ClinicalTrials.gg
RecruitingNCT07699614Updated Jul 13, 2026

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

An observational study in Obstructive Pulmonary Disease and Restrictive Pulmonary Disease, sponsored by Duke University. Recruiting at 1 site in Botswana. Open to participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by Duke University · Observational

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
900
Ages
35 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Obstructive Pulmonary Disease
  • Restrictive Pulmonary Disease
03

In context

Lung Diseases, Obstructive

202 studies on the registry are indexed under Lung Diseases, Obstructive; 22 are open to participants now.

This study's planned enrollment of 900 is above the median of 185 across 48 observational studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
900 participants (estimated)
Target follow-up
4 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 350 PWH and 550 HIV-uninfected adults

    Adults with and without HIV

06

What researchers measure

Primary outcomes

  1. Duke Activity Status Index (DASI) score

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

    Time frame: 60 months

  2. Six minute walk test

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

    Time frame: 60 months

07

Study locations

1 of 1 sites recruiting
  • Local Health Facilities in Gaborone
    Gaborone, 267, Botswana
    Recruiting
    • Charity Boiditswe, Nursing · Contactbcharitysefelani@yahoo.com · 718 69568
    • Lesedi Makgeng, Public Health · Contactmakgengl@bup.org.bw · 3170933
    • Robert Gross, Medical · Principal investigator
    • Sweta Patel, Medical · Sub investigator
    • Merrian Brooks, Medical · Sub investigator
08

References and documents

Individual participant data

Plan to share: No — This not the research plan

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Dec 2029, 60 months after the start.

Of 25 observational studies under Lung Diseases, Obstructive, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 53. This study's planned 60 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 9, 2025
First posted
Jul 13, 2026
StartActual
Dec 1, 2024
Primary completionEst.
Dec 20, 2029
CompletionEst.
Dec 20, 2030
Last update
Jul 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07699614
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Jul 13, 2026
Start date
Dec 1, 2024
Primary completion
Dec 20, 2029 (estimated)
Completion
Dec 20, 2030 (estimated)
Last update
Jul 13, 2026

Study contacts

Relebogile Thipe, Nursing
Contact
thre2001@gmail.com
+2673170933
Sweta Patel, Medical
Contact
sweta.patel@duke.edu
: (919) 668-0325
Robert Gross, Medical
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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