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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT06897059
Eligibility Criteria:
Inclusion Criteria:
* Assigned female at birth
* Age 15-24 years
* Healthy and weight at least 35kg
* Sexually active (had a male sexual partner in the past 6 months)
* Consistent access to a smartphone
* HIV-negative (clinic test)
* PrEP naive or no PrEP use in the past 6 months
* Eligible to start oral PrEP
Exclusion Criteria:
* Unable to currently start PrEP
* Abnormal laboratory, medical, physical, or social finding which could impact study participation, by investigator discretion
* Unwilling or unable to provide informed consent
* Participating in another PrEP trial
* Unwilling to provide at least 2 forms of contact for follow-up
* Taking renal toxic medications
* Sexual partner known to be HIV-positive
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
15 Years
Maximum Age:
24 Years
Study:
NCT06897059
Study Brief:
Protocol Section:
NCT06897059