Randomized Control Trial Copper Intrauterine Device and Depo-medroxyprogesterone Acetate (DMPA) of HIV+ Women in Malawi
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
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 therapy. The only prior randomized trial looking at the IUD compared to
hormonal contraception noted a high rate of IUD discontinuations. Understanding IUD
acceptability and continuation is critical to improve utilization.
- Objective 1: Determine WHO medical eligibility and the willingness for IUD placement
- Objective 2: Compare method-related side effects and adverse events
- Objective 3: Assess the 1-year acceptability and continuation rates
Methods: To address our objectives the investigators have designed a two Phase Study:
- A cross-sectional screening to evaluate contraceptive medical eligibility and
desirability
- A randomized controlled trial that will compare acceptability and adherence to DMPA
compared to the Copper IUD: enrolling 200 women stable on antiretroviral therapy to
follow for 1 year
Phase:
N/A
Details
Lead Sponsor:
Emory University
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID) University of North Carolina