'I feel like a person has a right to use a product to protect themselves ': a qualitative study of the risk-benefit calculus on women's contraceptive use and choice.

Background Reducing pregnancy risk requires a multidimensional approach to sexual and reproductive health product development. The purpose of this analysis is to identify, compare, and contrast women's pre-use beliefs and attitudes about three different forms of contraceptives: intravaginal rings; spermicide in conjunction with condoms; and oral contraceptive pills - and explore how those attitudes and beliefs, along with actual method-use experience, may affect potential choices in contraceptive method moving forward. The relationship of beliefs and attitudes to their risk-benefit calculations when using these methods was also considered.? METHODS: Women used one or more contraceptive methods, each for 3-6 months. Qualitative data from individual in-depth interviews completed after each 3-month use period were analysed using a summary matrix framework. Data were extracted and summarised into themes. Each woman's experiences were compared among the methods she used; comparisons were also made across participants. RESULTS: The data consist of 33 90-120 min in-depth qualitative interviews from 16 women aged 20-34 years, in which they discussed various elements of their method use experience. One prominent theme was identified: the influence of attitudes and beliefs on the risk-benefit calculus. There were six key elements within the theme: pregnancy prevention; dosing and the potential for user error; side-effects; familiarity; disclosure; and sexual partnerships. CONCLUSIONS: Women weighed perceived risks and benefits in their decision-making and, ultimately, their contraception choices. Understanding women's beliefs and attitudes that contribute to a calculation of risk-benefit can inform the development of sexual and reproductive health products.

A Qualitative Systematic Review of Women's Experiences Using Contraceptive Vaginal Rings: Implications for New Technologies.

CONTEXT: Vaginal rings are available for contraception and hormone replacement, and are being developed as HIV/STD or multipurpose prevention technologies. A comprehensive understanding of women's expectations of and experiences with rings is urgently needed to inform product development and to optimize ring use. METHODS: Three databases (PubMed, Global Health and CINAHL) were searched for English-language, peer-reviewed articles published between January 1996 and November 2017 that reported qualitative data on barriers to and facilitators of use of female-controlled contraceptive methods. Data on study methods, findings and conclusions pertaining to contraceptive rings were extracted, organized and analyzed. RESULTS: Twenty-six articles, all published since 2008, met the inclusion criteria. Seven studies focused largely or entirely on rings (and involved current, former or potential users), while the others focused on other contraceptive methods but included ring-specific data. Familiarity with the ring was low, and women commonly had initial concerns about the method-often related to insertion and removal, cleanliness and discomfort with touching their vagina-that were typically overcome over time. Other major themes were issues related to ring use and discontinuation, the importance of ring-related properties and characteristics, and considerations related to sexual partners and health care providers. CONCLUSIONS: Qualitative data have the potential to inform ring design and promotion. Future research should further explore women's expectations and experiences with the ring, the value of involving male partners in ring evaluation, and evaluation of interventions to improve patient-provider communication concerning ring choice and use.

RESUMEN Contexto: Los anillos vaginales están disponibles para la anticoncepción y el reemplazo hormonal, y se están desarrollando como tecnologías de prevención del VIH/ETS o de propósitos múltiples. Se necesita con urgencia una comprensión integral de las expectativas y experiencias de las mujeres con los anillos para fundamentar el desarrollo del producto y optimizar el uso del anillo. Métodos: Entre enero de 1996 y noviembre de 2017, se realizaron búsquedas en tres bases de datos (PubMed, Global Health y CINAHL) sobre artículos en idioma inglés sometidos a revisión por pares, que aportaron datos cualitativos sobre barreras y facilitadores del uso de métodos anticonceptivos controlados por mujeres. Los datos sobre los métodos de estudio, hallazgos y conclusiones relacionados con los anillos anticonceptivos se extrajeron, organizaron y analizaron. Resultados: Veintiséis artículos, todos publicados desde 2008, cumplieron con los criterios de inclusión en el análisis. Siete estudios se centraron en gran medida o completamente en los anillos (e involucraron usuarias actuales, anteriores o potenciales), mientras que los otros estudios se centraron en otros métodos anticonceptivos, pero incluyeron datos específicos sobre el anillo. La familiaridad con el anillo era baja y las mujeres generalmente expresaron preocupaciones iniciales sobre el método ­muchas veces en relación con la inserción y extracción, la limpieza y la incomodidad al tocar su vagina­ que típicamente se superaban con el tiempo. Otros temas importantes fueron aspectos relacionados con el uso y la interrupción del uso del anillo, la importancia de las propiedades y características relacionadas con el anillo y consideraciones relacionadas con parejas sexuales y proveedores de servicios médicos. Conclusiones: Los datos cualitativos tienen potencial para fundamentar el diseño y la promoción de los anillos vaginales. Las investigaciones futuras deben explorar más a fondo las expectativas y experiencias de las mujeres con respecto al anillo, el valor de involucrar a los compañeros masculinos en la evaluación del anillo y la evaluación de las intervenciones para mejorar la comunicación entre paciente y proveedor con respecto a la elección y el uso del anillo.

RÉSUMÉ Contexte: L'anneau vaginal, déjà proposé à des fins de contraception et de traitement hormonal de substitution, fait aujourd'hui l'objet d'une mise au point parmi les technologies de prévention du VIH/sida ou polyvalente. Il est impératif de bien comprendre les attentes et le vécu des utilisatrices pour éclairer la mise au point du produit et en optimiser l'usage. Méthodes: Trois bases de données (PubMed, Global Health et CINAHL) ont été consultées à la recherche d'articles en langue anglaise évalués par les pairs et publiés entre janvier 1996 et novembre 2017, faisant état de données qualitatives sur les obstacles et les facteurs propices à l'usage des méthodes contraceptives contrôlées par les femmes. Les données relatives aux méthodes d'étude, aux observations et aux conclusions pertinentes à l'anneau contraceptif en ont été extraites, puis organisées et analysées. Résultats: Vingt-six articles publiés, tous depuis 2018, ont répondu aux critères d'inclusion. Sept études concernaient largement ou exclusivement l'anneau (avec participation des utilisatrices actuelles, passées ou potentielles); les autres examinaient d'autres méthodes contraceptives mais présentaient des données spécifiques à l'anneau. L'anneau n'était guère familier aux femmes, dont les préoccupations initiales à l'égard de la méthode ­ souvent liées aux questions d'insertion et de retrait, d'hygiène et de gêne au contact du vagin ­ se dissipaient toutefois au fil du temps. Les autres grands thèmes touchaient à l'utilisation de l'anneau et à l'arrêt de la méthode, à l'importance de ses propriétés et caractéristiques et à des considérations relatives aux partenaires sexuels et aux prestataires de soins de santé. Conclusions: Les données qualitatives offrent un potentiel utile à la conception et à la promotion de l'anneau. La recherche future devra examiner davantage les attentes et le vécu des femmes à son égard, l'importance de la participation des partenaires masculins à son évaluation et l'évaluation des interventions entreprises pour améliorer la communication entre patientes et prestataires quant au choix et à l'utilisation de la méthode.

A Qualitative Study of the Contraceptive Effect on Women's Sexual Experiences: Beyond Hormonal Effects.

OBJECTIVE: To elucidate the effects of the intravaginal ring, oral contraceptive pill (OCP), and spermicide plus condom on women's sexual experiences through an in-depth understanding of the physical characteristics of these contraceptive methods. METHODS: We conducted qualitative in-depth interviews with women (aged 18-45 years) who used up to three contraceptive methods (intravaginal ring, OCP, and spermicide plus condom). Women completed in-depth interviews after each 3-month use period. We used a summarized matrix framework and thematic content analysis to explore how each method affected participants' sexual experiences. RESULTS: Sixteen women completed interviews, yielding 33 transcripts. Women reported physical effects on their sexual experiences while using the intravaginal ring and spermicide plus condom. The OCP was often discussed as lacking these physical effects. Discussion themes included product administration (eg, navigating intravaginal ring removal) and physical product awareness (eg, spermicide as a lubricant). From these experiences, women often altered and individualized their use and subsequent opinions of the contraceptive method. CONCLUSION: The range of contraceptive effects on women's sexual experiences shape their use and opinions of the product, leading to either increased motivation and consistent use or poor adherence and discontinuation. Awareness of these individualized experiences can help providers better understand and guide their patients towards successful contraceptive use.

A Qualitative Systematic Review of Women's Experiences Using Contraceptive Vaginal Rings: Implications for New Technologies.

