PIH34 Assessing the Understandability and Importance of Patient Reported Outcomes Impacting Adherence and Outcomes of a NON-Hormonal Vaginal Microbicide to Prevent and Protect Against Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (GC)

Abstract

Treatment satisfaction, particularly sexual satisfaction, with a microbicidal vaginal gel (EVO100) to prevent urogenital CT and GC can influence adherence to the regimen. This qualitative research assessed the understandability and importance of questions/instruments used to assess product and global sexual satisfaction in the Phase 2b clinical study EVO-003 (NCT03107377). Concept elicitation and cognitive debriefing interviews were carried out in women with previous experience using EVO100. The cognitive interview methods reflected a theoretical model of the survey response process that involved 4 stages: comprehension or interpretation, information retrieval, judgment formation, and response editing. The interviews explored the concepts of sexual satisfaction and understandability of the Female Sexual Function Index (FSFI) global sexual satisfaction and product satisfaction questions. Patients were also asked about the importance of a microbicide to protect against infection and understanding the impact on sexual satisfaction. Twenty-one participants were interviewed. Average age was 27.62 (range: 20-42) years. Seventeen (81.0%) participants were White, three (14.3%) were Black and one (4.8%) was Native American. Eleven (52.4%) of participants reported being Hispanic. All participants reported the FSFI global sexual satisfaction item was well understood. The recall period was acceptable, and participants could easily recall their experiences over the 4-weeks. The second standardized question reviewed during the interviews was global product satisfaction. All 21 participants reported the question was well understood and there were no recommendations for change. Participants reported product satisfaction and the impact of microbicide on sexual satisfaction were important and meaningful concepts to assess and would be tied to product use. Participants reported adherence with use of EVO100 was related to product satisfaction and the impact on global sexual satisfaction as well as efficacy. All participants indicated that this information was important to know for women considering a microbicidal vaginal gel like EVO100.