Vaccine safety surveillance in Kenya using GAIA standards: A feasibility assessment of existing national and subnational research and program systems.

BACKGROUND: Active surveillance systems for monitoring vaccine safety among pregnant women address some of the limitations of a current passive surveillance approach utilized in low- and middle-income countries (LMIC). However, few active surveillance systems in LMIC exist. Our study assessed the feasibility of utilizing three existing data collection systems in Kenya for active surveillance of maternal immunization and to assess the applicability of Global Alignment of Immunization Safety Assessment in pregnancy (GAIA) case definitions that were initially developed for clinical trials within these systems. METHODS: We assessed applicability of GAIA case definition for maternal Tetanus Toxoid exposure, stillbirth, low birth weight, small for gestational age, Neonatal Invasive Blood Stream Infection (NIBSI), prematurity and neonatal death in two routine web-based health information systems (Kenya EMR and DHIS-2), and a web-based population-based pregnancy research platform (ANCOV1) in Kenya. RESULTS: All three HIS were capable of reporting selected outcomes to varying degrees of GAIA certainty. The ANCOV platform was the most robust in collecting and collating clinical data for effective maternal pharmacovigilance. The utilization of facility- and district-aggregated data limits the usefulness of DHIS-2 in pharmacovigilance as currently operationalized. While the Kenya EMR contained individual level data and meets the key considerations for effective pharmacovigilance, it was used primarily for HIV care and treatment records in a small proportion of health facilities and would require additional resources to expand to all antenatal care facilities and to link maternal and infant records. DISCUSSION: Population-based research studies may offer a responsive short-term option for implementing maternal vaccine pharmacovigilance in LMICs. However, the foundation exists for long-term capacity building within the national health electronic data systems to provide this critical service as well as ensure participation of the country in international studies on maternal vaccine safety.

A smartphone game to prevent HIV among young Kenyans: local perceptions of mechanisms of effect.

Electronic games delivered via smartphones have the potential to become valuable tools in HIV prevention in high-prevalence and low-resource international settings. To ground theoretical elaboration around novel mHealth interventions in contextual realities, it is important to understand the mechanisms of their effects as perceived by local populations. Such perspectives are particularly important when working cross-culturally. 'Tumaini' is an interactive narrative-based smartphone game that uses a 'choose-your-own-adventure' format. It is designed to prevent HIV among young African adolescents (aged 11-14) by increasing age and condom use at first sex. It was developed with a US-based commercial game developer and is grounded in social behavioral theory, evidence-based practice and contextually relevant scenarios. In a 2017 randomized pilot study (n = 60) in Western Kenya, 'Tumaini' showed promising effects on behavioral mediators of sexual debut. In subsequent focus group discussions, adolescent participants and their parents shared their perceptions of the game's mechanisms of effect, which included motivation to play, future orientation, decision-making, relationship to a diverse range of characters and a bridging of the virtual and real worlds. These findings align with our theoretical framework, confirm its successful translation into the intervention and will inform mediation analyses in an upcoming efficacy trial.