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 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT01191203
Eligibility Criteria:
Inclusion Criteria:
* Can provide informed consent
* Women ages 18-45
* Known HIV + status on antiretroviral therapy for at least 6 months
* Not currently pregnant
* Willing to initiate either DMPA or CuT380A-IUD. Women currently using DMPA or CuT380A-IUD will be excluded
* Do not desire to become pregnant within next 12 months
* Intend to stay in Lilongwe region for the duration of the study
* No known uterine anomalies based upon history
* Greater than or equal to 4 weeks post partum
* No known or suspected genital tract cancer
* No evidence of current pelvic inflammatory disease or cervicitis. Women with cervicitis at the time of examination will be treated with antibiotics and eligibility will be reassessed at a follow-up visit at least 7 days after treatment
* No pelvic inflammatory disease within prior 3 months
* No contraindications to DMPA or the CuT380A-IUD per the WHO medical eligibility criteria or Malawi National Reproductive Health Service Delivery Guidelines, 2007
* Based on clinical assessment, no condition that would preclude start of study intervention
Exclusion Criteria:
* Women ages younger than18 or older than 45
* Known HIV + status on antiretroviral therapy less than 6 months or not on antiretroviral therapy
* Pregnant
* Uterine anomaly
* Less than 4 weeks post partum
* Suspected genital tract cancer
Inclusion Criteria:
•Current STI or PID
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01191203
Study Brief:
Protocol Section:
NCT01191203