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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT03256435
Eligibility Criteria:
Inclusion Criteria:
* 18-35 years of age
* assigned male sex at birth
* African American race
* report having sex with another person assigned male at birth who identifies as a man within the last year
* report behavioral risk for HIV infection (consistent with the CDC guidelines for prescribing PrEP: unprotected anal intercourse (UAI) with at least one HIV-infected or unknown serostatus partner in the preceding 6 months)
* HIV-uninfected by antibody test
* able to understand and speak English (for consenting and counseling).
Exclusion Criteria:
* unable to provide informed consent, including people with severe mental illness requiring immediate treatment or with mental illness limiting their ability to participate
* for aims 2 and 3 only, participants who are positive for Hepatitis B antigen or diagnosed with renal insufficiency (Glomerular Filtration Rate\<50)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT03256435
Study Brief:
Protocol Section:
NCT03256435