The Evidence for Contraceptive Options and HIV Outcomes (ECHO) Study is an open-label randomised clinical trial that will compare three highly effective, reversible methods of contraception — a progestin-only injectable called depot-medroxyprogesterone acetate (DMPA), a levonorgestrel implant and the non-hormonal copper intrauterine device — to evaluate whether there is a link between use of any of these methods and increased risk of acquiring HIV infection.
WHY ECHO IS NEEDED
More than 150 million women worldwide use various hormonal contraceptives for family planning. In sub-Saharan Africa, progestin-only injectables are the most commonly used method.
Some studies suggest that the progestin-only injectable DMPA might increase a woman’s risk of acquiring HIV infection, while other studies show no such association. All of the data on this question are from observational studies that have a number of limitations; most were designed to answer different questions and may be biased because they could not control for other important factors affecting women’s risk of HIV infection.
The lack of conclusive data about the relationship between DMPA and HIV is of greatest concern in southern and eastern Africa, where levels of DMPA use and women’s lifetime risk of HIV infection are both high. Women need to know about any risks associated with contraceptive use, including that of increased HIV acquisition, so they can make informed choices. They also need to know if no association is verified, so each woman can continue to use her contraceptive method of choice with confidence, avoiding unintended pregnancies that can result in unsafe abortion, maternal death and illness.
In February 2012 and again in July 2014, an expert group convened by the World Health Organization (WHO) found that the current data on the safety of progestin-only injectables were inconclusive. WHO issued guidelines stating that women at high risk of acquiring HIV could continue to use progestin-only contraceptives without restrictions. However, the guidelines recommend that women at high risk of acquiring HIV be advised that progestin-only injectables “may or may not increase their risk of HIV acquisition.” They state that women and couples at high risk of HIV who are considering progestin-only injectables “should also be informed about and have access to HIV prevention measures, including male and female condoms.” WHO continues to monitor all emerging evidence on the safety of all methods of contraception.
WHO also called for research carefully designed to show whether or not there is a relationship between use of progestin-only injectables and HIV acquisition. The ECHO Study is the first large-scale randomised clinical trial to address this critical public health question.
The ECHO Study is a multi-center, multi-country, open-label, randomised clinical trial designed to fill an important gap in HIV and reproductive health research by providing conclusive information about the comparative risks and benefits of using three highly effective contraceptive methods.
• About 7800 sexually active HIV-negative women ages 16 to 35 will be enrolled at 12 study sites in Kenya, South Africa, Swaziland and Zambia.
• Participants are randomly assigned to use one of three contraceptive methods: DMPA, a progestin implant containing levonorgestrel or the copper intrauterine device (IUD).
• Investigators will measure HIV acquisition, pregnancy, method continuation and complications associated with contraceptive use among participants.
• Participants are expected to attend quarterly visits for up to 18 months or until the close of the study.
• The participating women are encouraged to remain on their assigned methods for the duration of the study but may change methods if they wish.
• Women who want to join the study will learn about the study procedures and the risks and benefits of participation through a consent process designed to ensure that their participation is informed and voluntary.
• Results, expected in 2019, will help guide the implementation of safe, effective policies and services that will enable women at high risk of HIV to make fully informed choices about contraception and HIV prevention.
FHI 360, the University of Washington, WHO and the Wits Reproductive Health and HIV Institute (RHI) coordinate the ECHO Study, in partnership with research institutions in Kenya, South Africa, Swaziland and Zambia.
The ECHO Study is funded by a consortium of donors, including the Bill & Melinda Gates Foundation, the Swedish International Development Cooperation Agency (Sida) and the Medical Research Council of South Africa. The U.S. Agency for International Development and the South African government are donating some of the contraceptives used in the study.
For more information on the ECHO Study, see http://echo-consortium.com/.