Microbicide Acceptability Research Articles

Rectal Douching and Microbicide Acceptability among Young Men who Have Sex with Men.

Men who have sex with men (MSM) commonly report engaging in rectal douching (RD) practices prior to receptive anal intercourse. Researchers are interested in the possibility of designing a RD with a microbicide component. In our analyses, we examined whether YMSM who engaged in RD behaviors differ in HIV prevention behaviors from their non-RD peers. We then examined whether RD frequency was associated with rectal microbicide acceptability. Half the participants (47.8%) reported having ever douched. Participants were more likely to douche if they were racial/ethnic minorities (AOR = 2.24, p = 0.02) and had recently tested for HIV (AOR = 1.96, p = 0.04). Greater douching frequency was associated with racial/ethnic minorities (β = 0.20, p = 0.009) and recent HIV testing (β = 0.19, p < 0.01). Participants who reported frequently douching indicated greater microbicide acceptability (β = 0.32, p < 0.001). Designing behaviorally congruent products remains a priority in next generation Pre-Exposure Prophylaxis (PrEP) and a rectal douche might be an additional tool if found to be efficacious.

Using sensory and consumer science in drug delivery system optimization: mixed methods in women of color as a case study

Although sensory and consumer science methods may have originated in the food and beverage industries, they have widespread application for many other products, including fast moving consumer goods, personal care, and more recently, pharmaceuticals. Here, we present the later as a case study, showing how sensory methods can be applied to preclinical optimization of drug delivery systems. Past clinical trials suggest vaginal microbicides may be an effective means for women to protect themselves from HIV and other sexually transmitted infections (STIs); critically however, these microbicides will not work if they are not used due to poor acceptability. Multiple factors influence microbicide acceptability, including product features as well as cultural and social factors. In an iterative process, we developed soft-gel vaginal suppositories and have shown that properties like firmness, size, and shape all influence women’s willingness to try. However, our prior work was conducted among white women in a rural setting, so we revisited these questions in women of color using both quantitative and qualitative methods. Here, women of color evaluated suppositories of different fracturability, firmness, size, and shape. We assessed willingness to try and imagined ease of insertion, and used Just About Right (JAR) scales to measure appropriateness of firmness and size. To better understand reasons underlying these quantitative results, qualitative reactions to suppositories of different sizes, shapes, and firmness level were obtained via focus groups with women of color. This work illustrates a) how sensory and consumer science methods can be used to optimize acceptability of drug delivery systems, and b) how mixed methods provide more complete insights than purely quantitative approaches.

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

ABSTRACTVaginal 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.

Interactive Voice Response System: Data Considerations and Lessons Learned During a Rectal Microbicide Placebo Adherence Trial for Young Men Who Have Sex With Men.

BackgroundRectal microbicides, if proven effective, may aid in reducing human immunodeficiency virus (HIV) incidence; however, demonstration of efficacy and effectiveness is contingent on accurate measurement of product adherence. Delays in self-report, in particular, may affect the accuracy of behavioral data.ObjectiveThe aim of this study was to capitalize on mobile phone use by young men who have sex with men (YMSM), and examine the use of an interactive voice response system (IVRS) by YMSM aged 18-30 years enrolled in a multisite, 12-week microbicide safety and acceptability trial.MethodsYMSM (N=95) enrolled across 3 sites (Boston, Pittsburgh, and San Juan) were asked to report their use of an applicator applied placebo rectal gel product during receptive anal intercourse (RAI) using the IVRS. IVRS was available in Spanish and English. After the 12-week trial, we examined whether IVRS problems were associated with YMSM’s sociodemographic characteristics (eg, age, race and ethnicity, and education), sexual behavior, or recruitment site. We used a multinomial logistic regression to compare YMSM who experienced no IVRS problems (n=40) with those who reported one IVRS problem (n=25) or two or more IVRS problems (n=30).ResultsWe recorded 1494 IVRS calls over 12 weeks. Over half of the participants (55/95; 58%) experienced challenges using the IVRS during the 12-week trial. YMSM reporting greater RAI occasions during the trial were more likely to experience one (odds ratio [OR]=1.08, 95% CI (1.02-1.14); P ≤.01) or more (OR=1.10, 95% CI (1.03-1.16); P ≤.001) IVRS challenges. Greater educational attainment was associated with multiple IVRS challenges (OR=7.08, 95% CI (1.6-31.6); P ≤.01). Participants in the Puerto Rico site were most likely to report multiple IVRS problems.ConclusionsAlthough IVRS was a useful data collection technology in our trial, several challenges experienced by English and Spanish speaking YMSM diminish its overall acceptability. We discuss strategies to optimize future development of IVRS data quality protocols based on lessons learned.

