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

Status
Completed
Phase
Open Label
Principal Investigator(s)
http://echo-consortium.com/about-echo/coordinating-partners-study-sites/
Objective

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.

 

Results: There was no substantial difference found in HIV risk among the methods evaluated, and all methods were safe and highly effective. HIV incidence was high in this population of women seeking pregnancy prevention, emphasising the need for integration of HIV prevention within contraceptive services for African women. These results support continued and increased access to these three contraceptive methods.

Prevention Option(s)
Hormonal Contraceptives and HIV
Study Design
Randomized
Open label
Arms and Assigned Interventions
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.
Mode of Delivery
Intramuscular
Products
DMPA
ARMs
Experimental
Description
Women randomized to implants will receive Levonorgestrel implant (LNG) implants in the arm, at enrollment from trained clinicians.
Products
Levonorgestrel
ARMs
Experimental
Description
Women randomized to IUDs will receive their IUDs at enrollment. Trained providers will insert T380a copper IUDs using standard insertion techniques.
ARMs
Experimental
November 2015
October 2018
Enrollment
7 830
16
Years
35
Years
Population
Women
Sites

Madibeng Centre for Research

Brits
South Africa

Emavundleni (EMA) CRS

Cape Town
South Africa

MatCH Edendale Research Center

Pietermaritzburg, Kwa-Zulu Natal
South Africa

Wits Reproductive Health and HIV Institute (Wits RHI)

Johannesburg
South Africa

Setshaba Research Centre

Shoshanguve
South Africa

Kisumu CRS

Kenya

Effective Care Research Unit (ECRU)

East London
South Africa

Aurum Klerksdorp Gavin Churchyard Legacy Centre

Klerksdorp
South Africa

Site(s) - Ladysmith

South Africa

MatCH Research Site

Durban
South Africa

FLAS/ICAP Clinic 1& Clinic 2

Manzini
Swaziland

University Teaching Hospital

Lusaka
Zambia