Recruiting

mHealth & e-Navigator

Sponsor:

Florida International University

Code:

NCT06375135

Conditions

ART Adherence

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TXTXT

e-Navigation

Ecological Momentary Assessment (EMA) supported e-Navigation.

Study Details

Brief 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.

Conditions

ART Adherence

Study ID

NCT06375135

Start date

Jun 6, 2024

Status verified date

Jan, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

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.

Primary outcome measure

  • 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). ]

Central Contacts and Locations

Central contacts

Michelle M Hospital, Ph.D., LMHC

305-348-4867michelle.hospital@fiu.edu

Locations

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

Recruiting

Miami, Florida, United States, 331370000

Contacts

Sheryl J Zayas, MD

305-576-1234szayas@careresource.org

Principal Investigator:

Sheryl J Zayas, MD

More Information

Sponsor

Florida International University

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

  • HIV/AIDS
  • Treatment text
  • Ecological Momentary Assessment
  • Antiretroviral therapy adherence
  • medication adherence
  • viral suppression
  • HIV care strategies
  • Latino
  • Hispanic
  • SMART design

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Florida International University on 2026-01-30.