- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04316715
Life-Steps Counseling to Enhance Adherence and Engagement in PrEP Care
August 14, 2023 updated by: Steven Safren, University of Miami
Evaluation of Life-Steps to Enhance Adherence and Engagement in PrEP Care
The purpose of this study is to test how different types of interventions may affect how someone takes their pre-exposure prophylaxis (PrEP) medication.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marc Puccinelli, Ph.D.
- Phone Number: 3052433508
- Email: mpuccinelli@miami.edu
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- Recruiting
- University of Miami
-
Contact:
- Marc Puccinelli, Ph.D.
- Phone Number: 305-243-3508
- Email: mpuccinelli@miami.edu
-
Principal Investigator:
- Steven A Safren, Ph.D.
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Fenway Health
-
Contact:
- Jairan Sadeghi, BSN
- Phone Number: 857-313-6978
- Email: jsadeghi@fenwayhealth.org
-
Principal Investigator:
- Kenneth Mayer, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age: 18 years or older
- 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
- PrEP naïve or is currently prescribed PrEP and reports uncertainty about future adherence
- Medical providers at each site will determine that the participant is indicated for PrEP per Centers for Disease Control (CDC) guidelines
- Screens in for currently having one or more of the following psychosocial syndemic problems: depression; heavy alcohol use; problematic substance use or polydrug use; history of trauma or abuse; and/or current interpersonal violence
- Owns a cell phone that has texting and internet / data capacity
Exclusion Criteria:
- Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview
- Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of enrollment (these patients will be referred immediately for treatment, but may join the study when this is resolved)
- Laboratory or clinical findings that would preclude PrEP initiation (e.g. decreased creatinine clearance)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Life-Steps for PreP
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.
|
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.
Participants get daily text messages on their cell phone reminding them to take their PrEP medication.
|
No Intervention: Standard of Care
Participants in this group will not receive an intervention outside the standard of care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TFV-DP concentrations
Time Frame: 3, 6, 9, 12, 15, and 18 months
|
Medication adherence as reported by Tenofovir diphosphate (TFV-DP) concentrations measured using dried blood spot (DBS) testing.
|
3, 6, 9, 12, 15, and 18 months
|
Wilson Medication Adherence self-report
Time Frame: up to 18 months
|
Medication adherence as reported by the Wilson Medication Adherence self-report.
The questionnaire has a total score ranging from 0-40, with a higher score indicating greater adherence.
|
up to 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retention in PrEP care
Time Frame: 3, 6, 9, 12, 15, and 18 months
|
The percentage of participant attendance at follow up visits over 18 month study participation
|
3, 6, 9, 12, 15, and 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Steven A Safren, Ph.D., University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 3, 2020
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
August 1, 2024
Study Registration Dates
First Submitted
March 19, 2020
First Submitted That Met QC Criteria
March 19, 2020
First Posted (Actual)
March 20, 2020
Study Record Updates
Last Update Posted (Actual)
August 15, 2023
Last Update Submitted That Met QC Criteria
August 14, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20190646
- R01MH118043 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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