Meaning-making matters in product design: users’ sensory perceptions and experience evaluations of long-acting vaginal gels and intravaginal rings

ObjectiveUsers’ sensory perceptions and experiences of intravaginal products can inform acceptability and adherence. Focusing on the meanings women derive from formulation/device characteristics facilitates developers’ design iterations toward optimizing user experience. We investigated how users of long-acting gels and intravaginal rings (IVRs) impute meaning to characteristics that may affect future product use.Study designFocus groups were conducted with contraceptive IVR and vaginal lubricant users. Current perceptibility science and historical theory on the cultural acceptability of fertility regulating methods informed the analysis.ResultsA total of 21 IVR users and 29 lubricant users attended focus groups in which they manipulated products in their hands and discussed reactions to product characteristics. Participants used prior product experiences and sensory perceptions of prototype manipulations to inform meanings about product properties and performance for pregnancy, disease prevention, comfort, and perceived efficacy. The meanings derived from product characteristics depended on why the product would be used; a characteristic deemed problematic in one risk context may be considered preferable in another.ConclusionsIntravaginal product users create narratives that ascribe influence or causality to product characteristics. These meanings, whether correct or incorrect biologically, will shape vaginal product acceptability, use, and effectiveness.ImplicationsLong-acting and sustained-release drug delivery systems will be part of the multipurpose prevention continuum. Developers must consider how sensory experiences and culturally salient assumptions shape the meanings users make of product design characteristics. Those meanings will ultimately impact use and effectiveness.     

Variations in microbicide gel acceptability among young women in the USA and Puerto Rico

In a multi-site study of vaginal microbicide acceptability conducted with sexually active young women, quantitative assessments revealed significant differences in acceptability by site. Participants in Puerto Rico rated the gel more favourably than mainland US participants in terms of liking the gel and likelihood of future use. To explain these differences, we examined responses to qualitative behavioural assessments. Young women in mainland USA associated gel leakage with uncomfortable sensations experienced during menstruation, while young women in Puerto Rico had positive associations of gel use with douching. These negative or positive associations affected assessments of the gel's physical qualities. In addition, young women's perceptions of primary partners' support for microbicide use influenced sexual satisfaction with the gel and, ultimately, product acceptability. Finally, geographic HIV-risk context contributed to heightened HIV-risk perception, which influenced likelihood of future microbicide use, even for women in stated monogamous relationships. Future microbicide acceptability studies should take into account potential differences in acceptability by site such as HIV-risk perception based on local HIV prevalence, popularity of vaginal hygiene products in a specific area and male attitudes in different cultures concerning women's use of HIV protection strategies.     

"We have our protector": misperceptions of protection against HIV among participants in a microbicide efficacy trial

OBJECTIVES: We examined perceptions of the effectiveness and acceptability of a candidate microbicide among 94 South African female sex workers who had participated in a phase 3 microbicide trial for HIV prevention. METHODS: Sixteen focus groups were conducted in 2001, 12 to 15 months after participants were informed that the candidate microbicide had been determined to be ineffective in preventing HIV and other sexually transmitted infections (STIs). RESULTS: Participants clearly indicated that they understood the experimental nature of the candidate microbicide, and they recognized that they had been informed after the trial that the product was ineffective. Nevertheless, most continued to believe that the candidate microbicide helped prevent HIV and other STIs, alleviated reproductive tract pain and STI symptoms, and helped to clean the vagina. CONCLUSIONS: These findings underscore the importance of understanding women's perceptions of the efficacy of candidate microbicides and the rationale for these beliefs. These issues need to be addressed in counseling throughout microbicide trials for HIV prevention. These results also demonstrate how desperate many women at high risk of HIV infection may be for new HIV prevention technologies.     

