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

NCT07699614 | Recruiting

• 2 other identifiers: PRO00116223857249
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Pulmonary Disease; Restrictive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

350 PWH and 550 HIV-uninfected adults

Adults with and without HIV

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Local Health Facilities in Gaborone

Gaborone, 267, Botswana

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Rapid HIV test. Saliva, sputum, and stool will be collected at enrollment.

MeSH Terms

Conditions

Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robert Gross, Medical

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Relebogile Thipe, Nursing

CONTACT

+2673170933; thre2001@gmail.com

Sweta Patel, Medical

CONTACT

: (919) 668-0325; sweta.patel@duke.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: July 13, 2026
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 20, 2029
• Study Completion (Estimated): December 20, 2030
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)