Assessing Microbicide Acceptability: A Comprehensive and Integrated Approach

Abstract

A safe, effective, and acceptable microbicide is needed in order to decisively impact the global AIDS pandemic. As such, microbicide acceptability research is of paramount importance. In order to best utilize limited financial resources and save precious development time, acceptability studies should be fully integrated into preclinical and clinical trial contexts where candidate products are being developed and tested. An integrated approach for examining theoretically valid and relevant variables is needed so that data across studies and products can more effectively advance the field. We propose an approach for measuring factors related to microbicide acceptability in each phase of product development, and dependent on what product-specific knowledge is already established in the field. We discuss the roles that behavioral and social science methodologies should play in all phases of microbicide development, as well as the challenges faced when conducting acceptability research in the context of preclinical and clinical trial settings. KeywordsMicrobicides; Acceptability; Measurement; Clinical trials; Preclinical development Each day, approximately 14,000 individuals globally are newly infected with HIV; of these, almost half are women (Boonstra, 2000;UNAIDS/WHO, 2005). Even as they face increased risk, many women have little control over HIV/STD prevention decisions. Currently, women must rely on HIV prevention methods that require the knowledge and consent of sex partners (i.e., male condom, female condom, and abstinence) (Bentley et al., 2000;Mason et al., 2003;Wulf, Frost, & Darroch, 1999).Microbicides could change this reality. While the focus has primarily been on developing topical vaginal microbicides, rectal microbicides will likely also have a significant impact on HIV infection rates among both women and men. By developing a product that can be used overtly or covertly (i.e., with or without a partner's knowledge, awareness, or consent), individuals can control their own protection against HIV and, potentially, other STDs. Although not all individuals want or need to use a product covertly, researchers and advocates are particularly interested in the possibility that microbicides could place prevention control in the hands of those who need it. The possibility of covert use would be particularly valuable NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author Manuscript in relationships and cultural systems where gender norms or social status limit one's ability to exert control over the timing or frequency of sexual acts. Microbicides containing contraceptive agents may also facilitate fertility regulation.Currently, there are nearly three dozen microbicide candidates in active preclinical and approximately one dozen in clinical development, representing a wide array of potential HIV prevention strategies (Finley, Plescia, Harrison, & des Vignes, 2006). Various biologic strategies to block HIV infection in the context of sexual exposure and several different delivery systems to dep...

Secrecy, empowerment and protection: positioning PrEP in KwaZulu-Natal, South Africa

“…Further research will need to explore ways of understanding the complexities and diversity of women's preferences (Montgomery et al 2010). More specifically, research that helps us understand how women will relate to a product can influence acceptance and adherence (Morrow and Ruiz 2008). In this study, critical conscientisation culminated in diverse product associations: women were awakened to the possibilities of enhanced protection against HIV infection (protection), product use in the absence of partner knowledge or approval (secrecy) and the overall notion of having the power to transform their lived experiences (empowerment).…”

“…Effective product positioning can increase demand by diverse users (Brady and Tolley 2014;Morrow and Ruiz 2008;Tolley et al 2014) and influence product user knowledge, acceptability and willingness to adopt new innovations. Research that explores the diversity of user needs and it relationship to product associations is crucial to advance the HIV prevention agenda, as women's HIV prevention options are often influenced by age, geo-spatial location and types of sexual encounters (Govender, Mansoor, and Abdool Karim 2016).…”

Perceptibility and the “Choice Experience”: User Sensory Perceptions and Experiences Inform Vaginal Prevention Product Design

“…10 In sum, formative qualitative interviews were used to generate a pool of items capturing the range of sensations elicited by various formulation properties, as experienced during use. We did not focus on conventional microbicide acceptability characteristics, such as smell, taste, and packaging [11][12][13][14][15] ; instead, we aimed to assess USPEs and how those USPEs may relate to rheological and other biophysical properties of topical vaginal formulations. Of note, USPE items are designed to capture user perceptions of formulation performance in factual terms.…”

Designing Preclinical Perceptibility Measures to Evaluate Topical Vaginal Gel Formulations: Relating User Sensory Perceptions and Experiences to Formulation Properties

“…Furthermore, we hypothesized that after dilution the higher viscosity gels (e.g., green and purple) would be stickier than the gels with lower viscosities. Of note, conventional microbicide acceptability characteristics, such as smell, taste, and packaging, 14,[59][60][61][62] were intentionally not the focus in Project LINK; sensory perceptions and experiences as a function of use (perceptibility), and how those USPEs may correspond to formulation properties, were the target constructs for evaluation. Items primarily attempted to capture gel performance (elicited sensations, flow: referred to as ''gel behavior'') in as objective a process as possible, limiting regard for cognitive judgment and opinion until later in the evaluation process.…”

“…[8][9][10][11] Yet even if highly efficacious, the public health impact of anti-HIV microbicides will depend on actual use (i.e., adherence) by at-risk individuals. [12][13][14][15][16] That is, the ultimate effectiveness of any biomedical prevention technology to reduce HIV incidence will require both biological efficacy and behavioral adherence.…”