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Acceptability of an open-label wait-listed trial design: Experiences from the PROUD PrEP study.

Gafos, Mitzy and Brodnicki, Elizabeth and Desai, Monica and McCormack, Sheena and Nutland, Will and Wayal, Sonali and White, Ellen and Wood, Gemma and Barber, Tristan and Bell, Gill and Clarke, Amanda and Dolling, David and Dunn, David and Fox, Julie and Haddow, Lewis and Lacey, Charles and Nardone, Anthony and Quinn, Killian and Rae, Caroline and Reeves, Iain and Rayment, Michael and White, David and Apea, Vanessa and Ayap, Wilbert and Dewsnap, Claire and Collaco-Moraes, Yolanda and Schembri, Gabriel and Sowunmi, Yinka and Horne, Rob (2017) Acceptability of an open-label wait-listed trial design: Experiences from the PROUD PrEP study. PloS one, 12 (4). e0175596. ISSN 1932-6203.

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Official URL: http://journals.plos.org/plosone/article?id=10.137...

Abstract

BACKGROUND

PROUD participants were randomly assigned to receive pre-exposure prophylaxis (PrEP) immediately or after a deferred period of one-year. We report on the acceptability of this open-label wait-listed trial design.

METHODS

Participants completed an acceptability questionnaire, which included categorical study acceptability data and free-text data on most and least liked aspects of the study. We also conducted in-depth interviews (IDI) with a purposely selected sub-sample of participants.

RESULTS

Acceptability questionnaires were completed by 76% (415/544) of participants. After controlling for age, immediate-group participants were almost twice as likely as deferred-group participants to complete the questionnaire (AOR:1.86;95%CI:1.24,2.81). In quantitative data, the majority of participants in both groups found the wait-listed design acceptable when measured by satisfaction of joining the study, intention to remain in the study, and interest in joining a subsequent study. However, three-quarters thought that the chance of being in the deferred-group might put other volunteers off joining the study. In free-text responses, data collection tools were the most frequently reported least liked aspect of the study. A fifth of deferred participants reported 'being deferred' as the thing they least liked about the study. However, more deferred participants disliked the data collection tools than the fact that they had to wait a year to access PrEP. Participants in the IDIs had a good understanding of the rationale for the open-label wait-listed study design. Most accepted the design but acknowledged they were, or would have been, disappointed to be randomised to the deferred group. Five of the 25 participants interviewed reported some objection to the wait-listed design.

CONCLUSION

The quantitative and qualitative findings suggest that in an environment where PrEP was not available, the rationale for the wait-listed trial design was well understood and generally acceptable to most participants in this study.

Item Type: Article
Subjects: WC Communicabable diseases
Divisions: Clinical Support > Infectious Diseases
Related URLs:
Depositing User: Preeti Puligari
Date Deposited: 31 May 2017 14:47
Last Modified: 31 May 2017 14:47
URI: http://www.repository.heartofengland.nhs.uk/id/eprint/1380

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