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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
144
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.
University of California San Francisco
San Francisco, California, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 8 months
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.
Time frame: 8 months
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