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Completed

NCT Number: NCT01191203

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

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Key information

Conditions

HIV

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Lighthouse Trust

Lilongwe, Malawi

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Copper IUD

Drug

Copper IUD (CuT360)

Depo Medroxyprogesterone acetate

Drug

DMPA 150 mg IM q 3 months

Other names: DMPA, Depo Provera

Primary outcomes

  1. Adherence

    Time frame: 1 year

    Number of clients continuing with method at 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 30, 2010
Registry last updated
Oct 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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