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Try out PMC Labs and tell us what you think. Learn More. Unprotected heterosexual intercourse is the leading cause of HIV acquisition in women. Due to the complex nature of correct and consistent condom use by both men and women, developing alternative female-controlled HIV prevention options is a global health priority.

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Vaginal films containing antiretroviral drugs are a potential delivery system for the prevention of HIV acquisition through sexual contact. Eighty-four sexually active, ethnically diverse women 18 to 30 years of age from Pittsburgh, Pennsylvania, participated in the study.

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Women visually and manually examined a variety of vaginal films, as well as three other vaginal products undergoing evaluation for HIV prevention: tablet, ring, and gel. Focus groups were audio-recorded, transcribed verbatim, and coded for content analysis. In general, women desired a comfortable, efficacious, easy-to-use, and minimally intrusive product.

One mechanism to combat this disadvantage is the use of female-controlled HIV prevention products. One potential female-controlled approach is topical pre-exposure prophylaxis or topical microbicides. These are products in development that when applied vaginally or rectally can prevent the acquisition of HIV.

Both coitally dependent and independent vaginal microbicides have been evaluated in large clinical trials Abdool Karim et al. Adherence issues have arisen with vaginal microbicide gel. Of interest is the development of a vaginal film containing antiretroviral s as an alternative vaginal microbicide dosage form. Hypothetical advantages of microbicide vaginal films include low cost, easy storage, portability, and minimal waste. Characteristics of vaginal films that women have liked include female control; covert use; ease of use; comfort; less mess compared to vaginal gel or suppository; fast dissolving time; less leakage; perception of a tight, dry vagina; and not being felt inside the vagina Coggins et al.

The primary problems described with vaginal films have included difficulty with insertion, uncertainty regarding adequacy of film placement using the fingers, and perceived interruption of sex Bunge et al. Raymond et al. First-in-human phase 1 trials of a dapivirine vaginal film and tenofovir vaginal film, both reverse transcriptase inhibitor-containing Craigslist women wanting sex Pittsburgh, have been conducted.

Bunge et al showed that film users, when compared to gel users, were less likely to report product leakage and to describe the product as uncomfortable, but more likely to define the product as difficult to vaginally insert. For those women who had poor product placement with films, prior tampon and lubricant use were not as prevalent as in those with good film placement Bunge, et al.

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In this study, the primary objective was to describe preferred physical characteristics of a vaginal film for HIV prevention in sexually active women, in order to optimize the de of this dosage form for this indication. The secondary objective was to describe attitudes toward the use of vaginal films for HIV prevention. Qualitative approaches such as focus groups allow subjects to describe their thoughts and preferences within an open discussion without the limitations of pre-determined items or assumptions that can be encountered with quantitative approaches like surveys and questionnaires.

Questionnaires were used both as a springboard for group discussion as well as a means to capture key elements of group discussions in a corroborating fashion Creswell, Participants were eligible if they were 1 female, 2 aged 18 to 30 years, and 3 able and willing to provide written informed consent.

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Women who reported no episodes of vaginal intercourse in the prior year or who were pregnant were not eligible for participation. Participants were recruited using IRB-approved advertisements placed in Pittsburgh area neighborhoods, colleges, research registries, craigslist. Participants in two other studies of reproductive tract infections at Magee-Womens Hospital of UPMC, who gave permission to be contacted for future studies, were also invited to participate.

Specifically, we sought to include likely users of vaginal microbicides by including women living in communities disproportionately affected by HIV, including African American women CDC, After confirming eligibility criteria and providing written informed consent, participants completed an initial questionnaire collecting sociodemographic and sexual history information. Participants then took part in a moderated group discussion lasting approximately 75 minutes. One trained moderator MF led all 12 focus groups.

The introduction, format, and primary discussion questions were consistent across all groups. During the introduction, the moderator provided a brief overview of vaginal film, tablet, gel, and ring, including a summary of different dosing and application methods as used for contraception. The primary group discussion questions included: 1 thoughts about the idea of a vaginal film; 2 thoughts about hypothetical vaginal film use; 3 characteristics of an ideal vaginal film; 4 preferred film characteristics; and 5 preferred vaginal product type among film, tablet, ring, and gel.

As part of the group discussion, women had the opportunity to view, hold, and touch a variety of placebo and nonoxynol-9 vaginal films immobilized on Plexiglass sheets Vaginal Contraceptive Film, VCF, by Apothecus Figure 1; A, B, and C. Women then shared their rankings with the group and Craigslist women wanting sex Pittsburgh the reasons for their preferences. Again, all vaginal film characteristic preferences and attitudes indicated by the participants are based on hypothetical, not actual product use. A Films of varying texture and thickness.

B Films of varying size and shape. C Films of varying appearance. From left to right, clear, translucent, and opaque. D From left to right, placebo ring, nonoxynol-9 vaginal tablet, and nonoxynol-9 vaginal gel.

