Using an AEFI Parent Diary Card Following Fractional-Dose Yellow Fever (fYF) Vaccination in Uganda; a Tool for Consideration for Future Clinical Trials in Low- and Middle-Income Countries

• Published in: International journal of infectious diseases 2022-03, Vol.116, p.S116-S117
• Main Authors: Sciarratta, C., Sserunga, M. Najjengo, Sekiziyivu, A.B., Lubega, I., Nakato, W. Nansozi, Twinomuhwezi, E., Tumwine, C., Wasswa, C. Kaliisa, Doshi, R., Chu, S., Gidudu, J.
• Format: Article
• Language: English
• ISSN: 1201-9712; 1878-3511
• DOI: 10.1016/j.ijid.2021.12.275

A randomized controlled trial (RCT) study is being conducted in Uganda to determine the safety and immunogenicity of fractional doses of the 17DD yellow fever vaccine in children aged 9 to 23 months. Adverse event(s) following immunization (AEFI) are being monitored through a novel approach for clinical vaccine trial settings in low- and middle-income countries: diary cards completed by participants’ parents during the first 14 days post-vaccination, when 95% of AEFI occur. The cards instruct parents how to use a digital thermometer and record prespecified conditions daily including fever. We assessed parent acceptability of the card along with its ability to obtain comprehensive AEFI data. We conducted qualitative surveys of a convenience sample of parents who completed an AEFI diary card per participant during their 14-day follow-up visits at 3 sites [2 urban, 1 rural]. Completed diary cards on file were systematically sampled (every 3rd) per site and reviewed for completeness of conditions including morning and evening temperatures, fever, seizure, diarrhea, persistent crying, rash, swelling at injection site, vomiting, and ‘other specify’. SAS Statistical Software was used to analyze quantitative data and qualitative data was analyzed using thematic analyses in MS Excel. Among 75 parents interviewed, 58 (77.3%) were ‘very confident’ in their understanding of the conditions listed and 69 (92.0%) reported it was ‘easy to understand’. Overall, 78.6% (n=59) of parents reported the card taught them how to use a digital thermometer to monitor their child's body temperature and how to track the child's health after vaccination. We reviewed 147 diary cards; 135 (91.8%) cards had >80% of all conditions completed and 130 (88.4%) cards had >80% of temperatures recorded twice daily. Our results show majority of parents that used a diary card for AEFI monitoring found it to be easy to use and understand. Most diary cards were completed for all prespecified conditions during the 14-day follow-up period. These results support the use of diary cards to monitor vaccine safety in Uganda and further exploration of the role of diary cards in AEFI monitoring during clinical trials in low- to middle-income countries.