"Like Holding an Umbrella Before It Rains": Acceptability of Future Rectal Microbicides Among Men Who Have Sex With Men in India-A Modified Technology Acceptance Model.

Topical rectal microbicides (RMs) are a new prevention technology in development that aims to reduce the risk of HIV acquisition from anal sex. We examined RM acceptability among men who have sex with men (MSM) in India. We conducted a qualitative exploratory study guided by a modified Technology Acceptance Model, with 10 focus groups ( n = 61) of MSM and 10 key informant interviews. Data were explored using framework analysis. RM acceptability was influenced by technological contexts: perceived usefulness of RMs, perceived ease of use of RM and applicator, and habits around condom and lubricant use; individual and interpersonal contexts: perceived relevance and preferences for product formulation and dosing frequency; and MSM community/social contexts: perceived social approval, RM-related stigma, social support. Implementation of RMs for MSM in India may be supported by multi-level interventions that engage community-based organizations in destigmatizing and distributing RMs, ideally gel-based products that enable on-demand use before sex.

Influences of geo-spatial location on pre-exposure prophylaxis use in South Africa: positioning microbicides for better product uptake

ABSTRACTYoung women bear a disproportionately high burden of HIV infection in sub-Saharan Africa, prioritising pre-exposure prophylaxis (PrEP) can be an integral part of HIV prevention combination strategies. Women initiated HIV prevention technology options will require consistent adherence, an imperative for product effectiveness. With several PrEP clinical trials underway; exploring women’s acceptability to advances in HIV prevention technologies can better facilitate demand creation for future PrEP roll out. This study utilised the opportunity of post-trial access to CAPRISA 008 women (trial) and non-trial women from three geo-spatial settings (urban, rural and peri-urban) to identify microbicide acceptability and how product associations of microbicides can influence future HIV prevention choices. Six participatory workshops using participatory action research with art-based activities and discussion groups were conducted in KwaZulu-Natal with 104 women from various geo-spatial locations and social status to understand microbicide acceptability and product associations. The data were analysed using thematic analysis. The study found that women’s acceptability and product association of the tenofovir gel microbicide differed according to rural and urban areas. Most urban women identified confidence, sexiness and classiness as key associations that will encourage microbicide acceptability and use, while rural women identified respect, responsibility and confidence as the key product associations, with increased focus on the individual and collective family/community benefits of product acceptance and use. Urban–rural differences suggest a market segmentation that is contextualised to be locally responsive to promote HIV prevention technologies. Various sexual encounters further determined the types of HIV prevention technologies women would consider. In line with WHO’s recommendation that PrEP should be an additional prevention choice for people at risk of HIV, this study underscores the importance of user engagement, understanding product associations and how this can influence product acceptability and promotion of HIV prevention technologies.

Project Gel a Randomized Rectal Microbicide Safety and Acceptability Study in Young Men and Transgender Women.

ObjectivesThe purpose of Project Gel was to determine the safety and acceptability of rectal microbicides in young men who have sex with men (MSM) and transgender women (TGW) at risk of HIV infection.MethodsMSM and TGW aged 18–30 years were enrolled at three sites; Pittsburgh, PA; Boston, MA; and San Juan, PR. Stage 1A was a cross-sectional assessment of sexual health and behavior in MSM and TGW. A subset of participants from Stage 1A were then enrolled in Stage 1B, a 12-week evaluation of the safety and acceptability of a placebo rectal gel. This was followed by the final phase of the study (Stage 2) in which a subset of participants from Stage 1B were enrolled into a Phase 1 rectal safety and acceptability evaluation of tenofovir (TFV) 1% gel.Results248 participants were enrolled into Stage 1A. Participants’ average age was 23.3 years. The most common sexually transmitted infection (STIs) at baseline were Herpes simplex (HSV)-2 (16.1% by serology) and rectal Chlamydia trachomatis (CT) (10.1% by NAAT). 134 participants were enrolled into Stage 1B. During the 12 week period of follow-up 2 HIV, 5 rectal CT, and 5 rectal Neisseria gonorrhea infections were detected. The majority of adverse events (AEs) were infections (N = 56) or gastrointestinal (N = 46) and were mild (69.6%) or moderate (28.0%). Of the participants who completed Stage 1B, 24 were enrolled into Stage 2 and randomized (1:1) to receive TFV or placebo gel. All participants completed Stage 2. The majority of AEs were gastrointestinal (N = 10) and of mild (87.2%) or moderate (10.3%) severity.ConclusionsIn this study we were able to enroll a sexually active population of young MSM and TGW who were willing to use rectal microbicides. TFV gel was safe and acceptable and should be further developed as an alternative HIV prevention intervention for this population.Trial RegistrationClinicalTrials.gov NCT01283360

