MedTrace Logo

LetSync: Pilot Test of Mobile Health (mHealth) Intervention

NCT04951544 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-03-23

Study results available
· View outcomes & findings →

Summary

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.

Conditions

Interventions

OTHER

LetSync app

Study B will entail a pilot randomized, controlled trial (RCT) of an app intervention, LetSync, to assess its acceptability, feasibility, and preliminary impact on retention in care and ART adherence as measured by antiretrovirals. Intervention participants will use LetSync and provide data. Participants in the control group do not receive the app and provide data. The enrollment and analysis approaches differ: To be eligible, Index participants needed to enroll with their partner (i.e., Partner participants). However, for data analyses of the outcomes, we do not separate by Index vs. Partner individuals because we do not analyze individuals by "Index" vs. "Partner", i.e., we include all individuals in analyses who provide the outcomes data of interest. Therefore, we report outcomes by individuals, but in Pre-Assignment Details and Data Tables, we also report number of intact dyads that started and completed the study by Milestone.

Sponsors & Collaborators

Principal Investigators

  • Judy Y Tan, Ph.D. · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-27
Primary Completion
2024-03-01
Completion
2024-03-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04951544 on ClinicalTrials.gov