跳至主要内容
临床试验/NCT07699614
NCT07699614招募中不适用

Determinants of Lung Health Among Batswana Adults With and Without HIV: the Go-Hema Study

Duke University1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
900
试验地点
1
主要终点
Duke Activity Status Index (DASI) score

研究概览

简要总结

Chronic respiratory diseases like chronic obstructive pulmonary disease (COPD) are responsible for millions of deaths each year, the majority of which occur in low- and middle-income countries (LMICs). LMICs also have high rates of abnormal lung function, including restrictive spirometric pattern (RSP), which can precede the development of chronic respiratory diseases and is associated with all-cause mortality. Additionally, LMICs in sub-Saharan Africa are home to the majority of the world's population of people with HIV (PWH). HIV increases the risk of COPD and COPD associated mortality, but the mechanisms underlying this risk are incompletely understood.

详细描述

To address the knowledge gap, the investigator propose a prospective cohort study to phenotype patterns of abnormal lung function and use multi-omics to identify associations between host-microbiome interactions, COPD, and lung function loss among adults with and without HIV in Botswana. The findings of this study will improve understanding of respiratory health and determinants of COPD among Batswana adults and contribute to the equitable development of novel COPD therapies by generating data from a population overrepresented in global COPD mortality but underrepresented in current COPD and microbiome research.

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. COPD affects nearly 300 million people globally and is the third leading cause of death.Despite advances in tobacco control programs, the prevalence of COPD is projected to increase as the global population ages, pneumonia incidence increases, and exposure to high levels of particulate air pollution persists. Additionally, COPD is a heterogenous disease with multiple partially understood phenotypes that exhibit varying responses to current therapies.Consequently, efforts to reduce incident COPD and COPD-associated mortality are complicated by challenges in reducing exposure to risk factors and an incomplete understanding of disease pathophysiology.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults 35 years of age or older
  • In case at a clinic in Botswana
  • Documented HIV status
  • Ability to provide informed consent

排除标准

  • Respiratory infection in the prior 4 weeks
  • Active pulmonary tuberculosis
  • Inability to perform spirometry including eye, abdominal, or
  • Thoracic surgery or myocardial infarction in the prior 6 weeks
  • Pregnancy

研究组 & 干预措施

350 PWH and 550 HIV-uninfected adults

Adults with and without HIV

结局指标

主要结局

Duke Activity Status Index (DASI) score

时间窗: 60 months

The DASI will be assessed over time to determine pulmonary function.

Six minute walk test

时间窗: 60 months

A six minute walk test will be assessed over time to determine pulmonary function.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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