Point of Care Early Infant Diagnosis Patient Impact Study

NCT02744404 | Completed

• 1 other identifier: Malawi POC EID
• Study Type: observational
• Target: 1,752
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• ART initiation retention

  Proportion of HIV-positive infants initiated on anti-retroviral therapy

  6-9 months

Secondary Outcomes (2)

• Test turnaround time

  6-9 months

• Tests received

  6-9 months

Study Arms (2)

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.

Interventions

POC EID DEVICE

POC EID

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinton Health Access Initiative Inc.: lead
• Ministry of Health, Malawi: collaborator
• UNICEF: collaborator

Study Sites (7)

Kamuzu Central Hospital

Lilongwe, Malawi

Location

Machinga District Hospital

Liwonde, Malawi

Location

Mzuzu Central Hospital

Mzuzu, Malawi

Location

Nsanama Health Center

Nsanama, Malawi

Location

Ntaja Health Center

Ntaja, Malawi

Location

Ntcheu District Hospital

Ntcheu, Malawi

Location

Migowi Health Center

Phalombe, Malawi

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 20, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 27, 2018

Record last verified: 2018-07

Locations

MA (7)