LetSync: Pilot Test of Mobile Health (mHealth) Intervention | NCT04951544

NCT04951544

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
5R01MH118967-03	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Institute of Mental Health (NIMH)	NIH

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Number of Participants Retained	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.

Eligibility Module

Name	Affiliation	Role
Judy Y Tan, Ph.D.	University of California, San Francisco	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Francisco		San Francisco	California	94158	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34475191	Derived	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.

Arm/Group Information

ID	Title	Description
FG000	Intervention Arm	This is the Intervention Arm of the LetSync Pilot Study to evaluate the feasibility and acceptability of the LetSync app intervention and associated protocols and procedures to inform a full-scale RCT. The Intervention Arm received the LetSync app to use through the 8-month trial.
FG001	Control Arm	This is the Control Arm of the LetSync Pilot Study to evaluate the feasibility and acceptability of the LetSync app intervention and associated protocols and procedures to inform a full-scale RCT. The Control Arm did not receive the LetSync app.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED	STARTED: 35 dyads in the intervention arm, 37 dyads in the control arm, 72 dyads total.	FG00070 subjects FG00174 subjects
COMPLETED		FG00062 subjectsCOMPLETED: Individuals from the same dyads remained in the study even if their partner exited (e.g., sometimes couples break up during the study, and then one partner exits the study while their partner chooses to remain). When the study started, there were 70 participants enrolled in the Intervention Arm, representing 35 intact dyads. When the study was completed, 62 participants remained in the intervention arm representing 31 intact dyads. FG00172 subjectsCOMPLETED: Individuals from the same dyads remained in the study even if their partner exited (e.g., sometimes couples break up during the study, and then one partner exits the study while their partner chooses to remain). When the study started, there were 74 participants enrolled in the Control Arm, representing 37 intact dyads. When the study was completed, 72 participants remained, representing 35 intact dyads + 2 non-intact dyads (35 x 2 + 2 = 72).
NOT COMPLETED		FG0008 subjects FG0012 subjects

Type	Comment	Reasons
Participant requested that their data be deleted from the study.		FG0001 subjects FG0010 subjects
Lost to Follow-up		FG0007 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Intervention Arm	This is the Intervention Arm of the LetSync Pilot Study to evaluate the feasibility and acceptability of the LetSync app intervention and associated protocols and procedures to inform a full-scale RCT. The Intervention Arm received the LetSync app to use through the 8-month trial. The unit of randomization was the dyad, i.e., each dyad - not an individual - was randomized to either the intervention or control. We did not randomize by individual index or partner participant; we randomized by the dyad, i.e., the couple together. Each arm contained both members of each dyad.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

The sampling 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 as "Index" vs. "Partner", i.e., we include all individuals who provide the outcomes data of interest. In this case, it is the Proportion of urine samples returned by anyone enrolled in the study.

Posted

Count of Participants

Participants

8 months

ID	Title	Description

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Intervention Arm	Adverse events could occur at the level of the dyad, e.g., intimate partner violence, or at the level of the individual, e.g., individual distress regarding study procedures. Because the smallest unit of analysis is the individual in this study, we opted to provide the number of individuals.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 27, 2023	Sep 18, 2025	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Jun 25, 2020	Sep 18, 2025	SAP_001.pdf
ICF	No	No	Yes	Informed Consent Form	Apr 8, 2024	Sep 18, 2025	ICF_002.pdf

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

OG000	Intervention Arm	This is the Intervention Arm of the LetSync Pilot Study to evaluate the feasibility and acceptability of the LetSync app intervention and associated protocols and procedures to inform a full-scale RCT. The Intervention Arm received the LetSync app to use through the 8-month trial.
OG001	Control Arm	This is the Control Arm of the LetSync Pilot Study to evaluate the feasibility and acceptability of the LetSync app intervention and associated protocols and procedures to inform a full-scale RCT. The Control Arm did not receive the LetSync app.