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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01191203
Recruitment Status : Completed
First Posted : August 30, 2010
Last Update Posted : October 25, 2013
University of North Carolina
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Lisa Haddad, Emory University

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

Condition or disease Intervention/treatment Phase
HIV Drug: Copper IUD Drug: Depo Medroxyprogesterone acetate Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : July 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Depo Medroxyprogesterone Acetate Drug: Depo Medroxyprogesterone acetate
DMPA 150 mg IM q 3 months
Other Names:
  • DMPA
  • Depo Provera

Active Comparator: Copper IUD (CuT360) Drug: Copper IUD
Copper IUD (CuT360)

Primary Outcome Measures :
  1. Adherence [ Time Frame: 1 year ]
    Number of clients continuing with method at 1 year

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 1 year ]

    -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

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01191203

The Lighthouse Trust
Lilongwe, Malawi
Sponsors and Collaborators
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

Responsible Party: Lisa Haddad, Principal Investigator, Emory University Identifier: NCT01191203     History of Changes
Other Study ID Numbers: IRB00037535
First Posted: August 30, 2010    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 2013

Keywords provided by Lisa Haddad, Emory University:
Acceptability and Adherence to methods

Additional relevant MeSH terms:
Medroxyprogesterone Acetate
Trace Elements
Growth Substances
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents