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Completed

NCT Number: NCT04951544

LetSync: Pilot Test of Mobile Health (mHealth) Intervention

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94158, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Proportion of Urine Samples Returned by Participants

    Time frame: 8 months

    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.

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

    Time frame: 8 months

    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.

  3. Self-reported Measure of Care Engagement

    Time frame: 8 months

    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.

Secondary outcomes

  1. Number of Participants Retained

    Time frame: 8 months

    Between baseline (T0) and 8 months (T4), the investigators will collect feasibility-related data in terms of number of participants retained in the study from baseline to 8-month (T4) by condition. This is a feasibility and acceptability pilot trial, and one of the main outcomes is acceptability of the trial protocol and procedures, as indicated by participant retention rate, calculated as: The number of participants that remained in the trial divided by the total number of participants at the start of the trial.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 7, 2021
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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