NCT04951544Completed
LetSync: Pilot Test of Mobile Health (mHealth) Intervention
Pilot-test of an mHealth Black Men Who Have Sex With Men (MSM) in Couples Intervention (LetSync v1.0, v2.0)
Source: ClinicalTrials.gov · Last updated 23 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 144 (actual)
- First submitted
- 16 Jun 2021
- Start date
- 27 Mar 2023
- Primary completion date
- 1 Mar 2024
- Lead sponsor
- University of California, San Francisco
- Diseases
- HIV
- NCT number
- NCT04951544
What you commit to
- Study type: Interventional
- Participants enrolled: 144
- From 27 Mar 2023 to the primary completion date, 1 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Are unwilling or unable to disclose HIV status to primary partner
- Present evidence of severe cognitive impairment that would prevent comprehension of study procedures assessed during informed consent
Other
- Those who:
- Report fear of intimate partner violence (IPV) resulting from participation
Who the study is looking for
- Individuals are eligible if they:
- Self-identify as racial/ethnic minority
- Self-identify as a cisgender man
- Are HIV-Positive themselves, or are the partner of someone who is living with HIV
- Are age 18 or older
- Have a primary relationship partner, defined as someone to whom the participant is committed above anyone else for three or more months
- Uses and owns a personal smartphone
- Willing and able to provide informed consent
- 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
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.