Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT03805451
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
16 Years
Maximum Age:
24 Years
Study:
NCT03805451
Study Brief:
Protocol Section:
NCT03805451