Sexually Transmitted and Blood Borne Infections Surveillance Division, Public Health Agency of Canada, Ottawa, Ontario, Canada
Sexually Transmitted and Blood Borne Infections Surveillance Division, Public Health Agency of Canada, Ottawa, Ontario, Canada.
BMJ Open. 2024 Aug 29;14(8):e082254. doi: 10.1136/bmjopen-2023-082254.
HIV is a major global public health issue. The risk of sexual transmission of HIV in serodiscordant couples when the partner living with HIV maintains a suppressed viral load of <200 copies of HIV copies/mL has been found in systematic reviews to be negligible. A recent systematic review reported a similar risk of transmission for viral load<1000 copies/mL, but quantitative transmission risk estimates were not provided. Precise estimates of the risk of sexual transmission at sustained viral load levels between 200 copies/mL and 1000 copies/mL remain a significant gap in the literature.
A systematic search of various electronic databases for the articles written in English or French will be conducted from January 2000 to October 2023, including MEDLINE, Embase, the Cochrane Central Register of Controlled Trials via Ovid and Scopus. The first step of a two-step meta-analysis will consist of a systematic review along with a meta-analysis, and the second step will use individual participant data for meta-analysis. Our primary outcome is the risk of sexual HIV transmission in serodiscordant couples where the partner living with HIV is on antiretroviral therapy. Our secondary outcome is the dose-response association between different levels of viral load and the risk of sexual HIV transmission. We will ascertain the risk of bias using the Risk Of Bias in Non-randomised Studies of Interventions (ROBINS-I) and Quality in Prognostic Studies (QUIPS), the risk of publication bias using forest plots and Egger's test and heterogeneity using I. A random effects model will estimate the pooled incidence of sexual HIV transmission, and multivariate logistic regression will be used to assess the viral load dose-response relationships. The Grading of Recommendations, Assessment, Development and Evaluation system will determine the certainty of evidence.
The meta-analysis will be conducted using deidentified data. No human subjects will be involved in the research. Findings will be disseminated through peer-reviewed publications, presentations and conferences.
CRD42023476946.
HIV 是一个重大的全球公共卫生问题。系统评价发现，当 HIV 感染者的病毒载量被抑制在<200 拷贝/ml 时，其性传播 HIV 的风险可以忽略不计。最近的一项系统评价报告称，病毒载量<1000 拷贝/ml 时的传播风险相似，但未提供定量传播风险估计。在 200 拷贝/ml 至 1000 拷贝/ml 之间持续病毒载量水平下，性传播风险的精确估计仍然是文献中的一个重大空白。
从 2000 年 1 月至 2023 年 10 月，我们将对各种英文或法文电子数据库中的文章进行系统检索，包括 MEDLINE、Embase、通过 Ovid 检索的 Cochrane 中央对照试验注册中心和 Scopus。两步荟萃分析的第一步将包括系统评价和荟萃分析，第二步将使用个体参与者数据进行荟萃分析。我们的主要结局是 HIV 感染者在接受抗逆转录病毒治疗时，与 HIV 血清学不一致的性伴侣之间的 HIV 性传播风险。我们的次要结局是不同病毒载量水平与 HIV 性传播风险之间的剂量-反应关系。我们将使用干预措施非随机研究中的偏倚风险（ROBINS-I）和预后研究中的偏倚风险（QUIPS）来确定偏倚风险，使用森林图和 Egger 检验来确定发表偏倚风险，使用 I 来确定异质性。随机效应模型将估计性 HIV 传播的总发生率，多元逻辑回归将用于评估病毒载量的剂量-反应关系。推荐评估、制定与评价系统（Grading of Recommendations, Assessment, Development and Evaluation，GRADE）将确定证据的确定性。
荟萃分析将使用去识别数据进行。研究不会涉及人类受试者。研究结果将通过同行评议的出版物、演讲和会议进行传播。
CRD42023476946。
