Summary

Eligibility
for males ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Judy Y Tan, Ph.D.
Photo of Judy Y Tan
Judy Y Tan

Description

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.

Official Title

Pilot-test of an mHealth Black Men Who Have Sex With Men (MSM) in Couples Intervention (LetSync v1.0, v2.0)

Keywords

HIV/AIDS mHealth Intervention African American men Acquired Immunodeficiency Syndrome HIV Infections LetSync v1.0 LetSync v2.0

Eligibility

You can join if…

Open to males ages 18 years and up

Individuals are eligible if they:

  • Self-identify as Black or African American
  • 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

You CAN'T join if...

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

Location

  • University of California San Francisco
    San Francisco California 94158 United States

Lead Scientist at UCSF

  • Judy Y Tan, Ph.D.
    Associate Professor, Medicine. Authored (or co-authored) 35 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04951544
Study Type
Interventional
Last Updated