Early Infant Diagnosis Point of Care Pilot
- Conditions
- HIV
- Interventions
- Device: Alere q
- Registration Number
- NCT02634450
- Lead Sponsor
- Instituto Nacional de Saúde, Mozambique
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 179
- Born to HIV positive mother
- From 4 weeks to 18 months of age
- Came to CCR consultation for Early Infant Diagnosis
- With a valid positive test by other center
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Alere q 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
- Primary Outcome Measures
Name Time Method 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. 3 months after treatment initiation Patients were considered retained in care at 90 days if they had visited the health facility within the previous 30 days.
- Secondary Outcome Measures
Name Time Method 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 number of days between specimen collection and initiation of antiretroviral treatment. Up to 6 months The median age at time of antiretroviral treatment initiation Up to 6 months
Trial Locations
- Locations (8)
Centro de Saude Moamba
🇲🇿Moamba, Maputo, Mozambique
Centro de Saude de Manga Loforte
🇲🇿Beira, Sofala, Mozambique
Centro de Saude Munhava
🇲🇿Beira, Sofala, Mozambique
Centro de Saude de Ponta Gea
🇲🇿Beira, Sofala, Mozambique
Centro de Saude NHACONJO
🇲🇿Beira, Sofala, Mozambique
Centro de Saude de Machava II
🇲🇿Maputo, Mozambique
Centro de Saúde de Khongolote
🇲🇿Maputo, Mozambique
Centro de Saude Matola Gare
🇲🇿Maputo, Mozambique