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Using Mobile Technology (pMOTAR) to Assess Reactogenicity: Protocol for a Pilot Randomized Controlled Trial.

Kathryn Therese Mngadi1,2, Bhavna Maharaj1, Yajna Duki1,2

  • 1Centre for the AIDS Programme of Research in South Africa, Durban, South Africa.

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|October 5, 2018
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Summary
This summary is machine-generated.

A new Unstructured Supplementary Service Data (USSD) tool may improve HIV vaccine safety data collection. This mobile-based method shows promise for accuracy and completeness compared to traditional paper forms in South African trials.

Keywords:
AIDS vaccinesHIV preventive vaccinesmobile applicationsmobile health applicationresearch protocoltelemedicine

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Area of Science:

  • Clinical research
  • Vaccinology
  • Public health

Background:

  • Accurate safety monitoring is crucial for HIV vaccine approval and uptake.
  • Current paper-based safety data collection in HIV Vaccine Trials Network (HVTN) trials is slow, error-prone, and labor-intensive.
  • Unstructured Supplementary Service Data (USSD) offers a potentially more accurate and complete method for safety data collection via accessible mobile phones in South Africa.

Purpose of the Study:

  • To develop and implement a USSD tool for real-time safety data collection in HIV vaccine trials.
  • To assess the feasibility and acceptability of the USSD tool among participants and staff.
  • To compare the completeness and accuracy of data collected via USSD against the traditional hardcopy tool.

Main Methods:

  • A feasibility study nested within a phase 1/2a preventive HIV vaccine trial (HVTN 108) in South Africa.
  • Participants randomized 1:1 to either a hardcopy or USSD data collection tool.
  • Data collected at third and fourth injection time points; online surveys for feasibility and acceptability; comparison of error rates between tools.

Main Results:

  • Regulatory approval obtained for the study.
  • USSD tool developed with all necessary reactogenicity reporting fields.
  • Feasibility and accessibility surveys successfully deployed on tablets in English and isiZulu; data collection complete, analysis pending.

Conclusions:

  • Improved data collection tools are needed for active HIV preventive vaccine trials in Southern Africa.
  • Results will inform the potential use of the USSD tool in future vaccine studies.
  • The USSD tool could enhance efficiency and reduce errors in vaccine safety monitoring.