Early Infant Diagnosis Point of Care Pilot

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02634450
• Date of registration: 05/12/2015
• Prospective Registration: No
• Primary sponsor: Instituto Nacional de Saúde, Mozambique
• Public title: Early Infant Diagnosis Point of Care Pilot
• Scientific title: Evaluation of Point-Of-Care Testing Assays for Early Infant in Mozambique-Cluster Randomised Trial
• Date of first enrolment: September 2015
• Target sample size: 179
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02634450
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Mozambique

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 18 Months
Gender: All

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Device: Alere q

Primary Outcome(s)

the proportion of HIV-positive infants who initiated antiretroviral therapy that were retained in care at 90 days of follow-up. [Time Frame: 3 months after treatment initiation]

The proportion of HIV-positive infants initiating antiretroviral therapy within 60 days of sample collection [Time Frame: up to 6 months]

Secondary Outcome(s)

The median age at time of results received by patient [Time Frame: Up to 6 months]

The median number of days between specimen collection and results received by patient [Time Frame: Up to 6 months]

The median age at time of antiretroviral treatment initiation [Time Frame: Up to 6 months]

The median number of days between specimen collection and initiation of antiretroviral treatment. [Time Frame: Up to 6 months]

Secondary ID(s)

POC EID PILOT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

UNITAID

UNICEF

Clinton Health Access Initiative, Mozambique