Improving early infant HIV diagnosis in Kenya: study protocol of a cluster-randomized efficacy trial of the HITSystem

BACKGROUND: Early infant diagnosis among human immunodeficiency virus (HIV)-exposed infants is a critical component of prevention of mother-to-child transmission programs. Barriers to early infant diagnosis include poor uptake, low retention at designated re-testing intervals, delayed test results, passive systems of communication, and poor linkage to treatment. This study will evaluate the HIV Infant Tracking System (HITSystem), an eHealth intervention that streamlines communication and accountability between the key early infant diagnosis stakeholders: HIV+ mothers and their HIV-exposed infants, healthcare providers, and central laboratory personnel. It is hypothesized that the HITSystem will significantly improve early infant diagnosis retention at 9 and 18 months postnatal and the timely provision of services. METHODS/DESIGN: Using a phased cluster-randomized controlled trial design, we will evaluate the impact of the HITSystem on eight primary benchmarks in the 18-month long cascade of care for early infant diagnosis. Study sites are six government hospitals in Kenya matched on geographic region, resource level, and patient volume. Early infant diagnosis outcomes of mother-infant dyads (n = 120 per site) at intervention hospitals (n = 3) where the HITSystem is deployed at baseline will be compared to the matched control sites providing standard care. After allowing for sufficient time for enrollment and 18-month follow-up of dyads, the HITSystem will be deployed at the control sites in the end of Year 3. Primary outcomes are retention among mother-infant dyads, initiation of antiretroviral therapy among HIV-infected infants, and the proportion of services delivered within the optimal time window indicated by national and study guidelines. Satisfaction interviews with participants and providers will inform intervention improvements. Cost-effectiveness analyses will be conducted to inform the sustainability of the HITSystem. Hypothesized outcomes include significantly higher retention throughout the 18-month early infant diagnosis process, significantly more services provided on-time at intervention sites, and a potential savings to the healthcare system. DISCUSSION: This study will evaluate the public health impact of the HITSystem to improve critical early infant diagnosis outcomes in low-resource settings. Cost-effectiveness analyses will inform the feasibility of scale-up in other settings. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02072603