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 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT02550067
Eligibility Criteria:
Inclusion Criteria:
* 16-35 years of age (previously pregnant 16 and 17 year olds, where permissible by national regulations and local IRB approval)
* HIV-seronegative
* Wants to use effective contraception
* Is able and willing to provide written informed consent
* Agrees to be randomized to either DMPA, LNG implant, or copper IUD
* Agrees to use assigned method for 18 months
* Agrees to follow all study requirements
* Intends to stay in the study area for the next 18 months, and willing and able to provide adequate locator information
* If has had a recent third trimester birth, is at least 6 weeks postpartum
* Is sexually active (has had vaginal sex within the last 3 months) or was pregnant within the last 3 months
* Agrees not to participate in studies of drugs or vaccines or any other clinical research study while participating in this study.
Exclusion Criteria:
* Reported medical contraindications (WHO MEC Category 3 or 4) to DMPA, LNG implant, or copper IUDs, including: recent septic abortion; suspicious unexplained vaginal bleeding; breast, cervical, uterine, or ovarian cancer; high BP or heart disease, venous thromboembolism, stroke, or diabetes; liver disease or liver tumours; use of liver enzyme inducing medications
* Is found to have pelvic tuberculosis or uterine fibroids with distortion of the uterine cavity on pelvic exam
* Has untreated mucus and purulent cervicitis on exam, untreated pelvic inflammatory disease (PID), or untreated known gonorrhea or chlamydia
* Has received a DMPA or NET-En injection in the last 6 months
* Has used an implant or an IUD in the last 6 months
* Is pregnant or intending to become pregnant in the next 18 months
* Has had a hysterectomy or sterilization
* Has previously participated in the study
* Has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe or complicate data interpretation.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
35 Years
Study:
NCT02550067
Study Brief:
Protocol Section:
NCT02550067