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Behavioural Intervention

mHealth + e-Navigator for Medication Adherence (Project STEP Trial)

N/A
Recruiting
Led By Diana M Sheehan, Ph.D, M.P.H
Research Sponsored by Florida International University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or older
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up art adherence will be measured at each study visit. for efficacy analysis, art adherence will be measured at 6-months (end of intervention) and at 12-months (6-months post-intervention).
Awards & highlights

Summary

This trial is looking at different ways to help Latino men who have HIV stick to their medication. They are comparing two different strategies to see which one works better. One strategy involves sending treatment reminders via text

Who is the study for?
This trial is for adult Latino men who have sex with men (MSM) and are living with HIV. Participants should be currently on antiretroviral therapy (ART) but may struggle with taking their medication consistently.
What is being tested?
The study tests two strategies to improve ART adherence using text messages and e-Navigation, which includes remote patient guidance. Some participants will start with texts only and add e-Navigation if needed, while others get both from the start and may add extra EMA-supported navigation.
What are the potential side effects?
Since this trial focuses on text messaging and electronic navigation support systems rather than medications, traditional side effects are not a concern. However, there might be privacy concerns or stress related to regular communication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have missed taking my medication as prescribed in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for efficacy analysis, viral suppression will be measured at 6-months (end of intervention) and at 12-months (6-months post-intervention).
This trial's timeline: 3 weeks for screening, Varies for treatment, and for efficacy analysis, viral suppression will be measured at 6-months (end of intervention) and at 12-months (6-months post-intervention). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ART adherence
Secondary outcome measures
HIV viral load

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2 (starts with TXTXT and e-Navigation)Experimental Treatment3 Interventions
Arm 2 will begin with TXTXT and e-Navigation. ART adherence will be assessed at 3 months. If they are 90% adherent or above, they will continue with TXTXT and e-Navigation only for an additional 3 months. If they are less than 90% adherent, they will be re-randomized into staying only with TXTXT and e-Navigation, or into receiving TXTXT, e-Navigation plus EMA support for an additional 3 months. At 6 months, all interventions will end. Participants in this arm will be followed for 6 months after interventions cease.
Group II: Arm 1 (starts on TXTXT only)Experimental Treatment2 Interventions
Arm 1 will begin with TXTXT only. ART adherence will be assessed at 3 months. If they are 90% adherent or above, they will continue with TXTXT only for an additional 3 months. If they are less than 90% adherent, they will be re-randomized (1:1) into staying only with TXTXT, or into receiving TXTXT plus e-Navigation for an additional 3 months. At 6 months, all interventions will end. Participants in this arm will be followed for 6 months after interventions cease.

Find a Location

Who is running the clinical trial?

Florida International UniversityLead Sponsor
100 Previous Clinical Trials
17,177 Total Patients Enrolled
Ann & Robert H Lurie Children's Hospital of ChicagoOTHER
264 Previous Clinical Trials
5,192,904 Total Patients Enrolled
Care Resource Community Health CentersUNKNOWN
~167 spots leftby Mar 2027
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