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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02744404
Other study ID # Malawi POC EID
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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