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

NCT ID: NCT01191203

Last Updated: 2013-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-12-31

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

Conditions

HIV

Keywords

Acceptability and Adherence to methods

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Depo Medroxyprogesterone Acetate

Group Type: ACTIVE_COMPARATOR

Depo Medroxyprogesterone acetate

Intervention Type: DRUG

DMPA 150 mg IM q 3 months

Copper IUD (CuT360)

Group Type: ACTIVE_COMPARATOR

Copper IUD

Intervention Type: DRUG

Copper IUD (CuT360)

Interventions

Copper IUD

Copper IUD (CuT360)

Intervention Type: DRUG

Depo Medroxyprogesterone acetate

DMPA 150 mg IM q 3 months

Intervention Type: DRUG

Other Intervention Names

DMPA; Depo Provera

Eligibility 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

•Current STI or PID

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina

OTHER

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Lisa Haddad

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa Haddad, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Sam Phiri, PhD

Role: PRINCIPAL_INVESTIGATOR

Lighthouse Trust

Locations

The Lighthouse Trust

Lilongwe, Lilongwe, Malawi

Countries

Malawi

Other Identifiers

IRB00037535

Identifier Type: -

Identifier Source: org_study_id