Using integrated mixed methods to develop behavioral measures of factors associated with microbicide acceptability.

Our current understanding of factors associated with microbicide acceptability and consistent use typically has been derived from separate and distinct qualitative or quantitative studies. Specifically, rarely have investigators used mixed methods to both develop and validate behavioral measures. We utilized an integrated mixed methods design, including qualitative metasyntheses, cognitive interviews and expert reviews, psychometric evaluation, and confirmatory qualitative analyses of the correspondence between quantitative items and original qualitative data to develop and validate measures of factors associated with microbicide acceptability and use. We describe this methodology and use the development of the Relationship Context Scale to illustrate it. As a result of independent confirmatory analyses of qualitative passages corresponding to survey items, we demonstrated that items from the same subscales are frequently double coded within a particular textual passage, and thematically related, suggesting associations that resulted in a unique factor structure within the subscale. This integrated mixed method design was critical to the development of this psychometrically validated behavioral measure, and could serve as a model for future measure development.

Willingness to use microbicides varies by race/ethnicity, experience with prevention products, and partner type.

OBJECTIVE: To investigate women's willingness to use vaginal microbicides to reduce/prevent HIV infection, using measures grounded in the individual, behavioral, and social contexts of sex. DESIGN: A cross-sectional study that enrolled a sample (N = 531) of 18-55 year old Latina, African-American, and White women in the U.S. between October, 2004, and July, 2005. MAIN OUTCOME MEASURES: Willingness to use microbicides and individual- and context-related variables (e.g., demographics, relationship status). RESULTS: Exploratory and confirmatory factor analyses supported a one-dimensional, 8-item scale, with high internal consistency (alpha = .91). Subgroup analyses within the Latina (n = 166), African- American (n = 193), and White sub-samples (n = 172) also supported a unidimensional scale with strong internal validity and high reliability. Race/ethnicity as a contextual factor, a woman's history of using prevention products, and the nature of the sexual partnership were predictive of willingness to use microbicides (R = .41). That is, women with greater frequencies of condom use, a history of spermicide use, and non-main sexual partners had higher predicted Willingness to Use Microbicides scale scores, while White women had lower predicted scores. CONCLUSION: The Willingness to Use Microbicides scale serves as the first psychometrically validated measure of factors related to microbicide acceptability. Developing and implementing psychometrically validated and contextualized microbicide acceptability measures, in an effort to understand microbicide users and circumstances of use, is crucial to both clinical trials and future intervention studies.

Willingness to use microbicides is affected by the importance of product characteristics, use parameters, and protective properties.

BACKGROUND: Along with efficacy, a microbicide's acceptability will be integral to its impact on the pandemic. Understanding Product Characteristics that users find most acceptable and determining who will use which type of product are key to optimizing use effectiveness. OBJECTIVES: To evaluate psychometrically the Important Microbicide Characteristics (IMC) instrument and examine its relationship to willingness to use microbicides. RESULTS: Exploratory and confirmatory factor analyses revealed 2 IMC subscales (Cronbach's coefficient alpha: Product Characteristics subscale (alpha = 0.84) and Protective Properties subscale (alpha = 0.89)). Significant differences on Product Characteristics subscale scores were found for history of douching (P = 0.002) and employment status (P = 0.001). Whether a woman used a method to prevent pregnancy or sexually transmitted disease (STD) in the last 3 months (P < 0.001) and whether she used a condom during the last vaginal sex episode (P < 0.001) were significantly related to her rating of the importance of microbicides being contraceptive. Product Characteristics (r = 0.21) and Protective Properties (r = 0.27) subscale scores and whether a microbicide had contraceptive properties (r = 0.24) were all significantly associated (P < 0.001) with willingness to use microbicides. CONCLUSIONS: Formulation and use characteristics and product function(s) affect willingness to use microbicides and should continue to be addressed in product development. The IMC instrument serves as a template for future studies of candidate microbicides.

The utility of non-proportional quota sampling for recruiting at-risk women for microbicide research.

In the context of a measurement development study designed to contextualize microbicide acceptability, a sample that represented a range of at-risk women and maintained the statistical power needed for validity analyses was required. A non-proportional quota sampling strategy focused on race/ethnicity and number of sexual partners was utilized. This strategy resulted in enrollment of approximately equal proportions of Latina (31%), Black (36%), and White (32%) women, and an approximately 1:2 ratio of single-partnered (29%) and multi-partnered (71%) women. About 17% of women screened were ineligible based on eligibility criteria; an additional 16% were ineligible based on quota closures. Most participants were recruited through word of mouth (39%), community-based organizations (19%), or media sources (19%). Women recruited through word of mouth had the highest screen-to-interview completion percentage (67%). Non-proportional quota sampling is a feasible option for ensuring adequate representation of sample characteristics in microbicide research, but this goal should be weighed against cost and staff burden.