Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Waitlist Available
Sponsor: University of California, San Francisco
No Placebo Group
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.
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.Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 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 GroupActive Control1 Intervention
This arm will wait to begin the intervention using the LetSync app v2.0 from T3 to T4, Month 8 to Month 14.
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of California San FranciscoSan Francisco, CA
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
National Institute of Mental Health (NIMH)Collaborator