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 @ 4:30 PM
Ignite Modification Date:
2025-12-24 @ 4:30 PM
NCT ID:
NCT03464266
Eligibility Criteria:
Inclusion Criteria:
* Inclusion criteria:
* Age 16-25
If age 16-17:
* qualification as an emancipated minor (due to past pregnancy, being married, having a child, or catering for their own livelihood) or a mature minor (due to having a sexually transmitted infection) or able to have a parent/guardian provide informed consent
* HIV-uninfected
* Initiated DMPA within the past 90 days or using condoms only for contraception
* Willing and able to provide written informed consent
* Not planning to get pregnant in the next 24 months
* Sexually active
* Planning to remain in the study area for the next 2 years
Exclusion Criteria:
* Exclusion criteria:
* Currently enrolled in a biomedical HIV-1 prevention study
* Current or prior use of PrEP consecutively in the last 3 months
* Abnormal renal function (creatinine clearance \<60 min/ml)
* Hepatitis B infection
* Currently pregnant or breastfeeding
* Current DMPA use for longer than 90 days
* Use of implant, IUD, or oral contraceptives
* Past hysterectomy, oophorectomy, or tubal ligation
* Current or recent history of primary or secondary amenorrhea
* Taking medications known to interfere with bone metabolism (steroids, anti-convulsants, bisphosphonates, cancer drugs).
* Has any other condition that would preclude the ability to provide informed consent, make study participation unsafe, complicate the interpretation of study findings or otherwise interfere with achievement of the study objectives, in the investigator's discretion.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
25 Years
Study:
NCT03464266
Study Brief:
Protocol Section:
NCT03464266