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Margaret E. Bentley, PhD, Andrew M. Fullem, MSPH, Elizabeth E. Tolley, MA, Clifton W. Kelly, MS, Neelam Jogelkar, MS, Namtip Srirak, PhD, Liness Mwafulirwa, RN, Gertrude Khumalo-Sakutukwa, MSW, MSc and David D. Celentano, ScD, MHS

Margaret E. Bentley is with the Carolina Population Center, University of North Carolina, Chapel Hill, NC. Andrew M. Fullem is with John Snow Inc, Boston, Mass. Elizabeth E. Tolley is with Family Health International, Durham, NC. Clifton W. Kelly is with the Fred Hutchinson Cancer Center, Seattle, Wash. Neelam Jogelkar is with the National AIDS Research Institute, Pune, India. Namtip Srirak is with the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand. Liness Mwafulirwa is with the Johns Hopkins University College of Medicine Research Project, Blantyre, Malawi. Gertrude KhumaloSakutukwa is with the Center for AIDS Prevention, University of California, San Francisco. David D. Celentano is with the Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md.

Correspondence: Requests for reprints should be sent to Margaret E. Bentley, Carolina Population Center Department of Nutrition, 123 West Franklin St, Suite 308B, Chapel Hill, NC 27516 (e-mail: pbentley{at}unc.edu).

	ABSTRACT

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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 postlicensure dissemination can help maximize acceptability and use.

	INTRODUCTION

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In the United States and throughout the world, women represent the largest percentage of newly infected HIV-positive individuals,^1,2 yet in many settings their ability to protect themselves is limited. The effectiveness and use of male and female condoms are limited by the need for women to negotiate for use with their sexual partners.³ Microbicide products that women could electively use, instead of depending on male use of condoms, hold great promise for HIV prevention, particularly among women who perceive themselves to be at high risk of infection.⁴

More than 60 candidate products are currently in various stages of development, and 17 have reached the stage of clinical testing to determine safety, efficacy, and acceptability.^5,6 The Rockefeller Foundation Microbicide Initiative defines acceptability as a woman’s willingness and ability to use a product or technology in everyday life; it includes her perception of risk and her concerns about or experiences with side effects, alternative products, behavioral choices, cost, and access. Data regarding such perceptions and concerns are needed to identify factors that facilitate or discourage effective microbicide use in diverse settings.⁷

Because approved microbicides are not available, most acceptability research has relied on indirect study designs. Some studies have surveyed potential users about desirable and undesirable product attributes; others have solicited reactions to existing products of similar design, such as spermicides by high-risk women and men individually and in couples.^8,9–17 Recently, some investigators have called attention to social context, as well as physical and clinical attributes of products, with regard to acceptability.¹⁸

Conducting microbicide acceptability research during clinical trials permits us to assess factors that pertain to actual products being developed for marketing among diverse, at-risk populations and settings. The recent increase in phase I clinical trials has included acceptability research in several settings.^19–27

We report on the acceptability of a microbicide, BufferGel, developed by ReProtect Inc, Baltimore, Md.²⁸ This odorless and clear gel with a pH of 3.9 buffers twice its volume of semen to a pH of approximately 5.0, maintaining the protective acidity of the vagina during and after intercourse.²⁸ BufferGel has no surfactant or detergent properties likely to cause irritation or clinical lesions. Safety data have been reported elsewhere,^29,30 as well as acceptability results among low-risk US women in Rhode Island.¹⁹

The study enrolled HIV-negative, low-risk women in 4 countries—Malawi, Zimbabwe, India, and Thailand—that have diverse sexual and hygiene practices and varied prevalence of HIV and other sexually transmitted diseases (STDs). Overall acceptability of BufferGel, self-perceptions of HIV risk, ease/convenience of use during sex, and potential for undisclosed use were assessed through semistructured interviews and segregated focus group discussions among women and among male partners of sexually active women participants.

