Evaluation of the HIV Infant Tracking System (HITSystem) to optimise quality and efficiency of early infant diagnosis: a cluster-randomised trial in Kenya

Abstract

Background: The HIV Infant Tracking System (HITSystem) is a web-based intervention linking providers of early infant diagnosis, laboratory technicians, and mothers and infants to improve outcomes for HIV-exposed infants. We aimed to evaluate the efficacy of the HITSystem on key outcomes of early infant diagnosis.

Methods: We did a cluster-randomised trial at six hospitals in Kenya, which were matched on geographic region, resource level, and volume of patients (high, medium, and low). We randomly allocated hospitals within a matched pair to either the HITSystem (intervention; n=3) or standard of care (control; n=3). A random number generator was used to assign clusters. Investigators were unaware of the randomisation process. Eligible participants were mothers aged 18 years or older with an infant younger than 24 weeks presenting for their first early infant diagnosis appointment. The primary outcome was complete early infant diagnosis retention, which was defined as receipt of all indicated age-specific interventions until 18 months post partum (for HIV-negative infants) or antiretroviral therapy initiation (for HIV-positive infants). Analysis was per protocol in all randomised pairs judged eligible, excluding infant deaths and those who moved or were transferred to another health facility. Modified intention-to-treat sensitivity analyses judged all infant deaths and transfers as incomplete early infant diagnosis retention. Separate multivariable logistic regression analyses were done with intervention group, hospital volume, and significant covariates as fixed effects. This trial is registered with ClinicalTrials.gov, number NCT02072603; the trial has been completed.

Findings: Between Feb 16, 2014, and Dec 31, 2015, 895 mother-infant pairs were enrolled. Of these, 87 were judged ineligible for analysis, 26 infants died, and 92 pairs moved or were transferred to another health facility. Thus, data from 690 mother-infant pairs were analysed, of whom 392 were allocated to the HITSystem and 298 to standard of care. Mother-infant pairs were followed up to Sept 30, 2017. Infants diagnosed as HIV-positive were followed up for a median of 2·1 months (IQR 1·6-4·8) and HIV-negative infants were followed up for a median of 17·0 months (IQR 16·6-17·6). Infants enrolled in the HITSystem were significantly more likely to receive complete early infant diagnosis services compared with those assigned standard of care (334 of 392 [85%] vs 180 of 298 [60%]; adjusted odds ratio [OR] 3·7, 95% CI 2·5-5·5; p<0·0001). No intervention effect was recorded at high-volume hospitals, but strong effects were seen at medium-volume and low-volume hospitals. Modified intention-to-treat analyses for complete early infant diagnosis were also significant (334 of 474 [70%] vs 180 of 334 [54%]; adjusted OR 2·0, 95% CI 1·4-2·7; p<0·0001). No adverse events related to study participation were reported.

Interpretation: The HITSystem intervention is effective and feasible to implement in low-resource settings. The HITSystem algorithms have been modified to include HIV testing at birth, and an adapted HITSystem 2.0 version is supporting HIV-positive pregnant women to prevent perinatal transmission and optimise maternal and infant outcomes.

Funding: National Institute of Child Health and Human Development.

Copyright © 2018 Elsevier Ltd. All rights reserved.

Figures

Figure 1:. Trial profile

Participants enrolled after Dec 31, 2015, were excluded from this analysis to permit complete follow-up until age 18 months for all participants. Missed opportunities for enrolment included mother–infant pairs enrolled in early infant diagnosis who were not assessed for study eligibility and recruitment.Three of 65 documented transfers or moves at the intervention site were mothers who refused treatment (one refused ART, two refused to undergo early infant diagnosis) and, thus, were not deemed candidates for ART.

Figure 2:. Proportions of participants receiving complete early infant diagnosis services

Proportions were adjusted for significant covariates, comprising maternal age, maternal education level, HIV disclosure status, hospital volume, and arm × volume interaction.

Figure 3:. Turnaround times for each step of early infant diagnosis in infants diagnosed with HIV at their initial PCR test

At control sites in infants diagnosed HIV-positive at their first test (n=6), a dried bloodspot was obtained at median age 11·4 weeks (IQR 8·7–15·4), the PCR result was available after a further 6·3 weeks, the mother was notified of this result after 7·0 weeks, and ART was initiated after another 0·4 weeks. At intervention sites in infants diagnosed HIV-positive at their first test (n=20), a dried bloodspot was obtained at median age 6·4 weeks (IQR 6·0–7·7), the PCR result was available after a further 4·1 weeks, the mother was notified of the result after 2·0 weeks, and ART was initiated after another 5·0 weeks. ART=antiretroviral therapy.