Early Infant Diagnosis Point of Care Pilot

NCT02634450 | Completed

• 1 other identifier: POC EID PILOT
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 8

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

Keywords

HIV; Diagnostic; children

Outcome Measures

Primary Outcomes (2)

• The proportion of HIV-positive infants initiating antiretroviral therapy within 60 days of sample collection

  up to 6 months

• 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 Outcomes (4)

• The median age at time of results received by patient

  Up to 6 months

• The median number of days between specimen collection and results received by patient

  Up to 6 months

• The median age at time of antiretroviral treatment initiation

  Up to 6 months

• The median number of days between specimen collection and initiation of antiretroviral treatment.

  Up to 6 months

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

ACTIVE COMPARATOR

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

Device: Alere q

Interventions

Alere q DEVICE

Intervention

Eligibility Criteria

• Age: 4 Weeks - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Born to HIV positive mother
• From 4 weeks to 18 months of age
• Came to CCR consultation for Early Infant Diagnosis

You may not qualify if:

• With a valid positive test by other center

Sponsors & Collaborators

• Instituto Nacional de Saúde, Mozambique: lead
• Clinton Health Access Initiative Inc.: collaborator
• UNICEF: collaborator
• UNITAID: collaborator

Study Sites (8)

Centro de Saude Moamba

Moamba, Maputo Province, Mozambique

Location

Centro de Saude de Manga Loforte

Beira, Sofala, Mozambique

Location

Centro de Saude de Ponta Gea

Beira, Sofala, Mozambique

Location

Centro de Saude Munhava

Beira, Sofala, Mozambique

Location

Centro de Saude NHACONJO

Beira, Sofala, Mozambique

Location

Centro de Saude de Machava II

Maputo, Mozambique

Location

Centro de Saude Matola Gare

Maputo, Mozambique

Location

Centro de Saúde de Khongolote

Maputo, Mozambique

Location

Related Publications (1)

• 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.

  PMID: 29746301 DERIVED

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2015
• First Posted: December 18, 2015
• Study Start: September 1, 2015
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: July 26, 2017

Record last verified: 2017-07

Locations

MO (8)