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.

项目摘要/摘要 背景：在撒哈拉以南非洲（SSA），艾滋病毒预防落后于联合国艾滋病规则的目标。大约 每年有730,000名成年人被感染，其中男性占了这些新感染的三分之一以上。 生物医学HIV预防策略，例如口服和可注射的预防前预防（PREP） 减少艾滋病毒收购的有希望的措施。但是，向所有男人提供准备是不可行的，并且 不必要。需要采取风险分层方法来确定艾滋病毒收购风险最高的男性和 最需要准备。尽管已经为女性开发了多种风险评估工具，但很少有工具 他们是为男人开发的。那些已经开发的人在内部和 外部有效性。该提案的目的是开发一种风险评估工具，以识别最高风险的男性 用于在区域代表性数据集中使用严格的分析方法获取HIV。 方法和特定目的：在AIM 1中，我们将使用来自15个SSA国家的全国代表性数据 尼日利亚艾滋病从2015年至2019年收集为基于人群的HIV影响评估（PHIA）的一部分 指标和影响调查（NAIIS）以及南非国家艾滋病毒的患病率和行为 调查（SABSSM）。这15次调查代表249,000个新的年度男性感染，人口为122 百万易感男人。这些调查都有一组生物标志物（极限 - 抗原伴侣酶 免疫测定，HIV-1病毒载量和抗逆转录病毒药物检测）表示最近的HIV-1感染。我们将 应用两种机器学习方法来开发风险评估工具，以识别最大的15-49岁男性 HIV-1的风险。我们将计算接收器操作特征曲线（AUC）下的区域以及 精选阈值的灵敏度和特异性。在AIM 2中，我们将在10次第二轮中外部验证工具 国家调查于2020 - 2022年在SSA进行，并选择最终工具。使用最终工具，我们将估计 有意义的阈值处的AUC以及灵敏度和特异性。在每个阈值下，我们将计算 患有HIV-1感染风险增加的男性人数，准备治疗所需的人数以避免一种新的 感染，并避免感染的估计数量。 团队：这是由多个主要研究人员（MPI）领导的提案 - 一个具有艾滋病毒的流行病学知识 使用复杂的调查数据具有SSA的预防和其他具有丰富的统计经验的预防。团队 包括在机器学习和预防生物医学HIV方面具有专业知识的共同投资者。他们得到了支持 由区域艾滋病毒预防专家的技术咨询小组； PHIA的主要调查员， NAIIS和SABSSM调查；以及艾滋病毒研究领域的专业生物统计学家。 影响：我们将使用严格的方法来开发一种区域工具来识别艾滋病毒收购风险最高的男性。 这项研究对于靶向的HIV反应至关重要，最终结束了SSA中的HIV流行。