Point of Care Early Infant Diagnosis Patient Impact Study

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02744404
• Other study ID #: Malawi POC EID
• Status: Completed
• Start date: September 2015
• Est. completion date: September 2016

Study information

• Verified date: July 2018
• Source: Clinton Health Access Initiative Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1752
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Device:
• POC EID

Locations

Country	Name	City	State
Malawi	Kamuzu Central Hospital	Lilongwe
Malawi	Machinga District Hospital	Liwonde
Malawi	Mzuzu Central Hospital	Mzuzu
Malawi	Nsanama Health Center	Nsanama
Malawi	Ntaja Health Center	Ntaja
Malawi	Ntcheu District Hospital	Ntcheu
Malawi	Migowi Health Center	Phalombe

Sponsors (3)

Lead Sponsor	Collaborator
Clinton Health Access Initiative Inc.	Ministry of Health, Malawi, UNICEF

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ART initiation retention	Proportion of HIV-positive infants initiated on anti-retroviral therapy	6-9 months
Secondary	Test turnaround time	Number of days from testing to result being received by the health care facility	6-9 months
Secondary	Tests received	Proportion of tests received by the health care facility	6-9 months