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

This study has been completed.
Sponsor:
Collaborators:
University of North Carolina
Information provided by (Responsible Party):
Lisa Haddad, Emory University
ClinicalTrials.gov Identifier:
NCT01191203
First received: June 2, 2010
Last updated: October 23, 2013
Last verified: October 2013

June 2, 2010
October 23, 2013
July 2010
December 2011   (final data collection date for primary outcome measure)
Adherence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Number of clients continuing with method at 1 year
Same as current
Complete list of historical versions of study NCT01191203 on ClinicalTrials.gov Archive Site
Adverse Events [ Time Frame: 1 year ] [ Designated as safety issue: No ]

-Number of clients who experience adverse events such as pelvic inflammatory disease, lower genital tract infection, and infection related complications, such as abdominal pain, and irregular vaginal bleeding, as well as lower tract infection determined by clinical examination.

Side effects such as abnormal vaginal discharge, abnormal bleeding, IUCD expulsion, and other side effects, as measured by clinical examination and client self-report.

-Risk of excessive vaginal bleeding or anemia: determined by self report and hemoglobin level

Same as current
Not Provided
Not Provided
 
Randomized Control Trial Copper Intrauterine Device and Depo-medroxyprogesterone Acetate (DMPA) of HIV+ Women in Malawi
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

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV
  • Drug: Copper IUD
    Copper IUD (CuT360)
  • Drug: Depo Medroxyprogesterone acetate
    DMPA 150 mg IM q 3 months
    Other Names:
    • DMPA
    • Depo Provera
  • Active Comparator: Depo Medroxyprogesterone Acetate
    Intervention: Drug: Depo Medroxyprogesterone acetate
  • Active Comparator: Copper IUD (CuT360)
    Intervention: Drug: Copper IUD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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

Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Malawi
 
NCT01191203
IRB00037535
No
Lisa Haddad, Emory University
Emory University
  • University of North Carolina
  • National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Lisa Haddad, MD Emory University
Principal Investigator: Sam Phiri, PhD Lighthouse Trust
Emory University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP