed antiretroviral therapy (ART) with a tenofovir-based regimen.
- Documented virologic non-suppression, urine tenofovir testing without tenofovir detected, or self-reported adherence <100%.
- Reports stimulant use.
- Has a mailing address within the U.S.
- Currently has a smartphone with photo capabilities.
Who cannot join
- Have any health condition that may interfere with participation or the ability to provide informed consent, including any debilitating or life-threatening conditions.
- Not prescribed ART.
- Unwilling to perform urine self-testing or to attend a local Quest site for viral load monitoring.
- Unable to provide a hair sample of ~50-100 strands of hair that are non-gray, not bleached, and at least 1cm in length
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kevin Sassaman contact
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94110
Matthew Spinelli, MD, MAS, 415-806-8554, matthew.spinelli@ucsf.edu
About this study
Official title: Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) mHealth Randomized Controlled Hybrid Type I Effectiveness Implementation Trial
Men who are living with HIV and use stimulants face many challenges and barriers that may interfere with remembering to take their HIV medication. Forgetting to take HIV medication puts men living with HIV at a greater risk of becoming virally unsuppressed. Researchers are doing this study to test if a remote intervention can help participants improve remembering to take their HIV medications and reduce the HIV viral load among men living with HIV who use stimulants.
Read the detailed description
A resurgent stimulant epidemic among men living with HIV could compromise the U.S. Ending the HIV Epidemic goals by interfering with HIV care engagement, adherence, and virologic suppression among men living with HIV. Prominent multi-level factors interfere with HIV virologic suppression for men living with HIV, particularly among those who use stimulants. This study is a nested randomized clinical trial to test a multi-component intervention to improve virologic suppression, adherence, and stimulant use among men living with HIV who use stimulants. The intervention, known as reSTART, will combine an evidence-based positive affect mobile health (mHealth) intervention, a home-based urine point-of-care test for adherence self-monitoring, and motivational interviewing and messages. The goal of the reSTART intervention is to improve or maintain adherence to HIV medications and reduce stimulant use. By this high-impact study's end, the investigators will have identified the impact of a multi-component reSTART mHealth intervention using novel point-of-care adherence self-monitoring on HIV virologic suppression and stimulant use.
- Being tested
- reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention, urine tenofovir point-of-care self-test
- Keywords
- HIV, Stimulant Use, mHealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth InterventionBehavioural
Also called Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART)
The reSTART intervention integrates a mobile health application, a urine tenofovir point-of-care self-test, and adherence feedback with motivational messages to increase HIV medication intake, reduce stimulant use, and improve HIV virologic suppression.
urine tenofovir point-of-care self-testDevice
urine tenofovir point-of-care self-test
| Study group | Role | What they receive |
|---|---|---|
| reSTART Intervention | Experimental | The reSTART intervention will be administered to this group and includes: (1) adherence self-monitoring tools delivered during a single baseline motivational interviewing session; (2) the urine tenofovir point-of-care self-test with adherence feedback and visualizations with motivational messages; (3) a positive affect intervention delivered via a mobile health application which supports stimulant-using men in reducing stimulant use. Receives: Behavioral: reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention; Device: urine tenofovir point-of-care self-test |
| Standard of Care | No intervention | The control group will receive standard of care and will not receive the reSTART intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR
The primary endpoint will be change in viral suppression comparing baseline to post-intervention viral load results measured by HIV-1 RNA, Quantitative, Real-Time PCR. Viral suppression is defined as viral load results that yield less than 50 copies/mL.
Measured: Baseline to 6-months post-intervention
Secondary outcomes (3)
Stimulant Use measured quantitatively by stimulant levels in hair
Stimulant levels will be compared pre- and post-intervention and measured quantitatively using liquid chromatography-mass spectrometry laboratory techniques.
Measured: Baseline to 6-months post-intervention
Long-term Viral Suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR.
As a secondary endpoint, long-term viral suppression will be measured at 12-months and compared to baseline viral load results from HIV-1 RNA, Quantitative, Real-Time PCR. Viral suppression is defined as viral load results that yield less than 50 copies/mL.
Measured: Baseline to 12-months post-intervention
Adherence to Tenofovir-based antiretroviral therapy
Urine tenofovir levels measured by the urine tenofovir point-of-care self-test lateral flow assay at baseline and 6-months post-intervention will be compared to assess the presence or absence of tenofovir and changes in adherence to HIV medications.
