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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191203
• Other study ID #: IRB00037535
• Status: Completed
• Phase: N/A
• First received: June 2, 2010
• Last updated: October 23, 2013
• Start date: July 2010
• Est. completion date: December 2011

Study information

• Verified date: October 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: National Health Sciences Research Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• Copper IUD
Copper IUD (CuT360)
• Depo Medroxyprogesterone acetate
DMPA 150 mg IM q 3 months

Locations

Country	Name	City	State
Malawi	The Lighthouse Trust	Lilongwe

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	National Institute of Allergy and Infectious Diseases (NIAID), University of North Carolina

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Number of clients continuing with method at 1 year	1 year	No
Secondary	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	No