NCT06375135 Efficacy of mHealth + e-Navigator Stepped Care Intervention for ART Adherence Among Latino Men With HIV
| NCT ID | NCT06375135 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Florida International University |
| Condition | ART Adherence |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-06-06 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2024-06-06 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Michelle M Hospi\utal, Ph.D, LMHC
PRINCIPAL INVESTIGATOR
Florida International University
Frequently Asked Questions
Who can join the NCT06375135 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying ART Adherence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06375135 currently recruiting?
Yes, NCT06375135 is actively recruiting participants. Contact the research team at michelle.hospital@fiu.edu for enrollment information.
Where is the NCT06375135 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT06375135 clinical trial?
NCT06375135 is sponsored by Florida International University. The principal investigator is Michelle M Hospi\utal, Ph.D, LMHC at Florida International University. The trial plans to enroll 250 participants.