International Epidemiologic Databases to Evaluate AIDS-Southern Africa (IeDEA-SA)

评估南部非洲艾滋病的国际流行病学数据库 (IeDEA-SA)

• 批准号: 8299380
• 负责人: Mary-Ann Davies
• 金额: $ 386.83万
• 依托单位: UNIVERSITAT BERN
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-07-15 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8299380
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Adolescent; Adult; Affect; Anthropometry; Anti-Retroviral Agents; Birth; Botswana; CD4 Positive T Lymphocytes; Cancer Patient; Caring; Cessation of life; Child; Clinical; Comorbidity; Country; Data; Databases; Epidemic; Epidemiology; Exposure to; Fertility; Government; Growth; HIV; Health Policy; Infant; International; Intervention; Lesotho; Link; Malawi; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Meta-Analysis; Methods; Monitor; Mozambique; Nature; Patients; Pregnancy Outcome; Pregnant Women; Program Effectiveness; Recurrence; Regimen; Risk; Rural; Screening procedure; South Africa; Southern Africa; Surveys; Time; Toxic effect; Tuberculosis; Viral Load result; Zambia; Zimbabwe; cohort; feeding; follow-up; mathematical model; mortality; neoplasm registry; postnatal; premature; public health research; resistance mutation; response; treatment program; treatment strategy; trend

DESCRIPTION (provided by applicant): Background: This proposal asks for continued support of leDEA-SA, a large collaborative network of HIV care and antiretroviral treatment (ART) programs in Southern Africa. Aims: (i) to provide the best available data on long-term program effectiveness in children, adolescents and adults; (ii) to describe long-term regimen durability and tolerability and examine different monitoring and treatment strategies, with a focus on viral load and second-line ART; (iii) to describe co-morbidities, focusing on tuberculosis and cancer and (iv) to follow up pregnant women on ART and cohorts of ART-exposed non HIV-infected infants and infected infants, and (v) to build capacity in the region. Methods: 20 urban and rural ART programs from 7 countries (Botswana, Lesotho, Malawi, Mozambique, Republic of South Africa, Zambia, Zimbabwe) with follow-up up to 10 years will pool data to create a database of 400,000 HIV-infected adults, 10,000 adolescents, 36,000 children and 6,700 infants, with about 70% of patients on ART. In South Africa, HIV data will be linked to the National Cancer Registry, National Death and Birth Registers, and the Tuberculosis Register. Mortality, loss to follow-up, tuberculosis and recurrent tuberculosis, and AIDS-defining and other cancers will be analyzed, as well as fertility, CD4 cell trajectories, treatment-limiting toxicities, response to second-line ART and resistance mutations in adults and children failing ART. Trends in exposure to antenatal and postnatal ARVs, pregnancy outcomes including prematurity and anthropometry, feeding practices and growth over 18 months will be examined in sub- cohorts of pregnant women and infants. We will survey the provision of care to cancer patients, and compare different screening strategies for invasive cervical cancer. Statistical analyses will consider the hierarchical nature of the data, missing data and loss to follow-up, competing risks and time-dependent confounding, and new methods will be developed. Accumulating results will be used to build and parameterize a mathematical model of ART in children, adolescents and adults, which will reflect the realities of HIV care and ART in Southern Africa, and inform health policy. RELEVANCE: Southern Africa is the region most heavily affected by the HIV epidemic. Since 2004, efforts by governments and others have resulted in a massive increase in HIV/AIDS interventions and particularly ART. Operational, clinical and public health research is urgently needed to guide the long-term delivery of HIV care and ART to the many patients in need, including pregnant women, infants, children and adolescents.

描述（由申请人提供）： 背景：该提案请求 leDEA-SA 的持续支持，leDEA-SA 是南部非洲艾滋病毒护理和抗逆转录病毒治疗 (ART) 项目的大型合作网络。目标： (i) 提供有关儿童、青少年和成人长期方案有效性的最佳可用数据； (ii) 描述长期治疗方案的持久性和耐受性，并检查不同的监测和治疗策略，重点关注病毒载量和二线抗逆转录病毒疗法； (iii) 描述合并症，重点关注结核病和癌症，(iv) 对接受 ART 的孕妇以及接受 ART 的非 HIV 感染婴儿和感染婴儿群体进行随访，以及 (v) 建设该地区的能力。方法：来自 7 个国家（博茨瓦纳、莱索托、马拉维、莫桑比克、南非共和国、赞比亚、津巴布韦）的 20 个城市和农村 ART 项目，后续长达 10 年，将汇集数据，创建一个包含 400,000 名艾滋病毒感染成年人的数据库，10,000 名青少年、36,000 名儿童和 6,700 名婴儿，其中约 70% 的患者正在接受治疗 艺术。在南非，艾滋病毒数据将与国家癌症登记处、国家死亡和出生登记处以及结核病登记处相关联。将分析死亡率、失访、结核病和复发性结核病、艾滋病定义和其他癌症，以及生育力、CD4 细胞轨迹、限制治疗的毒性、对二线 ART 的反应以及成人和儿童的耐药突变。 ART 失败的儿童。将在孕妇和婴儿的子队列中检查产前和产后抗逆转录病毒药物暴露趋势、妊娠结局（包括早产和人体测量）、喂养方式和 18 个月内的生长情况。我们将调查癌症患者的护理情况，并比较浸润性宫颈癌的不同筛查策略。统计分析将考虑数据的层次性质、缺失数据和失访、竞争风险和时间依赖性混杂因素，并将开发新方法。积累的结果将用于建立儿童、青少年和成人抗逆转录病毒治疗的数学模型并对其进行参数化，该模型将反映南部非洲艾滋病毒护理和抗逆转录病毒治疗的现实情况，并为卫生政策提供信息。 关联： 南部非洲是受艾滋病毒流行影响最严重的地区。自 2004 年以来，在各国政府和其他方面的努力下，艾滋病毒/艾滋病干预措施，特别是抗逆转录病毒疗法大幅增加。迫切需要开展业务、临床和公共卫生研究，以指导向许多有需要的患者（包括孕妇、婴儿、儿童和青少年）长期提供艾滋病毒护理和抗逆转录病毒治疗。