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Behavioral Intervention

Mobile Health App for HIV Care Management in Stimulant Users (START Trial)

N/A
Recruiting
Led By Adam W Carrico, PhD
Research Sponsored by Florida International University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Identifies as male
Self-reported HIV diagnosis for 3 or more months and currently taking anti-retroviral therapy (ART)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

START Trial Summary

This trial is testing whether a cell phone app can help HIV+ men on meth to better manage their HIV care.

Who is the study for?
The START trial is for men who were assigned male at birth, are HIV-positive, over 18 years old, live in the continental US, and have struggled with sticking to their HIV treatment while using stimulants like methamphetamine. They must speak English and be willing to use a cell phone app to help manage their medication adherence.Check my eligibility
What is being tested?
This study tests the START mobile health application's effectiveness in helping men adhere better to their HIV treatments while managing stimulant abuse issues. Participants will be randomly placed into groups where some will use this new app as part of their care routine.See study design
What are the potential side effects?
Since the intervention involves using a cell phone application rather than a drug or medical procedure, there are no direct physical side effects expected from participating in this trial.

START Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I identify as male.
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I have been HIV positive for over 3 months and am on ART.
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I am 18 years old or older.
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I was assigned male at birth.

START Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Detectable HIV Viral Load
Secondary outcome measures
Detectable Viral Load
Positive Affect
Self-Reported Anti-Retroviral Therapy (ART) Adherence
+1 more

START Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: START mHealth InterventionExperimental Treatment1 Intervention
Participants randomized to receive the START mHealth intervention will have access to the mHealth application for 6 months following randomization.
Group II: Website referralsActive Control1 Intervention
Participants in this condition will receive no intervention and will have access to a website with resources related to substance use disorder treatment and HIV treatment.

Find a Location

Who is running the clinical trial?

Florida International UniversityLead Sponsor
100 Previous Clinical Trials
17,205 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,468 Previous Clinical Trials
2,618,998 Total Patients Enrolled
University of MiamiLead Sponsor
901 Previous Clinical Trials
409,636 Total Patients Enrolled

Media Library

START (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05140876 — N/A
HIV Research Study Groups: Website referrals, START mHealth Intervention
HIV Clinical Trial 2023: START Highlights & Side Effects. Trial Name: NCT05140876 — N/A
START (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05140876 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment still recruiting participants?

"Indeed, the information hosted on clinicaltrials.gov shows that recruitment for this clinical trial is currently in progress and has been since June 15th 2022 when it was initially posted. Data from July 25th 2022 indicates that 350 patients are being sought at a single site."

Answered by AI

How many participants has the clinical trial attracted thus far?

"Affirmative. According to clinicaltrials.gov, this medical research project is still accepting participants; it was posted on June 15th 2022 and further amended on July 25th 2022. This trial wishes to bring in 350 people from one single site."

Answered by AI

Who else is applying?

What site did they apply to?
University of MIami
What portion of applicants met pre-screening criteria?
Met criteria
~75 spots leftby Oct 2024