study design2

 

Women interested in joining the study learn about the study procedures and the risks and benefits of participating through an informed consent process. The women who decide to enrol are randomly assigned by computer to receive one of three contraceptives: DMPA, the Jadelle implant or the copper IUD.

Enrolment and eligibility

Approximately 7 800 sexually active HIV-negative women ages 16 to 35 will be enroled in the ECHO Study. Young women ages 16 and 17 years may join the study upon approval based on local and national regulations and the relevant ethics committee’s guidance.

Women who want to join the study should be seeking contraception and not want to become pregnant for the duration of the study. They will also be counselled extensively on how the study works and must be willing to be randomised to any of the three study products.

Duration

The study began in December 2015, when two sites in South Africa started screening and enrolling participants. Enrolment of all participants is expected to take approximately 18 months, and the total duration of the study in the field will be approximately 36 months from the first enrolment to the last follow up visit.

The study could end earlier, because the protocol is endpoint-driven. This means that the study will run until it reaches its research goal. If the study proceeds as planned, the study team anticipates that the results will be released in 2019.