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NCT Number: NCT07699614

Lung Health and the Microbiome Among Adults in Botswana: the Go-hema Cohort

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.

Recruiting

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Health Facilities in Gaborone

Gaborone, 267, Botswana

Location status: Recruiting

Location contact

Charity Boiditswe, Nursing

CONTACT

[email protected]

718 69568

Lesedi Makgeng, Public Health

CONTACT

[email protected]

3170933

Merrian Brooks, Medical

SUB_INVESTIGATOR

Robert Gross, Medical

PRINCIPAL_INVESTIGATOR

Sweta Patel, Medical

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Duke Activity Status Index (DASI) score

    Time frame: 60 months

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

  2. Six minute walk test

    Time frame: 60 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Relebogile Thipe, Nursing

CONTACT

[email protected]

+2673170933

Sweta Patel, Medical

CONTACT

[email protected]

: (919) 668-0325

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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