Lung Health and the Microbiome Among Adults in Botswana: the Go-hema Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Obstructive Pulmonary Disease, Restrictive Pulmonary Disease. Basic parameters: from 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Botswana
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Determinants of Lung Health Among Batswana Adults With and Without HIV: the Go-Hema Study
Overview
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.
Detailed description
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.
Primary outcome measures
- Duke Activity Status Index (DASI) score [Time frame: 60 months]
- Six minute walk test [Time frame: 60 months]
Eligibility criteria
Inclusion criteria
- Adults 35 years of age or older
- In case at a clinic in Botswana
- Documented HIV status
- Ability to provide informed consent
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Botswana · 1 center
- Local Health Facilities in Gaborone — Gaborone
Identifiers
NCT: NCT07699614 · PRO00116223 · 857249