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

January 28, 2026 updated by: Michelle M. Hospital, PhD, LMHC, BBA, Florida International University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 331370000
        • Recruiting
        • Care Resource Community Health Centers, Inc., d/b/a CARE RESOURCE
        • Contact:
        • Principal Investigator:
          • Sheryl J Zayas, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 (starts on TXTXT only)
Arm 1 will begin with TXTXT only. ART adherence will be assessed at 3 months. If they are 90% adherent or above, they will continue with TXTXT only for an additional 3 months. If they are less than 90% adherent, they will be re-randomized (1:1) into staying only with TXTXT, or into receiving TXTXT plus e-Navigation for an additional 3 months. At 6 months, all interventions will end. Participants in this arm will be followed for 6 months after interventions cease.
Behavioral: TXTXT
Treatment Text (TXTXT) is composed of personalized 2-way SMS text message reminders and encouraging messages. Daily text message reminders will be sent according to the participants medication schedule for six months. A study coordinator will enter the participants phone number in the TXTXT system and set the program to provide daily reminders at the time consistent with the clinical dosing schedule of their ART. Participants will have the option of choosing to create a personalized message that may be changed at any time, because the messages are personalized, they may be in any language the participant desires. Fifteen minutes after this initial message, participants will be asked to send a text message response indicating if they took their medications. Participants responses will be followed by one of a set of randomly selected encouraging messages depending on their affirmative or negative response.
Behavioral: e-Navigation

Develop an e-Navigation intervention using all three components of CDCs STEPS to Care intervention:(1) patient navigation, (2) care coordination, and (3) HIV-self-management.

Patient Navigation: Remote one-on-one sessions, will help improve medication adherence, access to social services, and prompt re-engagement in care.

Care coordination: Frequent and open communication with the care team. E-navigator will share client progress and needs, support information-sharing and decision-making to improve health outcomes for clients.

HIV self-management: HIV education and guidance with goal setting. E-navigator will help clients build knowledge and skills for self-care, navigating the health care system, and independent health maintenance.

The e-Navigator will meet with participants bi-weekly at first but may meet less frequently over time as barriers are addressed. Meetings will be conducted via videoconferencing and will be used to check in and provide individualized support.
Experimental: Arm 2 (starts with TXTXT and e-Navigation)
Arm 2 will begin with TXTXT and e-Navigation. ART adherence will be assessed at 3 months. If they are 90% adherent or above, they will continue with TXTXT and e-Navigation only for an additional 3 months. If they are less than 90% adherent, they will be re-randomized into staying only with TXTXT and e-Navigation, or into receiving TXTXT, e-Navigation plus EMA support for an additional 3 months. At 6 months, all interventions will end. Participants in this arm will be followed for 6 months after interventions cease.
Behavioral: TXTXT
Treatment Text (TXTXT) is composed of personalized 2-way SMS text message reminders and encouraging messages. Daily text message reminders will be sent according to the participants medication schedule for six months. A study coordinator will enter the participants phone number in the TXTXT system and set the program to provide daily reminders at the time consistent with the clinical dosing schedule of their ART. Participants will have the option of choosing to create a personalized message that may be changed at any time, because the messages are personalized, they may be in any language the participant desires. Fifteen minutes after this initial message, participants will be asked to send a text message response indicating if they took their medications. Participants responses will be followed by one of a set of randomly selected encouraging messages depending on their affirmative or negative response.
Behavioral: e-Navigation

Develop an e-Navigation intervention using all three components of CDCs STEPS to Care intervention:(1) patient navigation, (2) care coordination, and (3) HIV-self-management.

Patient Navigation: Remote one-on-one sessions, will help improve medication adherence, access to social services, and prompt re-engagement in care.

Care coordination: Frequent and open communication with the care team. E-navigator will share client progress and needs, support information-sharing and decision-making to improve health outcomes for clients.

HIV self-management: HIV education and guidance with goal setting. E-navigator will help clients build knowledge and skills for self-care, navigating the health care system, and independent health maintenance.

The e-Navigator will meet with participants bi-weekly at first but may meet less frequently over time as barriers are addressed. Meetings will be conducted via videoconferencing and will be used to check in and provide individualized support.

Behavioral: Ecological Momentary Assessment (EMA) supported e-Navigation.
Participants in the Ecological Momentary Assessment (EMA) supported e- Navigation intervention will be asked to complete 4 to 6-minute EMAs via a secure survey link three times per week to assess adherence barriers in real or near real time. In addition to time-based EMA (study prompted), participants will also be able to submit event based EMAs (participant prompted) at any time. The e-Navigator will review responses to EMAs and remotely assist participants in addressing these barriers within 2 business days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ART adherence
Time Frame: 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%).
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV viral load
Time Frame: 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).
For efficacy analysis, viral suppression will be measured at 6-months (end of intervention) and at 12-months (6-months post-intervention).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida International University

Collaborators

Ann & Robert H Lurie Children's Hospital of Chicago
Care Resource Community Health Centers, Inc.

Investigators

  • Principal Investigator: Michelle M Hospi\utal, Ph.D, LMHC, Florida International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R1MD017205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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