N/A
Completed N=144
LetSync: Pilot Test of Mobile Health (mHealth) Intervention
Source: ClinicalTrials.gov NCT04951544 ↗Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: Proportion of Urine Samples Returned by Participants — 54; 65 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Urine Samples Returned by Participants |
54; 65 | — |
| PRIMARY Levels of Antiretroviral (ARV, TFVDP) Concentration in Dried Blood Spot (DBS) Samples |
485.03; 595.55 | — |
| PRIMARY Self-reported Measure of Care Engagement |
31.2; 36.5 | — |
| SECONDARY Number of Participants Retained |
61; 72 | — |
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
Those who:
- Report fear of intimate partner violence (IPV) resulting from participation
- 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
Data sourced from ClinicalTrials.gov (NCT04951544). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.