Early Infant Diagnosis Point of Care Pilot

NCT ID: NCT02634450

Last Updated: 2017-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-09-30

Brief 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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control

Current practice of Early Infant Diagnosis in Mozambique: using conventional system of collecting blood on Dried Blood Spot and sending it to central laboratory for PCR processing and receiving result by SMS printer.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Point Of Care Device (Alere q) is used for Early Infant Diagnosis, with the sample collected and processed in the consultation room with the device

Group Type: ACTIVE_COMPARATOR

Alere q

Intervention Type: DEVICE

Interventions

Alere q

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 4 Weeks
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinton Health Access Initiative Inc.

OTHER

Sponsor Role: collaborator

UNICEF

OTHER

Sponsor Role: collaborator

UNITAID

OTHER

Sponsor Role: collaborator

Instituto Nacional de Saúde, Mozambique

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro de Saude Moamba

Moamba, Maputo Province, 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 Saude de Machava II

Maputo, , Mozambique

Centro de Saude Matola Gare

Maputo, , Mozambique

Centro de Saúde de Khongolote

Maputo, , Mozambique

Countries

Mozambique

References

Jani IV, Meggi B, Loquiha O, Tobaiwa O, Mudenyanga C, Zitha A, Mutsaka D, Mabunda N, Vubil A, Bollinger T, Vojnov L, Peter TF. Effect of point-of-care early infant diagnosis on antiretroviral therapy initiation and retention of patients. AIDS. 2018 Jul 17;32(11):1453-1463. doi: 10.1097/QAD.0000000000001846.

Reference Type: DERIVED

PMID: 29746301 (View on PubMed)

Other Identifiers

POC EID PILOT

Identifier Type: -

Identifier Source: org_study_id