Blockage and flow: intimate experiences of condoms and microbicides in a South African clinical trial

Based on qualitative research undertaken during a phase-three microbicide gel trial, this paper explores female participants' experiences and perceptions of gel and condom use and the opinions of their male partners and community members. Participants were aware that condoms were effective in preventing HIV infection and that the efficacy of the microbicide was unproven. Yet, in narratives about gel and condom use, participants ascribed improvements to their reproductive health and intimate relationships with men to gel use. In contrast, condoms were believed to prevent disease, yet also embodied mistrust, were believed to contain dangerous substances and were felt to block the womb. These apparently contradictory views about condoms and gels are explored in the light of conceptions of flow and blockage. Health is achieved by maintaining a steady balance of substances within the body, while preventing fluid flow results in illness. We argue that women enrolled in the trial broadened the meaning of the gel beyond its primary intended effect of preventing HIV. Through their accounts of gel use, women 'reinvented' the gel as a substance that transformed their bodies and sexual relations. This has implications for understanding how local knowledge of health and illness intersects with biomedical knowledge.     

Acceptability of a microbicide among women and their partners in a 4-country phase I trial

OBJECTIVES: We analyzed qualitative and quantitative data for 98 HIV-negative, low-risk women in Malawi, Zimbabwe, India, and Thailand who participated in a safety and acceptability study of BufferGel, a vaginal microbicide to determine the across-country acceptability of vaginal microbicides among women and their partners. METHODS: Quantitative survey data were collected at 7 and 14 days after use among enrolled women, and exit interviews were conducted with women and their partners in separate focus group discussions. RESULTS: Acceptability was high in all sites (73% of women approved of the microbicide). Women in Africa, where HIV infection rates are highest, were virtually unanimous in their desire for such a product, suggesting that an individual's perception of being at risk for HIV will outweigh concerns about side effects, problems applying a product, or other factors, when products are shown to be efficacious. But men and women reported that use, which was kept secret from an intimate partner, would be difficult and might "break the trust" of a relationship. CONCLUSIONS: Acceptability research across diverse settings through all stages of microbicide research, development, and post-licensure dissemination can help maximize acceptability and use.     

An exploratory,randomized, crossover MRI study of microbicide delivery with the SILCS diaphragm compared to a vaginal applicator

BackgroundMicrobicide gels studied for HIV prevention often are delivered via a single-use vaginal applicator. Using a contraceptive diaphragm such as the SILCS diaphragm for gel delivery could have advantages, including lower cost and additional pregnancy prevention.Study DesignWe performed an exploratory, nonblinded, randomized, crossover study among healthy, sexually active, nonpregnant women. Using BufferGel®, we evaluated three microbicide delivery methods for gel distribution and retention: SILCS single-sided gel delivery, SILCS double-sided gel delivery and a vaginal applicator (without SILCS). Magnetic resonance images were taken at baseline, after gel insertion, and immediately and 6 h after simulated intercourse. Three women completed all gel delivery methods described in this article.ResultsMagnetic resonance imaging analysis indicated similar gel spread in the vagina among all three methods. SILCS single-sided gel application resulted in the most consistent longitudinal coverage; SILCS double-sided gel application was the most consistent in the transverse dimension.ConclusionsGel coverage was similar with all three methods. These results suggest that the SILCS microbicide delivery system is comparable to vaginal applicators for delivery of gel products intravaginally.     

Examining the context of microbicide acceptability among married women and men in India

Married women in India are increasingly at risk of HIV, often due to their husbands' extramarital sexual behaviour. Topical microbicides may provide protection to women who are unable to negotiate condom use. During the formative phase of a study to develop measures related to microbicide acceptability, we conducted in‐depth interviews with 14 ‘high‐risk’ and 16 ‘low‐risk’ married women and 15 husbands. Some participants had recently completed a 2‐week microbicide safety trial. A sequence of in‐depth interviews with each participant explored the context of microbicide acceptability, including perceptions of couple harmony, vulnerability to HIV, sexual power, and ability to control life events. Women's perceptions of control and sexual power influenced attitudes towards microbicide use. HIV risk was most commonly associated with partner infidelity and easily detected, according to both men and women, by a lack of marital harmony. Despite this, high‐risk women denied perceiving HIV risk until confronted with specific evidence of a husband's positive HIV or STI diagnosis. This study provides an in‐depth examination of HIV risk for Indian married women, identifying potential determinants of microbicide use, and providing guidance for the development of psychometric scales to measure couple harmony, HIV risk perception, and sexual power and control.     

