SURVEILLANCE, ASSESSMENT AND DETECTION OF INFLUENZA ASSOCIATED RESPIRATORY INFECTIONS IN HIV POSITIVE AND NEGATIVE INDIVIDUALS IN LUSAKA, ZAMBIA

NCT07030075 | Recruiting

• 1 other identifier: 5955-2024
• Study Type: observational
• Target: 594
• Locations: 1 country
• Sites: 2

Brief Summary

Background and rationale:The World Health Organisation (WHO), estimates influenza global deaths at 290,000 to 650,000 annually. Although influenza is mostly associated with upper respiratory tract infections (URTIs), its role in lower respiratory tract infections (LRTIs) and the associated poor clinical outcomes have been overlooked in sub-Saharan Africa. A study conducted in eight SSA countries estimated that 8.2% of cases and 2.8% of deaths from LRTIs were due to primary infection with influenza. Pneumonia and influenza-associated illness are responsible for 8.5% of respiratory deaths in Zambia. However, in routine practice, testing to distinguish between bacterial and viral etiology of RTIs is seldom done outside sentinel surveillance due to the high cost and lack of available testing options. This consequently underestimates viral RTIs in the population. It is particularly important to diagnose flu early on in vulnerable populations so that they receive timely and appropriate medical care. Although Zambia is a high HIV burden country with a prevalence of 11%, there is presently no study that has described the burden of influenza in the HIV positive population. This research study will address gaps in current scientific knowledge, providing key insights about the prevalence, circulating types, seasonality and associated clinical outcomes of influenza, RSV and SARS-CoV-2 infection in Zambia in the post COVID-19 era. Objectives Primary To determine the prevalence of influenza (A and/or B) infections in a high HIV burden setting in Lusaka, Zambia over one or more influenza seasons. Secondary

1. 1.To determine the prevalence of influenza co-infection with RSV and/or SARS-CoV-2
2. 2.To determine the clinical outcomes of influenza (A and/or B) infection among Zambian adults, with and without co-infection with RSV and COVID-19, by HIV and COVID-19 vaccination status.
3. 3.To evaluate the accuracy and yield of aerosol-based sampling for diagnosis of respiratory viruses (influenza, SARS-CoV-2, and RSV) compared to nasal/ nasopharyngeal swabs, for rapid diagnosis of infection among symptomatic individuals in Zambia.
4. 4.To evaluate the acceptability of exhaled breath aerosol (XBA) sampling for diagnosis and screening of respiratory infections of pandemic potential.

Conditions

Influenza; RSV; COVID - 19

Outcome Measures

Primary Outcomes (1)

• Prevalence

  Proportion of participants with a positive test (Influenza, RSV or COVID) over the total number of study participants

  18months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Persons encountered at the facility entry points will be informed of the study through sensitization activities. Entry points will include the outpatient departments (OPD), emergency room, antiretroviral therapy (ART) clinics, chest clinics, and maternal and child health (MCH) clinics. All adults over the age of 18 years old presenting with flu-like symptoms will be screened for eligibility.

You may qualify if:

• i. age ≥18 years old ii. presenting with flu-like symptoms or acute respiratory infection with ≥2 to 7 days history of cough and /or sore throat and fever, +/- sneezing, +/- congestion, +/- myalgia, +/- fatigue, +/- wheezing, shortness of breath)\[55-57\] iii. willing to share their HIV status or be tested iv. willing to share their COVID-19 vaccination status v. able and willing to give informed consent vi. willing to provide a nasal/ nasopharyngeal sample for testing as part of standard of care vii. willing to provide exhaled breath aerosol samples i.e. wear a mask and provide a breath sample viii. willing to fill a symptoms diary card for symptom tracking for 7 days ix. agree to be followed-up and attend study visits up to two weeks after study entry

You may not qualify if:

• i. individuals who are unwilling to provide any reference standard samples such as the nasopharyngeal swabs ii. those with symptoms for \>7 days, or iii. those unwilling or unable to provide informed consent

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia: lead
• Heidelberg University: collaborator

Study Sites (2)

Chawama 1st level Hospital

Lusaka, Lusaka Province, 10101, Zambia

RECRUITING

Kanyama 1st Level Hospital

Lusaka, Lusaka Province, 10101, Zambia

RECRUITING

MeSH Terms

Conditions

Influenza, Human; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 19, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

ZA (2)