This month, the HITSystem was featured in The Lancet HIV, the leading peer reviewed journal shaping the study of HIV/AIDS today. The publication is the culmination of a 5-year clinical trial that evaluated the effectiveness of the HITSystem in HIV Early Infant Diagnosis (EID). The article is a joint venture between the University of Kansas Medical Center and Global Health Innovations. We have summarized some of the most notable outcomes from the study below.
The full publication can be found by visiting:
HOW A NOVEL, WEB-BASED INTEGRATED SYSTEM IS IMPROVING THE QUALITY AND EFFICIENCY OF EARLY INFANT DIAGNOSIS: A CLUSTER RANDOMIZED TRIAL IN KENYA
For infants who have been exposed to HIV, early infant diagnosis(EID) is a critical and time-sensitive service to identify HIV-positive infants for rapid initiation of lifesaving antiretroviral therapy (ART). The quality and efficiency of EID services in resource-limited settings remains hampered by several barriers, including late presentation for care, long wait times for lab results, challenges to notifying mothers, minimal retention of infants in care, and delayed ART initiation and treatment for HIV-positive infants.
In 2011, Global Health Innovations (GHI) developed the HIV Infant Tracking System (HITSystem) to address the limitations of EID services in resource-limited settings. Using available technology (internet and SMS texting), the HITSystem improves communication and accountability between health care providers, laboratories, and parents, to optimize outcomes for HIV-exposed infants.
The HITSystem expedites lab testing results, facilitates rapid initiation on treatment, and increases retention in care. Infants are tracked until they are conclusively determined to be HIV-negative at 18 months and discharged from EID care or they are established to be HIV-positive and initiated on ART.
Study Concept Development
In 2012, the rate of mobile phone use in Kenya was estimated at 75%. Evidence for mobile health (mHealth) interventions for HIV care was promising but scant. At the time, no data from randomized controlled trials assessing mHealth interventions had been published on EID outcomes. We designed a cluster-randomized trial to assess if the HITSystem could really improve key measures of EID care quality and efficiency in Kenya.
The study yielded several interesting outcomes and was able to show that 100% of HIV-positive infants enrolled in the HITSystem were initiated on life-saving anti-retroviral medication, versus 73% with standard care. Just as important, infants enrolled in the HITSystem were significantly more likely to receive complete EID services compared with those assigned the normal standard of care (85% vs. 60%).
Complete EID services for an infant include:
Initiation of medication for opportunistic infection prophylaxis
PCR testing (used to detect HIV’s genetic material)
Return of the PCR test result to the hospital
Notifying the mother of the PCR result
Initiation of ART for HIV-positive infants only
Re-testing at 9 months and 18 months for HIV-negative infants only
Several significant efficiencies in EID services were also achieved at sites that implemented the HITSystem: turnaround times for infant PCR test results were 2.6 weeks faster than at control sites, mothers were notified of their infants’ test results 1.3 weeks faster than at control sites, and median infant age at ART initiation was 7.6 weeks younger at sites implementing the HITSystem.
Optimizing the full cascade of care which includes identifying, linking, treating, and initiating HIV positive infants on antiretroviral therapy soon after diagnosis leads to a reduction in mortality.
In other nascent EID studies cited in the literature, HIV exposed infants have only been followed until the result of their first PCR test at 8-10 weeks postpartum, furthermore few studies report ART initiation for infants diagnosed with HIV, and no other Kenyan-based studies have assessed infant age at ART initiation.
The strengths of our trial include its prospective design, and long duration of infant follow-up (until 18 months postpartum). To date, our study provides the most complete look at the feasibility, utility and success of an mHealth early infant diagnosis intervention to significantly improve the quality and efficiency of EID services among HIV exposed infants.
The HITSystem is an innovative public health intervention that makes the most of accessible mobile and internet technology to significantly improve the quality and efficiency of EID services in Kenya and other resource-limited settings.
Qualitative data gathered from interviews with mothers, clinical and laboratory providers, helps to emphasize the ease of use and perceived usefulness of the HITSystem, which contributes to successful adoption of the system in programmatic settings. The HITSystem continues to be reconfigured to reflect Kenya’s new and more exhaustive guidelines for HIV care, demonstrating the flexibility of the system as well.
A cost-effectiveness analysis currently underway, will inform decisions about regional and potential national scale-up of the HITSystem in Kenya. Wider use of a system-level intervention that accelerates diagnosis and supports retention among mother-infant pairs can be implemented to significantly strengthen HIV prevention and treatment for improved maternal and pediatric health outcomes.