Intravaginal insertion in KwaZulu-Natal: sexual practices and preferences in the context of microbicide gel use

Intravaginal insertion is often associated with the concept of ‘dry’ sex. All HIV-prevention microbicides tested to date have been vaginally applied lubricant-based gels. In this paper, we examine whether the use of intravaginal insertions could be in conflict with the introduction of vaginal microbicide gels. The Africa Centre site was part of the Microbicides Development Programme evaluating PRO2000/5 microbicide gel. We conducted in-depth-interviews and focus-group discussions with women enrolled in the trial as well as women and men from the community. The analysis focused on people's knowledge of intravaginal insertion in the community and trial participants' experience of using trial gels. Intravaginal use of a variety of products was widely acknowledged. We found that the experience of using trial gels – which made sex ‘hot’, ‘tight’ and ‘dry’ – matched the desired outcomes of intravaginal insertion. We found that vaginal ‘dryness’ described the removal of excessive amounts of unusual discharge, rather than the removal of normal vaginal secretions and that intravaginal insertion is not exclusively associated with a desire for ‘dry’ sex. Study findings provide evidence that vaginal microbicide gels may be more acceptable in communities where intravaginal insertion is practiced than was previously thought.     

The influence of social constructs of hegemonic masculinity and sexual behaviour on acceptability of vaginal microbicides in Zambia

Vaginal microbicides are heralded as a woman’s HIV prevention method. This study, conducted in a microbicide clinical trial setting in Zambia, explored how the social construction of masculinity and sexual behaviour influenced the acceptability of vaginal microbicides. The data were generated from 18 In-depth Interviews and 8 Focus Group Discussions. The data were analysed thematically. The study found that hegemonic masculinity influenced the use of vaginal microbicides positively and negatively, in multiple ways including: decision to initiate gel use, autonomous use of the gel, and consistent use of the gel. Men were seen as heads of households and decision-makers who approved their partners’ intentions to initiate gel use. Autonomous gel use by women was not supported because it challenged men’s dominant position in sexual matters and at a family level. The socially accepted notion that men engaged in multiple sexual relationships also influenced women’s decision to use the gel. Sustained gel use depended on the perceived effect of the gel on men’s sexual desires, sexual performance, fertility, and sexual behaviour. This study suggests that acceptability of microbicides partially lies within the realm of men, with use constrained and dictated by cultural constructs and practice of masculinity and gender.     

Examining the context of microbicide acceptability among married women and men in India

Married women in India are increasingly at risk of HIV, often due to their husbands' extramarital sexual behaviour. Topical microbicides may provide protection to women who are unable to negotiate condom use. During the formative phase of a study to develop measures related to microbicide acceptability, we conducted in-depth interviews with 14 'high-risk' and 16 'low-risk' married women and 15 husbands. Some participants had recently completed a 2-week microbicide safety trial. A sequence of in-depth interviews with each participant explored the context of microbicide acceptability, including perceptions of couple harmony, vulnerability to HIV, sexual power, and ability to control life events. Women's perceptions of control and sexual power influenced attitudes towards microbicide use. HIV risk was most commonly associated with partner infidelity and easily detected, according to both men and women, by a lack of marital harmony. Despite this, high-risk women denied perceiving HIV risk until confronted with specific evidence of a husband's positive HIV or STI diagnosis. This study provides an in-depth examination of HIV risk for Indian married women, identifying potential determinants of microbicide use, and providing guidance for the development of psychometric scales to measure couple harmony, HIV risk perception, and sexual power and control.     

