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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); University of North Carolina
• Treatments: Copper; Medroxyprogesterone; Medroxyprogesterone Acetate

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