LetSync: Pilot Test of Mobile Health (mHealth) Intervention

NCT04951544 | Completed Results

• 1 other identifier: 5R01MH118967-03
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

HIV/AIDS; mHealth; Intervention; African American men

Outcome Measures

Primary Outcomes (3)

• Proportion of Urine Samples Returned by Participants

  The investigators will use self-collected urine samples as another objective measure of drug adherence for participants living with HIV. The investigators will mail participants a urine sample collection kit with necessary supplies and detailed instructions via online demonstration video. Participants will self-collect and administer the urine sample and send a photo of the results to study staff. Urine test results were collected between baseline (T0) and 8 months (T4) as proportion of samples returned.

  8 months

• Levels of Antiretroviral (ARV, TFVDP) Concentration in Dried Blood Spot (DBS) Samples

  The investigators will use the UNC Pharmacology Lab to analyze ARV levels in dried blood spot (DBS) samples as an objective measure of drug adherence and exposure for HIV-infected participants. The investigators will mail participants a DBS sample collection kit with necessary supplies, detailed instructions via online demonstration video, and a prepaid return envelope. DBS samples will be collected and analyzed between baseline (T0) and 8 months (T4). ARV levels of TFVDP will be measured as nanograms per milligram (ng/mg) of DBS will be log-transformed for data analysis. Changes since Baseline of ARV levels will be measured.

  8 months

• Self-reported Measure of Care Engagement

  Self-reported care engagement will be measured with the 10-item Index of Engagement in HIV Care rated on a Likert-type scale ranging from 1 to 5, 'Strongly disagree' to 'Strongly agree'. The minimum summed score is 10, the maximum summed score is 50. A score will be calculated is the sum of all items without missing responses, with a higher score representing better care engagement and lower score representing worse care engagement.

  8 months

Secondary Outcomes (1)

• Number of Participants Retained

  8 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

This arm will start the intervention using LetSync app v1.0 from T1 to T4, baseline/Month 0 to Month 8.

Other: LetSync app

Control

NO INTERVENTION

Interventions

LetSync app OTHER

Study B will entail a pilot randomized, controlled trial (RCT) of an app intervention, LetSync, to assess its acceptability, feasibility, and preliminary impact on retention in care and ART adherence as measured by antiretrovirals. Intervention participants will use LetSync and provide data. Participants in the control group do not receive the app and provide data. The enrollment and analysis approaches differ: To be eligible, Index participants needed to enroll with their partner (i.e., Partner participants). However, for data analyses of the outcomes, we do not separate by Index vs. Partner individuals because we do not analyze individuals by "Index" vs. "Partner", i.e., we include all individuals in analyses who provide the outcomes data of interest. Therefore, we report outcomes by individuals, but in Pre-Assignment Details and Data Tables, we also report number of intact dyads that started and completed the study by Milestone.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must identify as a cis-gender man - that is, they must currently identify as a man and have been born a male.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (1)

• 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.

  PMID: 34475191 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Judy Tan
• Organization: Cedars-Sinai, UCSF

judy.tan@cshs.org

310-423-1499

Study Officials

• Judy Y Tan, Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 7, 2021
• Study Start: March 27, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 23, 2026
• Results First Posted: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)