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LetSync: Pilot Test of Mobile Health (mHealth) Intervention

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ClinicalTrials.gov Identifier: NCT04951544
Recruitment Status : Not yet recruiting
First Posted : July 7, 2021
Last Update Posted : July 7, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Other: LetSync v1.0 Other: LetSync v2.0 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot-test of an mHealth Black Men Who Have Sex With Men (MSM) in Couples Intervention (LetSync v1.0, v2.0)
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention Group
This arm will start the intervention using LetSync app v1.0 from T1 to T4, baseline/Month 0 to Month 14.
Other: LetSync v1.0
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. Participants will then continue to use LetSync v1.0 while the Waitlist-Control group begins to use LetSync v2.0.

Active Comparator: Waitlist-Control Group
This arm will wait to begin the intervention using the LetSync app v2.0 from T3 to T4, Month 8 to Month 14.
Other: LetSync v2.0
LetSync v2.0 will be developed by taking feedback from participants regarding LetSync v1.0. Participants in the waitlist-control group will be given LetSync v2.0 to use during the last 6 months of the trial.




Primary Outcome Measures :
  1. Levels of Antiretroviral (ARV) concentration in small scalp hair samples [ Time Frame: 14 months ]

    The investigators will use the UCSF Hair Analysis Laboratory to analyze ARV levels in small hair samples as an objective measure of drug adherence and exposure for HIV-infected participants. The investigators will mail participants a hair sample collection kit with necessary supplies, detailed instructions via online demonstration video, and a prepaid return envelope. Hair samples will be collected and analyzed between baseline (T1) and 14 months (T4).

    ARV levels will be measured as nanograms per milligram (ng/mg) of hair will be log-transformed for data analysis. Changes since Baseline of ARV levels will be measured.


  2. Self-reported measure of care engagement [ Time Frame: 14 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'. This will be included in questionnaires administered to participants between baseline (T1) and 14 months (T4).

    A mean Index score will be calculated (the sum of all items without missing responses divided by that number of items), with a higher score representing better care engagement and lower score representing worse care engagement. Changes since Baseline of the mean Index score will be measured.


  3. Self-reported measure I of antiretroviral therapy (ART) adherence [ Time Frame: 14 months ]
    Self-reported antiretroviral therapy (ART) adherence will be measured using an aggregated or composite score derived from the following items. Frequency of missed doses will be represented by summing the following two items: how many doses were missed over the last 30 days, and how many doses missed over the past three months for at least four days in a row.

  4. Self-reported measure II of antiretroviral therapy (ART) adherence [ Time Frame: 14 months ]

    Self-reported antiretroviral therapy (ART) adherence will be measured using an aggregated or composite score derived from the following items on a Likert-type scale of 1 to 5, 'Strongly disagree' to 'Strongly agree': Self-rated ability of taking medications the way they should, how often they took medications the way they should.

    For self-rated ability of taking medications and frequency of taking them, a mean score will be calculated (the sum of all items without missing responses divided by that number of items). A higher score represents excellent ability of taking medications and a lower score represents poor ability of taking medications. Changes in Baseline for the mean Index score will be measured.



Secondary Outcome Measures :
  1. Feasibility or usability of LetSync app v1.0 (how easy or convenient is v1.0 to use) [ Time Frame: 14 months ]

    Between baseline (T1) and 14 months (T4), the investigators will collect feasibility-related data via the app using a validated 10-item Feasibility instrument. The items are on a five-point Likert scale ranging from 'Strongly disagree' to 'Strongly agree'. A mean Feasibility score will be calculated (the sum of all items without missing responses divided by that number of items). A higher score indicates high feasibility, whereas a lower score indicates low feasibility.

    Feasibility data collected only between baseline (T1) and 6 months (T2) will be used to develop LetSync app v2.0 for the Waitlist-control arm. Investigators will continue collecting acceptability data on LetSync app v1.0 from the Intervention arm.


  2. Acceptability of or Satisfaction in using LetSync app v1.0 [ Time Frame: 14 months ]

    Between baseline (T1) and 14 months (T4), the investigators will collect acceptability data via the app using a validated 5-item Feasibility instrument. The items are on a five-point Likert scale (1 to 5) ranging from 'Strongly disagree' to 'Strongly agree'. A mean Acceptability score will be calculated (the sum of all items without missing responses divided by that number of items). A higher score indicates high acceptability, whereas a lower score indicates low feasibility.

    Acceptability data collected only between baseline (T1) and 6 months (T2) will be used to develop LetSync app v2.0 for the Waitlist-control arm. Investigators will continue collecting acceptability data on LetSync app v1.0 from the Intervention arm.


  3. Feasibility of LetSync app v2.0 (how easy or convenient is v2.0 to use) [ Time Frame: 6 months ]

    The investigators will collect feasibility data via the app using a validated 10-item Feasibility instrument. The items are on a five-point Likert scale ranging from 'Strongly disagree' to 'Strongly agree'. A mean Feasibility score will be calculated (the sum of all items without missing responses divided by that number of items). A higher score indicates high feasibility, whereas a lower score indicates low feasibility.

    Feasibility data will be collected from the Waitlist-control arm between 8 months (T3) and 14 months (T4) for a total of six months.


  4. Acceptability of or satisfaction with using LetSync app v2.0 [ Time Frame: 6 months ]

    The investigators will collect acceptability data via the app using a validated 10-item Feasibility instrument. The items are on a five-point Likert scale ranging from 'Strongly disagree' to 'Strongly agree'. A mean Acceptability score will be calculated (the sum of all items without missing responses divided by that number of items). A higher score indicates high feasibility, whereas a lower score indicates low feasibility.

    Acceptability data will be collected from the Waitlist-control arm between 8 months (T3) and 14 months (T4), for a total of six months.


  5. Self-reported care engagement [ Time Frame: 14 months ]
    The investigators will collect data on participants' self-reported care engagement; this will be comprised of scheduled, cancelled, rescheduled, and attended visits to their HIV and/or primary care provider within the last three to six months. Data will be collected via questionnaires administered to participants between baseline (T1) and 14 months (T4). The investigators will measure changes from Baseline for each item of interest.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants must identify as a cis-gender man - that is, they must currently identify as a man and have been born a male.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04951544


Contacts
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Contact: Judy Y Tan, Ph.D. 415-502-1000 ext 14624 judy.tan@ucsf.edu

Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94158
Contact: Judy Tan, PhD    415-476-6052    judy.tan@ucsf.edu   
Principal Investigator: Judy Tan, PhD         
Sponsors and Collaborators
University of California, San Francisco
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Judy Y Tan, Ph.D. University of California, San Francisco
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04951544    
Other Study ID Numbers: 5R01MH118967-03 ( U.S. NIH Grant/Contract )
5R01MH118967-03 ( U.S. NIH Grant/Contract )
First Posted: July 7, 2021    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
HIV/AIDS
mHealth
Intervention
African American men
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
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
Immunologic Deficiency Syndromes
Immune System Diseases