LetSync: Pilot Test of Mobile Health (mHealth) Intervention (NCT04951544) | Clinical Trial Compass
CompletedNot Applicable
LetSync: Pilot Test of Mobile Health (mHealth) Intervention
United States144 participantsStarted 2023-03-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Urine Samples Returned by Participants
Timeframe: 8 months
2
Levels of Antiretroviral (ARV, TFVDP) Concentration in Dried Blood Spot (DBS) Samples