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NCT06375135 · ClinicalTrials.gov registry record · NA
Efficacy of mHealth + e-Navigator Stepped Care Intervention for ART Adherence Among Latino Men With HIV
A NA study of ART Adherence, sponsored by Florida International University.
- Recruiting
- Registry status
- NA
- Development phase
- 250
- Enrollment target
- 1
- Study location
NCT06375135: Recruiting NA study of ART Adherence, sponsored by Florida International University.
NCT06375135 is a NA study of ART Adherence that is actively recruiting participants, run by Florida International University. The registered enrollment target is 250 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06375135, a NA study of ART Adherence, is actively recruiting participants, sponsored by Florida International University.
- RECRUITING
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to evaluate the efficacy of stepped care strategies to improve ART adherence among adult Latino men 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 men 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 men 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 men 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) s
Primary Outcome
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
Conditions Studied
Interventions
- BEHAVIORAL TXTXT
- BEHAVIORAL e-Navigation
- BEHAVIORAL Ecological Momentary Assessment (EMA) supported e-Navigation.
Study Locations (1)
Florida
- Care Resource Community Health Centers, Inc., d/b/a CARE RESOURCE - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2024-06-06 |
| Est. Completion | 2027-03-31 |
| Phase | NA |
What NCT06375135 shows while recruiting
NCT06375135 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).
The record links to 1 condition, with ART Adherence appearing as the primary indexed condition, and to 3 interventions - of which TXTXT is the first listed.
NCT06375135 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06375135 about?
NCT06375135 is a clinical study titled "Efficacy of mHealth + e-Navigator Stepped Care Intervention for ART Adherence Among Latino Men With HIV". The goal of this study is to evaluate the efficacy of stepped care strategies to improve ART adherence among adult Latino men 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 st...
What is the current status of trial NCT06375135?
This trial is currently recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2024-06-06. Estimated completion is 2027-03-31.
What conditions does trial NCT06375135 study?
This clinical trial studies the following conditions: ART Adherence.
What interventions are being tested in trial NCT06375135?
The interventions under investigation include: TXTXT (BEHAVIORAL), e-Navigation (BEHAVIORAL), Ecological Momentary Assessment (EMA) supported e-Navigation. (BEHAVIORAL).
Who is sponsoring clinical trial NCT06375135?
This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06375135 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06375135's enrollment target sits among peer trials
250 410th of 2000 higher than 1,567 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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