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NCT Number: NCT06375135

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 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.

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Key information

Conditions

ART Adherence Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Medication Adherence Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Miami, Florida, 331370000, United States

Location status: Recruiting

Location contact

Sheryl J Zayas, MD

CONTACT

[email protected]

305-576-1234

Sheryl J Zayas, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Latino or Hispanic
  • Self-report male sex
  • Age 18 or older
  • Diagnosed with HIV and prescribed ART least 1 month prior to study screening and enrollment
  • 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.
  • Cell phone ownership and SMS use: Participants must own a personal cell phone for the intervention.

Treatment and study plan

TXTXT

Behavioral

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.

e-Navigation

Behavioral

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.

Ecological Momentary Assessment (EMA) supported e-Navigation.

Behavioral

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.

Primary outcomes

  1. 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%).

Secondary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle M Hospital, Ph.D., LMHC

CONTACT

[email protected]

305-348-4867

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Collaborators

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

Registry information

Acronym: Project STEP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 19, 2024
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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