Abstract：
Globally, women have higher herpes simplex virus type 2 (HSV-2) prevalence than men; data from observational studies suggest a possible association of HSV-2 acquisition with use of intramuscular depot medroxyprogesterone acetate (DMPA-IM).
Within a randomized trial of the effect of 3 contraceptive methods-DMPA-IM, a copper intrauterine device (IUD), and a levonorgestrel (LNG) implant-on human immunodeficiency virus (HIV) acquisition, we assessed HSV-2 acquisition. HSV-2 and HIV seronegative women, aged 16-35 years, and seeking effective contraception were followed for 12-18 months at 12 sites in Eswatini, Kenya, South Africa, and Zambia from 2015 to 2018. HSV-2 serologic testing was done at enrollment and final study visits. Intention-to-treat analysis using Poisson regression with robust standard errors compared HSV-2 incidence by contraceptive method.
At baseline, 4062 randomized women were HSV-2 seronegative, of whom 3898 (96.0%) had a conclusive HSV-2 result at their final study visit. Of these, 614 (15.8%) acquired HSV-2, at an incidence of 12.4/100 person-years (p-y): 10.9/100 p-y among women assigned DMPA-IM, 13.7/100 p-y the copper IUD, and 12.7/100 p-y the LNG implant. Incidence rate ratios (IRR) for HSV-2 acquisition were 0.80 (95% confidence interval [CI], .65-.97) for DMPA-IM compared with copper IUD, 0.86 (95% CI, .71-1.05) for DMPA-IM compared with LNG implant, and 1.08 (95% CI, .89-1.30) for copper IUD compared with LNG implant. HSV-2 acquisition risk was significantly increased among women who also acquired HIV during follow-up (IRR 3.55; 95% CI, 2.78-4.48).
In a randomized trial, we found no association between HSV-2 acquisition and use of 3 contraceptive methods.
ClinicalTrials.gov number NCT02550067.
Within a randomized trial of the effect of 3 contraceptive methods-DMPA-IM, a copper intrauterine device (IUD), and a levonorgestrel (LNG) implant-on human immunodeficiency virus (HIV) acquisition, we assessed HSV-2 acquisition. HSV-2 and HIV seronegative women, aged 16-35 years, and seeking effective contraception were followed for 12-18 months at 12 sites in Eswatini, Kenya, South Africa, and Zambia from 2015 to 2018. HSV-2 serologic testing was done at enrollment and final study visits. Intention-to-treat analysis using Poisson regression with robust standard errors compared HSV-2 incidence by contraceptive method.
At baseline, 4062 randomized women were HSV-2 seronegative, of whom 3898 (96.0%) had a conclusive HSV-2 result at their final study visit. Of these, 614 (15.8%) acquired HSV-2, at an incidence of 12.4/100 person-years (p-y): 10.9/100 p-y among women assigned DMPA-IM, 13.7/100 p-y the copper IUD, and 12.7/100 p-y the LNG implant. Incidence rate ratios (IRR) for HSV-2 acquisition were 0.80 (95% confidence interval [CI], .65-.97) for DMPA-IM compared with copper IUD, 0.86 (95% CI, .71-1.05) for DMPA-IM compared with LNG implant, and 1.08 (95% CI, .89-1.30) for copper IUD compared with LNG implant. HSV-2 acquisition risk was significantly increased among women who also acquired HIV during follow-up (IRR 3.55; 95% CI, 2.78-4.48).
In a randomized trial, we found no association between HSV-2 acquisition and use of 3 contraceptive methods.
ClinicalTrials.gov number NCT02550067.
摘要：
全球范围内,女性2型单纯疱疹病毒(HSV-2)的患病率高于男性;观察性研究的数据提示HSV-2的获得与肌内储库醋酸甲羟孕酮(DMPA-IM)的使用可能相关.
在一项关于3种避孕方法-DMPA-IM效果的随机试验中，铜宫内节育器（IUD），和左炔诺孕酮（LNG）植入人类免疫缺陷病毒（HIV）的获取，我们评估了HSV-2的获得。HSV-2和HIV血清阴性妇女，16-35岁,并在埃斯瓦蒂尼的12个地点追踪了12-18个月的有效避孕方法，肯尼亚,南非,赞比亚从2015年到2018年。在登记和最终研究访视时进行HSV-2血清学检测。使用具有稳健标准误差的Poisson回归进行意向治疗分析，通过避孕方法比较HSV-2发病率。
在基线，4062名随机女性为HSV-2血清阴性，其中3898人(96.0%)在最后一次研究访视时获得了确定的HSV-2结果.其中,614（15.8％）获得HSV-2，发生率为12.4/100人年（p-y）：分配DMPA-IM的女性中的10.9/100p-y，13.7/100p-y铜宫内节育器，和12.7/100p-yLNG植入物。HSV-2采集的发病率比(IRR)为0.80(95%置信区间[CI]，.65-.97)用于DMPA-IM与铜宫内节育器相比，与LNG植入物相比，DMPA-IM为0.86（95%CI，.71-1.05），与液化天然气植入物相比，铜宫内节育器和1.08（95%CI，.89-1.30）。在随访期间也感染了HIV的女性中，HSV-2感染风险显着增加（IRR3.55；95％CI，2.78-4.48）。
在一项随机试验中,我们发现HSV-2的获得和使用3种避孕方法之间没有关联.
ClinicalTrials.gov编号NCT02550067。
在一项关于3种避孕方法-DMPA-IM效果的随机试验中，铜宫内节育器（IUD），和左炔诺孕酮（LNG）植入人类免疫缺陷病毒（HIV）的获取，我们评估了HSV-2的获得。HSV-2和HIV血清阴性妇女，16-35岁,并在埃斯瓦蒂尼的12个地点追踪了12-18个月的有效避孕方法，肯尼亚,南非,赞比亚从2015年到2018年。在登记和最终研究访视时进行HSV-2血清学检测。使用具有稳健标准误差的Poisson回归进行意向治疗分析，通过避孕方法比较HSV-2发病率。
在基线，4062名随机女性为HSV-2血清阴性，其中3898人(96.0%)在最后一次研究访视时获得了确定的HSV-2结果.其中,614（15.8％）获得HSV-2，发生率为12.4/100人年（p-y）：分配DMPA-IM的女性中的10.9/100p-y，13.7/100p-y铜宫内节育器，和12.7/100p-yLNG植入物。HSV-2采集的发病率比(IRR)为0.80(95%置信区间[CI]，.65-.97)用于DMPA-IM与铜宫内节育器相比，与LNG植入物相比，DMPA-IM为0.86（95%CI，.71-1.05），与液化天然气植入物相比，铜宫内节育器和1.08（95%CI，.89-1.30）。在随访期间也感染了HIV的女性中，HSV-2感染风险显着增加（IRR3.55；95％CI，2.78-4.48）。
在一项随机试验中,我们发现HSV-2的获得和使用3种避孕方法之间没有关联.
ClinicalTrials.gov编号NCT02550067。