CONTEXT: Vaginal rings are available for contraception and hormone replacement, and are being developed as HIV/STD or multipurpose prevention technologies. A comprehensive understanding of women's expectations of and experiences with rings is urgently needed to inform product development and to optimize ring use. METHODS: Three databases (PubMed, Global Health and CINAHL) were searched for English-language, peer-reviewed articles published between January 1996 and November 2017 that reported qualitative data on barriers to and facilitators of use of female-controlled contraceptive methods. Data on study methods, findings and conclusions pertaining to contraceptive rings were extracted, organized and analyzed. RESULTS: Twenty-six articles, all published since 2008, met the inclusion criteria. Seven studies focused largely or entirely on rings (and involved current, former or potential users), while the others focused on other contraceptive methods but included ring-specific data. Familiarity with the ring was low, and women commonly had initial concerns about the method-often related to insertion and removal, cleanliness and discomfort with touching their vagina-that were typically overcome over time. Other major themes were issues related to ring use and discontinuation, the importance of ring-related properties and characteristics, and considerations related to sexual partners and health care providers. CONCLUSIONS: Qualitative data have the potential to inform ring design and promotion. Future research should further explore women's expectations and experiences with the ring, the value of involving male partners in ring evaluation, and evaluation of interventions to improve patient-provider communication concerning ring choice and use.

User evaluations offer promise for pod-intravaginal ring as a drug delivery platform: A mixed methods study of acceptability and use experiences.

BACKGROUND: Effective HIV prevention requires efficient delivery of safe and efficacious drugs and optimization of user adherence. The user's experiences with the drug, delivery system, and use parameters are critical to product acceptability and adherence. Prevention product developers have the opportunity to directly control a drug delivery system and its impact on acceptability and adherence, as well as product efficacy. Involvement of potential users during preclinical design and development can facilitate this process. We embedded a mixed methods user evaluation study into a safety and pharmacokinetics (PK) trial of a pod-intravaginal ring delivering antiretroviral agents. METHODOLOGY: Women enrolled in two cohorts, ultimately evaluating the safety/PK of a pod-IVRs delivering TDF-alone, TDF-FTC, and/or TDF-FTC-MVC. A 7-day use period was targeted for each pod-IVR, regardless of drug or drug combination. During the clinical study, participants provided both quantitative (i.e., survey) and qualitative (i.e., in-depth interview) data capturing acceptability, perceptibility, and adherence behaviors. Initial sexual and reproductive health history surveys, daily diaries, a final acceptability and willingness to use survey, and a qualitative in-depth interview comprised the user evaluation data for each pod-IVR experienced by the participants. FINDINGS: Overall, the majority of participants (N = 10) reported being willing to use the pod-IVR platform for HIV prevention should it advance to market. Confidence to use the pod-IVR (e.g., insertion, removal) was high. There were no differences noted in the user experience of the pod-IVR platform; that is, whether the ring delivered TDF-alone, TDF-FTC, or TDF-FTC-MVC, users' experiences of the ring were similar and acceptable. Participants did report specific experiences, both sensory and behavioral, that impacted their use behaviors with respect to the ring, and which could ultimately impact acceptability and adherence. These experiences, and user evaluations elicited by them, could both challenge use or be used to leverage use in future trials and product rollout once fully articulated. CONCLUSIONS: High willingness-to-use data and lack of salient differences in user experiences related to use of the pod-IVR platform (regardless of agents delivered) suggests that the pod-IVR is a feasible and acceptable drug delivery device in and of itself. This finding holds promise both for an anti-HIV pod-IVR and, potentially, a multipurpose prevention pod-IVR that could deliver both prevention for sexually transmitted infections (STIs) including HIV and contraception. Given the very early clinical trial context, further acceptability, perceptibility, and adherence data should continue to be explored, in the context of longer use periods (e.g., 28-day ring use), and in the contexts of sexual activity and menses. Using early design and development contexts to gain insights into potential challenges and facilitators of drug delivery systems such as the pod-IVR could save valuable resources and time as a potential biomedical technology moves through the clinical trial pipeline and into real-world use.

User input in iterative design for prevention product development: leveraging interdisciplinary methods to optimize effectiveness.

The development of HIV-preventive topical vaginal microbicides has been challenged by a lack of sufficient adherence in later stage clinical trials to confidently evaluate effectiveness. This dilemma has highlighted the need to integrate translational research earlier in the drug development process, essentially applying behavioral science to facilitate the advances of basic science with respect to the uptake and use of biomedical prevention technologies. In the last several years, there has been an increasing recognition that the user experience, specifically the sensory experience, as well as the role of meaning-making elicited by those sensations, may play a more substantive role than previously thought. Importantly, the role of the user-their sensory perceptions, their judgements of those experiences, and their willingness to use a product-is critical in product uptake and consistent use post-marketing, ultimately realizing gains in global public health. Specifically, a successful prevention product requires an efficacious drug, an efficient drug delivery system, and an effective user. We present an integrated iterative drug development and user experience evaluation method to illustrate how user-centered formulation design can be iterated from the early stages of preclinical development to leverage the user experience. Integrating the user and their product experiences into the formulation design process may help optimize both the efficiency of drug delivery and the effectiveness of the user.