The Acceptability of a Vaginal Microbicide Among South African Men. (ARTICLES).(Statistical Data Included)

Context: With the explosive nature of the South African AIDS epidemic, there is an urgent need for HIV prevention methods controlled by women. Because several microbicide trials are going on in South Africa and elsewhere, there also is an urgent need to determine South African men's perceptions of and preferences for a potential vaginal microbicide.

Methods: Two hundred and forty-three men were recruited from three sites in South Africa: sexually transmitted disease (STD) clinics (N=95), the general population (N=98) and universities (N=50). A brief demonstration of a potential vaginal gel microbicide was followed by a private interview, which included questions about men's demographic characteristics, sexual activities, condom use and willingness to support their partner's use of a vaginal product.

Results: The mean ages of men from STD clinics, the general population and universities were 30,28 and 23 years, respectively. Forty-five percent of men from STD clinics, 69% from the general population and 65% of the university students reported a dislike for male condoms. More than 80% of the entire sample wanted their partner to be protected against HIV and other STDs. The majority of the men in the three groups (77-87%) would like their partner to use a microbicide and 66-82% said they would like to be involved in the decision to use a microbicide. Men were more likely to express a preference for microbicides than for condoms. In addition, they were more likely to prefer a vaginal product that prevents HIV and STD transmission and does not act as a contraceptive than one that acts only as a contraceptive. The majority (58-67%) of men reported that excess lubrication was not a desired product characteristic.

Conclusions: Vaginal microbicides may be acceptable to South African men. The amount of lubrication provided by the product and noninterference with sexual pleasure may be keys to product acceptability. Preference for an effective noncontraceptive microbicide was greater than for a contraceptive product.

As the HIV epidemic enters its third decade, women bear the burden of infection. Globally, as of the end of 1999, the Joint United Nations Programme on HIV/AIDS (UNAIDS) estimated that 15.7 million women were infected with HIV. (1) In Sub-Saharan Africa, where heterosexual HIV transmission is the predominant mode of infection, the numbers of women infected are startling, with women's peak infection rates occurring at earlier ages than those of men. It is further estimated that there are 12 women infected for every 10 men. (2)

The escalation of HIV infection among women is largely because women's position in society is inferior to men's and they often are unable to make informed choices about their sexual health. In a large number of developing countries, women are unable to negotiate the use of condoms during sexual encounters. (3) Although condoms are highly effective for the prevention of HIV transmission, their effectiveness demands consistent and proper use, which requires partner negotiation and participation.

UNAIDS has made an urgent call for the development of female-controlled methods of protection against male-to-female HIV transmission. (4) Such methods include vaginal microbicides and female condoms. Although women can initiate female condom use, consistent use of the product requires the involvement and consent of the male partner. Conversely, a woman is in complete control of vaginal microbicide use. Vaginal microbicides are compounds that are formulated as gels, suppositories, foams, tablets, sponges or creams and can prevent infection in a variety of ways. To date, products under development act by killing the pathogen, preventing attachment of the pathogen to the vaginal mucosa or preventing replication of the pathogen once it has entered the host cell.

A key concept in the development of a vaginal microbicide or any new product for human use is the assessment of the product's acceptability. Acceptability is determined not only by product characteristics, but also by the way in which the product is provided to the potential user, by whether the potential user fully understands the product's benefits, by ease of use, by potential harmful effects and by whether it requires dual method use (that is, use of a microbicide in combination with another barrier method). (5)

The acceptability of actual and hypothetical vaginal microbicides among men and women has been established among a wide variety of populations. (6) Acceptability studies involving the use of vaginal products have been incorporated in microbicide Phase I trials, (*) thus providing key information on acceptable volumes and doses, delivery mechanisms, formulation preferences and aesthetic appeal. (7) Hypothetical studies have provided further insight into varied cultural and sexual behavior practices around the globe. (8)

In South Africa, vaginal microbicide acceptability studies have been conducted among sex workers. (9) In one of these studies, women suggested that they needed to inform their steady male partners (a partner who does not pay for sex) of the product they were using. (10) These findings are in keeping with another study suggesting that men's inability to control their female partner's disease prevention method choices may influence women's use of the method. (11)

Although data on HIV prevalence in the general population in South Africa are limited, prevalence data collected nationally from women attending public antenatal clinics in 2000 showed that 25% of the women were infected with HIV. Provincial HIV prevalence data in 2000 suggested that Kwazulu Natal had the highest prevalence at 36%, followed by Mpumalanga at 30%. The province of Gauteng had a prevalence of 20% and Western Cape had a prevalence of 9%. (12) Additional data from a study conducted in 1999 on the prevalence of HIV among a large South African working population indicate that 23%, 5% and 1% of the working population in Kwazulu Natal, Gauteng and Western Cape, respectively, tested positive for HIV. (13) The study also found that 14% of black workers, 4% of Indian workers, 2% of white workers and 2% of workers of other ethnic groups were infected with HIV.

The explosive nature of the South African AIDS epidemic and the dire need for HIV prevention methods controlled by women were the impetus for our research. As several microbicide trials are going on in South Africa and elsewhere, it is imperative to determine South African men's perceptions of and preferences for a potential female-controlled HIV prevention method, such as a vaginal microbicide. The specific aims of this article are to assess the acceptability of a vaginal microbicide to men, and the degree to which men might prefer microbicide use to condom use.

Methods

Sample and Questionnaire

We recruited 243 men from three different populations in three South African cities. From June to August 1999,95 men were recruited from sexually transmitted disease (STD) clinics in Durban (in the province of Kwazulu Natal); 98 men were recruited from the general population in Cape Town (in the province of Western Cape) and Durban; and 50 male university students were recruited from Pretoria (in the province of Gauteng). We chose the three different settings to ascertain whether sexual preferences varied among different groups of South Africans. Trained field workers approached the men to participate in the study and conducted interviews with them that day. The University of Natal Ethics Board approved the study.

Prior to being interviewed, men received a brief demonstration of a vaginal gel. Because we were participating in a Phase III trial of the vaginal microbicide Col 1492 (Advantage 24), we used that product for demonstration. The product is a white bioadhesive gel packaged in a disposable applicator. Each applicator contained 1.5 ml of the gel. The consistency and amount of the gel likely to be inserted into a woman's vagina were demonstrated by squeezing the gel out of the applicator. Men who wanted to feel the texture of the gel were allowed to do so. Previous experience with sex workers suggested that men who visited them had a preference for dry sex, (*) hence the importance of demonstrating the volume of the product to be inserted into the vagina. (14) We…