Lifesteps for PrEP for Medication Adherence

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Miami, Miami, FLMedication AdherenceLifesteps for PrEP - Behavioral
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
PrEP N' Shine: Strength Based Case Management (Stage 1)
1
USE-MI System
2
SHINE Intervention

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: 3, 6, 9, 12, 15, and 18 months

Month 18
Retention in PrEP care
TFV-DP concentrations
up to 18 months
Wilson Medication Adherence self-report

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
PrEP N' Shine: Strength Based Case Management (Stage 1)
1
USE-MI System
3
SHINE Intervention

Trial Design

2 Treatment Groups

Standard of Care
1 of 2
Life-Steps for PreP
1 of 2

Active Control

Experimental Treatment

250 Total Participants · 2 Treatment Groups

Primary Treatment: Lifesteps for PrEP · No Placebo Group · N/A

Life-Steps for PrePExperimental Group · 2 Interventions: Daily text message reminders, Lifesteps for PrEP · Intervention Types: Behavioral, Behavioral
Standard of CareNoIntervention Group · 1 Intervention: Standard of Care · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daily text message reminders
2012
Completed Phase 3
~110

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3, 6, 9, 12, 15, and 18 months

Who is running the clinical trial?

University of MiamiLead Sponsor
806 Previous Clinical Trials
386,866 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,584 Previous Clinical Trials
1,984,488 Total Patients Enrolled
Steven A Safren, Ph.D.Principal InvestigatorUniversity of Miami
1 Previous Clinical Trials
9 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You identify yourself as a man who has sex with other men.
You have never taken PrEP medication before, or you are currently taking PrEP but are unsure if you can stick to the scheduled doses.
You currently have mental health issues like depression, heavy alcohol or drug use, past trauma or abuse, or current violence in your personal relationships.
You have a cell phone with text and internet/data capabilities.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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