Randomized Control Trial Copper Intrauterine Device and D... | NCT01191203

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

NCT01191203

Sponsor

Emory University

Status

Completed

Last Update Posted

Oct 25, 2013Estimated

Enrollment

200Actual

Phase

Not Applicable

Conditions

Interventions

Copper IUD
Depo Medroxyprogesterone acetate

Countries

Malawi

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jun 2, 2010

First Submission Date that Met QC Criteria

Aug 27, 2010

First Posted Date

Aug 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2013

Last Update Posted Date

Oct 25, 2013Estimated

Name	Class
University of North Carolina	OTHER
National Institute of Allergy and Infectious Diseases (NIAID)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Depo Medroxyprogesterone Acetate	Active Comparator		Drug: Depo Medroxyprogesterone acetate
Copper IUD (CuT360)	Active Comparator		Drug: Copper IUD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Copper IUD	Drug	Copper IUD (CuT360)	Copper IUD (CuT360)
Depo Medroxyprogesterone acetate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adherence	Number of clients continuing with method at 1 year	1 year

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Lisa Haddad, MD	Emory University	Principal Investigator
Sam Phiri, PhD	Lighthouse Trust	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The Lighthouse Trust		Lilongwe	Lilongwe		Malawi

Intervention Browse Module

MeSH Terms

ID	Term
D007435	Intrauterine Devices, Copper
D017258	Medroxyprogesterone Acetate
C050795	N,N-dimethyl-4-anisidine

Ancestor Terms

ID	Term
D007436	Intrauterine Devices, Medicated
D007434	Intrauterine Devices
D003274	Contraceptive Devices, Female
D003273	Contraceptive Devices

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Browse Branches

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