Hypothetical Rectal Microbicide Acceptability and Factors Influencing It among Men Who Have Sex with Men in Tianjin, China.

ObjectivesTo measure potential acceptability of rectal microbicides and to explore factors likely to affect their acceptability among men who have sex with men (MSM).MethodsCross-sectional and retrospective surveys were conducted in this study. A questionnaire and a scale were used to measure the acceptability score for physical and functional characteristics of hypothetical rectal microbicides. We also evaluated the involvement of other factors such as sexual behaviors, social context, etc.ResultsMSMs we interviewed showed a high acceptability to rectal microbicides, indicated by the mean acceptability score of 2.92 (SD, 0.54, scale of 1–4). The results also suggested that microbicides were preferred in a cream form that can moisten and lubricate the rectum, prevent HIV infection and go unnoticed by their partners. Multivariate analysis showed that the microbicides acceptability varied significantly by education level (β = 0.135; P = 0.028), having casual partners (β = 0.174; P = 0.007), frequency of lubricant use (β = 0.134; P = 0.031), history of HIV test (β = 0.129; P = 0.036), willingness to use lubricant (β = 0.126; P = 0.045), locus of control by partners regarding STI infection (β = 0.168; P = 0.009).ConclusionsA positive response to rectal microbicides among MSMs was found in our study, suggesting that rectal microbicides might have a potential market in MSMs and they might play an important role in HIV/STIs prevention as a supplement. Further studies may be considered to combine the acceptability study with clinical research together to understand the true feelings of MSMs when they use the products.

HIV-Related Stigma and HIV Prevention Uptake Among Young Men Who Have Sex with Men and Transgender Women in Thailand.

HIV-related stigma is a pervasive structural driver of HIV. With an HIV epidemic among young men who have sex with men (MSM) and transgender women (TG) in Thailand characterized as explosive, we conducted a cross-sectional survey among MSM and TG aged 18-30 years. From April-August 2013, participants recruited using venue-based sampling from gay entertainment sites and community-based organizations completed a tablet-assisted survey interview in Thai language. We conducted multiple logistic regression to assess correlations between HIV-related stigma (felt-normative, vicarious domains) and socio-demographic variables, HIV vulnerabilities (gay entertainment employment, sex work, forced sex history), and HIV prevention uptake (condom use, HIV testing, rectal microbicide acceptability). Among participants (n = 408), 54% identified as gay, 25% transgender, and 21% heterosexual. Two-thirds (65.7%) were employed at gay entertainment venues, 67.0% had more than three male partners (past month), 55.6% had been paid for sex, and 4.5% were HIV-positive. One-fifth (21.3%) reported forced sex. Most participants reported experiencing felt-normative and vicarious HIV-related stigma. Adjusting for socio-demographics, participants with higher total HIV-related stigma scores had significantly lower odds of HIV testing and rectal microbicide acceptability, and higher odds of having experienced forced sex. Both vicarious and felt-normative dimensions of HIV-related stigma were inversely associated with HIV testing and rectal microbicide acceptability. Our findings suggest that HIV-related stigma harms the health of HIV-negative MSM and TG at high risk for HIV infection. HIV-related interventions and research among young MSM and TG in Thailand should address multiple dimensions of HIV-related stigma as a correlate of risk and a barrier to accessing prevention.

