Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-30 @ 8:29 AM
Study NCT ID:
NCT01191203
Status:
COMPLETED
Last Update Posted:
2013-10-25
First Post:
2010-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Control Trial Copper Intrauterine Device and Depo-medroxyprogesterone Acetate (DMPA) of HIV+ Women in Malawi
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Prospective Assessment of Acceptability and Adherence Associated With Use of the Copper Intrauterine Device (CuT380A-IUCD) Compared to Depo-medroxyprogesterone Acetate (DMPA) Among HIV Positive Women in Lilongwe, Malawi
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: