Life-Steps Counseling to Enhance Adherence and Engagement in PrEP Care
Evaluation of Life-Steps to Enhance Adherence and Engagement in PrEP Care
2 other identifiers
interventional
300
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2020
CompletedFirst Posted
Study publicly available on registry
March 20, 2020
CompletedStudy Start
First participant enrolled
September 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedResults Posted
Study results publicly available
September 16, 2026
CompletedSeptember 16, 2026
August 1, 2026
4.8 years
March 19, 2020
April 8, 2026
August 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Participants With TFV-DP Concentrations Consistent With Adherence (≥4 Doses/Week)
Medication adherence as reported by Tenofovir diphosphate (TFV-DP) concentrations measured using dried blood spot (DBS) testing. Measured by the concentration of PrEP medication in dried blood spots (DBS), displaying levels consistent with adherence (4+ pills per week). Outcomes reported categorically as "adherent" vs. "not adherent." Count of participants measures participants with TFV-DP concentrations consistent with adherence (4+ pill per week).
3, 6, 9, 12, 15, and 18 months
Wilson Medication Adherence Self-Report
Medication adherence as reported by the Wilson Medication Adherence self-report. The questionnaire has a score ranging from 0-1, with a higher score indicating greater adherence.
3, 6, 9, 12, 15, and 18 months
Secondary Outcomes (1)
Retention in PrEP Care
3, 6, 9, 12, 15, and 18 months
Study Arms (2)
Life-Steps for PreP
EXPERIMENTALParticipants 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.
Standard of Care
NO INTERVENTIONParticipants in this group will not receive an intervention outside the standard of care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (2)
University of Miami
Miami, Florida, 33136, United States
Fenway Health
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The number of participants at each visit fluctuates due to attendance.
Results Point of Contact
- Title
- Steven A. Safren, PhD
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Steven A Safren, Ph.D.
University of Miami
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 19, 2020
First Posted
March 20, 2020
Study Start
September 3, 2020
Primary Completion
July 8, 2025
Study Completion
August 1, 2025
Last Updated
September 16, 2026
Results First Posted
September 16, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share