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

FHI 360

Status

Completed

Conditions

Contraception

HIV

Treatments

Drug: Copper IUD

Drug: LNG

Drug: DMPA

Study type

Interventional

Funder types

Other

Identifiers

NCT02550067

523201

Details and patient eligibility

About

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.

Full 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.

Enrollment

7,830 patients

Sex

Female

Ages

16 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

7,830 participants in 3 patient groups

Depot medroxyprogesterone acetate (DMPA)

Active Comparator group

Description:

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.

Treatment:

Drug: DMPA

Levonorgestrel implant (LNG)

Active Comparator group

Description:

Women randomized to implants will receive LNG implants in the arm, at enrolment from trained clinicians.

Treatment:

Drug: LNG

Copper T380a IUD

Active Comparator group

Description:

Women randomized to IUDs will receive their IUDs at enrolment. Trained providers will insert T380a copper IUDs using standard insertion techniques.