Measured: Baseline to 6-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start9 Feb 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral InterventionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled Hybrid Type I Effectiveness Implementation Study
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Florida International University, San Diego State University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Matthew Spinelli, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125235
- Sponsor's protocol ID
- 25-44467
- Other IDs
- UH3DA058304
- Acronym
- reSTART
- Status last verified
- Mar 2026
- First submitted
- 1 Aug 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) mHealth Randomized Controlled Hybrid Type I Effectiveness Implementation Trial
- ClinicalTrials.gov ID
- NCT07125235
- Acronym / sponsor ID
- reSTART / 25-44467
- Keywords
- HIV, Stimulant Use, mHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Florida International University, San Diego State University, National Institute on Drug Abuse (NIDA)
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 15 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.
Men who are living with HIV and use stimulants face many challenges and barriers that may interfere with remembering to take their HIV medication. Forgetting to take HIV medication puts men living with HIV at a greater risk of becoming virally unsuppressed. Researchers are doing this study to test if a remote intervention can help participants improve remembering to take their HIV medications and reduce the HIV viral load among men living with HIV who use stimulants.
Detailed description
A resurgent stimulant epidemic among men living with HIV could compromise the U.S. Ending the HIV Epidemic goals by interfering with HIV care engagement, adherence, and virologic suppression among men living with HIV. Prominent multi-level factors interfere with HIV virologic suppression for men living with HIV, particularly among those who use stimulants. This study is a nested randomized clinical trial to test a multi-component intervention to improve virologic suppression, adherence, and stimulant use among men living with HIV who use stimulants. The intervention, known as reSTART, will combine an evidence-based positive affect mobile health (mHealth) intervention, a home-based urine point-of-care test for adherence self-monitoring, and motivational interviewing and messages. The goal of the reSTART intervention is to improve or maintain adherence to HIV medications and reduce stimulant use. By this high-impact study's end, the investigators will have identified the impact of a multi-component reSTART mHealth intervention using novel point-of-care adherence self-monitoring on HIV virologic suppression and stimulant use.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Controlled Hybrid Type I Effectiveness Implementation Study
| Arm | Type | Receives |
|---|---|---|
| reSTART Intervention | Experimental | Behavioral: reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention, Device: urine tenofovir point-of-care self-testThe reSTART intervention will be administered to this group and includes: (1) adherence self-monitoring tools delivered during a single baseline motivational interviewing session; (2) the urine tenofovir point-of-care self-test with adherence feedback and visualizations with motivational messages; (3) a positive affect intervention delivered via a mobile health application which supports stimulant-using men in reducing stimulant use. |
| Standard of Care | No intervention | –The control group will receive standard of care and will not receive the reSTART intervention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Prescribed antiretroviral therapy (ART) with a tenofovir-based regimen.
- Documented virologic non-suppression, urine tenofovir testing without tenofovir detected, or self-reported adherence <100%.
- Reports stimulant use.
- Has a mailing address within the U.S.
- Currently has a smartphone with photo capabilities.
Key exclusion criteria (4 listed)
- Have any health condition that may interfere with participation or the ability to provide informed consent, including any debilitating or life-threatening conditions.
- Not prescribed ART.
- Unwilling to perform urine self-testing or to attend a local Quest site for viral load monitoring.
- Unable to provide a hair sample of ~50-100 strands of hair that are non-gray, not bleached, and at least 1cm in length
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 |
|---|---|---|
| reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth InterventionAlso: Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART)The reSTART intervention integrates a mobile health application, a urine tenofovir point-of-care self-test, and adherence feedback with motivational messages to increase HIV medication intake, reduce stimulant use, and improve HIV virologic suppression. | Behavioural | reSTART Intervention |
| urine tenofovir point-of-care self-testurine tenofovir point-of-care self-test | Device | reSTART Intervention |
Primary outcome
Viral suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR
Time frame: Baseline to 6-months post-intervention
The primary endpoint will be change in viral suppression comparing baseline to post-intervention viral load results measured by HIV-1 RNA, Quantitative, Real-Time PCR. Viral suppression is defined as viral load results that yield less than 50 copies/mL.
3 secondary outcomes
Stimulant Use measured quantitatively by stimulant levels in hair
Time frame: Baseline to 6-months post-intervention
Long-term Viral Suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR.
Time frame: Baseline to 12-months post-intervention
Adherence to Tenofovir-based antiretroviral therapy
Time frame: Baseline to 6-months post-intervention
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 13 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Kevin Sassaman contact
Matthew Spinelli, MD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention and urine tenofovir point-of-care self-test in people with Behavioral Intervention and Viral Suppression of HIV Infection, run by University of California, San Francisco at 1 site 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 5 inclusion and 4 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 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Shivani Mahuvakar (415-878-6384, shivani.mahuvakar@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR (time frame: Baseline to 6-months post-intervention). 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 13 Mar 2026.