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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT04038060
Eligibility Criteria:
Inclusion Criteria:
* Female at birth
* Age 18-25 years
* Per participant report, sexually active, defined as having vaginal or anal intercourse at least once in the month prior to screening
* Literate in one or more of the study languages
* Willing and able to provide informed consent
* Able and willing to provide adequate locator information
* Regular access to a mobile phone with SMS and WhatsApp capacity
* Agrees not to participate in other research studies involving drugs or medical devices for the duration of study participation
Exclusion Criteria:
* Planning to relocate in the next 12 months
* Has a job or other obligations that would require long absences from the area (\> 4 weeks at a time) for 12 months
* A reactive or positive HIV test at Enrollment
* Any reported PrEP use within the last 6 months
* Concomitant participation in a clinical trial using investigational agents, including placebo-controlled clinical trials using such agents
* Prior participation in the active arm, or current participation in any arm, of an HIV vaccine trial
* Positive pregnancy test
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
25 Years
Study:
NCT04038060
Study Brief:
Protocol Section:
NCT04038060