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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Contraception Drug: DMPA Drug: LNG Drug: Copper IUD Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7830 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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)
Actual Study Start Date : December 14, 2015
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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 Name: Copper T380a IUD


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Compare pregnancy rates among women randomized to DMPA, LNG and copper IUD [ Time Frame: From enrollment to 18 months ]
  2. 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 ]
  3. Compare contraceptive continuation rates among women randomized to DMPA, LNG and copper IUD [ Time Frame: From enrollment to 18 months ]
  4. Compare SAEs among women randomized to DMPA, LNG and copper IUD [ Time Frame: From enrollment to 18 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02550067


Locations
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Kenya
Kisumu East Research Care and Training Program
Kisumu, Kenya
South Africa
Madibeng Centre for Research
Brits, South Africa
Emavundleni Research Centre
Cape Town, South Africa
MatCH Research Unit Commercial City
Durban, South Africa
Effective Care Research Unit (ECRU) Frere Maternity Hospital
East London, South Africa, 5201
Wits Reproductive Health and HIV Institute (WRHI)
Johannesburg, South Africa
Aurum Klerksdorp Gavin Churchyard Legacy Centre
Klerksdorp, South Africa, 2570
QM ladysmith
Ladysmith, South Africa
MatCH Research Unit Edendale
Pietermaritzburg, South Africa
Setshaba Research Centre
Soshanguve, South Africa
Swaziland
FLAS/ICAP Clinic 1& Clinic 2
Manzini, Swaziland
Zambia
University Teaching Hospital, Lusaka, Zambia
Lusaka, Zambia
Sponsors and Collaborators
FHI 360
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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT02550067    
Other Study ID Numbers: 523201
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
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
Informed Consent Form (ICF)
Time Frame: The data are available 3 months following publication of primary analysis, for 36 months.

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Product Manufactured in and Exported from the U.S.: No
Keywords provided by FHI 360:
HIV infection
DepoLevonorgestrel
Contraception
DMPA
 Copper IUD
Levonorgestrel implant
IUD
Additional relevant MeSH terms:
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Copper
Medroxyprogesterone Acetate
Levonorgestrel
Medroxyprogesterone
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
 Contraceptives, Oral, Synthetic
Contraceptives, Oral
Trace Elements
Micronutrients
Contraceptives, Oral, Hormonal
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents