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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
  Purpose

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 Intervention
HIV
Drug: Copper IUD
Drug: Depo Medroxyprogesterone acetate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Adherence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of clients continuing with method at 1 year


Secondary Outcome Measures:
  • 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



Enrollment: 200
Study Start Date: July 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191203

Locations
Malawi
The Lighthouse Trust
Lilongwe, Malawi
Sponsors and Collaborators
Emory University
University of North Carolina
Investigators
Principal Investigator: Lisa Haddad, MD Emory University
Principal Investigator: Sam Phiri, PhD Lighthouse Trust
  More Information

No publications provided

Responsible Party: Lisa Haddad, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01191203     History of Changes
Other Study ID Numbers: IRB00037535
Study First Received: June 2, 2010
Last Updated: October 23, 2013
Health Authority: Malawi: National Health Sciences Research Committee

Keywords provided by Emory University:
Acceptability and Adherence to methods

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

ClinicalTrials.gov processed this record on November 27, 2014