INTEGrating Ag-RDTs for COVID-19 in MNCH,HIV and TB Services in Cameroon and Kenya

NCT05382130 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152082

Last updated 2024-01-11

No results posted yet for this study

Summary

Integration of antigen-detecting rapid diagnostic tests (Ag-RDT) for COVID-19 into services that provide care for vulnerable populations such as pregnant women, children, people with HIV infection, and patients with tuberculosis (TB) will identify more people with Coronavirus infection. This will allow for earlier treatment and tracing of contacts to decrease the spread of the coronavirus. This study is looking at two models for providing the testing in Maternal, Newborn and Child Health (MNCH), Tuberculosis (TB) and HIV clinics in Cameroon and Kenya. In some clinics, attendees with be screened for Coronavirus symptoms and history of exposure and if positive they will receive the rapid coronavirus test right in the clinic. In other facilities, all people attending the clinic with be provided with the coronavirus testing even if they screen negative to see how many people are infected but do not show any symptoms. Hospitalized and non-hospitalized patients with the coronavirus infection will be followed to document their illness and health outcomes. We will also ask health care workers about how well the testing in these clinics is working and what are some of their challenges, and collect information about the costs associated with both the models of testing.

Conditions

Interventions

DIAGNOSTIC_TEST

Test all

In the "test all" arm, SARS-CoV-2 infection screening questions will be administered to all clinic attendees followed by SARS-CoV-2 Ag-RDT testing irrespective of screening results.

Sponsors & Collaborators

  • UNITAID

    collaborator OTHER
  • Kenya Ministry of Health

    collaborator OTHER_GOV
  • Ministry of Public Health, Cameroon

    collaborator UNKNOWN
  • Elizabeth Glaser Pediatric AIDS Foundation

    lead OTHER

Principal Investigators

  • Nilesh Bhatt, MD,MMed,PhD · Elizabeth Glaser Pediatric AIDS Foundation

  • Boris Tchounga, MD, PhD · Elizabeth Glaser Pediatric AIDS Foundation

  • Rose Otieno Masaba, MD, MSc · Elizabeth Glaser Pediatric AIDS Foundation

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-17
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Cameroon
  • Kenya

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05382130 on ClinicalTrials.gov