Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) Clinical Trial

ConditionsBehavioral Intervention Viral Suppression of HIV Infection ART Adherence

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexMale

Age18-70

SponsorUniversity of California, San Francisco

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention
Behavioral
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-test
Device
urine tenofovir point-of-care self-test

Treatment groups

270 Participants

are divided into 2 treatment groups

Group A: reSTART InterventionExperimental treatment 2 interventions

Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

Baseline to 6-months post-intervention

Secondary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

Baseline to 6-months post-intervention

Other outcomes

Acceptability of the Intervention using the Theoretical Framework of Acceptability Questionnaire

The acceptability of the intervention will be measured using the Theoretical Framework of Acceptability Questionnaire. Questions will be framed using Likert scales where a score of 1 corresponds to completely unacceptable and a score of 5 corresponds to completely acceptable.

Time frame

Enrollment to 6-months post-intervention