Investigating end-user perspectives to inform the development of a novel non-hormonal intravaginal ring to prevent pregnancy and sexually transmitted infections

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PROJECT III – ABSTRACT Women of reproductive age need multipurpose prevention technology (MPT) products to address unintended pregnancy and sexually transmitted infections (STIs) which have a significant impact on their health and well- being. MPTs in development include intravaginal rings (IVRs), most of which contain hormones. To meet the needs of women who want a non-hormonal method, the Population Council (PC) P50 Center will develop the CZL-IVR, containing three active pharmaceutical ingredients (APIs)—copper (C), zinc (Z), and lactide (L)—that collectively have contraceptive, anti-STI, and anti-bacterial vaginosis activity. End-user research is critical for designing an MPT IVR that users will find acceptable to increase the likelihood of uptake and consistent use. The PC P50 Center Project 3 is driven by a conceptual framework informed by the Theory of Planned Behavior. We will use novel and mixed research approaches to evaluate user-centered (e.g., attitudes, subjective norms and perceived control over IVR use) and product-centered (e.g., physical characteristics, dosing regimen, benefits/risks of APIs) factors influencing IVR acceptability and intention-to-use a non-hormonal MPT IVR. In Aim 1, we will conduct a randomized, open-label, parallel group, crossover study among 60 18-49-year-old women at Emory University (Atlanta, Georgia) who will be randomly assigned to the sequence of using four non- medicated IVRs of differing compression strengths, across two visits. Women will respond to an IVR Acceptability Measurement Tool (IAMT) questionnaire to assess the impact of differing compressive strengths on ease of use (insertion/removal), sensation and involuntary expulsions during routine activities (walking, running, squatting, etc.) when wearing each of the IVRs in a controlled setting. After using all four IVRs, women will have a semi- structured interview with a card-sorting exercise regarding their opinions about the ideal characteristics of an MPT IVR. In Aim 2, we will conduct an exploratory single arm, noncomparative clinical trial of a non-medicated prototype IVR with an embedded temperature sensor among 64 18-49-year-old sexually active women at Emory (half parous, half nulliparous) instructed to wear the IVR continuously for 30 days, including during sexual intercourse, toileting, and menstruation. We will measure adherence to IVR use via daily text messages, a weekly online questionnaire, and the embedded temperature sensor, which will record deviations from core body temperature as a biomarker of adherence. We will assess acceptability with the IAMT questionnaire, expanded to include the impact of the IVR on sexual acceptability. We will also compare temperature sensor data and self- reports to identify the best questions for assessing adherence in future CZL-IVR trials. We will also conduct one- on-one interviews with a subsample of women and male partners to gather in-depth opinions about IVR acceptability. In Aim 3, via a national survey in 1,000 18-49-year-old women, we will implement a discrete choice experiment to determine preferred product characteristics and trade-offs users would make in selecting a non- hormonal MPT IVR and conduct a latent class analysis to identify the women most likely to use the CZL-IVR.