From Policy to Practice: Experiences from the ECHO trial following revisions of the WHO Medical Eligibility Criteria for Contraceptive Use (MEC) guidance on DMPA-IM

Abstract

ObjectivesIn 2017, the World Health Organization (WHO) medical eligibility criteria (MEC) for contraception category for intramuscular depot medroxyprogesterone acetate (DMPA-IM) was changed from MEC Category 1 to 2 for women at high risk of HIV acquisition, due to accumulating evidence that this method may increase women’s risk of acquiring HIV. We assessed the impact of communicating this category change on sexual behavior, method satisfaction and method continuation rates among women in the Evidence for Contraceptive options and HIV Outcomes (ECHO) trial. Study designECHO was conducted in eSwatini, Kenya, South Africa and Zambia. Women were randomized (1:1:1) to DMPA-IM, levonorgestrel (LNG) implant or copper intrauterine device (Cu IUD). All women enrolled in the ECHO trial were counseled on the MEC change when it occurred. Using Cox regression, we compared the hazards of DMPA-IM discontinuation before and after the MEC category change in DMPA-IM users. Using segmented regression, we assessed sexual behavior and DMPA-IM satisfaction before and after MEC category change. ResultsMost (91.3%) of the 2606 women randomized to DMPA-IM continued using the method throughout the study, with a decrease in the hazards of discontinuation after the MEC change (hazard ratio 0.37; 95%CI=0.26-0.52, p<0.001). Among 1740 women included in analysis of changes in sexual behavior outcomes, no evidence of an effect of the MEC change was observed. There was some evidence of an increase in disatisfaction with DMPA-IM immediately after the MEC change, with the odds of women reporting a higher score (more dissatisfied) increasing by 1.38 compared with before the MEC change (95%CI=1.11-1.72). However, overall satisfaction with the method during the study was very high (90% of women said that they were ‘very satisfied’). ConclusionsWhile counseling on possible theoretical risks associated with contraceptive methods in the MEC is an important medical ethical standard, in this study it did not adversely impact continuation or sexual behavior, while there was some evidence on increase in dissatisfaction. There is however a need to monitor how changes in MEC categories are implemented. In August 2019, after the results of the ECHO trial were released, the WHO MEC category for progestogen-only injectables and Cu IUDs for women at high risk of HIV moved back from a Category 2 to a Category 1.