search
Back to results

LetSync: Pilot Test of Mobile Health (mHealth) Intervention

Primary Purpose

HIV/AIDS

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LetSync v1.0
LetSync v2.0
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV/AIDS focused on measuring HIV/AIDS, mHealth, Intervention, African American men

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of California San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Waitlist-Control Group

Arm Description

This arm will start the intervention using LetSync app v1.0 from T1 to T4, baseline/Month 0 to Month 14.

This arm will wait to begin the intervention using the LetSync app v2.0 from T3 to T4, Month 8 to Month 14.

Outcomes

Primary Outcome Measures

Levels of Antiretroviral (ARV) 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 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.
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'. This will be included in questionnaires administered to participants between baseline (T0) and 8 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.
Self-reported measure I of antiretroviral therapy (ART) adherence
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.
Self-reported measure II of antiretroviral therapy (ART) adherence
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.
Presence of Antiretroviral (ARV) medication in urine sample
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 will be collected between baseline (T0) and 8 months (T4).

Secondary Outcome Measures

Feasibility or usability of LetSync app v1.0 (how easy or convenient is v1.0 to use)
Between baseline (T0) and 8 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.
Acceptability of or Satisfaction in using LetSync app v1.0
Between baseline (T0) and 14 months (T5), 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.
Self-reported care engagement
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 (T0) and 8 months (T4). The investigators will measure changes from Baseline for each item of interest.

Full Information

First Posted
June 16, 2021
Last Updated
February 28, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT04951544
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
HIV/AIDS, mHealth, Intervention, African American men

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
This arm will start the intervention using LetSync app v1.0 from T1 to T4, baseline/Month 0 to Month 14.
Arm Title
Waitlist-Control Group
Arm Type
Active Comparator
Arm Description
This arm will wait to begin the intervention using the LetSync app v2.0 from T3 to T4, Month 8 to Month 14.
Intervention Type
Other
Intervention Name(s)
LetSync v1.0
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
LetSync v2.0
Intervention Description
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 Measure Information:
Title
Levels of Antiretroviral (ARV) concentration in dried blood spot (DBS) samples
Description
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 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.
Time Frame
8 months
Title
Self-reported measure of care engagement
Description
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 (T0) and 8 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.
Time Frame
8 months
Title
Self-reported measure I of antiretroviral therapy (ART) adherence
Description
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.
Time Frame
8 months
Title
Self-reported measure II of antiretroviral therapy (ART) adherence
Description
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.
Time Frame
8 months
Title
Presence of Antiretroviral (ARV) medication in urine sample
Description
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 will be collected between baseline (T0) and 8 months (T4).
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Feasibility or usability of LetSync app v1.0 (how easy or convenient is v1.0 to use)
Description
Between baseline (T0) and 8 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.
Time Frame
8 months
Title
Acceptability of or Satisfaction in using LetSync app v1.0
Description
Between baseline (T0) and 14 months (T5), 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.
Time Frame
8 months
Title
Self-reported care engagement
Description
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 (T0) and 8 months (T4). The investigators will measure changes from Baseline for each item of interest.
Time Frame
8 months

10. Eligibility

Sex
Male
Gender Based
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.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judy Y Tan, Ph.D.
Phone
415-502-1000
Ext
14624
Email
judy.tan@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy Y Tan, Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judy Tan, PhD
Phone
415-476-6052
Email
judy.tan@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Judy Tan, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34475191
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.
Results Reference
derived

Learn more about this trial

LetSync: Pilot Test of Mobile Health (mHealth) Intervention

We'll reach out to this number within 24 hrs