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

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Pulmonary Disease; Restrictive Pulmonary Disease

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 Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

• Study Contact: Name: Relebogile Thipe, Nursing; Phone Number: +2673170933; Email: thre2001@gmail.com
• Study Contact Backup: Name: Sweta Patel, Medical; Phone Number: : (919) 668-0325; Email: sweta.patel@duke.edu

Study Locations

• Botswana
  • Gaborone, Botswana, 267
    • Recruiting
    • Local Health Facilities in Gaborone
    • Contact: Charity Boiditswe, Nursing; Phone Number: 718 69568; Email: bcharitysefelani@yahoo.com
    • Contact: Lesedi Makgeng, Public Health; Phone Number: 3170933; Email: makgengl@bup.org.bw
    • Principal Investigator: Robert Gross, Medical
    • Sub-Investigator: Sweta Patel, Medical
    • Sub-Investigator: Merrian Brooks, Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
350 PWH and 550 HIV-uninfected adults; Adults with and without HIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duke Activity Status Index (DASI) score	The DASI will be assessed over time to determine pulmonary function.	60 months
Six minute walk test	A six minute walk test will be assessed over time to determine pulmonary function.	60 months

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Robert Gross, Medical, UNIVERSITY of PENNSYLVANIA

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): December 20, 2029
• Study Completion (Estimated): December 20, 2030

Study Registration Dates

• First Submitted: June 9, 2025
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive
• Other Study ID Numbers: PRO00116223; 857249 (Other Identifier: UPenn ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This not the research plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No