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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 250 (estimated) |
| Sponsor | Florida International University Academic / other |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | June 6, 2024 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | January 30, 2026 |
| Trial ID | NCT06375135 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.
-
reSTART: remote support to help men with HIV take their medication and reduce stimulant use
This trial will test whether a remote program of positive messages, motivational support, and a home urine tenofovir self-test can help men with HIV who use stimulants remember their HIV medicines and lower their viral load.
-
Using a point-of-care urine tenofovir test to improve HIV treatment adherence and viral suppression
This will test whether giving adults with HIV who are not yet virally suppressed a quick urine test showing recent tenofovir use, plus targeted counseling, helps them reach viral suppression in clinics in the Eastern Cape, South Africa.
-
Evaluating the effectiveness of a new HIV treatment based on patient adherence
This study is testing a new HIV treatment to see how well it works for people who stick to their medication schedule and how it affects their overall health over two years.
-
Supportive housing program for people with HIV
This study is testing a supportive housing program for people with HIV to see if it helps them manage their health better and stay in stable housing.
-
Reducing alcohol use and improving HIV treatment for men in fishing communities
This study is testing a new program to help men with HIV in fishing communities cut down on drinking and stick to their HIV treatment to improve their health.
-
Motivation Matters! text messages to help women stick to HIV treatment
This project will test whether the Motivation Matters! text-message program helps women with HIV who are starting ART take their medicine and reach an undetectable viral load by six months.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.