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Life-Steps Counseling + Text Reminders for Medication Adherence

N/A

Recruiting

Led By Steven A Safren, Ph.D.

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male sex at birth or trans man (current gender identity is male) assigned female sex at birth

Self-reports as a person who has sex with men

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 9, 12, 15, and 18 months

Awards & highlights

Study Summary

This trial is testing different ways to help people remember to take their PrEP medication every day.

Who is the study for?

This trial is for adults who were assigned male at birth or are trans men, indicated for PrEP by CDC guidelines, and have issues like depression, substance use, or trauma. They must own a smartphone with texting/internet and be new to PrEP or unsure about sticking to it. People can't join if they're unable to consent due to severe illness/cognitive impairment, have kidney issues preventing PrEP use, or active suicidal thoughts/untreated major mental illness.Check my eligibility

What is being tested?

The study is testing how daily text message reminders and LifeSteps counseling might help people take their PrEP medication more consistently. Participants will receive interventions aimed at improving adherence and engagement in their preventive care routine.See study design

What are the potential side effects?

Since the interventions involve counseling and text messages rather than medications, there are no direct side effects from the treatments being tested in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man or a trans man.

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I identify as a man who has sex with men.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 9, 12, 15, and 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 9, 12, 15, and 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 9, 12, 15, and 18 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

TFV-DP concentrations

Wilson Medication Adherence self-report

Secondary outcome measures

Retention in PrEP care

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Life-Steps for PrePExperimental Treatment2 Interventions

Participants in this group will receive standard of care treatment plus daily text message reminders. A subset of participants who demonstrate continued adherence challenges will also receive 4-6 weekly sessions of the Lifesteps for PrEP intervention.

Group II: Standard of CareActive Control1 Intervention

Participants in this group will not receive an intervention outside the standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daily text message reminders

2012

Completed Phase 3

~110

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

902 Previous Clinical Trials

409,826 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,449 Total Patients Enrolled

Steven A Safren, Ph.D.Principal InvestigatorUniversity of Miami

1 Previous Clinical Trials

9 Total Patients Enrolled

Media Library

Lifesteps for PrEP Clinical Trial Eligibility Overview. Trial Name: NCT04316715 — N/A

Medication Adherence Research Study Groups: Standard of Care, Life-Steps for PreP

Medication Adherence Clinical Trial 2023: Lifesteps for PrEP Highlights & Side Effects. Trial Name: NCT04316715 — N/A

Lifesteps for PrEP 2023 Treatment Timeline for Medical Study. Trial Name: NCT04316715 — N/A

Frequently Asked Questions

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

What is the current enrolment number of this research project?

"Affirmative. The information available on clinicaltrials.gov demonstrates that, since its original posting in September 3rd 2020, this medical experiment is still recruiting participants. A total of 250 patients are required to be enrolled from two distinct sites."

Answered by AI

Are there any open opportunities to participate in this research trial?

"Affirmative. Clinicaltrials.gov states that this medical research project, which was initially posted on September 3rd 2020 is currently recruiting participants. In total, 250 individuals are necessary to be gathered from 2 distinct locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Life-Steps Counseling to Enhance Adherence and Engagement in PrEP Care

Steven Safren 2020. "Life-Steps Counseling to Enhance Adherence and Engagement in PrEP Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04316715.