Doxycycline post-exposure prophylaxis for prevention of sexually transmitted infections among Kenyan women using HIV pre-exposure prophylaxis: study protocol for an open-label randomized trial.
Doxycycline post-exposure prophylaxis for prevention of sexually transmitted infections among Kenyan women using HIV pre-exposure prophylaxis: study protocol for an open-label randomized trial.
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非洲妇女面临感染人类免疫缺陷病毒(HIV)的不成比例的风险，占非洲新感染病例的一半以上，同样面临不成比例的性传播感染(STI)负担。全球正在观察到非常高的性传播感染流行率，特别是在为预防艾滋病毒而采取暴露前预防措施(PrEP)的人群中。多西环素暴露后预防(DPEP)已被提议作为一种STI预防策略，以减少衣原体、梅毒和可能的淋病，目前正在对在高收入环境中服用PrEP的顺性男性(MSM)和变性人女性进行试验。在这里，我们设计并描述了第一个开放标签试验，以确定dPEP降低顺性女性STI发病率的有效性。我们正在进行一项开放的1：1随机试验，研究dPEP与标准护理(性传播感染筛查和治疗以及不使用dPEP的降低风险咨询)之间的关系，对象是446名服用 ≥ 18岁和 ≤ 30岁的肯尼亚妇女。对女性进行为期12个月的跟踪调查，每季度进行一次性传播感染检测、治疗和依从性咨询。主要试验结果将是随机分组之间沙眼衣原体、淋病奈瑟菌和梅毒螺旋体的综合发病率。我们还将评估dPEP在淋球菌和沙眼衣原体分离株中的可接受性、耐受性、安全性、对性行为的影响、依从性和抗菌素耐药性(AMR)的发生。最后，我们将估计每个STI事件的成本和避免的并发症，包括不遵守和利益相关的AMR或副作用。这项试验的结果可能会对性传播感染和性健康的全球流行产生直接影响。如果有效，dPEP可以将性传播感染预防交到妇女手中。虽然dPEP可能能够预防性传播感染，但它带来了可能抵消其好处的重要风险；关于这些潜在风险和好处的平衡的全球辩论需要数据来为政策和实施提供信息，我们的研究旨在填补这一空白。临床试验.gov NCT04050540。
Women in Africa face disproportionate risk of human immunodeficiency virus (HIV) acquisition, accounting for more than half of new infections in Africa and similarly face a disproportionate burden of sexually transmitted infections (STIs). Very high STI prevalence is being observed globally, especially among people taking pre-exposure prophylaxis (PrEP) for HIV prevention. Doxycycline post-exposure prophylaxis (dPEP) has been proposed as an STI prevention strategy to reduce chlamydia, syphilis, and possibly gonorrhea, and trials are ongoing among cisgender men who have sex with men (MSM) and transgender women who are taking PrEP in high-income settings. We designed and describe here the first open-label trial to determine the effectiveness of dPEP to reduce STI incidence among cisgender women. We are conducting an open-label 1:1 randomized trial of dPEP versus standard of care (STI screening and treatment and risk-reduction counseling without dPEP) among 446 Kenyan women aged ≥ 18 and ≤ 30 years old women taking PrEP. Women are followed for 12 months, with quarterly STI testing, treatment, and adherence counseling. The primary trial outcome will be the combined incidence of Chlamydia trachomatis, Neisseria gonorrhoeae, and Treponema pallidum, compared between the randomized groups. We will also assess dPEP acceptability, tolerability, safety, impact on sexual behavior, adherence, and occurrence of antimicrobial resistance (AMR) in N. gonorrhoeae and C. trachomatis isolates. Finally, we will estimate cost per incident STI case and complications averted accounting for nonadherence and benefits relative AMR or side effects. The results of this trial may have immediate implications for the global epidemic of STIs and sexual health. If effective, dPEP could put STI prevention into women’s hands. While dPEP may be able to prevent STIs, it carries important risks that could counter its benefits; global debate about the balance of these potential risks and benefits requires data to inform policy and implementation and our study aims to fill this gap. ClinicalTrials.gov NCT04050540.
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DOI：
10.3390/antibiotics7030058
发表时间：
2018-07-12
期刊：
Antibiotics (Basel, Switzerland)
影响因子：
--
作者：
Kularatne R;Maseko V;Gumede L;Kufa T
通讯作者：
Kufa T
影响因子：
1.4
作者：
Djomand G;Gao H;Singa B;Hornston S;Bennett E;Odek J;McClelland RS;John-Stewart G;Bock N
通讯作者：
Bock N
影响因子：
3.7
作者：
Kamali, Anatoli;Price, Matt A.;Gilmour, Jill
通讯作者：
Gilmour, Jill
影响因子：
6
作者：
Kiweewa, Flavia Matovu;Brown, Elizabeth;Mhlanga, Felix
通讯作者：
Mhlanga, Felix
DOI：
10.1097/qai.0000000000000525
发表时间：
2015-04-15
影响因子：
3.6
作者：
Corneli, Amy L.;McKenna, Kevin;Van Damme, Lut
通讯作者：
Van Damme, Lut