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 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT03196492
Eligibility Criteria:
Inclusion Criteria:
* Age 13-24
* Female sex
* Seeking contraceptive/ STI services OR has had a child OR is legally married
* Has had consensual vaginal sex
* Two years have passed since menses started
* HIV negative by self-report
* Willing to refrain from using douches, washes, or other similar feminine hygiene products. (Tampons are allowed)
* Planning to receive the Depo-Provera shot, -OR- Have regular menstrual cycles with at least 21 - 45 days between menses and plans to use no hormonal birth control.
Exclusion Criteria:
* Any other immunodeficiency (e.g. organ transplant recipient)
* Recently pregnant (within 4 weeks), currently pregnant, or planning to become pregnant within the next 12 months
* Currently breastfeeding
* Hysterectomy or a known genital tract anomaly
* Amenorrhea (except if caused by contraceptive method like the implant)
* Antibiotic or antifungal use within past 30 days
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
13 Years
Maximum Age:
24 Years
Study:
NCT03196492
Study Brief:
Protocol Section:
NCT03196492