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

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Drug: Depo Medroxyprogesterone acetate; Drug: Copper IUD

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Lilongwe, Malawi
    • The Lighthouse Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Depo Medroxyprogesterone Acetate	Drug: Depo Medroxyprogesterone acetate; DMPA 150 mg IM q 3 months; Other Names: Depo Provera; DMPA
ACTIVE_COMPARATOR: Copper IUD (CuT360)	Drug: Copper IUD; Copper IUD (CuT360)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Number of clients continuing with method at 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	-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	1 year

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); University of North Carolina

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: June 2, 2010
• First Submitted That Met QC Criteria: August 27, 2010
• First Posted (ESTIMATE): August 30, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 25, 2013
• Last Update Submitted That Met QC Criteria: October 23, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Acceptability and Adherence to methods
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Trace Elements; Micronutrients; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Contraceptive Agents, Male; Copper; Medroxyprogesterone Acetate; Medroxyprogesterone
• Other Study ID Numbers: IRB00037535