Hofmeyr G Justus, Morrison Charles S, Baeten Jared M, Chipato Tsungai, Donnell Deborah, Gichangi Peter, Mugo Nelly, Nanda Kavita, Rees Helen, Steyn Petrus, Taylor Douglas
Effective Care Research Unit, Universities of Witwatersrand and Fort Hare, Eastern Cape Department of Health, East London, South Africa.
Global Health, Population and Nutrition, FHI 360, Durham, NC, USA.
Gates Open Res. 2018 Mar 13;1:17. doi: 10.12688/gatesopenres.12775.2. eCollection 2017.
, animal, biological and observational clinical studies suggest that some hormonal methods, particularly depot medroxyprogesterone acetate - DMPA, may increase women's risk of HIV acquisition. DMPA is the most common contraceptive used in many countries worst affected by the HIV epidemic. To provide robust evidence for contraceptive decision-making among women, clinicians and planners, we are conducting the Evidence for Contraceptive Options and HIV Outcomes (ECHO) study in four countries with high HIV incidence and DMPA use: Kenya, South Africa, Swaziland, and Zambia (Clinical Trials.gov identifier NCT02550067). We randomized HIV negative, sexually active women 16-35 years old requesting effective contraception and agreeing to participate to either DMPA, the copper T 380A intrauterine device or levonorgestrel implant. Participants attend a contraception support visit after 1 month and quarterly visits thereafter for up to 18 months. Participants receive a standard HIV prevention package and contraceptive side-effect management at each visit. The primary outcome is HIV seroconversion. Secondary outcomes include pregnancy, serious adverse events and method discontinuation. The sample size of 7800 women provides 80% power to detect a 50% relative increase in HIV risk between any of the three method pairs, assuming 250 incident infections per comparison. Several WHO consultations have concluded that current evidence on HIV risk associated with DMPA is inconclusive and that a randomized trial is needed to guide policy, counselling and choice. Previous studies suggest that women without a specific contraceptive preference are willing to accept randomization to different contraceptive methods. Stringent performance standards are monitored by an independent data and safety monitoring board approximately every 6 months. The study has been conducted with extensive stakeholder engagement. The ECHO study is designed to provide robust evidence on the relative risks (HIV acquisition) and benefits (pregnancy prevention) between three effective contraceptive methods.
动物、生物学和观察性临床研究表明，某些激素避孕方法，尤其是醋酸甲羟孕酮长效避孕针（DMPA），可能会增加女性感染艾滋病毒的风险。DMPA是在受艾滋病毒疫情影响最严重的许多国家中使用最普遍的避孕方法。为了为女性、临床医生和规划者在避孕决策方面提供有力证据，我们正在肯尼亚、南非、斯威士兰和赞比亚这四个艾滋病毒高发且使用DMPA的国家开展避孕选择与艾滋病毒结局证据（ECHO）研究（临床试验.gov标识符NCT02550067）。我们将年龄在16至35岁、艾滋病毒检测呈阴性、有性活动、要求有效避孕并同意参与研究的女性随机分为三组，分别使用DMPA、铜T 380A宫内节育器或左炔诺孕酮植入剂。参与者在1个月后参加一次避孕支持访视，此后每季度访视一次，为期最长18个月。每次访视时，参与者都会接受标准的艾滋病毒预防套餐和避孕副作用管理。主要结局是艾滋病毒血清转换。次要结局包括妊娠、严重不良事件和停用避孕方法。假设每组比较中有250例新发感染，7800名女性的样本量有80%的把握检测出三种避孕方法中任意两种之间艾滋病毒风险相对增加50%。世卫组织的几次磋商得出结论，目前关于DMPA与艾滋病毒风险的证据尚无定论，需要进行一项随机试验来指导政策制定、咨询和选择。先前的研究表明，没有特定避孕偏好的女性愿意接受随机分配到不同的避孕方法。一个独立的数据和安全监测委员会大约每6个月监测一次严格的性能标准。该研究是在广泛的利益相关者参与下进行的。ECHO研究旨在提供关于三种有效避孕方法之间相对风险（感染艾滋病毒）和益处（预防妊娠）的有力证据。
