A Framework for Examining the Sustained Acceptability of Microbicides

Severy, Lawrence J.; Tolley, Elizabeth E.; Woodsong, Cynthia; Guest, Greg

doi:10.1007/s10461-005-1687-y

Cited by 71 publications

(56 citation statements)

References 62 publications

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“…For microbicides with the potential to curb the HIV/AIDS pandemic, data pertaining to actual usage is crucial. Acceptability research during this phase could not only continue to examine the various product-and use-related factors examined in clinical trials, but could also provide data on factors that mediate use (Severy, Tolley, Woodsong, & Guest, 2005b), as well as factors that influence product preference (in the case of multiple available products) and the diffusion of microbicides as a prevention innovation. Additionally, given the probability of a partially effective product being made available, acceptability data pertaining to microbicide use in combination with other prevention strategies (e.g., condoms, contraception) would be necessary for a more comprehensive understanding of how individuals choose prevention methodologies and make decisions about when, where, and with whom to use various prevention strategies.…”

Section: Phase IVmentioning

confidence: 99%

Assessing Microbicide Acceptability: A Comprehensive and Integrated Approach

Morrow

Ruiz

2007

AIDS Behav

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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...

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Section: Phase IVmentioning

confidence: 99%

Assessing Microbicide Acceptability: A Comprehensive and Integrated Approach

Morrow

Ruiz

2007

AIDS Behav

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“…Items were developed for self-efficacy, norms, partner labeling, risk perception, relationship quality, and sexual behavior through a careful review and modification of measures described in the HIV/STD literature (Abraham, Sheeran, Abrams, & Spears, 1996;Anderson, Wilson, Doll, Jones, & Barker, 1999;Armitage & Conner, 2001;BasenEngquist, 1992;Buunk, Bakker, Siero, van den Eijnden, & Yzer, 1998;Chan, Cheung, Gray, Ip, & Lee, 2004;Civic, 1999;Forsyth & Carey, 1998;Giles, Liddell, & Bydawell, 2005;Jennings-Dozier, 1999;Rise, Thompson, & Verplanken, 2003;Severy, Robinson, FindleyKlein, & McNulty, 2006;Severy et al, 2005;Sheeran & Abraham, 1994;Sheeran & Orbell, 1998;Smith et al, 1996;Soet, DiIorio, & Dudley, 1998;Soler et al, 2000;St Lawrence et al, 1998), as well as expert reviews of proposed items and ordering of those items. Both section (i.e., topic) and item ordering was decided as a function of the study's desire to contextualize a woman's process of responding to the questionnaire.…”

Section: Participant Recruitment and Enrollmentmentioning

confidence: 99%

“…It will be critical for successful uptake of the products, and thus their impact on rates of HIV transmission, to understand who would use microbicides and why. For instance, will product use vary by partner type or number, cultural influences on the sexual context, or other factors (Severy, Tolley, Woodsong, & Guest, 2005)? Given a greater understanding of which factors affect microbicide uptake and use, behavioral and social scientists, as well as health care providers and systems, will be better able to develop and target appropriate interventions.…”

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confidence: 99%

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

Morrow¹,

Fava²,

Rosen³

et al. 2007

Health Psychology

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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, AfricanAmerican, and White women in the U.S. between October, 2004, andJuly, 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 (α = .91). Subgroup analyses within the Latina (n = 166), AfricanAmerican (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-TheWillingness 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.

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“…Although some studies have investigated acceptability in terms of product-related factors, such as color and consistency; delivery method; product form; application process; messiness; lubrication; potential for adverse reactions; and effects on sexual pleasure (Hammett et al, 2000;Hardy, Jimenez, de Padua, & Zaneveld, 1998;Hira et al, 1995;Mason et al, 2003;Raymond et al, 2005), little is known about inter-and intra-personal psychological aspects that affect acceptability and use (Severy, Tolley, Woodsong, & Guest, 2005;Ramjee et al, 2006). Very few studies have assessed male partner acceptance of a vaginal microbicide used during sex or investigated the link between male partner acceptance and female acceptance (Bentley et al, 2004;CarbelloDieguez et al, 2007;Mantell et al, 2005;Low-Beer et al, 2002).…”

Section: Introductionmentioning

confidence: 99%

The role of men in women's acceptance of an intravaginal gel in a randomized clinical trial in Blantyre, Malawi: a qualitative and quantitative analysis

Salter

Celentano

et al. 2008

AIDS Care

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Survey questionnaires and focus group discussions were used to investigate the association between a female participant's acceptance and her perception of her male partner's acceptance of an intravaginal gel as a prototype microbicide. Women who perceived their male partners would accept using the gel were more likely to highly accept the gel as compared to women who perceived their male partners would not accept using the gel (OR=24.57; 95%CI: 16.49-36.61). Qualitative analysis supported a positive association between female acceptability and perceived male partner acceptability. Qualitative research reiterated this finding and also found that men and women had different approaches to assess gel acceptability. Women integrated perceptions of their partner's acceptance into their own acceptability and reported their partners had positive experiences. In contrast, men reported a more neutral experience with the gel and assessed the gel without overt consideration of their partner's experiences. These results indicate that female perceptions of male partner acceptability and actual male partner acceptability need to be considered when addressing female-controlled product acceptability and use.

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A Framework for Examining the Sustained Acceptability of Microbicides

Cited by 71 publications

References 62 publications

Assessing Microbicide Acceptability: A Comprehensive and Integrated Approach

Assessing Microbicide Acceptability: A Comprehensive and Integrated Approach

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

The role of men in women's acceptance of an intravaginal gel in a randomized clinical trial in Blantyre, Malawi: a qualitative and quantitative analysis

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