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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT05016232
Eligibility Criteria:
Inclusion Criteria:
* Age: 18 years or older
* Male sex at birth
* Self-identify as a woman, a transgender woman, or another identity along the male-to-female gender spectrum
* PrEP naïve
* PrEP indicated per CDC guidelines (incl. HIV negative)
* Owns a cell phone or willing to use one in the study
* Able to understand and speak English or Spanish
Exclusion Criteria:
* Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at time of visit
* Has lived in RI for less than three months (as a means to enhance participant retention)
* Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of interview (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. Hepatitis B infection, decreased creatinine clearance)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05016232
Study Brief:
Protocol Section:
NCT05016232