(pMOTAR): A Pilot Study of Mobile Technology to Assess Reactogenicity (Preprint)

Résumé fourni par la source

BACKGROUND Accurate safety monitoring in HIV vaccine trials is vital to eventual licensure and consequent uptake of products. Current practice is to capture related side effects in a hardcopy tool, reconciled post vaccination, which is time-consuming, laborious and fraught with error. Unstructured Supplementary Service Data (USSD), commonly used to purchase airtime, has been suggested for collection of safety data in vaccine trials. With saturated access to mobile phones in South Africa, this cheap, accessible tool, may improve accuracy and completeness of collected data, and prove feasible and acceptable over the hardcopy tool. OBJECTIVE To develop and implement an USSD tool for real time safety data collection, that is feasible and acceptable to participants and staff, allowing for a completeness and accuracy comparison with the hardcopy tool. METHODS This pilot study of Mobile Technology to Assess Reactogenicity (pMOTAR) is being conducted at a single study site in South Africa enrolling participants in a phase 1/2a preventive HIV vaccine trial, as an open-label, randomised controlled trial, to all consenting HVTN 108 participants who continue to receive vaccinations. Participants are randomised 1: 1 to the hardcopy or USSD tool, with data collection targeted to the 3rd and 4th injections in the parent trial. Online feasibility and acceptability surveys will be completed by staff and participants at the post-vaccination visit. Error rates between the hardcopy tool and the USSD print-out and associated documentation will be itemised and compared. We hypothesize that the USSD tool will be shown to be feasible and acceptable to staff and participants and to have superior quality and completion rates to the hardcopy tool. RESULTS The study has received regulatory approval. The USSD tool has been designed and developed to include all the data fields required for reactogenicity reporting. Online feasibility and accessibility surveys in both languages have been successfully installed on a tablet. The study has been initiated. CONCLUSIONS Several HIV preventive vaccine trials are currently active in Southern Africa, making tools to improve efficiencies and minimise error necessary. Our results will help to determine if the USSD tool can be used in future vaccine studies and eventual roll out.

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