Remote Intervention for HIV Medication Adherence

(reSTART Trial)

SM
Overseen ByShivani Mahuvakar
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: University of California, San Francisco
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

MS

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

Documented virologic non-suppression, urine tenofovir testing without tenofovir detected, or self-reported adherence <90%
Reports stimulant use
Currently has a smartphone with photo capabilities
See 2 more

Exclusion Criteria

Have any health condition that may interfere with participation or the ability to provide informed consent, including any debilitating or life-threatening conditions
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
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

6 months
Remote intervention with baseline motivational interviewing session

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with assessments of viral suppression and stimulant use

6 months

Long-term Follow-up

Long-term viral suppression is assessed at 12 months post-intervention

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • reSTART Objective Adherence Self-Monitoring and Positive Affect mHealth Intervention
Trial Overview This trial tests a remote intervention called reSTART, which includes a urine tenofovir self-test and a mobile health (mHealth) program designed to monitor medication adherence and boost positive behaviors.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: reSTART InterventionExperimental Treatment2 Interventions
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Florida International University

Collaborator

Trials
114
Recruited
19,400+

San Diego State University

Collaborator

Trials
182
Recruited
119,000+

Citations

Study Details | NCT07125235 | Reactive Driven Support for ...The reSTART intervention integrates a mobile health application, a urine tenofovir point-of-care self-test, and adherence feedback with motivational messages to ...
Recent mHealth interventions to support medication ...Three studies measured intervention impact on adherence and found increased ART use intentions (n=1), self-reported adherence (n=1), and viral suppression (n=1, ...
Reactive Driven Support for Treatment, Adherence, ...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 ...
Supporting treatment adherence for resilience and thriving ...START is a randomized controlled trial (RCT) testing the efficacy and cost-effectiveness of a mHealth application that integrates evidence-based positive ...
mHealth Interventions To Support Self-Management In HIVOur review found evidence that mHealth interventions can have significant impact on outcomes including adherence to ART [23, 24, 26, 27, 30, 34, 45, 55], viral ...
Remote Intervention for HIV Medication Adherence ...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 ...
A Remote Intervention Based on mHealth and Community ...The remote CHAMPS pilot study demonstrated the feasibility and acceptability of combining mHealth tools with CHW support to promote medication adherence among ...
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