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

Arm | Intervention/treatment |
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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.
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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.
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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.
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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 |
- 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
- 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 ]

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

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
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 |
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. |
Product Manufactured in and Exported from the U.S.: | No |
HIV infection DepoLevonorgestrel Contraception DMPA |
Copper IUD Levonorgestrel implant IUD |
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 |