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Women next had the opportunity to view, hold, and touch a placebo vaginal ring International Partnership for Microbicides and nonoxynolcontaining vaginal tablet and gel Encare vaginal contraceptive insert by Blairex and vaginal contraceptive gel by Ortho Options Figure 1; D. The focus group discussion was followed by a final questionnaire collecting theoretical preferences regarding vaginal products for HIV prevention in general and also specific to vaginal film.

Each study session lasted 2 hours, including informed consent. Means and standard deviations were calculated for continuous data.

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Focus group discussions were audio-recorded and transcribed verbatim. Specifically, we relied on the processes of grounded theory, including constant comparison among focus group transcripts and open coding to label and categorize emergent data, but modified this approach with the inclusion of existing research questions to generate the full analysis Glaser, Two investigators independently read and coded the transcripts and met to compare coding and create a codebook in an iterative and collaborative manner.

Agreement on discrepant codes was achieved through a discussion process between coders. The codebook and coding processes were stored and organized using Atlas. The final codebook was systematically applied to all focus group transcripts by the same two investigators independently to minimize interpretive bias Patton, Had there been any differences in interpretation, a third investigator would have arbitrated this difference; no interpretative differences were noted. In addition to investigator corroboration by using two independent coders, other methods of corroboration included review of study findings among the larger study group, work-in-progress presentations, and review of study findings with HIV microbicide researchers external to the study Patton, All reviewers endorsed good corroboration of our themes.

Participant characteristics are found in Table 1. These characteristics reflect information recorded by the women on one of the self-administered written study questionnaires. Eighty-four women participated in the study.

use of vaginal products was common, although only three women reported having ever used a vaginal film. Participants were predominantly young mean age All 84 women completed the written questionnaires.

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Participants reported their beliefs that films were likely to be very comfortable, very easy to insert, and result in no change in sexual pleasure either personally or for a sexual partner Table 2. We held a total of 12 focus groups, each with five to ten participants. In discussing preferred physical characteristics of vaginal films, five major themes emerged: ease and accuracy of use, desire for efficacy, discretion, comfort and minimal impact within the vagina, and minimizing disruption of sex.

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All of these explanatory themes were emergent. Table 4 contains participant quotations that illustrate these five themes. Participants justified hypothetical preference for film characteristics based on beliefs that certain characteristics could impact correct versus incorrect use. For example, one woman described how the larger film increased her confidence that she would receive adequate protection. Several others felt that a small vaginal film would simplify insertion. For film appearance, most participants found a minimum level of visual discernibility reassuring and preferred a translucent or opaque film over a clear film.

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Women were more divided about the optimal film texture and thickness that would promote easy and accurate insertion. Smooth, thin film was preferred by one woman specifically because of perceived ease of insertion.


Also prominent in preferred vaginal film characteristics was the desire for efficacy in preventing HIV infection. Film characteristics that many women associated with greater efficacy included larger size, square shape, texture, and translucent or opaque rather than clear appearance. In particular, several women felt that a larger film would offer greater efficacy by dissolving and distributing over the vaginal surface to a greater extent than a smaller film. Only a minority of women felt vaginal film size would not matter with regards to efficacy in HIV prevention since medication type or content would be most important.

Square shape was another characteristic that several women associated with better vaginal mucosal coverage. With regards to film appearance, many women equated a higher degree of film opacity with greater medication content and efficacy.

Similarly, several women associated more texture with more medication. Participants were divided regarding whether more or less vaginal film thickness might provide greater efficacy.

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Many equated thick films to more medication or longer-lasting efficacy, while others envisioned greater medication release with rapid disintegration of thin films. Women felt efficacy in the context of alcohol consumption was important given their experiences of higher risk sexual encounters while drinking alcohol. As a result, extended efficacy was viewed as favorable, with suggestions for monthly, weekly, or daily dosing. Many participants desired discreet use of vaginal films. The importance of discreet use varied, however, from unobtrusiveness during sex to permitting concealment.

If you could disguise it as a lubricant, for me that would be an effective way to use it. Translucent and clear films were perceived to be less visually noticeable than opaque film, both during insertion in front of a partner and also in terms of any potential vaginal discharge. Several participants wanted discretion external to their sexual partnerships and expressed the desire for circumspect use around family and strangers:.


Some women considered circumspect use important because of a sense of stigma with HIV or with being at risk for HIV infection:. Because I know I would. Offering minimal impact on the vaginal environment was a strongly held notion pervasive throughout the focus group sessions that included both physical comfort and nominal impact on the natural state of the vagina.

Not being felt in the vagina was highly desirable and perceived to coincide with greater comfort. The vaginal film characteristics most frequently associated with comfort were being smooth and thin. Several women were particularly concerned about textured films possibly being uncomfortable without sufficient vaginal lubrication. Only a small minority of women believed that feeling a vaginal film within the vagina would be preferable, in order to physically sense when a vaginal film is correctly inserted. Several women perceived larger size film as more likely to be felt within the vagina.

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