	METHODS

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The study was conducted under the auspices of the National Institutes of Health (NIH)–funded HIV Network for Prevention Trials (HIVNET). The protocol team consisted of in-country investigators at the study sites in Malawi, Zimbabwe, India, and Thailand; partners at Johns Hopkins University and the University of California at San Francisco; and staff from Family Health International, the Fred Hutchinson Cancer Research Center (FHCRC), and NIH.

Study Design
Participants were asked to apply BufferGel for 14 days, morning and evening, and to wash and dry the applicator after use. Women in the sexually abstinent cohort were requested to refrain from sexual activity for the duration of the study. Sexually active women were asked to have sex at least twice a week and to use study-provided nonlubricated condoms during all acts of vaginal intercourse during the study period. Women agreed not to douche or clean their vaginas or to apply any other products to their vaginas during the study.

Following the study design and methods used in the Rhode Island safety and acceptability study,^19,29,30 we collected acceptability data for the international sites, using structured interviews and focus groups with men and women. All social scientists and data collectors participated in regional training in Africa and Asia to ensure standardization of methods.

During clinic visits at days 7 and 14, an interviewer administered a questionnaire on product characteristics (e.g., smell, color, texture) and applicator characteristics (e.g. portability, ease of use, comfort, cleaning). Women in the sexually active cohort were asked about partners’ reaction to the product and use of the product during sex. At day 14, all study participants answered questions about their willingness to use the product or reasons for being unwilling to use the product if it were approved. After completing the trial, women and their male partners were invited to join gender-specific focus group discussions. The focus group data were collected to provide context and meaning to the quantitative survey data.

Study Participants
Sexually active and sexually abstinent cohorts were recruited from patients visiting Queen Elizabeth Hospital, Blantyre, Malawi; Spilhaus Clinic, Harare, Zimbabwe; and Jahengeer Clinic, Pune, India; and from staff at Chiang Mai University, Chiang Mai, Thailand. Participants were HIV negative, had no history of STDs in the past 6 months, and were either sexually abstinent or in a stable, monogamous relationship. Inclusion and exclusion criteria have been described previously.^29,30 Written informed consent was obtained from all participants before any clinical examinations or questionnaires were administered.

Between July 1998 and April 1999, 288 women were screened, and 98 were enrolled in the study (30 sexually abstinent, 68 sexually active). The average age was 33 years (range: 18 to 44 years). Most women had completed either primary (44%) or some secondary (47%) school and were either unemployed (46%) or employed full-time (42%). Most abstinent (57%) and all sexually active women were married. Three women were dropped from the study because of a diagnosis of Candida at the day 7 visit; 2 left because of breakthrough menstrual bleeding; and 1 woman was not able to meet the product use adherence criterion of application on at least 12 of 14 days and elected not to continue. Of the 98 women who completed the study, 85 (93%) met the product use adherence criterion. Transcripts from 17 focus group discussions with 99 people were analyzed (at least 1 group for each women’s cohort and 1 men’s group from each country).

Data Analysis
Structured questionnaire data were entered with Microsoft Access 1997³² at the 4 international sites, transferred electronically to FHCRC, and converted into SAS database files.³² FHCRC statisticians resolved data queries with data managers at each site. Descriptive data were stratified by country and, when applicable, by cohort (sexually abstinent or sexually active). Small cell sizes precluded the use of statistical tests. The primary study endpoint (outcome indicator) for acceptability was the proportion of women who reported at the end of the study that they would be willing to use BufferGel if it were approved for vaginal application.

FDGs were taped, transcribed, and imported into Nud*ist 4³³ for analysis, and a data matrix and display approach was used. Researchers read all transcripts to identify and code themes used by Nud*ist 4 to generate reports of like-coded blocks of text. Text blocks associated with codes were analyzed for dimensions of attitude, perspective, and association with other codes. For central themes, data matrices were used to examine differences by country, gender, and cohort.

	RESULTS

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Overall Acceptability
Based on structured interview data, all women in the African sites and most (57% abstinent, 65% sexually active) women in Thailand said that they would use the product if approved, compared with much smaller proportions (17% and 60%, respectively) of women in India (Table 1). Men and women in African focus group discussions overwhelmingly expressed a need for protection from HIV and welcomed the possibility of having new products available that could prevent HIV transmission. By contrast, women in Indian focus group discussions who said that they would not use BufferGel believed that they were not at risk of HIV infection and did not need a protective method.