Psychometric Properties and Validity of a Multi-dimensional Risk Perception Scale Developed in the Context of a Microbicide Acceptability Study

Currently available risk perception scales tend to focus on risk behaviors and overall risk (vs partner-specific risk). While these types of assessments may be useful in clinical contexts, they may be inadequate for understanding the relationship between sexual risk and motivations to engage in safer sex or one's willingness to use prevention products during a specific sexual encounter. We present the psychometric evaluation and validation of a scale that includes both general and specific dimensions of sexual risk perception. A one-time, audio computer-assisted self-interview was administered to 531 women aged 18-55 years. Items assessing sexual risk perceptions, both in general and in regards to a specific partner, were examined in the context of a larger study of willingness to use HIV/STD prevention products and preferences for specific product characteristics. Exploratory and confirmatory factor analyses yielded two subscales: general perceived risk and partner-specific perceived risk. Validity analyses demonstrated that the two subscales were related to many sociodemographic and relationship factors. We suggest that this risk perception scale may be useful in research settings where the outcomes of interest are related to motivations to use HIV and STD prevention products and/or product acceptability. Further, we provide specific guidance on how this risk perception scale might be utilized to understand such motivations with one or more specific partners.

Using conjoint analysis to determine the impact of product and user characteristics on acceptability of rectal microbicides for HIV prevention among Peruvian men who have sex with men

ObjectivesMen who have sex with men (MSM) are in need of novel and acceptable HIV prevention interventions. In Peru, a Phase II clinical trial was recently completed evaluating rectally applied...

Perceptions and experiences of HIV and acceptability of vaginal microbicides in Zambia

Background/Aims: The development of vaginal microbicides for sexually transmitted infections (STIs) is a welcome clinical and research intervention for countries heavily burdened with HIV and AIDS. These microbicides are formulated as gels, creams, films and suppositories, and work by either providing a physical barrier that keeps HIV and other pathogens from reaching the target cells or by enhancing the natural vaginal defence mechanisms. This study examines women's and men's perceptions on STIs and acceptability of vaginal microbicides. Methods: An exploratory qualitative research study using five focus group discussions was conducted in the Kafue and Mumbwa districts in Zambia between 2009 and 2010. Five themes were identified: i) knowledge about HIV/AIDS; ii) condom use; iii) women's options and the challenges of using existing interventions; iv) use and acceptability of a placebo microbicide gel; v) partner involvement. Results: In general, participants were knowledgeable about the modes of HIV transmission and prevention. The majority of participants believed that condom use was the man's decision and current available HIV prevention techniques are often not controlled by women. Although the availability and use of microbicides would greatly empower women to protect themselves and their partner, many women have little control over their choice of contraception. Conclusions: Most social science research to date has confirmed the urgent need women feel for an HIV prevention method that they can control, particularly in countries with a severe generalised HIV epidemic. In this study, women and men expressed positive attitudes toward the use of microbicides.

Insights into Microbicide Acceptability and Preferences Among Urban Adolescent Girls

Microbicides potentially offer women and girls more control over their HIV protection. Despite numerous trials, data describing adolescents’ microbicide preferences are limited. To address this gap, the authors interviewed and surveyed 26 African American, urban, adolescent girls to identify whether microbicides would be an acceptable method of HIV protection, their likelihood to use, and preferred characteristics. Survey results reported that all participants’ were willing to use microbicides; however, interviews revealed hesitancy due to a myriad of concerns. Factors impacting adolescents’ microbicide acceptability differed from those of adult women, indicating a need for support tailored to adolescents’ concerns. Additional mixed-methods studies are necessary to promote microbicide acceptability and adherence among this vulnerable population.

Current Topics in Microbiology and Immunology: Microbicides for Prevention of HIV Infection

