The Evidence for Contraceptive Options and HIV Outcomes Trial (ECHO)

August 16, 2019 updated by: FHI 360

A Multi Center, Open-Label, Randomised Clinical Trial Comparing HIV Incidence and Contraceptive Benefits in Women Using Depot Medroxyprogesterone Acetate (DMPA), Levonorgestrel (LNG) Implant, and Copper Intrauterine Devices (IUDs)

The ECHO Study is an open-label randomized clinical trial that will compare three highly effective, reversible methods of contraception (including a non-hormonal method) to evaluate whether there is a link between use of any of these methods and increased risk of acquiring HIV infection. A randomized clinical trial among about 7,800 women in four countries, ECHO will deliver evidence to support and guide individual, policy and programmatic decisions on contraception for women at risk of acquiring HIV infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Approximately 7800 sexually active, HIV-negative women, 16-35 years old, seeking effective contraception, willing to be randomized to any of the study arms, and not desiring pregnancy for the duration of study participation will be randomly allocated to one of three study arms in a 1:1:1 ratio: depot medroxyprogesterone acetate (DMPA), levonorgestrel (LNG) implant, copper intrauterine device (IUD).

Enrollment will require an estimated 18 months and the total duration of the clinical portion of the study is estimated to be 36 months.

The primary objective is to compare the risks of HIV acquisition between women randomized to DMPA, levonorgestrel (LNG) implant, and copper IUDs. Secondary objectives are to compare: 1) pregnancy rates among women randomized to DMPA, LNG implant, and copper IUDs, 2) rates of serious adverse events among women randomized to DMPA, LNG implant, and copper IUDs, 3) rates of adverse events that lead to method discontinuation among women randomized to DMPA, LNG implant, and copper IUDs, and 4) contraceptive method continuation rates among women randomized to DMPA, LNG implant, and copper IUDs. Tertiary objectives are to evaluate: 1) whether age modifies the relationship between the three contraceptive methods and HIV acquisition, 2) whether HSV-2 status modifies the relationship between the three contraceptive methods and HIV acquisition, and 3) early HIV disease progression among sero-converters randomized to DMPA, LNG implant, and copper IUDs. Ancillary studies will assess biological mechanisms at the interface of contraceptives and markers of HIV risk.

Study Type

Interventional

Enrollment (Actual)

7830

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kisumu, Kenya
        • Kisumu East Research Care and Training Program
  • South Africa
      • Brits, South Africa
        • Madibeng Centre for Research
      • Cape Town, South Africa
        • Emavundleni Research Centre
      • Durban, South Africa
        • MatCH Research Unit Commercial City
      • East London, South Africa, 5201
        • Effective Care Research Unit (ECRU) Frere Maternity Hospital
      • Johannesburg, South Africa
        • Wits Reproductive Health and HIV Institute (WRHI)
      • Klerksdorp, South Africa, 2570
        • Aurum Klerksdorp Gavin Churchyard Legacy Centre
      • Ladysmith, South Africa
        • QM ladysmith
      • Pietermaritzburg, South Africa
        • MatCH Research Unit Edendale
      • Soshanguve, South Africa
        • Setshaba Research Centre
  • Swaziland
      • Manzini, Swaziland
        • FLAS/ICAP Clinic 1& Clinic 2
  • Zambia
      • Lusaka, Zambia
        • University Teaching Hospital, Lusaka, Zambia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 16-35 years of age (previously pregnant 16 and 17 year olds, where permissible by national regulations and local IRB approval)
  • HIV-seronegative
  • Wants to use effective contraception
  • Is able and willing to provide written informed consent
  • Agrees to be randomized to either DMPA, LNG implant, or copper IUD
  • Agrees to use assigned method for 18 months
  • Agrees to follow all study requirements
  • Intends to stay in the study area for the next 18 months, and willing and able to provide adequate locator information
  • If has had a recent third trimester birth, is at least 6 weeks postpartum
  • Is sexually active (has had vaginal sex within the last 3 months) or was pregnant within the last 3 months
  • Agrees not to participate in studies of drugs or vaccines or any other clinical research study while participating in this study.

