Efficacy of mHealth + e-Navigator Stepped Care Intervention for ART Adherence Among Latino Men With HIV

Last updated: January 28, 2026
Sponsor: Florida International University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv Infections

Aids And Aids Related Infections

Hiv/aids

Treatment

TXTXT

Ecological Momentary Assessment (EMA) supported e-Navigation.

e-Navigation

Clinical Study ID

NCT06375135
R1MD017205
  • Ages > 18
  • Male

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) substance use, or (c) symptoms of depression between baseline and the 3-month follow-up.

Eligibility Criteria

Inclusion

  1. Latino or Hispanic

  2. Self-report male sex

  3. Age 18 or older

  4. Diagnosed with HIV and prescribed ART least 1 month prior to study screening and enrollment

  5. Suboptimal adherence defined as (1) laboratory evidence of at least one detectable viral load in the past 12 months (≥20 copies/mL), (2) electronic medical record of at least one <90% 30-day adherence period in the past 12 months, or (3) self-reported <90% past 30-day adherence.

  6. Cell phone ownership and SMS use: Participants must own a personal cell phone for the intervention.

Study Design

Total Participants: 250
Treatment Group(s): 3
Primary Treatment: TXTXT
Phase:
Study Start date:
June 06, 2024
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Care Resource Community Health Centers, Inc., d/b/a CARE RESOURCE

    Miami, Florida 331370000
    United States

    Site Not Available

  • Care Resource Community Health Centers, Inc., d/b/a CARE RESOURCE

    Miami 4164138, Florida 4155751 331370000
    United States

    Active - Recruiting

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