Primary clinical trial methods and ethics
BLOOD, SECONDARY
This study is a secondary study of the parent study i.e. the open-label randomized WHICH clinical trial. The primary aims of the WHICH trial were to evaluate estradiol levels and menstrual, psychological and behavioral measures relevant to HIV risk. The primary results will be reported elsewhere and are under review. A summarized protocol for the trial is available at This trial, conducted at two sites in South Africa from 2018 to 2019, equally randomized HIV-negative women aged 18–40 years to 150 mg DMPA-IM 12-weekly or 200 mg NET-EN intramuscular eight-weekly. Women seeking contraception were recruited at the East London and Mdantsane public health clinics and hospitals (Frere and Cecilia Makiwane Hospitals) (ECRU), South Africa (331 participants), and the research site of the University of the Witwatersrand MatCH Research Unit (MRU), based in Durban, KwaZulu-Natal, South Africa (189 participants). Exclusion criteria included participants who had received DMPA-IM in the previous six months or NET-EN in the previous four months via self-report, were living with HIV, or were using or intending to use medication which might have interfered with biological measurements such as steroids or drugs affecting renal function, such as pre-exposure prophylactic drugs (PrEP). Participants were recruited and followed from 5 November 2018 to 30 November 2019. We screened 546 and randomized 521 women to DMPA-IM (262) and NET-EN (259). A total of 86.9% (n = 453) completed a 25-week study visit with a similar number completing in both method groups.Blood samples were collected at study D0 and at 25W (about seven days after the 24W progestin injection), and serum was separated and stored at -80°C. Ethical approval for the trial was obtained from the Faculty of Health Sciences Human Research Ethics Committee (FHS HREC, M180528) of the University of Witwatersrand Research Ethics Committee, and from the East London Hospital Institutional Ethics Committee. Permission to conduct the trial was obtained from the Provincial Departments of Health of the Eastern Cape and KwaZulu-Natal. BMI and weight were measured by trained staff at D0 and 24W. Weight/BMI categories were assigned according to [