Obstructive Pulmonary DiseaseNCT07699614
Lung Health and the Microbiome Among Adults in Botswana: the Go-hema Cohort
An observational study of Obstructive Pulmonary Disease and Restrictive Pulmonary Disease, run by Duke University at 1 site in Botswana.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Pulmonary Disease, Restrictive Pulmonary Disease
- How many people
- 900 participants
- Where
- 1 siteBotswana
- Study dates
- 1 Dec 2024to 20 Dec 2030
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults 35 years and above with documented HIV status and without recent/active respiratory illness or inability to perform spirometry.
Who may be able to join
- Adults 35 years of age or older
- In case at a clinic in Botswana
- Documented HIV status
- Ability to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Botswana1 site, 1 recruiting
- Recruiting
Local Health Facilities in Gaborone
Gaborone, 267
Charity Boiditswe, Nursing, 718 69568, bcharitysefelani@yahoo.com
Lesedi Makgeng, Public Health, 3170933, makgengl@bup.org.bw
About this study
Official title: 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.
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.
- Medical subject headings
- Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 350 PWH and 550 HIV-uninfected adults | Adults with and without HIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duke Activity Status Index (DASI) score
The DASI will be assessed over time to determine pulmonary function.
Measured: 60 months
Six minute walk test
A six minute walk test will be assessed over time to determine pulmonary function.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Dec 2024
- Primary completion20 Dec 2029 (estimated)
- Study completion20 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Gross, Medical, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699614
- Sponsor's protocol ID
- PRO00116223
- Other IDs
- 857249
- Status last verified
- Jul 2026
- First submitted
- 9 Jun 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This not the research plan
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Lung Health Among Batswana Adults With and Without HIV: the Go-Hema Study
- ClinicalTrials.gov ID
- NCT07699614
- Acronym / sponsor ID
- PRO00116223
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 20 Dec 2029 (estimated)
- Study completion
- 20 Dec 2030 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 350 PWH and 550 HIV-uninfected adults | – | –Adults with and without HIV |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 35 years and above with documented HIV status and without recent/active respiratory illness or inability to perform spirometry.
Key inclusion criteria (4 listed)
- Adults 35 years of age or older
- In case at a clinic in Botswana
- Documented HIV status
- Ability to provide informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duke Activity Status Index (DASI) score
Time frame: 60 months
The DASI will be assessed over time to determine pulmonary function.
Six minute walk test
Time frame: 60 months
A six minute walk test will be assessed over time to determine pulmonary function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No. This not the research plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Gross, Medical principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Pulmonary Disease and Restrictive Pulmonary Disease, run by Duke University at 1 site in Botswana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Relebogile Thipe, Nursing (+2673170933, thre2001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duke Activity Status Index (DASI) score (time frame: 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.