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

Sponsor
Emory University (Other)
Overall Status
Completed
CT.gov ID
NCT01191203
Collaborator
University of North Carolina (Other), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
200
Enrollment
1
Location
2
Arms
17
Duration (Months)
11.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Copper IUD
  • Drug: Depo Medroxyprogesterone acetate
 N/A

Study Design

Study Type:
Interventional
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 :
Jul 1, 2010
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

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)

    Outcome Measures

    Primary Outcome Measures

    1. Adherence [1 year]

      Number of clients continuing with method at 1 year

    Secondary Outcome Measures

    1. Adverse Events [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Lighthouse Trust Lilongwe Malawi

    Sponsors and Collaborators

    • Emory University
    • University of North Carolina
    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Principal Investigator: Lisa Haddad, MD, Emory University
    • Principal Investigator: Sam Phiri, PhD, Lighthouse Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lisa Haddad, Principal Investigator, Emory University
    ClinicalTrials.gov Identifier:
    NCT01191203
    Other Study ID Numbers:
    • IRB00037535
    First Posted:
    Aug 30, 2010
    Last Update Posted:
    Oct 25, 2013
    Last Verified:
    Oct 1, 2013
    Keywords provided by Lisa Haddad, Principal Investigator, Emory University
    Acceptability and Adherence to methods
    Additional relevant MeSH terms:
    Copper
    Medroxyprogesterone Acetate
    Medroxyprogesterone

    Study Results

    No Results Posted as of Oct 25, 2013