Women in Africa worried about HIV affecting the next generation. A Zimbabwean woman commented "We have children who are growing up. They should stay alive. We are scared for them." Some Thai women also stated that they felt themselves to be at risk for HIV and envisioned using a product like BufferGel in the future, should it be proven effective. Indian women seemed to distance themselves from personal vulnerability; in their discussions of potential future use of BufferGel, they tended to focus on hypothetical promiscuous women: "Only women who are like that—women who go out, keep outside relations with many men . . . the other women have no reason to use this medicine."

Undisclosed Use
In focus group discussions, few women or men considered undisclosed use to be feasible, given the product’s characteristics. Properties of the gel that would make undisclosed product use difficult included increased wetness, stickiness, or telltale signs on men’s penises or on condoms. A man from Zimbabwe suggests that the gel cannot be used clandestinely, stating that men might "feel that something [is different]. . . . Why did it get wet so quickly? What is it? . . . So, you would ask what is happening?" However, to avoid a partner’s discovery, one Zimbabwean woman said, "you use half as much but insert deeply—and if the partner asks, just tell him it is normal vaginal discharge. He won’t know exactly what it is." Some women were not sure that they would be able to apply the product privately before intercourse.

Whether feasible or not, undisclosed use also was viewed as undesirable and potentially risky. African men and women explained in focus group discussions that undisclosed use would be inappropriate "because we are one body" or "we are one when we are in this house." Possible adverse outcomes of a wife’s undisclosed use, if such use is detected, included disagreement in the home, being sent to one’s parents’ house, physical violence, or even divorce. Zimbabwean women anticipated a need to attribute their use of such a product to health concerns that would not impugn their partners’ sexual fidelity: "It is better to be honest with him that you are using BufferGel to protect yourself from different infections. Even if you know that it is for preventing HIV, you just tell him that it is protecting you from cancer or other gynecological problems." One woman in the sexually abstinent cohort in Zimbabwe observed that "single women have the right to tell [the man] ‘I am using this, whether you like it or not.’ It’s different for a married woman, who might be sent packing if she does that."

Ease of Insertion and Applicator Features
Almost all participants (92%) found the applicator easy to insert; 31% of women disliked having to clean and reuse it (Table 1). In focus group discussions, concerns about cleaning offset ease of insertion in women’s overall appraisal, especially among women who did not have access to running water or feared loss of privacy when using a communal tap. A woman from Malawi worried about leaving it out to dry if droplets "could result in other infections, and you would think it’s the gel [that caused the infection, when] it’s the applicator." A Thai woman tried to disinfect the applicator with alcohol, although not instructed to do so, and experienced burning sensations on using it. Indian and Thai women worried about storing the gel and applicator away from children who might play with the items or ask questions. Single-dose disposable applicators and tablet or suppository delivery systems were suggested as alternatives, but these suggestions did not entirely resolve storage concerns and evoked questions about cost.

Responses to BufferGel’s Physical Characteristics
Women liked many characteristics of BufferGel (Tables 1 and 2), in particular that it is colorless (94%) and odorless (81%). In focus groups discussions, a few participants compared BufferGel’s color to that of women’s natural discharge: "similar to the fluid that women discharge from their body," as a Zimbabwean man expressed it. The majority of Indian women in the abstinent cohort said that the product’s lack of odor was advantageous "because no one can make out that it has been used." In Zimbabwe focus group discussions, 1 man and several women suggested that using the gel could help women prevent odor. A woman from Malawi said that the lack of odor "means that the gel is a strong drug." A few men from Thailand and Zimbabwe requested that a deodorant or nice scent be added to the gel. According to survey data, less than half of women (49%) had some concerns related to the gel’s consistency, especially wetness or drippiness (Table 1). In focus group discussions with sexually active women, a few Africans and the majority of Indians and Thais found the gel too thin, slippery, or prone to leaking, sometimes comparing it to the slow trickling that a woman experiences during her menstrual period. Leakage caused 31% of women to report that BufferGel soiled their clothes (Table 1). Some managed to mitigate this leakage with pads or cotton wool provided by the study. Other women recommended changing BufferGel so that it was not so liquid or suggested that it could be formulated to be effective in smaller volumes or reformulated as a suppository.

