Status:
COMPLETED
Life-Steps Counseling to Enhance Adherence and Engagement in PrEP Care
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Adherence, Medication
Eligibility:
MALE
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04316715
Start Date
September 3 2020
End Date
August 1 2025
Last Update
August 26 2025
Active Locations (2)
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1
University of Miami
Miami, Florida, United States, 33136
2
Fenway Health
Boston, Massachusetts, United States, 02215