Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Evaluation of Point-Of-Care Testing Assays for Early Infant in Mozambique-Cluster Randomised Trial
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.


Options:
A: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention; Type: ACTIVE_COMPARATOR; Interventions: Device: Alere q | Intervention Type: DEVICE; Name: Alere q; Assigned to Arm(s): Intervention
B: Arm Label: Alere q HIV-1/2 Detect for point of care infant testing; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Alere q HIV-1/2 Detect for point of care infant testing, Behavioral: HIV DNA PCR testing (Standard of Care) | Arm Label: GeneXpert HIV-1 Qual for point of care infant testing; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: GeneXpert HIV-1 Qual for point of care infant testing, Behavioral: HIV DNA PCR testing (Standard of Care) | Intervention Type: BEHAVIORAL; Name: Alere q HIV-1/2 Detect for point of care infant testing; Assigned to Arm(s): Alere q HIV-1/2 Detect for point of care infant testing | Intervention Type: BEHAVIORAL; Name: GeneXpert HIV-1 Qual for point of care infant testing; Assigned to Arm(s): GeneXpert HIV-1 Qual for point of care infant testing | Intervention Type: BEHAVIORAL; Name: HIV DNA PCR testing (Standard of Care); Assigned to Arm(s): Alere q HIV-1/2 Detect for point of care infant testing, GeneXpert HIV-1 Qual for point of care infant testing
C: Arm Label: Primary Health care clinics; Type: N/A; Interventions: N/A | Arm Label: Pregnant and breast feeding women; Type: N/A; Interventions: N/A
D: Arm Label: In-vitro Diagnostics; Type: OTHER; Interventions: Other: In-vitro Diagnostics | Intervention Type: OTHER; Name: In-vitro Diagnostics; Assigned to Arm(s): In-vitro Diagnostics

Answer: A