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 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT02713750
Eligibility Criteria:
Inclusion Criteria:
* Female 12 to 24 years of age
* HIV-positive status
* HIV-disclosed before screening visit
* Having had first menstrual cycle (menarche)
* Sexually active
* Willing to participate in the study and signed informed consent form, including signed inform consent by caretaker for subjects \<18 years of age
Exclusion Criteria:
* Being pregnant at the time of screening visit
* Mental or physical conditions that may limit informed participation in the study
* Having active AIDS or opportunistic infections
Non-eligible subjects to use hormonal contraception:
* Thrombosis or history of it
* Family history of thrombosis
* Hypertension (for combined oral contraceptives)
* Hyperlipidemia (toxicity grade \>3)
* Diabetes mellitus with vascular involvement
* Presence or history of liver hepatic disease
* Malignant disease of genital organs and breast
* Undiagnosed vaginal bleeding
* Lactation
* Hypersensitivity to steroid hormones
Eligible subjects to use intrauterine device:
* In case of HAART, last CD4 count \> 200 cells/mm3 no more than 6 months prior to the screening
* If without HAART, last CD4 count \>350 cells/mm3 no more than 6 months prior to the screening
* Normal cervical Pap smear in the last 6 months/in the day of IUD insertion
Non-eligible subjects to use intrauterine device:
* Having an active infection of the vagina or cervix
* Having pelvic inflammatory disease (PID) or have a recent history of PID
* Having a bleeding disorder or taking anticoagulants
* Having abnormalities of the uterus
* Having a uterine infection after childbirth or a septic abortion
* Having uterine bleeding of unknown origin
* Having an allergy to copper
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
12 Years
Maximum Age:
24 Years
Study:
NCT02713750
Study Brief:
Protocol Section:
NCT02713750