Several Thai men and one man from Zimbabwe disliked the sticky nature of the gel, although other men and women found this attribute desirable. As explained by a Malawian woman, "BufferGel had a tightening effect and it was not slippery, so I was happy with the product." Another woman from Zimbabwe said: "We did not have any wetness problems, because BufferGel used to sort of dry up and stick. So, it was not slippery. It was perfect." In fact, approximately half of the women from the Zimbabwe sexually active focus group discussion said that the consistency of BufferGel made "sex nicer than on normal days." They explained that dry sex is painful and prolongs the sexual episode: "With BufferGel it is not slippery. It is actually nicely sticky." The perception that the product enhanced sexual pleasure also was reflected in survey data; approximately half of women reported that their own (51%) or their partner’s (43%) sexual pleasure was increased (Table 2).

Perceived Side Effects
Some women and men in almost all focus group discussions indicated that they had anticipated side effects, believing, for example, "that I was going to be given harmful products that would burn my vagina." Several Indian women chose to participate in the abstinent cohort to protect their husband’s health. An Indian woman in the sexually active cohort said: "All the time we were wondering whether anything would happen to me or my husband. So, sex was dissatisfying." One Zimbabwean man worried about whether the gel "would affect me or my penis, that it would make me sick or something would happen." Another "was afraid that if I remove the condom and have sex without one, it might affect me." Most participants expressed surprise and satisfaction that the gel did not cause the problems they anticipated. One Zimbabwean woman, for example, said, "On the first day, I was surprised because I did not feel anything. I just felt like I did before [using the gel]."

	DISCUSSION

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Employing the same protocol and methodology previously used among low-risk women in Rhode Island¹⁹ in this multisite study in 4 less-developed countries, we found that overall acceptability of BufferGel was high and that women were unanimous in their belief that such products should be available to women if proven to be safe and effective. The womens’ perceptions of being at risk and the stage of the HIV epidemic within each setting placed the results in context for the researchers; in settings in which the HIV epidemic is more advanced (particularly in Zimbabwe and Malawi) and women therefore presumably perceived their risk to be high, acceptability was unanimous.

Across all settings, but particularly in the African sites, both men and women were concerned about not communicating with their partners about using such products. Focus group participants, particularly those from the African sites, concentrated on issues related to partner trust and the dangers—including violence—of undisclosed use in marriages or established relationships. Most participants expressed that even if a product could be used during sex without alerting the partner, it was important for couples to make the decision jointly to use the product. BufferGel’s wetness and its appearance on the man’s penis would alert men that a woman had inserted something into her vagina before sex. Men from all sites believed that they had the right to participate with their wives in discussing the use of microbicides. However, this discussion might raise questions about the fidelity of either or both partners, depending on which partner introduced the topic and how the rationale was presented. Some men acknowledged that microbicides would be an important option for "other" women—those without a husband or a regular partner or those who are "promiscuous." The availability of microbicide products may threaten some men’s perception of their control of women. Some women in the study anticipated this problem and suggested portraying microbicides as generic vaginal health products when describing their reasons for using them to a male partner.

It will be important, therefore, to anticipate men’s concerns and to develop strategies for promoting microbicides among stable partners and in marital relationships. Upon microbicide products’ becoming available in the marketplace, site-specific and subgroup-specific acceptability and marketing research can continue to address these issues as the populations increase in risk and cultural diversity. Women at higher risk might devise solutions for maintaining privacy or secrecy of use, but including men in acceptability and marketing research helps to clarify men’s major concerns and identify strategies that may effectively preempt or address these concerns. In general, men in this study appeared to be responsive to the need for women to protect themselves. With expanded trials, acceptability research should include community opinion leaders and authorities whose views may affect future dissemination of effective products.