Current Topics in Microbiology and Immunology: Microbicides for Prevention of HIV Infection teaches us that microbicide use has been recorded as early as 1850 bc (in Egypt), during the Middle Ages (Greece and Rome), and since 1918 in its more modern form for vaginal drug delivery. In addition to conveying this fascinating historical timeline, this book offers a detailed review of essentially all aspects of microbicide development, from the basic science underlying microbicide action, to strategic considerations when implementing international microbicide programs. Chapter 1, “Candidate Microbicides and Their Mechanisms of Action,” reviews the human immunodeficiency virus type 1 (HIV-1) viral replication cycle to illustrate the mechanism of action for various microbicides in development. Diagrams of the timeline of mucosal infection by HIV-1 and the steps in the viral replication cycle inhibited by each class of microbicides complement the text nicely. Chapter 2, “Microbicide Dosage Forms,” reviews methods of microbicide drug delivery, such as gels, tablets, rings, electrospun fibers, diaphragms, or films (similar to those currently used to deliver breath fresheners). Delivery methods are either coitally dependent (eg, gels) or independent (eg, rings). This chapter is dense with technical vocabulary describing microbicide product design, and the level of detail may be excessive for readers who are clinicians. The next 2 chapters, “Preclinical Safety Evaluation” and “Clinical Safety and Pharmacology Trial,” describe unique approaches to preclinical and clinical evaluation of microbicides given their local (vs systemic) sites of action. Special considerations include effects on sperm, vaginal microflora, and local inflammatory processes. Drug-specific approaches to evaluating the safety of microbicides are employed, given a surprising lack of standard criteria for evaluating these agents. The utility of using explanted cervical or rectal tissue to evaluate the anti-HIV activity of candidate drugs is discussed. The authors appropriately acknowledge the limitations of explant models, as some agents have been efficacious in explant models but ineffective in randomized human studies. Chapter 5, “Microbicides for Prevention of HIV Infection: Clinical Efficacy Trials,” informs the reader that many disappointing effectiveness studies of candidate microbicides have occurred over the past 20 years. However, in 2010, the CAPRISSA 004 trial of a pericoitally administered, intravaginal tenofovir gel represented a breakthrough in microbicide science. This study demonstrated that tenofovir gel decreased HIV-1 transmission by 39% among women in South Africa, compared with a placebo gel. Two subsequent studies with tenofovir gel tested the efficacy of daily gel use (the VOICE study) or pericoital use (FACTS 001) in African women. Both studies failed to demonstrate efficacy, though low adherence to study drug likely explains the lack of protection in these studies. Clearly, studies to understand ways to optimize microbicide acceptability and adherence are needed. At the start of chapter 6, “Rectal Microbicide Development,” an overview of the immunology and epidemiology associated with rectal transmission of HIV-1 sets the stage for why effective rectal microbicides are needed. Several phase 1 studies with rectally formulated versions of tenofovir gel have been successfully completed, and additional studies are being planned. The need for advocacy to support the development of rectal agents is highlighted, given the stigmatized or criminalized nature of anal sex in many regions of the world. The authors rightly emphasize that “from a human rights perspective, as well as a drug development perspective, there is much to be done.” “Developing Regulatory Strategy for Microbicides” (chapter 7) reviews the complex regulatory barriers to distributing microbicides worldwide. The final chapter, “Preparing for Microbicide Introduction, Rollout, and Sustained Access,” outlines strategies to disseminate new products in resource-limited settings where microbicides are most needed, notably Africa. This rollout process spans numerous disciplines, including social science research, to assess product acceptability and supply chain strategies to ensure sustained community access. The strength of this book is its comprehensive discussion of how microbicides work, how they are developed and tested, and how to distribute them internationally. A weakness is the dense jargon that fills many chapters, which could become onerous for readers without technical training in drug development. Overall, this book is well timed given several promising microbicides that are undergoing clinical studies and could be available for public use in the next several years. This text could be used as a primer for researchers entering the burgeoning field of microbicide development or for clinicians who provide these agents.

Optimizing HIV prevention for women: a review of evidence from microbicide studies and considerations for gender-sensitive microbicide introduction.

