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

8. juli 2026 opdateret af: Duke University

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

900

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Relebogile Thipe, Nursing
Telefonnummer: +2673170933
E-mail: thre2001@gmail.com

Undersøgelse Kontakt Backup

Navn: Sweta Patel, Medical
Telefonnummer: : (919) 668-0325
E-mail: sweta.patel@duke.edu

Studiesteder

Botswana
- - Gaborone, Botswana, 267
    - Rekruttering
    - Local Health Facilities in Gaborone
    - Kontakt:
      
      Charity Boiditswe, Nursing
      
      Telefonnummer: 718 69568
      
      E-mail: bcharitysefelani@yahoo.com
    - Kontakt:
      
      Lesedi Makgeng, Public Health
      
      Telefonnummer: 3170933
      
      E-mail: makgengl@bup.org.bw
    - Ledende efterforsker:
      
      Robert Gross, Medical
    - Underforsker:
      
      Sweta Patel, Medical
    - Underforsker:
      
      Merrian Brooks, Medical

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Voksen
Ældre voksen

Tager imod sunde frivillige

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adults 35 years and above with documented HIV status and without recent/active respiratory illness or inability to perform spirometry.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
350 PWH and 550 HIV-uninfected adults Adults with and without HIV

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Duke Activity Status Index (DASI) score Tidsramme: 60 months	The DASI will be assessed over time to determine pulmonary function.	60 months
Six minute walk test Tidsramme: 60 months	A six minute walk test will be assessed over time to determine pulmonary function.	60 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Duke University

Efterforskere

Ledende efterforsker: Robert Gross, Medical, University of Pennsylvania

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2024

Primær færdiggørelse (Anslået)

20. december 2029

Studieafslutning (Anslået)

20. december 2030

Datoer for studieregistrering

Først indsendt

9. juni 2025

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)