The Evidence for Contraceptive Options and HIV Outcomes Trial

HIV Clinical Trial

— ECHO  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550067
• Other study ID #: 523201
• Status: Completed
• Phase: N/A
• Start date: December 14, 2015
• Est. completion date: October 31, 2018

Study information

• Verified date: August 2019
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7830
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception
• HIV

Intervention

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.
• LNG
Women randomized to implants will receive LNG implants in the arm, at enrolment from trained clinicians.
• Copper IUD
Women randomized to IUDs will receive their IUDs at enrolment. Trained providers will insert T380a copper IUDs using standard insertion techniques.

Locations

Country	Name	City	State
Kenya	Kisumu East Research Care and Training Program	Kisumu
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	Wits Reproductive Health and HIV Institute (WRHI)	Johannesburg
South Africa	Aurum Klerksdorp Gavin Churchyard Legacy Centre	Klerksdorp
South Africa	QM ladysmith	Ladysmith
South Africa	MatCH Research Unit Edendale	Pietermaritzburg
South Africa	Setshaba Research Centre	Soshanguve
Swaziland	FLAS/ICAP Clinic 1& Clinic 2	Manzini
Zambia	University Teaching Hospital, Lusaka, Zambia	Lusaka

Sponsors (15)

Lead Sponsor

Collaborator

FHI 360

Effective Care Research Unit, Emavundleni Research Centre, Family Life Association of Swaziland, ICAP Columbia University, Kenya Medical Research Institute, Madibeng Centre for Research, Maternal Adolescent and Child Health Research, Qhakaza Mbokodo Research Clinic, Setshaba Research Centre, The Aurum Institute NPC, University of North Carolina, Chapel Hill, University of Washington, Wits Reproductive Health and HIV Institute, World Health Organization

Countries where clinical trial is conducted

Kenya,  South Africa,  Swaziland,  Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare risks of HIV acquisition between women randomized to DMPA, LNG and copper IUD	HIV infection as measured by documented HIV seroconversion occurring post-enrolment	From enrollment to 18 months
Secondary	Compare pregnancy rates among women randomized to DMPA, LNG and copper IUD		From enrollment to 18 months
Secondary	Compare rates of adverse events that lead to discontinuation among women randomized to DMPA, LNG and copper IUD		From enrollment to 18 months
Secondary	Compare contraceptive continuation rates among women randomized to DMPA, LNG and copper IUD		From enrollment to 18 months
Secondary	Compare SAEs among women randomized to DMPA, LNG and copper IUD		From enrollment to 18 months