IntroductionMicrobicides were conceptualized as a product that could give women increased agency over HIV prevention. However, gender-related norms and inequalities that place women and girls at risk of acquiring HIV are also likely to affect their ability to use microbicides. Understanding how gendered norms and inequalities may pose obstacles to women's microbicide use is important to inform product design, microbicide trial implementation and eventually microbicide and other antiretroviral-based prevention programmes. We reviewed published vaginal microbicide studies to identify gender-related factors that are likely to affect microbicide acceptability, access and adherence. We make recommendations on product design, trial implementation, positioning, marketing and delivery of microbicides in a way that takes into account the gender-related norms and inequalities identified in the review.MethodsWe conducted PubMed searches for microbicide studies published in journals between 2000 and 2013. Search terms included trial names (e.g. “MDP301”), microbicide product names (e.g. “BufferGel”), researchers’ names (e.g. “van der Straten”) and other relevant terms (e.g. “microbicide”). We included microbicide clinical trials; surrogate studies in which a vaginal gel, ring or diaphragm was used without an active ingredient; and hypothetical studies in which no product was used. Social and behavioural studies implemented in conjunction with clinical trials and surrogate studies were also included. Although we recognize the importance of rectal microbicides to women, we did not include studies of rectal microbicides, as most of them focused on men who have sex with men. Using a standardized review template, three reviewers read the articles and looked for gender-related findings in key domains (e.g. product acceptability, sexual pleasure, partner communication, microbicide access and adherence).Results and discussionThe gendered norms, roles and relations that will likely affect women's ability to access and use microbicides are related to two broad categories: norms regulating women's and men's sexuality and power dynamics within intimate relationships. Though norms about women's and men's sexuality vary among cultural contexts, women's sexual behaviour and pleasure are typically less socially acceptable and more restricted than men's. These norms drive the need for woman-initiated HIV prevention, but also have implications for microbicide acceptability and how they are likely to be used by women of different ages and relationship types. Women's limited power to negotiate the circumstances of their intimate relationships and sex lives will impact their ability to access and use microbicides. Men's role in women's effective microbicide use can range from opposition to non-interference to active support.ConclusionsIdentifying an effective microbicide that women can use consistently is vital to the future of HIV prevention for women. Once such a microbicide is identified and licensed, positioning, marketing and delivering microbicides in a way that takes into account the gendered norms and inequalities we have identified would help maximize access and adherence. It also has the potential to improve communication about sexuality, strengthen relationships between women and men and increase women's agency over their bodies and their health.

Interest in multipurpose prevention of HIV and pregnancy: perspectives of women, men, health professionals and community stakeholders in two vaginal gel studies in southern Africa.

The pipeline of vaginal microbicides for HIV prevention has expanded to include products for multipurpose prevention, but the interests of potential users and those advising on use have not been sufficiently investigated. Rather, assumptions about interest in multipurpose prevention technologies (MPTs) are inferred from what is known about acceptability and use of microbicides or contraceptives. This paper presents data on concerns and preferences for multipurpose prevention of HIV and pregnancy. Data were collected in two microbicide gel studies in Malawi and Zimbabwe. Participants were women using candidate vaginal products, their male partners, health professionals and community stakeholders. An individual interview was conducted with participants. Interviews were audio-recorded, transcribed, coded for content and analysed for key themes. Participants indicated strong interest in a vaginal HIV prevention product that could also prevent pregnancy. Reasons for this interest were convenience, problems with adverse effects with current contraceptive methods, concerns about long-term effects of contraceptives, and concerns about the health burdens of HIV infection during pregnancy. The main disadvantage of an MPT was recognition that while interest in preventing HIV is constant, contraceptive needs change over time. The study population indicated support for an MPT to prevent HIV and pregnancy. This support may be further strengthened if the product is also available for prevention of only HIV. Women and men will be more willing to use an MPT if they can be reassured that its use will have no long-term effect on fertility.

Learning from the private sector: towards a keener understanding of the end-user for microbicide introduction planning.

Introduction In planning for the introduction of vaginal microbicides and other new antiretroviral (ARV)-based prevention products for women, an in-depth understanding of potential end-users will be critically important to inform strategies to optimize uptake and long-term adherence. User-centred private sector companies have contributed to the successful launch of many different types of products, employing methods drawn from behavioural and social sciences to shape product designs, marketing messages and communication channels. Examples of how the private sector has adapted and applied these techniques to make decisions around product messaging and targeting may be instructive for adaptation to microbicide introduction.DiscussionIn preparing to introduce a product, user-centred private sector companies employ diverse methods to understand the target population and their lifestyles, values and motivations. ReD Associates’ observational research on user behaviours in the packaged food and diabetes fields illustrates how ‘tag along’ or ‘shadowing’ techniques can identify sources of non-adherence. Another open-ended method is self-documentation, and IDEO's mammography research utilized this to uncover user motivations that extended beyond health. Mapping the user journey is a quantitative approach for outlining critical decision-making stages, and Monitor Inclusive Markets applied this framework to identify toilet design opportunities for the rural poor. Through an iterative process, these various techniques can generate hypotheses on user drop-off points, quantify where drop-off is highest and prioritize areas of further research to uncover usage barriers. Although research constraints exist, these types of user-centred techniques have helped create effective messaging, product positioning and packaging of health products as well as family planning information. These methods can be applied to microbicide acceptability testing outside of clinical trials to design microbicide marketing that enhances product usage.ConclusionsThe introduction of microbicide products presents an ideal opportunity to draw on the insights from user-centred private sector companies’ approaches, which can complement other methods that have been more commonly utilized in microbicide research to date. As microbicides move from clinical trials to real-world implementation, there will be more opportunities to combine a variety of approaches to understand end-users, which can lead to a more effective product launch and ultimately greater impact on preventing HIV infections.

