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

Abstract

Summary 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 b...

Maternal viral load monitoring: Coverage and clinical action at 4 Kenyan hospitals

“…[41] Several emerging adaptations to traditional viral load testing processes, which may help address gaps in PMTCT VL monitoring. eHealth interventions that support clinical decision making and patient outreach have proven successful at improving completion of guidelineadherent care and increasing patient notification for EID results, [42] and may be similarly effective to improve VL uptake and result notification. Point-of-care diagnostics-which allow samples to be processed at the hospital in a matter of hours and are becoming more widely utilized for VL testing-may improve result notification and provision of timely clinical action by negating the need for patient recall to the hospital and reducing loss to follow up between sample collection and result notification.…”

Programmatic evaluation of feasibility and efficiency of at birth and 6-week, point of care HIV testing in Kenyan infant

“…It also highlights a need for interventions to target pregnant women living with HIV who are not engaged in PMTCT care, since these infants are not only at an increased risk of transmission [49] but also less likely to achieve complete infant testing [44]. Active tracking of mother-infant pairs throughout pregnancy and the early postpartum periods can improve early retention [4,50,51], helping to ensure timely infant HIV detection and diagnosis. Doing so may require developing systems to better track mother-infant pairs, including integration of PMTCT and MCH services [52,53] and assignment of infant ID numbers at birth, rather than at the first MCH visit.…”

“…Early infant diagnosis of HIV [EID] services are critical to identify infants living with HIV and initiate them on ART; however, only 69% of HIV-exposed infants in Kenya receive a virologic test [1]. Of those who are tested and identified as HIV-positive, 82% are initiated on treatment [1] at a median age of 17.1-25.1 weeks [3,4], well beyond the target of 12 weeks to reduce the risk of mortality and slow disease progression [5].…”

“…This requires clinicians to collect dried blood spots from infants at the health facility, label and ship the samples via courier to the laboratory, wait for the laboratory to process the sample and post the result, and then recall the mother to the hospital for result notification. This multistep process can take 3.6-8 weeks from sample collection to caregiver notification [4,6], and creates multiple opportunities for sample or result mismanagement and patient disengagement, thus preventing mothers from receiving their infant's result and initiating treatment (if positive) [7,8]. With recent guidelines recommending at birth and more frequent HIV testing for HIV-exposed infants in Kenya (2016) [9] and more frequent viral load tests for all patients on ART (2014) [10], the annual number of EID tests rose from 55,000 in 2015 to 140,000 by 2019 [11].…”

Adapting the HIV Infant Tracking System to Support Prevention of Mother-to-Child Transmission of HIV in Kenya: Protocol for an Intervention Development Pilot Study in Two Hospitals

“…Tailoring health messages to the individuals within the target population increases participant retention and is critical to the success of mHealth interventions [27-29]. Most mHealth interventions for EID have focused on lab-specific efficiency [30], patient-specific adherence, or retention support [31], whereas the HIV Infant Tracking System (HITSystem) mHealth intervention was the first to link laboratory, clinical, and patient stakeholders in one integrated system [32].…”