Clinical trial Recruiting at 1 site Interventional Ages 18 and up Men only

Improving HIV treatment adherence in Latino men who have sex with men

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

Run by Florida International University · NCT06375135 · Data updated 2026-11-12

This study is trying to see if using text messages alone or with extra support can help Latino men who have sex with men stick to their HIV treatment better over a year.

More HIV Antiretroviral Therapy (ART) Adherence trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment250 (estimated)
SponsorFlorida International University
Academic / other
Locations1 site (Miami, Florida)
StatusRecruiting
StartedJune 6, 2024
Main results expectedMarch 31, 2027
Study endsMarch 31, 2027
Registry record updatedJanuary 30, 2026
Trial IDNCT06375135 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are Latino or Hispanic men assigned male at birth who identify as gay or bisexual, are 18 years or older, and have been diagnosed with HIV.

Probably not a fit

Patients who do not own a personal cell phone or do not use SMS may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of stepped care strategies to enhance adherence to antiretroviral therapy (ART) among adult Latino men who have sex with men (MSM) living with HIV. It employs a sequential, multiple assignment, randomized trial (SMART) design to compare two approaches: one that starts with a text messaging intervention (TXTXT) and another that combines TXTXT with e-Navigation support. The study aims to assess both immediate and sustained impacts on ART adherence and viral suppression over a 12-month period. Participants will be monitored for their response to the interventions, allowing for adjustments based on their adherence levels.

Why it matters

Potential benefit: If successful, this study could significantly improve ART adherence and health outcomes for Latino MSM living with HIV.

How similar studies have gone: Previous studies have shown success with similar stepped care approaches in improving medication adherence, indicating potential for this study's success.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Care Resource Community Health Centers, Inc., d/b/a CARE RESOURCE
    Miami, Florida, United States
    Recruiting

Study contacts

  • Principal investigator: Michelle M Hospi\utal, Ph.D, LMHC — Florida International University
  • Study coordinator: Michelle M Hospital, Ph.D., LMHC
  • Email: michelle.hospital@fiu.edu
  • Phone: 305-348-4867

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.