Life Steps for PrEP for Youth
Completed · Not applicable
Conditions studied: HIV, Pre-exposure Prophylaxis, Medication Adherence
In brief
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 PrEP uptake and adherence in high risk young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM). Life-Steps for Pre-exposure prophylaxis (PrEP) is a manualized modular adherence intervention based on principles of cognitive-behavioral therapy (CBT), that allows for recipients of the intervention to focus on the greatest challenges that they perceive in maintaining optimal adherence to PrEP.
Key facts
- Study ID
- NCT03805451
- Run by
- Fenway Community Health
- People needed
- 32
- Starts
- 2019-09-27
- Expected to finish
- 2022-11-15
- Last updated by the study team
- 2023-03-22
Who can join
Age: 16 and older, up to 24. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- PRISM Health — Atlanta, Georgia, United States
- Core Center — Chicago, Illinois, United States
- Fenway Health — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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