Muslim women's reflections on the acceptability of vaginal microbicidal products to prevent HIV infection

This paper examines South African Muslim women's opinions of the acceptability of microbicidal products to prevent HIV infection if these were to become available in the future. In the context of the HIV pandemic, prophylactic methods such as male circumcision, vaccines and microbicidal preparations are increasingly thought of as ways to reduce the incidence of infection. We examine the extent to which participants' religious beliefs and the implications of religious norms and ideals might influence decision-making concerning hypothetical acceptability to use a microbicide. We conducted qualitative interviews with 29 Muslim women residing in South Africa, a country with one of the highest HIV prevalence rates in the world. Four themes emerged from the data, namely, (1) participants' questioning of the need for microbicides; (2) reasons they gave in favour of microbicide use; (3) the juxtaposition of microbicide use and religious ethics; and (4) the role of religious authorities in decision-making regarding microbicide use. The juxtaposition of microbicide use and religious ethics was further informed by three sub-themes, namely, the life-promoting nature of both Islam and microbicide use, the possibility that microbicide use could encourage sexual risk-taking among male partners, and that the use of these products contradicted womens' notions of ethical agency and ideals about marriage. These themes and sub-themes are analysed in the context of gender relations among South African Muslims. The study findings are significant in light of recent data showing the effectiveness of a microbicidal preparation in reducing the risk of HIV infection in South Africa. We also show that the acceptability of microbicidal products is to a certain extent linked to a variety of religious persuasions and ideals. When microbicides become available in the future, proponents of their use will need to consider religious reasoning of potential users, including that of Muslim women.     

Single and multiple exposure tolerance study of cellulose sulfate gel: a Phase I safety and colposcopy study

Vaginally applied gels offer a promising approach for preventing unwanted pregnancies and sexually transmitted infections. Cellulose sulfate (CS) is a non-cytotoxic antifertility agent that also exhibits in vitro antimicrobial activity against sexually transmitted pathogens, including HIV. This was a randomized, double-blinded, Phase I study of 2.5 mL and 5.0 mL doses of 6% CS gel. A single vaginal application of the gel followed by five consecutive daily doses was assessed for genital irritation, safety, vaginal leakage, and product acceptability compared to two controls, Conceptrol, which is a marketed contraceptive gel containing nonoxynol-9, and K-Y jelly. The results suggest that the safety of 6% CS was comparable to that of Conceptrol and K-Y jelly, and it may be associated with less genital irritation. The 2.5 mL dose of CS may be preferable according to the participants’ reports of leakage. All the products had similar acceptability profiles.     

Young Women’s Use of a Microbicide Surrogate: The Complex Influence of Relationship Characteristics and Perceived Male Partners’ Evaluations

Currently in clinical trials, vaginal microbicides are proposed as a female-initiated method of sexually transmitted infection prevention. Much of microbicide acceptability research has been conducted outside of the United States and frequently without consideration of the social interaction between sex partners, ignoring the complex gender and power structures often inherent in young women’s (heterosexual) relationships. Accordingly, the purpose of this study was to build on existing microbicide research by exploring the role of male partners and relationship characteristics on young women’s use of a microbicide surrogate, an inert vaginal moisturizer (VM), in a large city in the United States. Individual semi-structured interviews were conducted with 40 young women (18–23 years old; 85% African American; 47.5% mothers) following use of the VM during coital events for a 4 week period. Overall, the results indicated that relationship dynamics and perceptions of male partners influenced VM evaluation. These two factors suggest that relationship context will need to be considered in the promotion of vaginal microbicides. The findings offer insights into how future acceptability and use of microbicides will be influenced by gendered power dynamics. The results also underscore the importance of incorporating men into microbicide promotion efforts while encouraging a dialogue that focuses attention on power inequities that can exist in heterosexual relationships. Detailed understanding of these issues is essential for successful microbicide acceptability, social marketing, education, and use.     

