Remote Intervention for HIV Medication Adherence
(reSTART Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a remote support program, the reSTART Objective Adherence Self-Monitoring and Positive Affect mHealth Intervention, can assist men with HIV who use stimulants in remembering to take their HIV medication and reducing their viral load (amount of HIV in the blood). The program includes tools for tracking medication use, motivational messages, and a mobile app to support reducing stimulant use. Suitable participants should be taking HIV medication, occasionally forget doses, use stimulants, and own a smartphone. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance support for managing HIV and stimulant use.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must be on a tenofovir-based HIV treatment to participate.
What prior data suggests that this remote intervention is safe for improving HIV medication adherence?
Research has shown that mHealth interventions, such as the reSTART program, are generally user-friendly. One study found that mobile health tools effectively help people take their medication on time and are acceptable to participants. Most participants felt comfortable using the tools and did not report major issues. The reSTART program aims to assist individuals in adhering to their HIV medication and reducing stimulant use. Although specific information on side effects is not available, the emphasis on mobile tools and motivational support suggests a low-risk approach.12345
Why are researchers excited about this trial?
Researchers are excited about the reSTART Intervention because it offers a fresh approach to improving HIV medication adherence by leveraging mobile health technology. Unlike traditional methods that rely on direct healthcare provider involvement, this intervention empowers users with self-monitoring tools and motivational feedback through a smartphone app. This includes a point-of-care urine test for adherence and positive reinforcement messages aimed at reducing stimulant use. These features could make it easier for individuals to stick to their medication regimen by providing real-time, personalized support and feedback, potentially leading to better health outcomes.
What evidence suggests that the reSTART intervention is effective for improving HIV medication adherence?
Research shows that mobile health programs, like the reSTART program, can help people take their HIV medication more regularly and manage their condition better. In this trial, participants in the reSTART intervention arm will receive tools for self-monitoring, feedback, and motivational messages to help men with HIV remember to take their medication and reduce stimulant use. Studies have found that similar apps can increase the likelihood of taking medication, improve self-reported adherence, and even lead to better control of the virus. By doing this, the reSTART program aims to keep the amount of HIV in the blood low. These findings suggest that reSTART could be effective in helping people stick to their medication schedule and improve their health.13567
Who Is on the Research Team?
Matthew Spinelli, MD, MAS
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
The reSTART clinical trial is for men living with HIV who use stimulants and may struggle with taking their HIV medication regularly. The study aims to help them remember their treatment to maintain viral suppression.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive the reSTART intervention, which includes adherence self-monitoring tools, a urine tenofovir point-of-care self-test, and a positive affect intervention via a mobile health application
Follow-up
Participants are monitored for safety and effectiveness after the intervention, with assessments of viral suppression and stimulant use
Long-term Follow-up
Long-term viral suppression is assessed at 12 months post-intervention
What Are the Treatments Tested in This Trial?
Interventions
- reSTART Objective Adherence Self-Monitoring and Positive Affect mHealth Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Florida International University
Collaborator
San Diego State University
Collaborator