Randomized Control Trial Copper Intrauterine Device and Depo-medroxyprogesterone Acetate (DMPA) of HIV+ Women in Malawi

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

Timeline

Start

2010-07

Primary completion

2011-12

Completion

2011-12

Drugs

Indications