Abstract

SummaryGiven the range of pre‐exposure prophylaxis (PrEP) products currently being tested to prevent HIV in women, a standardized Acceptability and Use of PrEP Products Among Women Tool may facilitate comparisons of product acceptability and use across different geographies, trials, and users. We conducted three rounds of cognitive interviewing over 2 months in 2016, with 28 South African women who had experience participating in a range of PrEP product trials. The final instrument contained 41 items, including five new items that improved construct validity and 22 items modified for clarity. Changes were made due to unclear wording, difficulty answering, participant embarrassment, low response variability, and administrative formatting. Cognitive interviewing provided a means to address issues that would have inhibited this tool's ability to accurately collect data otherwise. This rapid, low‐cost study provided valuable insight into participants' understanding of questions and demonstrated the utility of cognitive interviewing in international clinical trials.

Highlights

  • Studies in recent years have demonstrated the effectiveness of biomedical approaches to HIV prevention, especially the use of pre‐exposure prophylaxis (PrEP) products that use antiretrovirals to reduce HIV transmission risk for uninfected individuals (Cáceres et al, 2015)

  • Women's preferences and needs for PrEP products have been shown to differ across settings (Mack et al, 2014; Severy, Tolley, Woodsong, & Guest, 2005; Tolley et al, 2010, 2014; Tolley & Severy, 2006)

  • We provide initial validation for the Acceptability and Use of PrEP Products Among Women Tool, a standardized instrument that can be used to assess product use and trial experience of women in PrEP product clinical trials

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Summary

| INTRODUCTION

Studies in recent years have demonstrated the effectiveness of biomedical approaches to HIV prevention, especially the use of pre‐exposure prophylaxis (PrEP) products (such as oral pills, vaginal gels, and vaginal rings) that use antiretrovirals to reduce HIV transmission risk for uninfected individuals (Cáceres et al, 2015). Women's preferences and needs for PrEP products have been shown to differ across settings (Mack et al, 2014; Severy, Tolley, Woodsong, & Guest, 2005; Tolley et al, 2010, 2014; Tolley & Severy, 2006). Understanding how these preferences for and experiences using different PrEP products vary is critical. Cognitive interviewing has been increasingly used to ensure comparability of survey items across cultural and linguistic groups (Willis & Miller, 2011)

| METHODS
| Ethical considerations
Findings
| DISCUSSION
CONFLICT OF INTEREST
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