A questionnaire-based study exploring participant perspectives in a perinatal human challenge trial
A questionnaire-based study exploring participant perspectives in a perinatal human challenge trial
Background: pregnant women have historically been excluded from most medical research, including human challenge studies. The proof-of-concept Lactamica 9 human challenge study investigated whether nasal inoculation of pregnant women with commensal bacteria leads to horizontal transmission to the neonate. Given the unique practical and ethical considerations of both human challenge studies and interventional research involving pregnant women and their newborns, we sought to investigate the motivations, concerns and experiences of these volunteers.
Methods: pre- and postparticipation questionnaires were given to all participants in the Lactamica 9 study. These fully anonymized qualitative and semiquantitative questionnaires used forced Likert scales, word association and free-text questions.
Results: pre- and postparticipation questionnaires were completed by 87.1% (27/31) and 62.5% (15/24) of eligible participants, respectively. Almost all preparticipation respondents agreed with altruistic motivations for participation, and most concerns were related to discomfort from study procedures, with few concerned about the theoretical risks of inoculation to themselves (5/27; 18.5%) or their baby (6/27; 22.2%). Participants most frequently associated the study intervention with the terms “bacteria,” “natural,” “protective” and “safe.” For the post participation questionnaire, 93.3% (14/15) found all study procedures acceptable, and qualitative feedback was almost entirely positive, with particular emphasis on the research team’s flexibility, approachability and friendliness.
Conclusions: the successful completion of the Lactamica 9 study demonstrates that human challenge research in healthy pregnant women can be acceptable and feasible. Participants’ initial concerns of potential discomfort were outweighed by predominantly altruistic motivations and perception of the intervention as “natural.”
human challenge, microbiome, participant perspectives, research in pregnancy
935-941
Bevan, James H.J.
e7868ec6-3bf3-4838-bb52-e1f22253c5d5
Theodosiou, Anastasia A.
c6e63581-c22d-4a2c-9d14-2e66594eb053
Corner, James
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Dorey, Robert B.
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Read, Robert C.
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Jones, Christine E.
48229079-8b58-4dcb-8374-d9481fe7b426
1 November 2023
Bevan, James H.J.
e7868ec6-3bf3-4838-bb52-e1f22253c5d5
Theodosiou, Anastasia A.
c6e63581-c22d-4a2c-9d14-2e66594eb053
Corner, James
5ce45b46-697b-418e-90d7-a5a4777fa802
Dorey, Robert B.
8d4b042f-1659-4e76-99c2-23cde78ca4f5
Read, Robert C.
b5caca7b-0063-438a-b703-7ecbb6fc2b51
Jones, Christine E.
48229079-8b58-4dcb-8374-d9481fe7b426
Bevan, James H.J., Theodosiou, Anastasia A., Corner, James, Dorey, Robert B., Read, Robert C. and Jones, Christine E.
(2023)
A questionnaire-based study exploring participant perspectives in a perinatal human challenge trial.
Pediatric Infectious Disease Journal, 42 (11), .
(doi:10.1097/inf.0000000000004036).
Abstract
Background: pregnant women have historically been excluded from most medical research, including human challenge studies. The proof-of-concept Lactamica 9 human challenge study investigated whether nasal inoculation of pregnant women with commensal bacteria leads to horizontal transmission to the neonate. Given the unique practical and ethical considerations of both human challenge studies and interventional research involving pregnant women and their newborns, we sought to investigate the motivations, concerns and experiences of these volunteers.
Methods: pre- and postparticipation questionnaires were given to all participants in the Lactamica 9 study. These fully anonymized qualitative and semiquantitative questionnaires used forced Likert scales, word association and free-text questions.
Results: pre- and postparticipation questionnaires were completed by 87.1% (27/31) and 62.5% (15/24) of eligible participants, respectively. Almost all preparticipation respondents agreed with altruistic motivations for participation, and most concerns were related to discomfort from study procedures, with few concerned about the theoretical risks of inoculation to themselves (5/27; 18.5%) or their baby (6/27; 22.2%). Participants most frequently associated the study intervention with the terms “bacteria,” “natural,” “protective” and “safe.” For the post participation questionnaire, 93.3% (14/15) found all study procedures acceptable, and qualitative feedback was almost entirely positive, with particular emphasis on the research team’s flexibility, approachability and friendliness.
Conclusions: the successful completion of the Lactamica 9 study demonstrates that human challenge research in healthy pregnant women can be acceptable and feasible. Participants’ initial concerns of potential discomfort were outweighed by predominantly altruistic motivations and perception of the intervention as “natural.”
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More information
e-pub ahead of print date: 18 July 2023
Published date: 1 November 2023
Additional Information:
Funding Information:
This work was supported by a Medical Research Council Clinical Research Training Fellowship awarded to Dr Anastasia Theodosiou, grant number MR/V002015/1.
Publisher Copyright:
© 2023 Lippincott Williams and Wilkins. All rights reserved.
Keywords:
human challenge, microbiome, participant perspectives, research in pregnancy
Identifiers
Local EPrints ID: 479825
URI: http://eprints.soton.ac.uk/id/eprint/479825
ISSN: 0891-3668
PURE UUID: 0b951335-8c1d-4095-bed3-cb5f4c382925
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Date deposited: 27 Jul 2023 13:48
Last modified: 18 Mar 2024 03:21
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Contributors
Author:
James H.J. Bevan
Author:
Anastasia A. Theodosiou
Author:
James Corner
Author:
Robert B. Dorey
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