Exclusion Criteria:

  • Reported medical contraindications (WHO MEC Category 3 or 4) to DMPA, LNG implant, or copper IUDs, including: recent septic abortion; suspicious unexplained vaginal bleeding; breast, cervical, uterine, or ovarian cancer; high BP or heart disease, venous thromboembolism, stroke, or diabetes; liver disease or liver tumours; use of liver enzyme inducing medications
  • Is found to have pelvic tuberculosis or uterine fibroids with distortion of the uterine cavity on pelvic exam
  • Has untreated mucus and purulent cervicitis on exam, untreated pelvic inflammatory disease (PID), or untreated known gonorrhea or chlamydia
  • Has received a DMPA or NET-En injection in the last 6 months
  • Has used an implant or an IUD in the last 6 months
  • Is pregnant or intending to become pregnant in the next 18 months
  • Has had a hysterectomy or sterilization
  • Has previously participated in the study
  • Has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe or complicate data interpretation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Depot medroxyprogesterone acetate (DMPA)
Women randomized to DMPA, will receive an intramuscular injection of DMPA (medroxyprogesterone acetate sterile aqueous suspension 150 mg per 1 mL) at enrolment. Subsequent injections will be given every 3 months (i.e., at quarterly study visits) at the study site.
Drug: DMPA
Women randomized to DMPA, will receive an intramuscular injection of DMPA (medroxyprogesterone acetate sterile aqueous suspension 150 mg per 1 mL) at enrolment. Subsequent injections will be given every 3 months (i.e., at quarterly study visits) at the study site.
Other Names:
  • Depot medroxyprogesterone acetate
Active Comparator: Levonorgestrel implant (LNG)
Women randomized to implants will receive LNG implants in the arm, at enrolment from trained clinicians.
Drug: LNG
Women randomized to implants will receive LNG implants in the arm, at enrolment from trained clinicians.
Other Names:
  • Levonorgestrel implant
Active Comparator: Copper T380a IUD
Women randomized to IUDs will receive their IUDs at enrolment. Trained providers will insert T380a copper IUDs using standard insertion techniques.
Drug: Copper IUD
Women randomized to IUDs will receive their IUDs at enrolment. Trained providers will insert T380a copper IUDs using standard insertion techniques.
Other Names:
  • Copper T380a IUD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare risks of HIV acquisition between women randomized to DMPA, LNG and copper IUD
Time Frame: From enrollment to 18 months
HIV infection as measured by documented HIV seroconversion occurring post-enrolment
From enrollment to 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare pregnancy rates among women randomized to DMPA, LNG and copper IUD
Time Frame: From enrollment to 18 months
From enrollment to 18 months
Compare rates of adverse events that lead to discontinuation among women randomized to DMPA, LNG and copper IUD
Time Frame: From enrollment to 18 months
From enrollment to 18 months
Compare contraceptive continuation rates among women randomized to DMPA, LNG and copper IUD
Time Frame: From enrollment to 18 months
From enrollment to 18 months
Compare SAEs among women randomized to DMPA, LNG and copper IUD
Time Frame: From enrollment to 18 months
From enrollment to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FHI 360

Collaborators

University of Washington
University of North Carolina, Chapel Hill
World Health Organization
Kenya Medical Research Institute
The Aurum Institute NPC
Wits Reproductive Health and HIV Institute
Effective Care Research Unit
Madibeng Centre for Research
Maternal Adolescent and Child Health Research
Qhakaza Mbokodo Research Clinic
Emavundleni Research Centre
Setshaba Research Centre
Family Life Association of Swaziland
ICAP Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2015

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

September 12, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Actual)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 16, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 523201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual participant data that underlie the results reported in the primary analysis, after deidentification, are available beginning 3 months following article publication ending after 36 months. The study protocol is available upon publication.The statistical code is available 3 months after publication from the corresponding author. Data is available for researchers who provide a methodologically sound proposal, which will be reviewed by the ECHO Management Committee. Proposals should be directed to icrc@uw.edu; to gain access, data requestors will need to sign a data access agreement and any proposal will require approval by the ECHO Management Committee.

IPD Sharing Time Frame

The data are available 3 months following publication of primary analysis, for 36 months.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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