Effective Care Research Unit, Frere Maternity Hospital, Eastern Cape Department of Health/Universities of the Witwatersrand and Fort Hare, P.O. Box 4097, East London, South Africa.
Evidence-Based Medicine Consultancy Ltd, Bath, UK.
Reprod Health. 2021 Sep 29;18(1):192. doi: 10.1186/s12978-021-01232-6.
The ECHO trial randomised 7829 women to depot medroxyprogesterone acetate (DMPA-IM), the copper intrauterine device (IUD) and the levonorgestrel (LNG) implant (1:1:1) and found no clear difference in HIV incidence between these three groups. We have previously hypothesized that oligo-amenorrhoea induced by DMPA-IM may have a protective effect on HIV acquisition. The aim of this ancillary study was to assess the effects of DMPA-IM, the IUD and the LNG implant on menstrual symptoms and sexual behavior and to correlate these with HIV acquisition.
At the Effective Care Research Unit (ECRU) in South Africa, of 615 women already randomised to DMPA-IM, the copper IUD and the LNG implant (1:1:1) 552 agreed to participate. Participants completed a 28-day symptom and behavior diary following their one-month ECHO trial visit and returning it at their 3-month follow-up visit. HIV acquisition data were retrieved from ECHO trial records.
Of 552 women enrolled on the ancillary study, 390 (70.6%) completed their daily diary; 130, 133, and 127 received DMPA-IM, IUD, and LNG implant, respectively. Thirty-three (5.9%) of these women acquired HIV. Women on the progestin-only contraceptives were more likely to experience amenorrhoea, as expected, and were less likely to have intra-menstrual coitus than IUD users (p < 0.001 for DMPA-IM vs IUD and p = 0.002 for implant vs IUD). Overall coital frequency was highest and condom usage lowest among DMPA-IM users. Intra-menstrual coitus correlated positively, and duration of menstruation correlated negatively, with HIV acquisition, although these effects were not statistically significant (p = 0.09 and p = 0.079, respectively).
Findings support the hypothesis that oligo-amenorrhoea and the associated reduced intra-menstrual coitus may mitigate the potential for an increased biological risk of HIV acquisition with DMPA-IM but more evidence is needed. Study registration number PACTR201706001651380.
ECHO 试验将 7829 名女性随机分为三组，分别接受 depot 甲羟孕酮醋酸酯（DMPA-IM）、铜宫内节育器（IUD）和左炔诺孕酮（LNG）植入剂（1:1:1），结果发现这三组之间 HIV 发病率无明显差异。我们之前假设 DMPA-IM 引起的月经稀少可能对 HIV 感染有保护作用。本辅助研究的目的是评估 DMPA-IM、IUD 和 LNG 植入剂对月经症状和性行为的影响，并将这些与 HIV 感染相关联。
在南非的有效护理研究单位（ECRU），在已经随机分配至 DMPA-IM、IUD 和 LNG 植入剂（1:1:1）的 615 名女性中，有 552 名同意参与。参与者在 ECHO 试验后的一个月访问时完成了为期 28 天的症状和行为日记，并在 3 个月随访时返回。从 ECHO 试验记录中检索到 HIV 感染数据。
在参加辅助研究的 552 名女性中，390 名（70.6%）完成了每日日记；130、133 和 127 名女性分别接受了 DMPA-IM、IUD 和 LNG 植入剂。其中 33 名（5.9%）女性感染了 HIV。正如预期的那样，使用孕激素避孕药的女性更有可能出现闭经，并且与 IUD 用户相比，她们更不可能在月经期间发生性行为（DMPA-IM 与 IUD 相比，p<0.001；植入剂与 IUD 相比，p=0.002）。总体性交频率最高，而使用避孕套的频率最低的是 DMPA-IM 用户。月经期间的性行为与 HIV 感染呈正相关，而经期持续时间与 HIV 感染呈负相关，尽管这些影响没有统计学意义（p=0.09 和 p=0.079）。
这些发现支持了这样的假设，即月经稀少和相关的月经期间性行为减少可能减轻 DMPA-IM 引起的 HIV 感染生物学风险增加的可能性，但还需要更多的证据。研究注册编号 PACTR201706001651380。
