PMC6005526_01
Flow chart of the study process detailing screen failure rates.. The study screen flow is presented detailing screen failure rates.
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Before enrolment, we asked all women whether they would be willing to participate in in depth interviews (IDIs) and/or focus group discussions (FGDs) prior, during and/or after the clinical trial [Fig 1].
Flow chart of quantitative and qualitative data collection in the Ring Plus study.. Quantitative and qualitative data collected before, during and after study end are presented.
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IAQs at screening, at enrolment after the first ring insertion, and at every subsequent ring removal follow-up visit [Fig 2]. In addition, at enrolment and each follow-up visit participants completed a self-rating adherence scale and received a diary card to document ring removals and expulsions as well as sexual and vaginal practices that occurred in between study visits within their home. We collected qualitative data at several time points before, during and after the study using IDIs and FGDs [Fig 2].
Theoretical framework used for data collection and analysis as adapted from Van der Straten et al and Merkatz et al.. The framework proposed by van der Straten et al was used for data collection and analysis; elements of the NES/EE CVR acceptability model by Merkatz et al such as side effect and bodily changes were added.
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Components from Merkatz's model on CVR acceptability (2014), such as side effects and satisfaction, were integrated into van der Straten's framework as well as new elements that emerged from the data [Fig 3].