Background: 

Pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate and emtricitabine has proven highly effective in preventing HIV acquisition and is therefore offered to all participants in the control group as part of the standard of care package in many new HIV prevention studies. We propose a methodology for predicting HIV incidence in a hypothetical “placebo arm” for open-label studies or clinical trials with active control among African women. We apply the method to an open-label PrEP study, HIV Prevention Trials Network 082, which tested strategies to improve PrEP adherence in young African women all of whom were offered PrEP.

Methods: 

Our model predicted HIV infection risk for female study cohorts in sub-Saharan Africa using baseline behavioral risk factors and contemporary HIV prevalence and viral suppression in the local male population. The model was calibrated to HIV incidence in the Vaginal and Oral Interventions to Control the Epidemic study.

Results: 

Our model reproduced the annual HIV incidence of 3.2%–4.8% observed over 1 year of follow-up in the placebo groups of 4 completed clinical studies. We predicted an annual HIV incidence of 3.7% (95% confidence interval: 3.2 to 4.2) among HIV Prevention Trials Network 082 participants in the absence of PrEP and other risk reduction interventions.

Conclusions: 

We demonstrated the potential of the proposed methodology to provide HIV incidence predictions based on assessment of individual risk behaviors and community and time-specific HIV exposure risk using HIV treatment and viral suppression data. These estimates may serve as comparators in HIV prevention trials without a placebo group.

中文翻译：

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使用艾滋病毒危险行为和男性艾滋病毒患病率和病毒抑制水平的社区级数据，基于模型的非洲妇女艾滋病毒发病率预测

背景： 

替诺福韦富马酸替诺福韦酯和恩曲他滨预防暴露（PrEP）已被证明在预防HIV感染方面非常有效，因此在许多新的HIV预防研究中，作为对照组的一部分，它被提供给对照组的所有参与者。我们提出了一种方法来预测假想的“安慰剂组”中的HIV发病率，用于在非洲妇女中进行有效控制的开放标签研究或临床试验。我们将该方法应用于开放标签的PrEP研究，即HIV预防试验网络082，该研究测试了提高所有获得PrEP的年轻非洲女性对PrEP依从性的策略。

方法： 

我们的模型使用基线行为风险因素以及当地男性人群的当代HIV流行率和病毒抑制率，预测了撒哈拉以南非洲女性研究人群的HIV感染风险。该模型已根据阴道和口腔干预措施中的HIV感染率进行了校准，以控制该流行病研究。

结果： 

我们的模型再现了在4个已完成临床研究的安慰剂组中，随访1年观察到的年度HIV发生率3.2％–4.8％。我们预计在没有PrEP和其他降低风险干预措施的情况下，HIV预防试验网络082参与者中的年度HIV发生率为3.7％（95％可信区间：3.2至4.2）。

结论： 

我们证明了所提出的方法的潜力，该方法可通过使用HIV治疗和病毒抑制数据评估个体风险行为和社区以及特定时间的HIV暴露风险来提供HIV发病率预测。这些估计值可在没有安慰剂组的情况下用作HIV预防试验的比较者。