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:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT05095818
Eligibility Criteria:
Inclusion Criteria:
* not living with HIV
* weight \>35 kg
* receiving OB/GYN care in our preselected clinics
* GYN patients: positive sexually transmitted infection (STI) diagnosis within past 6 months, or if seeking STI testing and a have a history of an STI
* OB patients: at least one positive answer to the following risk screen: inject illicit drugs; sex with a partner who injects illicit drugs; any past STIs; sex with a partner who has sex with both men and women; sex for money, drugs, other payment; sex with a partner currently infected with HIV; sex with more than one partner
Exclusion Criteria:
* symptoms or clinical signs consistent with acute HIV infection
* unknown HIV infection status
* allergies to the active substances or any excipients of PrEP
* estimated creatinine clearance of \<60 mL/minute
* active Hepatitis B infection
* participating in other clinical studies related to HIV and/or antiretroviral therapy
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
15 Years
Maximum Age:
45 Years
Study:
NCT05095818
Study Brief:
Protocol Section:
NCT05095818