mHealth + e-Navigator Stepped Care on ART Adherence in Latino MSM

Not Applicable

Recruiting

• Conditions: ART Adherence

• Registration Number: NCT06375135
• Lead Sponsor: Florida International University

Brief Summary

The goal of this study is to evaluate the efficacy of stepped care strategies to improve ART adherence among adult Latino MSM with HIV using a sequential, multiple assignment, randomized trial (SMART). The trial will compare a stepped care strategy of delivering TXTXT ("Treatment Text") first and stepping up to remote patient navigation for non-responders vs. a stepped care strategy of delivering TXTXT + e-Navigation first and stepping up to EMA-supported e-Navigation for non-responders. Both TXTXT and the foundations of the e-Navigation interventions are CDC evidence-based interventions (EBI). We propose to use a SMART design which explicitly allows building, testing, and optimizing stepped care strategies without compromising rigor or randomization. We propose three specific aims:

Aim 1. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two static (non-stepped) treatment regimens (TXTXT alone vs. TXTXT + e-Navigation) on ART adherence and viral suppression among Latino MSM with HIV. Hypothesis 1a. TXTXT + e-Navigation will be more efficacious than TXTXT alone. Aim 2. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two stepped care strategies (TXTXT with added e-Navigation for non-responders vs. TXTXT + e-Navigation with added EMA support for non-responders) on ART adherence and viral suppression among Latino MSM with HIV. Hypothesis 2a: TXTXT + e-Navigation with added EMA support for non-responders at the 3-month follow-up will be more efficacious than TXTXT with added e-Navigation for non-responders at the 3-month follow-up. Aim 3. Identify baseline and time-varying moderators on the association between stepped care strategy and ART adherence and viral suppression among Latino MSM with HIV. Hypotheses 3a-c: TXTXT with added e-Navigation for non-responders will be less efficacious than TXTXT + e-Navigation with added EMA support for non-responders for individuals who are: (a) older at baseline, or report (b) substance use, or (c) symptoms of depression between baseline and the 3-month follow-up.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-19
• Status Verified: 2024-06
• Study Start: 2024-06-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
ART adherence	ART adherence will be measured at each study visit. For efficacy analysis, ART adherence will be measured at 6-months (end of intervention) and at 12-months (6-months post-intervention).	ART adherence will be measured by self-report at each visit and by electronic pill dispenser throughout the study for both arms. Past 30-day adherence will be measured using a validated single-item Visual Analog Scale (VAS). Additionally, we will measure adherence through a Wisepill dispenser. The dispenser collects time-stamped data each time the dispenser is opened. Self-reported and Wisepill data will be analyzed as a continuous measure (proportion of pills taken) and dichotomized as adherent (≥90% of pills in past 30 days) and non-adherent (\<90%).

Secondary Outcome Measures

Name	Time	Method
HIV viral load	For efficacy analysis, viral suppression will be measured at 6-months (end of intervention) and at 12-months (6-months post-intervention).	HIV RNA copies per milliliter of blood plasma will be measured at baseline, 6-months (end of the intervention period), and 12-months (end of follow-up period). Collection of blood plasma levels will be conducted by Care Resource Health Center at their in-house laboratories. Viral load will be used as a continuous measure and dichotomized (suppressed \<200 copies/ml).

Trial Locations

Locations (1)

Care Resource Community Health Centers, Inc., d/b/a CARE RESOURCE; 🇺🇸 Miami, Florida, United States