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 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT04018651
Eligibility Criteria:
Inclusion Criteria:
* 18 + years of age;
* born female;
* Identifies as female;
* Identifies as African American, Hispanic/Latina or Haitian (self or parent);
* Able to provide informed consent;
* HIV uninfected;
* Sexual risk (previous STI, inconsistent condom use, transactional sex, HIV infected partner);
* History of alcohol or drug use in last 3 months;
* No uncleared PrEP contraindications;
* No psychosis.
Exclusion Criteria:
* Less than 18 years of age
* male gender assignment at birth
* current male gender identity
* does not identify as African American, Haitian or Hispanic/Latina (self or parent)
* reports history of or current untreated psychosis
* unable to provide informed consent
* HIV infected
* Refuses PrEP medication
* Untreated medical contraindication for PrEP
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04018651
Study Brief:
Protocol Section:
NCT04018651