Steyn Petrus, Beksinska Mags, Pleaner Melanie, Tam Hui-Zhen, Smit Jenni, Baisley Kathy, Taylor Douglas, Singata-Madliki Mandisa, Justus Hofmeyr G, Palanee-Phillips Thesla, Kiarie James N
UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), World Health Organization, Geneva, Switzerland.
MRU (MatCH Research Unit), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.
Contracept X. 2024 Sep 29;6:100111. doi: 10.1016/j.conx.2024.100111. eCollection 2024.
In 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. We assessed the impact of communicating this category change among women in the Evidence for Contraceptive options and HIV Outcomes (ECHO) trial.
ECHO 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). We compared the hazards of DMPA-IM discontinuation and assessed sexual behavior and DMPA-IM satisfaction before and after MEC category change.
In DMPA-IM users there was a decrease in the hazards of discontinuation after the MEC change (hazard ratio 0.37; 95% CI = 0.26-0.52, < 0.001). No evidence of an effect of the MEC change was observed in sexual behaviour outcomes. 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).
While 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.
Although we found no evidence in this analysis of an effect of the MEC change on any of the sexual behavioral outcomes among women after the change in category, it is still an important medical ethical standard to counsel on possible theoretical risks associated with contraceptive methods. Given the challenges of translating research findings to guidelines and further to counseling messages, evaluation of clinical guidelines implementation is necessary to understand the effects of implementation and to monitor both intended impacts and unintended consequences.
2017年,世界卫生组织(WHO)关于肌内注射醋酸甲羟孕酮(DMPA-IM)的避孕医学适用性标准(MEC)对有高感染艾滋病毒风险的女性从MEC 1类改为2类。我们在避孕选择与艾滋病毒结局证据(ECHO)试验中评估了向女性传达这一类别变化的影响。
ECHO试验在斯威士兰、肯尼亚、南非和赞比亚进行。女性被随机(1:1:1)分配至DMPA-IM组、左炔诺孕酮(LNG)植入组或铜宫内节育器(Cu IUD)组。我们比较了DMPA-IM停用的风险,并评估了MEC类别变化前后的性行为和DMPA-IM满意度。
在DMPA-IM使用者中,MEC变化后停用风险降低(风险比0.37;95%置信区间=0.26-0.52,P<0.001)。在性行为结果方面未观察到MEC变化产生影响的证据。有一些证据表明,MEC变化后女性对DMPA-IM的不满立即增加,报告得分较高(更不满意)的女性的比值比与MEC变化前相比增加了1.38(95%置信区间=1.11-1.72)。
虽然就MEC中与避孕方法相关的可能理论风险进行咨询是一项重要的医学伦理标准,但在本研究中,这并未对继续使用或性行为产生不利影响,同时有一些证据表明不满有所增加。然而,有必要监测MEC类别的变化是如何实施的。
尽管在本分析中我们未发现MEC类别变化对女性任何性行为结果有影响的证据,但就与避孕方法相关的可能理论风险进行咨询仍是一项重要的医学伦理标准。鉴于将研究结果转化为指南并进一步转化为咨询信息存在挑战,有必要对临床指南的实施进行评估,以了解实施的效果,并监测预期影响和非预期后果。