Couples' acceptability of the SILCS diaphragm for microbicide delivery

BackgroundDisposable plastic applicators used in microbicide gel studies are expensive and have a negative environmental impact. The SILCS diaphragm is a barrier contraceptive that could offer a reusable delivery system.Study DesignThirty-six couples in this randomized, cross-over study evaluated single- and double-sided gel delivery from a SILCS diaphragm compared with gel from an applicator. Couples used each gel scenario during two acts of intercourse and completed acceptability questionnaires after each.ResultsAll three scenarios received favorable ratings for ease of application, acceptability and perceived effectiveness. Both female and male participants tended to rate the gel applicator significantly more favorably than either SILCS gel delivery scenarios for all attributes except messiness/leakage and effectiveness. Additionally, about 60% of female participants and about half of male participants preferred the gel applicator to either of the gel delivery systems using SILCS. The preference for the SILCS scenario for pregnancy protection was statistically significant for both sexes. Male participants were also significantly more likely to prefer the SILCS single-sided delivery system to the gel applicator for protection from sexually transmitted infection.ConclusionsIn this study population, participants found the gel applicator to be more acceptable than either single- or double-sided gel delivery from a SILCS diaphragm. Further research of the SILCS as a microbicide delivery system should be implemented to assess its acceptability among study populations that reflect diverse potential user groups such as women and men from both low and high HIV prevalence settings including HIV-positive populations and with and without experience using female barrier methods.     

Acceptability of a novel vaginal microbicide during a safety trial among low-risk women

CONTEXT: The increasing recognition that women who are unable or unwilling to discuss or use condoms with their sexual partners need female-controlled methods for preventing sexually transmitted diseases (STDs), including HIV, has led to considerable focus on the development of vaginal microbicides. While many such products are being tested for safety and effectiveness, clinical trials generally overlook another key factor in a product's impact on infection rates-its acceptability to users. METHODS: A Phase I clinical trial of a microbicidal gel included an assessment of the product's acceptability among 27 low-risk participants. Information on acceptability was gathered from structured interviews, participants' daily diaries and unstructured exit interviews. RESULTS: Participants reported only minor side effects of product use, such as itching, burning and difficulty urinating; two women developed candida infections while participating in the study. None of the side effects could be conclusively linked to use of the gel. Some women noted product discharge and messiness as drawbacks of the method, but this experience varied according to how often the women applied the gel. For example, one-third of those who used it once daily said that at least some of the time, it was too "wet or drippy," compared with two-thirds of women who inserted the gel twice a day. However, participants considered these "nuisance factors" that could be outweighed by the potential protective characteristics of the product. The majority reported that they would use the product if it were available and proven efficacious, and if they perceived that they were at risk of STD infection. CONCLUSIONS: Additional testing of this product is urgently needed. Furthermore, as other products approach Phase I testing, acceptability assessments should be a key component of clinical trials.     

Single and multiple exposure tolerance study of polystyrene sulfonate gel: a phase I safety and colposcopy study

OBJECTIVES: To evaluate symptoms and signs of genital irritation, vaginal leakage and acceptability of polystyrene sulfonate (PSS), which is being studied as a vaginal contraceptive and microbicide. METHODS: Forty-nine women applied 2.5 mL of either 5% PSS, 10% PSS, PSS vehicle, or Conceptrol (a marketed spermicidal product containing 4% nonoxynol-9) for 6 consecutive days. RESULTS: All women completed the study except one in the Conceptrol group who experienced vaginal symptoms after her first use and was discontinued. After both the first use and after all uses, irritation was seen among more women in the Conceptrol group than in the PSS groups, reaching statistical significance with regard to any evidence of irritation, signs of irritation and product-related irritation. There were no adverse events that were serious, unexpected and related to product use in any group. The 5% concentration of PSS may be preferable in terms of leakage and acceptability. CONCLUSION: The results suggest that PSS has a safety profile comparable to that of the marketed nonoxynol-9 product, Conceptrol, and appears to be associated with less genital irritation.     

