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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT04097834
Eligibility Criteria:
Inclusion Criteria:
1. Must be self-identified as born female
2. Must be able to be provide written informed consent
3. Must be able to speak and understand English as determined by staff during recruitment
4. Must be 13-45 years old at time of consent
5. Must have been seen for a patient visit in one of the three implementation clinics during the preceding 60 days and identified as a PrEP candidate based on point-of-care HIV testing and risk assessment
Exclusion Criteria:
1. HIV-infected at the time of screening by self-report or screening laboratory assessment
2. Currently enrolled in an HIV vaccine trial
3. Has any condition that in the opinion of study staff would make participation in the study unsafe or interfere with achieving study objectives
4. Has been on PrEP for 7 or more consecutive days in the past
5. Currently receiving PrEP services at any location outside the 3 implementation clinics
6. Currently participating in another PrEP or candidate PrEP study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
13 Years
Maximum Age:
45 Years
Study:
NCT04097834
Study Brief:
Protocol Section:
NCT04097834