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

NCT04316715 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-08-26

No results posted yet for this study

Summary

The purpose of this study is to test how different types of interventions may affect how someone takes their pre-exposure prophylaxis (PrEP) medication.

Conditions

  • Adherence, Medication

Interventions

BEHAVIORAL

Lifesteps for PrEP

Four weekly nurse delivered counseling sessions plus two optional booster sessions. Sessions last approximately 40-50 minutes each. Sessions employ cognitive behavioral (CBT) techniques, motivational interviewing (MI), and psychoeducation.

BEHAVIORAL

Daily text message reminders

Participants get daily text messages on their cell phone reminding them to take their PrEP medication.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Miami

    lead OTHER

Principal Investigators

  • Steven A Safren, Ph.D. · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-03
Primary Completion
2025-07-08
Completion
2025-08-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04316715 on ClinicalTrials.gov