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

Research has demonstrated that certain vaginal gel products--microbicides containing antiretroviral drugs--may reduce HIV infection risk among women. But for vaginal gels to avert HIV and other sexually transmitted infections (STIs), at-risk women must be willing to use them as directed. These products must therefore be "acceptable" to women and an important component of acceptability is users' perception that the product will work to prevent infection. We sought to understand how women's perceptions of vaginal gel properties may shape their understanding of product efficacy for HIV and STI prevention. Sixteen women completed two in-depth qualitative interviews (k = 32) to identify the range and types of sensory perceptions they experienced when using two vaginal gels. We identified emergent themes and linkages between users' sensory perceptions and their beliefs about product efficacy. Users' predictions about product efficacy for preventing infection corresponded to measurable physical properties, including gel volume, location in the vagina, coating behavior, sensation of the gel in the vagina, leakage, and gel changes during coital acts. Although the women described similar sensory experiences (e.g., gel leaked from the vagina), they interpreted these experiences to have varying implications for product efficacy (e.g., leakage was predicted to increase or decrease efficacy). To improve microbicide acceptability, gel developers should investigate and deliberately incorporate properties that influence users' perceptions of efficacy. When a microbicide is approved for use, providers should educate users to anticipate and understand their sensory experiences; improving users' experience can maximize adherence and product effectiveness.

Adolescents’ and Young Women’s Use of a Microbicide Surrogate Product When Receiving Oral Sex

Study ObjectiveGenital herpes, which can be spread through oral sex, is an important target for microbicides. We examined episode-specific predictors of young women’s receptive oral sex and of microbicide surrogate use. DesignLongitudinal study. SettingParticipants were recruited to participate in a microbicide acceptability study from adolescent clinics and local colleges and through snowballing. ParticipantsYoung women (ages 14 to 21 y) who reported sexual contact on at least 1 weekly phone interview (n = 181) were included from the larger sample of 208 young women. Main Outcome MeasuresOn weekly diary phone interviews, participants reported whether or not their last sexual contact included receptive oral sex and whether or not their last sexual contact included use of a microbicide surrogate. Results and ConclusionsParticipants reported a total of 1042 episodes of sexual contact of which 311 included receptive oral sex and 354 included microbicide surrogate use. Being older, having sex for the first time with a partner, and having given oral sex were associated with having received oral sex during a sexual episode. Being older, being African American, and having discussed the microbicide surrogate with their partner were associated with having used the microbicide surrogate use during a sexual episode. These results indicate that oral sex should be considered in the design of clinical trials. Future studies need to evaluate ways to promote consistent microbicide use in the context of receiving oral sex as well as those factors (eg, taste, pleasure) which may serve as a barrier.

Acceptability of oral and topical HIV chemoprophylaxis in India: implications for at-risk women and men who have sex with men

With reducing HIV prevalence, India has made gains in containing the epidemic. Yet, unprotected sex and commercial sex work, unprotected anal sex between men and needle sharing among intravenous drug users continue to drive the epidemic. Development of effective, safe and acceptable topical (microbicides) and oral (pre-exposure prophylaxis (PrEP)) chemoprophylaxis could augment the already available tools for HIV prevention. This paper reviews the acceptability of topical microbicides and oral PrEP, in the context of the nature of the HIV epidemic, the sociocultural norms and the acceptability data obtained from studies carried out in India. Overall, men and women have a positive attitude towards the concept and use of microbicide products. Self-perceptions of HIV risk, product attributes, ease and convenience of use during sex, gender norms, the sociocultural context and the potential for undisclosed use were important factors influencing acceptability. A multipurpose product that would simultaneously address women's contraceptive and disease prevention needs would be devoid of the stigma attached to an anti-HIV product and may be more acceptable. Limited information on the acceptability of oral PrEP amongst high-risk groups merits further research, including carrying out demonstration projects for program introduction.