Point of Care Early Infant Diagnosis Patient Impact Study

July 26, 2018 updated by: Clinton Health Access Initiative Inc.

Evaluation of the Clinical Impact of Point-of-Care HIV Early Infant Diagnostic Technologies

In Malawi, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories. However, test volumes are growing and many parts of the country do not have close or easy access to laboratories. Test samples are transported over large distances and this can introduce testing delays, especially for patients in rural and remote areas of the country. There are growing numbers of high quality Point-Of-Care (POC) diagnostic technologies available and there is increasing interest in using these technologies to alleviate critical testing needs. This protocol describes an observational study looking at the patient impact of implementing POC EID technologies within the routine standard of care at seven facilities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1752

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Lilongwe, Malawi
        • Kamuzu Central Hospital
      • Liwonde, Malawi
        • Machinga District Hospital
      • Mzuzu, Malawi
        • Mzuzu Central Hospital
      • Nsanama, Malawi
        • Nsanama Health Center
      • Ntaja, Malawi
        • Ntaja Health Center
      • Ntcheu, Malawi
        • Ntcheu District Hospital
      • Phalombe, Malawi
        • Migowi Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be mother-infant pairs from the general population attending the seven clinics for routine HIV-related, PMTCT and post-natal care services. Study subjects will be infants from mother-infant pairs presenting consecutively to the clinic for EID testing per the national EID guidelines during the study period.

Description

Inclusion Criteria:

  • Younger than 12 months of age
  • Clinical or other indication for an EID test (screen or confirmation), such as birth to an HIV-positive mother

Exclusion Criteria:

  • Older than 12 months of age
  • Serious medical conditions which would make testing dangerous for the infant, or disrupt the accuracy of normal laboratory analysis and its interpretation
  • Already initiated ART

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
POC EID
Point of Care Early Infant Diagnosis qualitative technologies (Alere q) will be implemented. Sample collection and testing will happen in the same location within the health care facility.
Device: POC EID
Laboratory-based testing
Conventional laboratory-based testing using the Abbott m2000 technology will continue to be used per standard of care in Malawi. Dried blood spot samples will be collected at health care facilities and transported within the national network to centralized laboratories for testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ART initiation retention
Time Frame: 6-9 months
Proportion of HIV-positive infants initiated on anti-retroviral therapy
6-9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test turnaround time
Time Frame: 6-9 months
Number of days from testing to result being received by the health care facility
6-9 months
Tests received
Time Frame: 6-9 months
Proportion of tests received by the health care facility
6-9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinton Health Access Initiative Inc.

Collaborators

UNICEF
Ministry of Health, Malawi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

April 15, 2016

First Submitted That Met QC Criteria

April 15, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

July 27, 2018

Last Update Submitted That Met QC Criteria

July 26, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Malawi POC EID

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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