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

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 d

SUBMITTER: Gafos M 

PROVIDER: S-EPMC5398545 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature