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

NCT07125235 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2026-03-13

No results posted yet for this study

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. 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.

Conditions

  • Behavioral Intervention
  • Viral Suppression of HIV Infection
  • ART Adherence

Interventions

BEHAVIORAL

reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention

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.

DEVICE

urine tenofovir point-of-care self-test

urine tenofovir point-of-care self-test

Sponsors & Collaborators

  • Florida International University

    collaborator OTHER

  • San Diego State University

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Matthew Spinelli, MD, MAS · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-09
Primary Completion
2028-04-30
Completion
2028-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07125235 on ClinicalTrials.gov