Status:
COMPLETED
Randomized Control Trial Copper Intrauterine Device and Depo-medroxyprogesterone Acetate (DMPA) of HIV+ Women in Malawi
Lead Sponsor:
Emory University
Collaborating Sponsors:
University of North Carolina
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
The IUD is an extremely effective method of contraception yet few women use it worldwide. Considered safe to use in HIV+ women, few studies have evaluated its use among those using antiretroviral ther...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01191203
Start Date
July 1 2010
End Date
December 1 2011
Last Update
October 25 2013
Active Locations (1)
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1
The Lighthouse Trust
Lilongwe, Lilongwe, Malawi