Effective Care Research Unit (ECRU), East London Hospital Complex, University of Fort Hare, East London, South Africa.
FHI 360, Durham, North Carolina, USA.
BMJ Open. 2017 Nov 12;7(11):e019205. doi: 10.1136/bmjopen-2017-019205.
This is the protocol for an ancillary study to the multicentre Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial, a three-arm randomised trial comparing the effects of depot medroxyprogesterone acetate (DMPA), the levonorgestrel (LNG) implant and the copper intrauterine device (IUD) on HIV incidence (NCT02550067 pre-results). The ancillary study will compare other non-contraceptive effects of these three long-acting, reversible contraceptions about which there is little existing comparative evidence.
Women randomised to IUD, DMPA and LNG implant (1:1:1) at one of the ECHO trial sites will be asked to participate in the ancillary study at the 1-month follow-up visit. Research staff will interview women that consent to participate at the 3-month follow-up visit. Primary outcomes are depression, sexual dysfunction and menstrual disturbances. The Beck Depression Inventory will be used to assess depression and the Arizona Sexual Experiences Scale to assess sexual dysfunction. Participants will also be asked to prospectively complete a 28-day symptom diary. The required sample size is 522 participants. Depression scores will be analysed as continuous and categorical variables. Analysis will be by intention to treat.
The ancillary study protocol received ethical approval from the University of the Witwatersrand Committee for Research on Human Subjects on 17 February 2016 (reference no. 14112). The results will be disseminated in a peer-reviewed open-access journal.
PACTR201706001651380.
这是一项多中心证据避孕选择和艾滋病毒结局（ECHO）试验的辅助研究方案，该试验是一项三臂随机试验，比较了 depot 甲羟孕酮（DMPA）、左炔诺孕酮（LNG）植入物和铜宫内节育器（IUD）对艾滋病毒发病率的影响（NCT02550067 预结果）。辅助研究将比较这三种长效可逆避孕方法的其他非避孕效果，关于这些效果目前几乎没有比较性证据。
在 ECHO 试验的一个地点随机分配至 IUD、DMPA 和 LNG 植入物（1:1:1）的女性将在 1 个月随访时被邀请参加辅助研究。如果同意参加，研究人员将在 3 个月随访时对女性进行访谈。主要结局是抑郁、性功能障碍和月经紊乱。将使用贝克抑郁量表评估抑郁，使用亚利桑那性体验量表评估性功能障碍。参与者还将被要求前瞻性地完成 28 天症状日记。所需的样本量为 522 名参与者。抑郁评分将作为连续和分类变量进行分析。分析将按意向治疗进行。
辅助研究方案于 2016 年 2 月 17 日获得威特沃特斯兰德大学人类研究伦理委员会的伦理批准（编号 14112）。结果将在同行评议的开放获取期刊上发表。
PACT R201706001651380。
