Developing a regionally representative risk assessment tool to identify men at highest risk of HIV acquisition in sub-Saharan Africa

开发具有区域代表性的风险评估工具，以确定撒哈拉以南非洲地区感染艾滋病毒风险最高的男性

• 批准号: 10762645
• 负责人: Nora Rosenberg
• 金额: $ 41.68万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10762645
• 关键词: AIDS prevention; Accounting; Acquired Immunodeficiency Syndrome; Address; Adopted; Adult; Africa South of the Sahara; African; Anti-Retroviral Agents; Antigens; Area; Assessment tool; Avidity; Behavior; Biological Markers; Botswana; Caring; Central Africa; Communities; Complex; Country; Data; Data Set; Data Sources; Eligibility Determination; Enzyme Immunoassay; Epidemic; Epidemiology; Federal Government; Geography; Goals; Government; HIV; HIV-1; HIV/AIDS; Health; Household; Incidence; Individual; Infection; Injectable; Machine Learning; Measures; Methods; Modeling; Nigeria; Oral; Outcome; Performance; Population; Positioning Attribute; Predisposition; Prevalence; Prevention; Prevention strategy; Principal Investigator; ROC Curve; Research; Research Personnel; Risk; Risk Assessment; Sensitivity and Specificity; Series; South African; Specialist; Survey Methodology; Surveys; Techniques; Tenofovir; Time; Validation; Viral; Viral Load result; Woman; Work; Zambia; aged; analytical method; drug testing; experience; high risk; high risk men; machine learning method; male; men; mortality; population based; pre-exposure prophylaxis; predictive modeling; public health priorities; random forest; response; risk stratification; stem; tool; transmission process

PROJECT SUMMARY/ABSTRACT Background: In sub-Saharan Africa (SSA), HIV prevention has lagged behind UNAIDS targets. Approximately 730,000 adults are infected each year, with men accounting for more than one third of these new infections. Biomedical HIV prevention strategies, such as oral and injectable pre-exposure prophylaxis (PrEP), are promising measures for reducing HIV acquisition. However, providing PrEP to all men is infeasible and unnecessary. Risk stratification approaches are needed to identify men at highest risk of HIV acquisition and in greatest need of PrEP. Although multiple risk assessment tools have been developed for women, few tools have been developed for men. Those that have been developed have important limitations with respect to internal and external validity. The goal of this proposal is to develop a risk assessment tool for identifying men at highest risk for HIV acquisition using rigorous analytic methods in a regionally representative dataset. Methods and Specific Aims: In Aim 1, we will use nationally representative data from 15 SSA countries collected from 2015-2019 as part of the Population-based HIV Impact Assessments (PHIAs), the Nigeria AIDS Indicator and Impact Surveys (NAIIS), and the South African National HIV Prevalence, Incidence and Behaviour Survey (SABSSM). These 15 surveys represent 249,000 new annual male infections in a population of 122 million susceptible men. These surveys all have a set of biomarkers (limiting-antigen avidity enzyme immunoassay, HIV-1 viral load, and antiretroviral drug detection) indicative of recent HIV-1 infection. We will apply two machine-learning methods to develop risk assessment tools to identify men aged 15-49 at greatest risk of HIV-1. We will calculate the area under the receiver operating characteristic curve (AUC), as well as sensitivity and specificity at select thresholds. In Aim 2, we will externally validate the tools in ten second-round national surveys conducted in SSA from 2020-2022 and select a final tool. Using the final tool, we will estimate the AUC and the sensitivity and specificity at meaningful thresholds. At each threshold, we will calculate the number of men at increased risk of HIV-1 infection, the number needed to treat with PrEP to avert one new infection, and the estimated number of infections averted. Team: This is a proposal led by multiple Principal Investigators (mPIs)—one with epidemiologic expertise in HIV prevention in SSA and the other with extensive statistical experience using complex survey data. The team includes co-investigators with expertise in machine learning and biomedical HIV prevention. They are supported by a technical advisory panel of regional HIV prevention specialists; the principal investigators of the PHIA, NAIIS, and SABSSM surveys; and an expert biostatistician in the field of HIV research. Impact: We will use rigorous methods to develop a regional tool to identify men at highest risk of HIV acquisition. This research is crucial for a targeted HIV response and ultimately ending the HIV epidemic in SSA.

项目概要/摘要 背景：在撒哈拉以南非洲（SSA），艾滋病毒预防工作大约落后于联合国艾滋病规划署的目标。 每年有 730,000 名成年人被感染，其中男性占新增感染者的三分之一以上。 HIV 生物医学预防策略，例如口服和注射暴露前预防 (PrEP) 然而，向所有男性提供 PrEP 是不可行且可行的。 需要采取风险分层方法来识别感染艾滋病毒风险最高的男性。 尽管已经为女性开发了多种风险评估工具，但很少有工具能够实现这一目标。 那些为男性开发的产品在内部和外部方面具有重要的局限性。 该提案的目标是开发一种风险评估工具，用于识别风险最高的男性。 在具有区域代表性的数据集中使用严格的分析方法获取艾滋病毒。 方法和具体目标：在目标 1 中，我们将使用来自 15 个 SSA 国家的国家代表性数据 2015 年至 2019 年期间收集的数据，作为基于人口的艾滋病毒影响评估 (PHIA) 的一部分，尼日利亚艾滋病 指标和影响调查 (NAIIS) 以及南非全国艾滋病毒患病率、发病率和行为 调查 (SABSSM)。这 15 项调查代表了 122 名人口中每年新增的 249,000 名男性感染者。 这些调查都有一组生物标志物（限制抗原亲和力酶）。 免疫分析、HIV-1 病毒载量和抗逆转录病毒药物检测）是近期 HIV-1 感染的指标。 应用两种机器学习方法开发风险评估工具，识别年龄最大15-49岁的男性 我们将计算受试者工作特征曲线下的面积 (AUC) 以及 HIV-1 的风险。 在目标 2 中，我们将在十个第二轮中对工具进行外部验证。 我们将在 2020 年至 2022 年期间对 SSA 进行全国调查，并选择最终工具进行估算。 在每个阈值处，我们将计算 AUC 以及敏感度和特异性。 HIV-1 感染风险增加的男性人数，需要接受 PrEP 治疗以避免新感染的人数 感染，以及避免感染的估计数量。 团队：这是一项由多位首席研究员 (mPI) 领导的提案，其中一位具有 HIV 流行病学专业知识 SSA 的预防工作和其他具有使用复杂调查数据进行统计的丰富经验的团队。 包括在机器学习和生物医学艾滋病毒预防方面具有专业知识的联合研究人员。他们得到了支持。 由区域艾滋病毒预防专家组成的技术咨询小组； PHIA 的主要研究人员； NAIIS 和 SABSSM 调查；以及 HIV 研究领域的专家生物统计学家。 影响：我们将使用严格的方法开发区域工具来识别感染艾滋病毒风险最高的男性。 这项研究对于有针对性的艾滋病毒应对措施并最终结束撒哈拉以南非洲的艾滋病毒流行至关重要。