Early Infant Diagnosis Point of Care Pilot

HIV Clinical Trial

Official title:

Evaluation of Point-Of-Care Testing Assays for Early Infant in Mozambique-Cluster Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02634450
• Other study ID #: POC EID PILOT
• Status: Completed
• Phase: N/A
• First received: December 5, 2015
• Last updated: July 24, 2017
• Start date: September 2015
• Est. completion date: September 30, 2016

Study information

• Verified date: July 2017
• Source: Instituto Nacional de Saúde, Mozambique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In Mozambique, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories in Maputo, Nampula, Beira and Quelimane. However, test volumes are growing and many parts of the country do not have close 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 now new POC EID technologies becoming available that will enable diagnosis of HIV in infants within minutes or a couple of hours on site in the clinic, operated by non technical staff and without laboratory infrastructure. This protocol describes a plan to conduct an evaluation of a Point-Of-Care (POC) Early Infant Diagnosis (EID) testing technologies that are being considered for use in Mozambique, and to pilot those technologies in order to provide more effective diagnostics and clinical care to patients. During this implementation pilot, sites are randomized to use either conventional or POC EID testing only before the inclusion of the patients in the study. No consent will be asked to the parents or guardians. A written permission will be asked to the Direção Provincial de Saúde of both provinces to implement the POC device as routine in those intervention sites. All the information that will be analyzed will be collected from the routine care and it will be analyzed as a group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Months

Eligibility

Inclusion Criteria:

• Born to HIV positive mother

• From 4 weeks to 18 months of age

• Came to CCR consultation for Early Infant Diagnosis

Exclusion Criteria:

• With a valid positive test by other center

Related Conditions & MeSH terms

• HIV

Intervention

Device:
• Alere q

Locations

Country	Name	City	State
Mozambique	Centro de Saude de Manga Loforte	Beira	Sofala
Mozambique	Centro de Saude de Ponta Gea	Beira	Sofala
Mozambique	Centro de Saude Munhava	Beira	Sofala
Mozambique	Centro de Saude NHACONJO	Beira	Sofala
Mozambique	Centro de Saúde de Khongolote	Maputo
Mozambique	Centro de Saude de Machava II	Maputo
Mozambique	Centro de Saude Matola Gare	Maputo
Mozambique	Centro de Saude Moamba	Moamba	Maputo

Sponsors (4)

Lead Sponsor	Collaborator
Instituto Nacional de Saúde, Mozambique	Clinton Health Access Initiative, Mozambique, UNICEF, UNITAID

Country where clinical trial is conducted

Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of HIV-positive infants initiating antiretroviral therapy within 60 days of sample collection		up to 6 months
Primary	the proportion of HIV-positive infants who initiated antiretroviral therapy that were retained in care at 90 days of follow-up.	Patients were considered retained in care at 90 days if they had visited the health facility within the previous 30 days.	3 months after treatment initiation
Secondary	The median age at time of results received by patient		Up to 6 months
Secondary	The median number of days between specimen collection and results received by patient		Up to 6 months
Secondary	The median age at time of antiretroviral treatment initiation		Up to 6 months
Secondary	The median number of days between specimen collection and initiation of antiretroviral treatment.		Up to 6 months