Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT01191203
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 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
Study:
NCT01191203
Study Brief:
Protocol Section:
NCT01191203