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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02550067
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
University of Washington
Wits Reproductive Health and HIV Institute
World Health Organization
Madibeng Centre for Research
Maternal Adolescent and Child Health Research
Qhakaza Mbokodo Research Clinic
The Aurum Institute NPC
Effective Care Research Unit
Emavundleni Research Centre
Setshaba Research Centre
University of North Carolina, Chapel Hill
Family Life Association of Swaziland
ICAP Columbia University
Kenya Medical Research Institute
Information provided by (Responsible Party):
FHI 360

Tracking Information
First Submitted Date  ICMJE September 12, 2015
First Posted Date  ICMJE September 15, 2015
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE December 14, 2015
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2015)
Compare risks of HIV acquisition between women randomized to DMPA, LNG and copper IUD [ Time Frame: From enrollment to 18 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2015)
  • Compare pregnancy rates among women randomized to DMPA, LNG and copper IUD [ Time Frame: 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 ]
  • Compare contraceptive continuation rates among women randomized to DMPA, LNG and copper IUD [ Time Frame: From enrollment to 18 months ]
  • Compare SAEs among women randomized to DMPA, LNG and copper IUD [ Time Frame: From enrollment to 18 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Evidence for Contraceptive Options and HIV Outcomes Trial
Official Title  ICMJE 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)
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • HIV
  • Contraception
Intervention  ICMJE
  • 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 Name: Depot medroxyprogesterone acetate
  • Drug: LNG
    Women randomized to implants will receive LNG implants in the arm, at enrolment from trained clinicians.
    Other Name: Levonorgestrel implant
  • 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 Name: Copper T380a IUD
Study Arms  ICMJE
  • 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.
    Intervention: Drug: DMPA
  • Active Comparator: Levonorgestrel implant (LNG)
    Women randomized to implants will receive LNG implants in the arm, at enrolment from trained clinicians.
    Intervention: Drug: LNG
  • 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.
    Intervention: Drug: Copper IUD
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2017)
7830
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2015)
7800
Actual Study Completion Date  ICMJE October 31, 2018
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya,   South Africa,   Swaziland,   Zambia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02550067
Other Study ID Numbers  ICMJE 523201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: The data are available 3 months following publication of primary analysis, for 36 months.
Responsible Party FHI 360
Study Sponsor  ICMJE FHI 360
Collaborators  ICMJE
  • University of Washington
  • Wits Reproductive Health and HIV Institute
  • World Health Organization
  • Madibeng Centre for Research
  • Maternal Adolescent and Child Health Research
  • Qhakaza Mbokodo Research Clinic
  • The Aurum Institute NPC
  • Effective Care Research Unit
  • Emavundleni Research Centre
  • Setshaba Research Centre
  • University of North Carolina, Chapel Hill
  • Family Life Association of Swaziland
  • ICAP Columbia University
  • Kenya Medical Research Institute
Investigators  ICMJE Not Provided
PRS Account FHI 360
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP