Clinical trial NCT02634450: Early Infant Diagnosis Point of Care Pilot
Official title: Evaluation of Point-Of-Care Testing Assays for Early Infant in Mozambique-Cluster Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Diagnostic
children
Lead sponsor: Instituto Nacional de Saúde, Mozambique
Sponsor class: OTHER_GOV
Collaborators: name: Clinton Health Access Initiative Inc.
name: UNICEF
name: UNITAID
First posted: 2015-12-18
Enrollment: 179
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: The proportion of HIV-positive infants initiating antiretroviral therapy within 60 days of sample collection
timeFrame: up to 6 months
measure: the proportion of HIV-positive infants who initiated antiretroviral therapy that were retained in care at 90 days of follow-up.
timeFrame: 3 months after treatment initiation
Secondary outcomes:
measure: The median age at time of results received by patient
timeFrame: Up to 6 months
measure: The median number of days between specimen collection and results received by patient
timeFrame: Up to 6 months
measure: The median age at time of antiretroviral treatment initiation
timeFrame: Up to 6 months
measure: The median number of days between specimen collection and initiation of antiretroviral treatment.
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Moamba
country: Mozambique
facility: Centro de Saude Moamba
state: Maputo
city: Beira
country: Mozambique
facility: Centro de Saude de Manga Loforte
state: Sofala
city: Beira
country: Mozambique
facility: Centro de Saude de Ponta Gea
state: Sofala
city: Beira
country: Mozambique
facility: Centro de Saude Munhava
state: Sofala
city: Beira
country: Mozambique
facility: Centro de Saude NHACONJO
state: Sofala
city: Maputo
country: Mozambique
facility: Centro de Saude de Machava II
city: Maputo
country: Mozambique
facility: Centro de Saude Matola Gare
city: Maputo
country: Mozambique
facility: Centro de Saúde de Khongolote
Study officials:
References:
citation: 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.