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:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT06931106
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years at enrollment;
* Assigned male at birth with a history of ≥1 male-male sexual encounter (anal or oral intercourse);
* HIV-negative confirmed by antibody testing at baseline;
* No prior use of PrEP;
* Expressed interest in PrEP intervention and commitment to complete scheduled follow-ups and data collection procedures;
* Mentally competent to provide informed consent and participate in decision-making;
* High HIV risk (meeting ≥1 of the following in the past 6 months): (1) Condomless anal/penile-vaginal intercourse; (2)Shared needle use during illicit drug injection; (3) Sexual contact with HIV-positive partner(s); (4) Newly diagnosed STI; (5) Repeated use of PEP for HIV prevention; or (6) Self-identified as PrEP candidate through voluntary request.
Exclusion Criteria:
* Confirmed HIV-positive status or unknown serostatus with refusal of HIV testing;
* Clinically significant health conditions contraindicating PrEP use (e.g., creatinine clearance \<60 mL/min, documented hypersensitivity to PrEP components);
* Severe mental illness or neurological disorders impairing informed consent process.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT06931106
Study Brief:
Protocol Section:
NCT06931106