Acceptability of the Reality female condom and a latex prototype.

We report on the comparative acceptability of a prototype latex female condom and the polyurethane Reality female condom. We also identified factors associated with acceptability, measured via a composite index with domains related to ease of insertion, noise, and comfort during insertion and use. There were 135 couples in this randomized crossover trial. The average age was 30 years; more than 60% had education beyond high school; 40% were married; and participants were at low risk for sexually transmitted disease and pregnancy (due to the investigational status of the prototype). Participants were asked to use three of each of the study condoms during a 6-week period. Acceptability ratings on 12 items were summed into a composite index for each participant by condom type. The index midpoint (range) for females was 48 (12-84), and it was 32 (8-56) for males, with lower scores indicating higher acceptability (men completed only a subset of the acceptability questions). Both condoms were equally acceptable: Mean scores were 37 and 40 for the women's ranking of the prototype and Reality, respectively (P =.07) and 29 and 30 for men's rankings, respectively (P =.35). Multiple regression models to predict acceptability scores by gender were somewhat uninformative (most R(2) values were less than 0.10). Nevertheless, minority ethnicity (African American or Hispanic vs. white) was associated with higher acceptability by both genders for both condom types. Among women, for both condom types, less education (less than high school compared with high school or beyond) was associated with higher acceptability. Female condom acceptability may not be equally distributed across demographic groups, which is important for health educators to keep in mind when promoting the female condom.

RCT Entities:   Population Interventions Outcomes