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

NCT01191203 | Completed

• 1 other identifier: IRB00037535
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Adherence

  Number of clients continuing with method at 1 year

  1 year

Secondary Outcomes (1)

• Adverse Events

  1 year

Study Arms (2)

Depo Medroxyprogesterone Acetate

ACTIVE COMPARATOR

Drug: Depo Medroxyprogesterone acetate

Copper IUD (CuT360)

ACTIVE COMPARATOR

Drug: Copper IUD

Interventions

Copper IUD DRUG

Copper IUD (CuT360)

Copper IUD (CuT360)

Depo Medroxyprogesterone acetate DRUG

DMPA 150 mg IM q 3 months

Also known as: DMPA, Depo Provera

Depo Medroxyprogesterone Acetate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Current STI or PID

Sponsors & Collaborators

• Emory University: lead
• University of North Carolina: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

The Lighthouse Trust

Lilongwe, Lilongwe, Malawi

Location

MeSH Terms

Interventions

Intrauterine Devices, Copper; Medroxyprogesterone Acetate; N,N-dimethyl-4-anisidine

Intervention Hierarchy (Ancestors)

Intrauterine Devices, Medicated; Intrauterine Devices; Contraceptive Devices, Female; Contraceptive Devices; Equipment and Supplies; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lisa Haddad, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Sam Phiri, PhD

  Lighthouse Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: August 30, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 25, 2013

Record last verified: 2013-10

Locations

MA (1)