Clinical trial NCT04951544: LetSync: Pilot Test of Mobile Health (mHealth) Intervention
Official title: Pilot-test of an mHealth Black Men Who Have Sex With Men (MSM) in Couples Intervention (LetSync v1.0, v2.0)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV/AIDS
mHealth
Intervention
African American men
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-07-07
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.


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

Primary outcomes:
measure: Levels of Antiretroviral (ARV) concentration in dried blood spot (DBS) samples
timeFrame: 8 months
measure: Self-reported measure of care engagement
timeFrame: 8 months
measure: Self-reported measure I of antiretroviral therapy (ART) adherence
timeFrame: 8 months
measure: Self-reported measure II of antiretroviral therapy (ART) adherence
timeFrame: 8 months
measure: Presence of Antiretroviral (ARV) medication in urine sample
timeFrame: 8 months
Secondary outcomes:
measure: Feasibility or usability of LetSync app v1.0 (how easy or convenient is v1.0 to use)
timeFrame: 8 months
measure: Acceptability of or Satisfaction in using LetSync app v1.0
timeFrame: 8 months
measure: Self-reported care engagement
timeFrame: 8 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Judy Y Tan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim HC, Pollack LM, Saberi P, Neilands TB, Arnold EA, Bright DJ, Williams RW, Kegeles SM, Tan JY. Study protocol: a pilot randomised waitlist-controlled trial of a dyadic mobile health intervention for black sexual-minority male couples with HIV in the USA. BMJ Open. 2021 Sep 2;11(9):e055448. doi: 10.1136/bmjopen-2021-055448.