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通过提供移动健康服务中的伴侣通知来保护男男性行为者免受艾滋病毒和其他性传播疾病的侵害:一项实用的阶梯式楔形集群随机对照试验方案。

Protect MSM from HIV and other sexually transmitted diseases by providing mobile health services of partner notification: protocol for a pragmatic stepped wedge cluster randomized controlled trial.

机构信息

Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.

National Institute on Drug Dependence, Peking University, 38 Xueyuan Rd, Haidian District, Beijing, 100191, China.

出版信息

BMC Public Health. 2020 Jul 14;20(1):1107. doi: 10.1186/s12889-020-09162-x.

DOI:10.1186/s12889-020-09162-x
PMID:32664934
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7362655/
Abstract

BACKGROUND

Recently, more and more men who have sex with men (MSM) look for casual partners through online dating platforms in China. However, most are unable to know their partners' HIV and other sexually transmitted diseases (STD) statuses, leading to the rapid increase in HIV infection among Chinese MSM. Effective partner notification is urgently needed to increase the risk awareness of MSM and prevent HIV and other STDs transmission. However, the traditional intervention mainly targets to the HIV-positive MSM and the effect is not promising. Our study aims to provide Internet-based partner notification, along with a series of health services for HIV-negative MSM to protect them from HIV and other STDs.

METHODS

A pragmatic stepped wedge cluster randomized controlled trial design is used to evaluate the effectiveness of a new intervention paradigm, which aims to reduce HIV and other STDs incidences among MSM in China. Through integrating a mobile health (mHealth) service application (app) to the current HIV and other STDs prevention and control methods, the new paradigm provides partner notification of HIV, syphilis, hepatitis B, and hepatitis C statuses. A total of 6172 MSM in 16 districts of Beijing, China will be recruited and randomized to sequentially receive partner notification intervention through the app at 6-month intervals. The primary outcomes are HIV incidence and the additional cost of the intervention. The secondary outcomes include incidences of syphilis, hepatitis B, and hepatitis C, disease transmission social networks, testing adherence, knowledge of HIV and STDs control, health self-responsibility awareness, changes of high risk behaviors and other related outcomes. The generalized linear mixed models (GLMM) will be used to analyze the differences of outcomes in the control period and in the intervention period.

DISCUSSION

We expect that the HIV incidence will be significantly lower and the secondary outcomes will also be improved with providing health service of partner notification through mhealth intervention. The feasible and affordable public health intervention paradigm will have implications for HIV and STDs prevention and control among MSM and other key populations.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT04349748 . Registered on 16 April 2020.

摘要

背景

最近,越来越多的男男性行为者(MSM)在中国通过在线约会平台寻找偶然伴侣。然而,大多数人无法了解伴侣的 HIV 和其他性传播疾病(STD)状况,导致中国 MSM 中的 HIV 感染迅速增加。迫切需要有效的伙伴通知,以提高 MSM 的风险意识,防止 HIV 和其他 STD 的传播。然而,传统的干预措施主要针对 HIV 阳性 MSM,效果并不理想。我们的研究旨在为 HIV 阴性 MSM 提供基于互联网的伙伴通知,并提供一系列健康服务,以保护他们免受 HIV 和其他 STD 的感染。

方法

采用实用的 stepped wedge 聚类随机对照试验设计来评估一种新的干预模式的有效性,该模式旨在降低中国 MSM 中的 HIV 和其他 STD 发生率。通过将移动健康(mHealth)服务应用程序(app)整合到当前的 HIV 和其他 STD 预防和控制方法中,新的模式提供了 HIV、梅毒、乙型肝炎和丙型肝炎状况的伙伴通知。共有 6172 名来自中国北京市 16 个区的 MSM 将被招募并随机分配,每隔 6 个月通过 app 顺序接受伙伴通知干预。主要结果是 HIV 发病率和干预的额外成本。次要结果包括梅毒、乙型肝炎和丙型肝炎的发病率、疾病传播社交网络、检测依从性、HIV 和 STD 控制知识、健康自我责任意识、高危行为变化和其他相关结果。广义线性混合模型(GLMM)将用于分析对照期和干预期结果的差异。

讨论

我们期望通过 mHealth 干预提供伙伴通知健康服务将显著降低 HIV 发病率,并改善次要结果。可行且负担得起的公共卫生干预模式将对 MSM 和其他重点人群的 HIV 和 STD 预防和控制产生影响。

试验注册

ClinicalTrials.gov,NCT04349748。注册于 2020 年 4 月 16 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48a6/7362655/612f81537fb7/12889_2020_9162_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48a6/7362655/723dc7e2ee31/12889_2020_9162_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48a6/7362655/8eb7148ad6ce/12889_2020_9162_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48a6/7362655/5d4e659e1d08/12889_2020_9162_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48a6/7362655/612f81537fb7/12889_2020_9162_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48a6/7362655/723dc7e2ee31/12889_2020_9162_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48a6/7362655/8eb7148ad6ce/12889_2020_9162_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48a6/7362655/5d4e659e1d08/12889_2020_9162_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48a6/7362655/612f81537fb7/12889_2020_9162_Fig4_HTML.jpg

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