Safety and acceptability of 6% cellulose sulfate vaginal gel applied four times per day for 14 days

BACKGROUND: Six percent cellulose sulfate (CS) is a vaginal gel that has been in development as a microbicide. STUDY DESIGN: This was a single-center, multi-dose, Phase I, placebo-controlled, randomized, fully masked study conducted in Yaoundé, Cameroon, and involving sexually active women at low risk for sexually transmitted infections (STIs). METHODS: The study assessed the effect of CS and K-Y Jelly applied vaginally four times per day, for 14 consecutive days, on genital epithelial disruption, candidiasis and bacterial vaginosis (BV). Acceptability of the products was also assessed. Twenty-seven women were enrolled in each treatment group. RESULTS: Two (7.4%) of the women in each group developed genital epithelial disruption. One (3.7%) of the women in each group developed candidiasis, and one (3.7%) of the K-Y users developed BV. One (3.7%) of the CS users said she would not buy her product for pregnancy prevention but would for STI prevention. All the remaining women indicated they would buy their product for both indications. CONCLUSION: The results suggest that the safety and acceptability of 6% CS gel are comparable to that of K-Y Jelly.     

A randomized trial to determine the distribution of four topical gel formulations in the human vagina

Background

There is an urgent need for the development of a topical microbicide to protect against sexually transmitted infections. We compared distribution and acceptability of four different gel formulations to be used as a vehicle for a microbicide.

Study Design

This is a randomized, double-blind comparative study.Six women tested each of the four gels at two different time points. Magnetic resonance imaging (MRI) scans were taken both within 10-15 min following intravaginal gel insertion and 4 h following gel insertion, before and after simulated intercourse at both time points.

Results

Vaginal surface contact immediately after insertion ranged from 68% to 92%. Simulated intercourse increased surface contact for all gels (range, 90-106%). After 4 h, surface contact ranged from 86% to 102%. Simulated intercourse at that time resulted in decreased coverage for two gels and increased coverage for two gels. One gel was noted to have consistent broad coverage of the vagina both immediately and 4 h after insertion, increased coverage with simulated intercourse at both time points and the lowest standard deviation of disruption at all time points.

Conclusion

MRI used in combination with qualitative assessments of acceptability can be used to select optimal gels for use as vehicles for potential spermicides or microbicides. We conclude that a gel consisting of 3% hydroxypropyl methylcellulose and 1.5% of methyl cellulose is the most promising candidate gel.     

Who continues using the diaphragm and who doesn't: implications for the acceptability of female-controlled HIV prevention methods.

OBJECTIVES: This study examines the acceptability of the diaphragm with the aim of facilitating the development of female-controlled human immunodeficiency virus (HIV) prevention methods. More specifically, we assess associations between being a current (vs. former) diaphragm user and characteristics that are hypothesized to influence the acceptability of contraceptive methods; and explore reasons for discontinuing use of the diaphragm among former diaphragm users. DESIGN: The study involved a cross-sectional telephone survey with women who were members of a nonprofit health maintenance organization and who were either a current (n = 215) or former (n = 172) diaphragm user. METHODS: Participants were interviewed about the importance of contraceptive attributes; perceptions for the diaphragm; diaphragm use self-efficacy; perceived risk of and motivation to avoid pregnancy, HIV, and other sexually transmitted infections; and demographic characteristics, sexual, and contraceptive behavior. RESULTS: The likelihood of being a current diaphragm user (vs. former) increased with age, greater confidence in being able to use the diaphragm, greater perceived risk of pregnancy and more positive perceptions of the diaphragm. Women who valued attributes of hormonal contraceptives were less likely to be current users. Former diaphragm users reported that the following reasons were moderately to extremely important in their decision to stop using the diaphragm: difficulty inserting or removing the diaphragm (50.8%), dislike of leaving the diaphragm inside the vagina (46.8%), and wanting a more effective method for preventing pregnancy (44.2%). CONCLUSIONS: The findings suggest that specific characteristics of a product influence continued use and have implications for improving the acceptability of existing and new female-controlled HIV prevention methods.