Changes in Sexual Behavior during a Safety and Feasibility Trial of a Microbicide/Diaphragm Combination: An Integrated Qualitative and Quantitative Analysis

Abstract

If proven effective, vaginal microbicides and diaphragms will likely be part of a larger HIV prevention model that includes condoms and other prevention strategies. It is, therefore, important to understand how introducing new prevention methods may affect overall patterns of sexual risk behavior. Data presented were collected as part of a safety and feasibility study of ACIDFORM gel with a diaphragm among 120 women in South Africa. Interviews were administered at enrollment and months 1, 3, 5, and 6 of the trial. Focus groups were conducted at trial exit. Frequency of sex increased significantly after enrollment. This increase appears to be owing to perceived protection from HIV and greater sexual pleasure afforded by the gel. Male condom use was high overall but increased significantly from enrollment. Data suggest this is because of increased partner involvement, increased negotiating power afforded by study participation, and provision of free condoms perceived to be of high quality.

The Use of the Diaphragm Instead of Condoms in a Phase III Diaphragm Trial

“…AIDS Behav (2009) 13:564-572 567 We found that consistent product substitution was associated with a belief that diaphragms protect against HIV/STIs. ''Prevention method optimism'' has also been reported in other studies of female-initiated methods (Behets et al 2008;Guest et al 2007) and may reflect, in part, women's desperation about their lack of prevention options in settings of high HIV prevalence (Mantell et al 2006;Okal et al 2008;Orner et al 2006). As reported in a separate qualitative study with exited MIRA participants and their partners, optimistic bias seemed to have persisted despite intensive product counseling and participants' appropriate understanding of the trial context (including the effectiveness testing of the investigational products), and may have been reinforced by repeatedly testing negative for HIV/STIs after using the diaphragm alone (Kacanek et al 2008).…”

Behavioral Considerations for Engaging Youth in HIV Clinical Research

“…A number of qualitative studies, for example, carried out in conjunction with microbicide/diaphragm clinical trials report that many participants believed that the experimental condition/device was effective at HIV prevention. [38][39][40][41] Nonetheless, there generally was no clear indication from quantitative data of a concomitant decrease in condom use (ie, condom migration), which would have suggested some degree of risk compensation. 38,39,41 One study, however, found that women reported decreased use of condoms when interviewed through focus groups upon completion of the clinical trial.…”

User-Identified Gel Characteristics: A Qualitative Exploration of Perceived Product Efficacy of Topical Vaginal Microbicides

“…Previous studies have examined PPE among women in several countries (Bass, 2002; Greene et al, 2010; Guest et al, 2007; Mantell et al, 2006b; Saethre & Stadler, 2010), consistently documenting that users draw conclusions about microbicide efficacy, even if clinical efficacy is unknown. In at least one efficacy study, women expressed strong opinions that a candidate was effective for HIV prevention and other health benefits, despite being told by researchers that the product had no proven efficacy (Bass, 2002; Greene et al, 2010; Guest et al, 2007; Mantell et al, 2006b; Saethre & Stadler, 2010).…”

“…Perceived product efficacy (PPE) is a key feature driving the acceptability of, and potential adherence to, HIV/STI prevention products (Bass, 2002; Greene et al, 2010; Guest et al, 2007; Holmes, Maher, & Rosenthal, 2008; Mantell, Morar, Myer, & Ramjee, 2006b; Saethre & Stadler, 2010). PPE refers to a user’s perception of the extent to which a product is capable of producing a desired result.…”