NCT05685641

Point of Care Tests to Identify Opportunistic Infections in Advanced HIV Patients in Mexico City

Implementation Protocol for Rapid Diagnostic Tests for Opportunistic Infections in Reference Centers in Mexico City

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 211 (estimated)
• Sponsor: National Institute of Respiratory Diseases, Mexico · Other Government
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

In Mexico City, the main cause of mortality among people living with HIV (PLHIV) continues to be opportunistic infections (OIs). Early detection of OIs allows their timely treatment and improves their prognosis. The use of rapid diagnostic tests (RDT) based on antigens of the most frequent causative agents of OIs allows adequate screening of these patients and facilitates decision making at the point of care. Unfortunately, these studies are not widely available in the different PLHIV care centers in the CDMX. We will conduct an open-label, non-inferiority uncontrolled clinical trial to investigate the diagnostic performance of urinary lipoarabinomannan, urinary Histoplasma antigen and serum Cryptococcus antigen in patients presenting for care with advanced HIV in CDMX, supported by rapid cluster of differentiation 4 (CD4) testing with lateral flow technology. Four referral hospitals will participate over 12 months. All patients with diagnosed HIV disease and suspected advanced disease presenting for care at participating centers will be included in the study. An inventory of approximately 1000 RDT will be obtained and distributed among the participating sites. A study coordinator will be hired and will visit each site once a week to collect the study variables and follow up on the included patients. The primary outcome of the study will be the percentage of patients with advanced disease who present with diagnoses made by RDT compared to historical controls of patients diagnosed with OI in 2022 at participating centers by conventional methods. Secondary outcomes will be time to initiation of antiretroviral therapy (ART), time to initiation of OI treatment, and 30-day mortality after HIV diagnosis.

Conditions

• Acquired Immunodeficiency Syndrome
• Histoplasmosis AIDS
• Tuberculosis Infection
• Cryptococcal Meningitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Histoplasma Urine Antigen Lateral Flow Antigen test	Lateral Flow Antigen test for urine samples to detect Histoplasma capsulatum disseminated disease
DIAGNOSTIC_TEST	Cryptococcal Lateral Flow Antigen test	Lateral Flow Antigen test for serum or cerebrospinal fluid samples to detect Cryptococcus sp meningitis or disseminated disease
DIAGNOSTIC_TEST	Tuberculosis-lipoarabinomannan Lateral Flow Antigen test	Lateral Flow Antigen test for serum samples to detect Mycobacterium tuberculosus disease

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-03-30
• Completion: 2024-09-30
• First posted: 2023-01-17
• Last updated: 2023-01-17

Locations

4 sites across 1 country: Mexico

Regulatory

• FDA-regulated device study