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Introduction: Novel approaches to case identification and linkage to antiretroviral therapy (ART) are needed to close gaps in early infant diagnosis (EID) of HIV. Point-of-care (POC) EID is a recent innovation that eliminates the long turnaround times of conventional EID that limit patient management in the inpatient setting. The initial deployment of POC EID in Mozambique focused primarily on outpatient clinics; however, 2 high-volume tier-4 pediatric referral hospitals were also included. Methods: To assess the impact of inpatient POC EID, a retrospective review of testing and care data from Hospital Central de Beira (HCB) and Hospital Central de Maputo (HCM) was performed for the period September 2017 to July 2018, with comparison to the 8-month pre-POC period when dried blood spots were used for conventional EID. Results: Monthly testing volume increased from 8.5 tests pre-POC to 17.6 tests with POC (P<.001). Among 511 children with POC testing, the median age was 5 months, there was ongoing breastfeeding in 326 (63.8%), and 136 (26.6%) of mothers and 146 (28.6%) of infants had not received ART or antiretroviral prophylaxis, respectively. POC tests were positive in 152 (29.7%) infants, and 52 (37.5%) had a previous negative DNA polymerase chain reaction through the conventional outpatient EID program. Linkage to ART for infants with HIV-positive tests improved 64% during the POC period (P=.002). Inpatient mortality for infected infants during the POC period was 28.2%. Excluding these deaths, 61.2% of eligible infants initiated ART as inpatients, but only 29.8% of those discharged without ART were confirmed to have initiated as outpatients. Conclusions: Inpatient wards are a high-yield site for EID and ART initiation that have historically been overlooked in programming for prevention of mother-to-child transmission. POC platforms represent a transformative opportunity to increase inpatient testing, make definitive diagnoses, and improve timely linkage to ART. Scale-up plans should prioritize pediatric wards.
This study was a retrospective review of routine EID testing and patient care data from HCM and HCB, tier-4 reference hospitals providing the highest level of care in the public sector in the southern and central regions of Mozambique, respectively. In 2018, HCM admitted an average of 866 children per month, and HCB admitted an average 536 children per month. In both hospitals, the median age of admission is below 2 years old. The POC study period began from the time of POC implementation at each site (February 2017 for HCB and September 2017 for HCM) through July 2018. Eight months of pre-POC data, when testing was performed via dried blood spots (DBSs), were included from each site for comparison. Per national guidelines, HEIs aged 1 to 18 months who underwent inpatient EID testing were included.18 Patients with nonvalid EID results and those referred from other health facilities for EID testing (i.e., infants not admitted to the hospital but accessing the POC EID platform) were excluded. Patients who were known to be HIV infected at the time of admission were not eligible for EID testing and were not included. Infants already known to be HIV exposed at the time of admission (identified through review of maternal and child health documents and caregiver medical history) were routinely offered initial EID testing if standard testing at 1 month of age had been missed. They were also generally offered repeat EID testing if they had outdated previous negative outpatient EID test results or presenting conditions suggestive of HIV infection. For infants whose mothers had unknown serostatus or whose last negative test was more than 3 months prior to admission, national policy was to conduct routine opt-out ward-based PITC of mothers using rapid antibody tests to newly identify HEIs eligible for EID testing.18 The national EID algorithm during the time period of this study called for virologic testing at enrollment in the HEI clinic (recommended at 1 month of age), at 9 months if rapid antibody testing was positive, and at any time infants had signs and symptoms suggestive of HIV infection. For inpatient EID, guidelines are not specific about when to repeat virologic testing for HEIs who previously tested negative, but generally speaking, EID testing is repeated in children with malnutrition, developmental delay, or infectious illness that could be associated with immune suppression, or if previous testing was more than 2 months prior to admission. Active phone tracing of infected patients identified through hospital-based EID to confirm their continuity of care after discharge to primary health centers was recommended, but it was more routinely done at HCM than HCB during the period of this study. For the pre-POC period, DBS EID data were collected for each site from a national EID data database that contains test results, demographic information, and clinical information from standard national EID requisition forms which include PMTCT information on maternal ART, infant prophylaxis, breastfeeding status, and previous EID testing. ART information for the pre-POC period was obtained from site ART registers. A more comprehensive set of data were collected for the POC EID period from sources including onsite EID logbooks, EID requisition forms, 2 web-based databases (POC connectivity and the national online EID portal), ART registers, and call logs from a patient follow-up program (HCM only). A trained team of data collectors reviewed all available data sources to populate an anonymous, structured database that recorded patient demographics, EID testing dates and results, ART information, and follow-up status for all patients with POC EID testing in the study period. Data were collected and organized into Microsoft Excel (2003), and data analysis was conducted using STATA v12 (StataCorp©, 2011). Descriptive summary statistics were produced for testing volumes and positivity rates. Chi-square and Fisher's exact tests were applied to investigate differences in pre- and post-POC implementation results in addition to POC positivity rates for a set of patient characteristics including age, sex, PMTCT regimens, and previous access to conventional DNA polymerase chain reaction (PCR) results. All statistical analyses used P-values and 5% significance level for inference. Ethical approval for this assessment was obtained from Mozambique's National Health Bioethics Committee reference 80/CNBS/14. The Scientific Directorates of HCM and HCB also approved the study. These boards did not require the study to obtain consent from caregivers for use of the routine EID and ART data included in the analysis.
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