With the support of the
Elizabeth Glaser Pediatric Foundation (EGPAF), phased introduction of
point-of-care early infant diagnosis (POC EID) testing as part of routine care
for infants exposed to HIV began in December 2016 in Cameroon, Côte
d’Ivoire, Kenya, Lesotho, Mozambique, Rwanda, Swaziland and Zimbabwe.
The researchers implemented a
hub and spoke model in seven of the eight countries, in which the POC EID
devices were kept at ‘hub’ clinics. Other healthcare facilities, within one
hour’s drive of the hub, were ‘spokes’ which sent samples to the hub.
A wide range of sites were
selected, including regional hospitals, primary healthcare facilities,
prevention of mother-to-child transmission services, and maternity services.
They were in both rural and urban environments, some with high demand for EID and
some with low demand.
Two battery powered, quality-assured
POC testing devices, m-PIMA and GeneXpertGX-IV, were used in the intervention
sites. Healthcare workers were trained on sample collection. The ministry of
health in each country gave EGPAF approval to update the testing algorithm to
include POC EID.
The authors compared outcomes
before and after the introduction of POC EID. The baseline pre-intervention
sample comprised 30 HIV-exposed infants per study site tested with conventional
EID at a central laboratory. The post-intervention sample included all infants
tested with POC EID at a study site.
Retrospective data on
conventional EID was collected on 2875 infants exposed to HIV and tested at 96
healthcare facilities prior to March 2017.
Data on POC testing was
collected on 18,220 infants tested at 339 healthcare facilities in the 12 months from December 2016.
There was loss to follow-up for
both conventional and POC testing at each step, from sample collection to
return of results or antiretroviral initiation.