LetSync: Pilot Test of Mobile Health (mHealth) Intervention

University of California San Francisco (UCSF)

Status: Completed

Conditions: HIV/AIDS

Treatments: Other: LetSync v2.0; Other: LetSync v1.0

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04951544

5R01MH118967-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Intervention Group

Experimental group

Description:

This arm will start the intervention using LetSync app v1.0 from T1 to T4, baseline/Month 0 to Month 14.

Treatment:

Other: LetSync v1.0

Waitlist-Control Group

Active Comparator group

Description:

This arm will wait to begin the intervention using the LetSync app v2.0 from T3 to T4, Month 8 to Month 14.

Treatment:

Other: LetSync v2.0