'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.

Cost-effectiveness analysis of a cluster-randomized, culturally tailored, community health worker home-visiting diabetes intervention versus standard care in American Samoa.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is highly prevalent in American Samoa. Community health worker (CHW) interventions may improve T2DM care and be cost-effective. Current cost-effectiveness analyses (CEA) of CHW interventions have either overlooked important cost considerations or not been based on randomized clinical trials (RCTs). The Diabetes Care in American Samoa (DCAS) intervention which occurred in 2009-2010 was a cluster-randomized, culturally tailored, home-visiting CHW intervention and improved HbA1c levels. OBJECTIVE: To analyze the cost-effectiveness of the DCAS intervention against standard care using a RCT in a low-resource setting. METHODS: We collected clinical, utilization, and cost data over 2 years and modeled quality-adjusted life years (QALYs) gained based on the RCT glycated hemoglobin (HbA1c) improvements. We calculated an incremental cost-effectiveness ratio (ICER) from the societal perspective over a 2-year time horizon and reported all costs in 2012 USD ($). RESULTS: Two hundred sixty-eight American Samoans diagnosed with T2DM were cluster randomized into the CHW (n = 104) or standard care control (n = 164) arms. The CHW arm had a mean reduction of 0.53% in HbA1c, an increase of $594 in cost, and an increase of 0.05 QALYs. The ICER for the CHW arm compared to the control arm was $1121 per percentage point HbA1c reduced and $13 191 per QALY gained. CONCLUSIONS: Compared to a variety of willingness-to-pay thresholds from $39 000 to $154 353 per QALY gained, this ICER shows that the CHW intervention is highly cost-effective. Future studies of the cost-effectiveness of CHW T2DM interventions in similar settings should model lifetime costs and QALYs gained to better assess long-term cost-effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov , ID NCT00850824. Registered 9 February 2009, https://clinicaltrials.gov/ct2/show/NCT00850824 .

Designing Dual Compartment HIV Prevention Products: Women's Sensory Perceptions and Experiences of Suppositories for Rectal and Vaginal Use.

Dual compartment suppositories are being developed to prevent HIV and other sexually transmitted infections. Such products, for use in the rectum, the vagina, or both, could have a significant public health impact by decreasing global incidence of these diseases. In this study, 16 women each used two rheologically distinct suppositories in their vagina and rectum. User Sensory Perception and Experience (USPE) scales assessed sensory experiences during sexual activity to understand whether, and how, women perceive formulation properties in the vagina and rectum. Qualitative data from individual in-depth interviews captured women's descriptions and comparisons of the experiences. Significant differences and large Cohen's d effect sizes between vaginal and rectal experiences of suppository-A were found for three scales: Application (APP): Product Awareness, SEX: Initial Penetration; and SEX: Effortful. Qualitative data provided user experience details that credibly align with these score differences. Near significant differences and large effect sizes were found for two additional scales: SEX: Perceived Wetness with suppository-A and SEX: Messiness with suppository-B. In addition, other scale scores showed medium-to-large effect sizes that correspond to hypothesized sensations associated with biophysical properties of the suppositories. Statistical significance combined with large effect sizes and qualitative data accurately represent the hypothesized perceptibility of suppository properties and identifies performance characteristics relevant to acceptability and adherence; together these data provide discernment of factors that can guide the development of dual compartment products. The Clinical Trial Registration number: NCT02744261.

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.