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

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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

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

MedlinePlus related topics: Birth Control HIV/AIDS

Drug Information available for: Medroxyprogesterone acetate Levonorgestrel

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

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 :

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 ]

Eligibility Criteria

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

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