Actively Recruiting
Efficacy of mHealth and e-Navigator Stepped Care Intervention for ART Adherence Among Latino Men With HIV
Led by Florida International University · Updated on 2026-01-30
250
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Florida International University
Lead Sponsor
A
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate stepped care strategies to improve adherence to antiretroviral therapy (ART) among adult Latino men living with HIV. The study compares two approaches: one starting with TXTXT alone and stepping up to remote patient navigation for those not responding, and another starting with TXTXT plus e-Navigation and stepping up to EMA-supported e-Navigation for non-responders. The goal is to assess which strategy better supports medication adherence and viral suppression over time using a randomized SMART design. Participants will be assigned to one of two groups. Arm 1 begins with TXTXT only, which involves personalized daily SMS reminders and encouraging messages for six months. Those with less than 90% adherence at three months may receive added e-Navigation support, which includes remote patient navigation, care coordination, and HIV self-management sessions via video calls. Arm 2 starts with TXTXT plus e-Navigation, with non-responders at three months potentially receiving additional Ecological Momentary Assessment (EMA)-supported e-Navigation, involving frequent brief surveys to identify and address adherence barriers. All interventions end at six months, followed by a six-month follow-up period. Throughout the study, ART adherence will be measured at each visit, focusing on 6-month and 12-month assessments. Viral load suppression will also be evaluated at these times. Participants will engage in text messaging, video sessions, and EMA surveys as applicable. Researchers will monitor adherence, viral suppression, and factors influencing response to the stepped care strategies. The total study duration for participants is 12 months, including intervention and follow-up periods.
CONDITIONS
Brief Title
Efficacy of mHealth + e-Navigator Stepped Care Intervention for ART Adherence Among Latino Men With HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Latino or Hispanic
- Self-report male sex
- Age 18 or older
- Diagnosed with HIV and prescribed ART at least 1 month prior to study screening and enrollment
- Suboptimal adherence defined by at least one detectable viral load in the past 12 months, or less than 90% adherence in the past 30 days by self-report or electronic record
- Own a personal cell phone and use SMS text messaging
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants receive behavioral interventions involving daily personalized SMS reminders (TXTXT) and e-Navigation support, including remote one-on-one sessions and care coordination. Some participants may also complete brief ecological momentary assessments (EMAs) multiple times per week to identify and address adherence barriers.
Bi-weekly e-Navigation meetings initially, daily text reminders, and EMA surveys three times per week for some participants
Duration - 6 months
Participants are followed for 6 months after the intervention ends to monitor ART adherence and viral suppression.
Assessments at 12 months post-enrollment
Trial Site Locations
Total: 1 location
1
Care Resource Community Health Centers, Inc., d/b/a CARE RESOURCE
Miami, Florida, United States, 331370000
Actively Recruiting
Research Team
M
Michelle M Hospital, Ph.D., LMHC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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