Mobile Health Intervention for HIV/AIDS

Overseen By Judy Y Tan, Ph.D.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Antiretrovirals

Disqualifiers: Fear of IPV, Severe cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

160 Participants Needed

Trial Summary

What is the purpose of this trial?

The Pilot Test (AKA Study B) will entail a pilot randomized, controlled trial (RCT) of an mHealth behavioral intervention, LetSync, with 80 couples (N=160) to assess its acceptability, feasibility, and preliminary impact on retention in care and ART adherence as measured by antiretroviral concentrations in hair. Participants in the intervention arm will use LetSync v1.0 for 6 months and provide acceptability and feasibility data. In the ensuing 2 months, the investigators will make refinements based on participants' data to produce LetSync v2.0. Then, participants in the waitlist-control arm will receive LetSync v2.0, use it for 6 months, and provide acceptability and feasibility data. The intervention arm will continue using LetSync v1.0, for a total of 14 months. Based on acceptability and feasibility data from waitlist control arm participants between T3 and T4, the investigators will develop LetSync v3.0, which will be used for efficacy testing in a full RCT trial in the future.

Research Team

Judy Tan, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for cisgender men over 18 in a committed relationship, who are racial/ethnic minorities living with HIV or have a partner who is. They must own and use a smartphone and be willing to consent to the study. It's not for those fearing intimate partner violence from participating or unable to disclose their HIV status.

Inclusion Criteria

Partners are eligible if they: Self-identify as a cisgender man, Are age 18 or older, Have a primary relationship partner that is the referring participant, Uses and owns a personal smartphone, Willing and able to provide informed consent

You can participate in the study if you are 18 years or older, identify as a racial/ethnic minority, identify as a cisgender man, are HIV-positive or have a partner who is HIV-positive, have a committed primary relationship for more than 3 months, own a smartphone, and are willing to give consent.

Exclusion Criteria

You are afraid that participating in the study could result in violence from your partner, you cannot or will not tell your primary partner about your HIV status, or you have severe memory problems that would make it hard for you to understand what is involved in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Phase 1

Participants in the intervention arm use LetSync v1.0 for 6 months to assess acceptability and feasibility.

6 months

Intervention Phase 2

Refinements are made to LetSync based on data, and participants in the waitlist-control arm use LetSync v2.0 for 6 months.

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including data collection on ART adherence and care engagement.

8 months

Treatment Details

Interventions

• LetSync v1.0
• LetSync v2.0

Trial Overview The LetSync mHealth intervention is being tested on couples where at least one partner has HIV. The study will see if using the app helps them stay on track with their treatment and care. Participants will first try version 1.0, then some will test an updated version after feedback.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

This arm will start the intervention using LetSync app v1.0 from T1 to T4, baseline/Month 0 to Month 14.

Group II: Waitlist-Control Group Active Control 1 Intervention

This arm will wait to begin the intervention using the LetSync app v2.0 from T3 to T4, Month 8 to Month 14.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+