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

Emory University

Status

Completed

Conditions

HIV

Treatments

Drug: Copper IUD

Drug: Depo Medroxyprogesterone acetate

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01191203

IRB00037535

Details and patient eligibility

About

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

Enrollment

200 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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