PreprintArticleVersion 1Preserved in Portico This version is not peer-reviewed
Efficacy and Feasibility of SMS M-Health for the Detection of Adverse Events Following Immunisation (AEFIs) In re-Source-Limited Setting–The Zimbabwe Stimulated Telephone As-Sisted Rapid Safety Surveillance (Zm-STARSS) Randomised Con-Trol Trial
Version 1
: Received: 25 March 2023 / Approved: 30 March 2023 / Online: 30 March 2023 (03:51:08 CEST)
How to cite:
Nyambayo, P.P.M.; Gold, M.; Mehta, U.; Clark, S.; Manyevere, R.; Chirinda, L.; Zifamba, E.; Nyamandi, T. Efficacy and Feasibility of SMS M-Health for the Detection of Adverse Events Following Immunisation (AEFIs) In re-Source-Limited Setting–The Zimbabwe Stimulated Telephone As-Sisted Rapid Safety Surveillance (Zm-STARSS) Randomised Con-Trol Trial. Preprints2023, 2023030523. https://doi.org/10.20944/preprints202303.0523.v1
Nyambayo, P.P.M.; Gold, M.; Mehta, U.; Clark, S.; Manyevere, R.; Chirinda, L.; Zifamba, E.; Nyamandi, T. Efficacy and Feasibility of SMS M-Health for the Detection of Adverse Events Following Immunisation (AEFIs) In re-Source-Limited Setting–The Zimbabwe Stimulated Telephone As-Sisted Rapid Safety Surveillance (Zm-STARSS) Randomised Con-Trol Trial. Preprints 2023, 2023030523. https://doi.org/10.20944/preprints202303.0523.v1
Nyambayo, P.P.M.; Gold, M.; Mehta, U.; Clark, S.; Manyevere, R.; Chirinda, L.; Zifamba, E.; Nyamandi, T. Efficacy and Feasibility of SMS M-Health for the Detection of Adverse Events Following Immunisation (AEFIs) In re-Source-Limited Setting–The Zimbabwe Stimulated Telephone As-Sisted Rapid Safety Surveillance (Zm-STARSS) Randomised Con-Trol Trial. Preprints2023, 2023030523. https://doi.org/10.20944/preprints202303.0523.v1
APA Style
Nyambayo, P.P.M., Gold, M., Mehta, U., Clark, S., Manyevere, R., Chirinda, L., Zifamba, E., & Nyamandi, T. (2023). Efficacy and Feasibility of SMS M-Health for the Detection of Adverse Events Following Immunisation (AEFIs) In re-Source-Limited Setting–The Zimbabwe Stimulated Telephone As-Sisted Rapid Safety Surveillance (Zm-STARSS) Randomised Con-Trol Trial. Preprints. https://doi.org/10.20944/preprints202303.0523.v1
Chicago/Turabian Style
Nyambayo, P.P.M., Edlyne Zifamba and Tatenda Nyamandi. 2023 "Efficacy and Feasibility of SMS M-Health for the Detection of Adverse Events Following Immunisation (AEFIs) In re-Source-Limited Setting–The Zimbabwe Stimulated Telephone As-Sisted Rapid Safety Surveillance (Zm-STARSS) Randomised Con-Trol Trial" Preprints. https://doi.org/10.20944/preprints202303.0523.v1
Abstract
Abstract Introduction: The mHealth active participant centred (MAPC) adverse events following immunisation (AEFI) surveillance is a promising area for early AEFI detection resulting in risk minimisation. Passive (spontaneous) AEFI surveillance is the backbone for vaccine pharmacovigilance, but has inherent drawbacks of under reporting, and requires strengthening with active surveillance methods. The Zimbabwe stimulated telephone assisted rapid safety surveillance (Zm-STARSS) randomized controlled trial (RCT) sought to evaluate the efficacy and feasibility of AEFI detection using a short message service (SMS) and computer assisted telephone interview (CATI) approach. Method: A multicentre Zm-STARSS RCT enrolled consented adult vaccinees or parents or guardians of children receiving vaccines, including COVID-19 vaccines, at study vaccination clinics. At enrolment study participants were randomised to either SMS-CATI group or control group. SMS prompts were sent on days 0-2 and 14 post-vaccination to SMS-CATI group to ascertain if a medical event following immunisation (MEFI) had occurred. However, no SMSs were sent to the control group. SMS-CATI group who responded “Yes” to SMS prompts were interviewed by research healthcare workers (RHCWs) who completed a CATI to determine if an MEFI/AEFI had occurred whilst an AEFI in control group was determined from passive AEFI reporting channels. The primary study outcome was the AEFI detection rate in the SMS-CATI group compared to the control group. Results: A total of 704 (31%) participants responded to the SMS prompts, with 75% (528/704) indicating “No” and 25% (176/704) "Yes” to experiencing a MEFI. However, 31% (55/176) who responded “Yes” did not complete a CATI survey, but 69% (121/176) did; and 64% (77/121) of these indicated negative to AEFI experience whilst 36% (44/121) were affirmative. There were no AEFI reported in control group participants. Zm-STARSS showed promising results in that the AEFI detection rate using SMS-CATI was 2% (44/2280) on an intention to treat cohort. Conclusion: Despite the low SMS response and CATI completion rate, we demonstrated that Zm-STARSS SMS system improves AEFI detection compared to passive AEFI surveillance. We recommend cost-effective multi-channel digital approaches for holistic pharmacovigilance to improve AEFI detection in LMICs for all vaccines.
Keywords
Zimbabwe Stimulated Telephone Assisted Rapid Safety Surveillance (Zm-STARSS); mHealth active participant-centred (MAPC) Adverse Events Following Immunisation(AEFI) surveillance
Subject
Medicine and Pharmacology, Other
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