This study had a number of limitations. First, a phase I trial requires the enrollment of women who are at low risk for STDs/HIV, a population not representative of the women at highest risk for infection, whose approval of a microbicide product could be even stronger than that in our study. Second, the trial required condom use during all sexual acts; we did not study BufferGel’s acceptability during unprotected sex, when presumably microbicide use would be of greatest benefit. Twice-daily use is at the upper limit of the dose most women would require; therefore, issues related to messiness would likely be diminished for most users. It is difficult to conclude from 2 weeks’ use of an investigational product of unknown efficacy whether practical problems would became more troublesome after sustained use by high-risk women or would be resolved. For example, soiling of clothes was addressed by the use of absorbent pads. This solution might become either an acceptable routine or a recurring annoyance. Concerns about cleaning a reusable applicator are being addressed by packaging gels in single-use disposable applicators, but storage may be a consideration for either approach, as well as privacy.

Our data suggest that negative perceptions regarding product characteristics (wetness, drippiness, stickiness) should be identified in microbicide acceptability research. However, users’ perception of infection risk may outweigh these "nuisance factors" once microbicide products are proven efficacious, as we previously found in the Rhode Island trial.¹⁹ Larger trials among higher-risk women will provide an opportunity to investigate and address issues related to applicator characteristics, privacy, cleaning, and storage in diverse geographic, demographic, and sociocultural settings.

Microbicide acceptability research can contribute to product development and to messages used for introducing such products before specific products are proven efficacious for HIV prevention. Acceptability research through postlicensure dissemination can facilitate maximum access to products among those populations most in need of additional preventive technologies. This research should include social and contextual research into gender relations, sexuality, and sexual behavior to establish the context within which these products will be promoted and used.³⁴

	Acknowledgments

 
This work was financially supported by the HIV Network for Prevention Trials (HIVNET), sponsored by the National Institute of Allergy and Infectious Diseases (contract N01-A1–35173 with Family Health International and contract N01-A1–45200 with Fred Hutchinson Cancer Research Center). BufferGel was supplied by ReProtect Inc, Baltimore, Md.

We appreciate the hard work of the dedicated field teams in the 4 study sites and the participation of the women who enrolled in the trial. Among others, we especially thank Newton Kumwenda and Taha Taha from Malawi, Sungwal Rugpao from Thailand; Sanjay Mehendale from India, and Janneke van de Wijgert from the Zimbabwe site. We thank members of the HIVNET 009 protocol team for their guidance: Leslie Hjeldness, Anne Coletti, and Zeda Rosenberg. We are grateful to Tom Moench and Kevin Whaley of ReProtect for their support and frequent communication on technical issues during the implementation of the study, always with good humor. We thank Susan Shaw for her help in the preliminary coding and analysis of the qualitative data. We thank Janneke Van De Wijgert, Robert Bollinger, Kenneth Nelson, and Ken Mayer for their collaboration on the clinical aspects of the study. We wish to express our appreciation to the 3 anonymous reviewers for their careful reading and critique of our submitted manuscript, which greatly improved the revision. In particular, we thank Michael Gross for his interest and thoughtful editorial comments.

Human Participant Protection
The protocol was reviewed by institutional review boards at Johns Hopkins University and the University of California at San Francisco and in each of the countries in which the study was to be conducted. The appropriate drug control board in each country also reviewed the protocol and approved importation of the study product.

	Footnotes

 
Contributors
M. E. Bentley took the lead in designing the study, training the in-country teams, directing the analysis, and writing the article. A. M. Fullem worked closely with M. E. Bentley on study design, analysis, and writing. E. E. Tolley was responsible for analysis of the qualitative data and was a major contributor to the article. C. W. Kelly analyzed the quantitative data. N. Jogelkar, N. Srirak, L. Mwafulirwa, and G. Khumalo-Sakutukwa led implementation of the study in India, Thailand, Malawi, and Zimbabwe, respectively. D. D. Celentano was the principal investigator for the cross-site BufferGel Phase I trial.

Peer Reviewed

Accepted for publication July 13, 2003.

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