Status:
COMPLETED
Life Steps for PrEP for Youth
Lead Sponsor:
Fenway Community Health
Collaborating Sponsors:
Massachusetts General Hospital
University of North Carolina
Conditions:
HIV
Pre-exposure Prophylaxis
Eligibility:
MALE
16-24 years
Phase:
NA
Brief Summary
This is a formative study, designed to provide information required to tailor Life-Steps for Pre-Exposure Prophylaxis (PrEP), an evidence-based cognitive behavioral adherence intervention, to enhance ...
Detailed Description
Aim 1: To adapt Life-Steps for Pre-Exposure Prophylaxis (PrEP) to be culturally relevant and appropriate for at-risk young men who have sex with men (YMSM) and transgender women who have sex with men...
Eligibility Criteria
Inclusion
- age 16-24
- HIV-uninfected by self-report
- Assigned male sex at birth
- self-identify as a man who has sex with men or a trans woman who has sex with men
- able to understand English
- Self-reported HIV risk is defined as meeting at least one of the following criteria:
- At least one episode of unprotected anal intercourse with an HIV-positive partner with a penis or a partner with a penis of unknown HIV status during the last 6 months;
- Anal intercourse with 3 or more partners with a penis during the last 6 months;
- Exchange of money, gifts, shelter or drugs for anal sex with a partner with a penis during the last 6 months;
- Sex with a partner with a penis and has had an STI(sexually transmitted infection) during the last 6 months;
- Sexual partner of an HIV-positive person with a penis with whom condoms were not consistently used in the last 6 months; or
- At least one episode of anal intercourse where the condom broke or slipped off during the last 6 months
Exclusion
- Currently enrolled in another PrEP adherence study\*
- Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product.\*
- Enrollment in earlier phase of Life Steps for PrEP for Youth\*
- Unable to give informed consent/assent due to severe mental or physical illness/substance intoxication at baseline visit
- Has severe cognitive limitation that would limit their ability to comprehend the informed consent or assent
- Presence of an active (i.e. untreated) and interfering psychiatric disorder (e.g., bipolar disorder, schizophrenia, substance abuse)
Key Trial Info
Start Date :
September 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03805451
Start Date
September 27 2019
End Date
November 15 2022
Last Update
March 22 2023
Active Locations (3)
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1
PRISM Health
Atlanta, Georgia, United States, 30322
2
Core Center
Chicago, Illinois, United States, 60612
3
Fenway Health
Boston, Massachusetts, United States, 02215