Improving HIV treatment adherence in Latino men who have sex with men
Efficacy of mHealth + e-Navigator Stepped Care Intervention for ART Adherence Among Latino Men With HIV
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Florida International University Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06375135 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who do not own a personal cell phone or do not use SMS may not benefit from this study.
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 performed: Previous studies have shown success with similar stepped care approaches in improving medication adherence, indicating potential for this study's success.
Eligibility criteria
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 this trial is running
Miami, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.