Microbicides 2006: Who will control microbicides?

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Microbicides have been billed as a female-controlled HIV prevention method; but even though most women like the idea that they could use such a product without informing their partners, most would nevertheless prefer to tell their regular partners if they are using a microbicide, according to studies presented at the Microbicide 2006 conference. Some want to disclose the use of microbicides to enhance intimacy while others believe that gel-based lubricants would be detectable to their partners — and fear negative consequences.

Such consequences have already been observed in some of the clinical efficacy studies as researchers reported that failure to involve men in the clinical trials of microbicides has sometimes contributed to poorer adherence to microbicide use and has even led to some women dropping out of the studies. As a result, researchers are increasingly looking at ways of involving regular male partners in the trials from early on.

Many of the presentations from Microbicide 2006 can now be viewed online.

Entrenched gender inequality puts women at greater risk of HIV

The Ugandan Minister is well acquainted with the plight of women in Africa; once a refugee from northern Uganda, in addition to her government post, she is a registered nurse and midwife — and is the mother of 40 children (including AIDS orphans she has adopted).

“Women and girls in sub-Saharan Africa are more vulnerable to HIV infection,” she said. “The reason HIV has escalated into a pandemic is because inequality between women and men continues to be pervasive and persistent. The risk is compounded by subordination, discrimination and inequality [based on gender] under the law.”

Additionally, the social and economic disadvantages faced by women and girls in most societies, greatly increases their HIV vulnerability. Studies have shown that the most marginalised and poor African women are the most at risk.

The Minister said that sometimes she disguises herself and goes out to talk to commercial sex workers. “The girls who are on the streets are not there by choice,” she said, but as the result of poverty. Being poor in rural areas also increases HIV risk. “In the rural setting, it is more difficult to use a condom because many people do not have electricity and cannot afford kerosene for the lamps. Does a woman have to light a stick or some grass to help the man put on a condom? Those practicalities are real,” she said.

But ultimately, it is subordination to male dominance that puts women most at risk. And should an effective microbicide be identified, gender inequality could make the product difficult to promote.

“Microbicides are branded to be female-controlled or aimed at empowering women in sexual encounters which threatens the traditional gender roles and societal norms”, said Minister Bakoru. “But the development of microbicides could be seen as a venture leading to taking power away from the men. And within your societies, you know who is in charge of sex and how it is played, and who enjoys it most and who doesn’t.”

Many women do not feel entitled to refuse sex even if her husband mistreats her according to a World Health Organization (WHO) sponsored study involving 24,000 women from ten countries, which Heise presented at the conference. This often includes sex that is humiliating or degrading, or painful to the woman.

Minister Bakoru mentioned dry sex, a practice which increases women’s vulnerability — and which could conflict with gel-based microbicides that increase lubrication. “Dry sex is not a pleasure for the women but for the man.”

Sexual violence is also used as a tool to control women. In the WHO study, between 6% and 59% of the women in the study have been subjected to sexual violence by their partners. Across all sites, partners were cited as the perpetrators by more than 72% of women reporting sexual violence, with the proportion exceeding 90% in the provincial study sites of Bangladesh, Ethiopia, Peru, and Thailand.

“Across all the WHO study sites, men who are violent are also more likely to have outside partners,” said Heise, and she noted that a number of studies have found that women with violent partners are at an increased risk of acquiring HIV. “Given that condom use in primary partnerships is universally low, this puts women in violent relationships at higher risk of HIV and other sexually transmitted infections than other partnered women,” she said.

Giving women prevention options

The recurring motif of the Microbicides 2006 conference, represented everywhere on conference bags, programmes, and banners, was an illustration of a beautiful African woman in a traditional dress, with hands outstretched as if receiving a gift — presumably, given the conference theme — of a way that she controls to protect herself from exposure to HIV. This is in contrast to condoms, which, although highly effective if used properly and consistently, require negotiation with her male partner — a negotiation that the woman is likely to lose in many situations in the developing world.

But will microbicides really be so different?

At least in resource-limited settings, a number of the experts assembled at the conference aren’t so sure.

“I’m one of the strongest advocates for microbicides,” said Lori Heise, who is the Director of the Global Campaign for Microbicides, “but I also think we have to realise the limitations of this technology. The same factors that make microbicides necessary, are also going to really make it hard for some women to use them.” According to Heise, some of these factors include male dominance, fear of violence and discomfort with sexuality.

And speaking on the first morning of the conference, Zoë Bakoko Bakoru, the Ugandan Minister for Gender, Labour and Social Development said, “no single tool or technology can overcome the structural, cultural and institutional disadvantages that increase women’s vulnerabilities to HIV infection.”

“The discourse on microbicides needs to promote the rights of women to have control over their sexuality without trivialising the profound injustices that women face,” stressed Minister Bakoru.

Disclosure for the sake of intimacy

But even when the context of partnership and sex appears to be loving and trusting, women are at risk.

“Ironically, trust and affection within marriage and other long-term relationships are sometimes part of the problem,” said Minister Bakoru. “We have been preaching a lot about the use of condoms, but the use of condoms is also decided by the man. And research has also shown that when people have used condoms three or four times, then the question comes ‘don’t you trust me?’ and the condom is thrown to the side.”

A number of studies suggest that the desire for love and trust within a relationship will lead to microbicide use being negotiated in much the same way as is condom use.

“The majority of studies show that women want to tell their partners about using a microbicide,” said Professor Joanne Mantell, a public health and social scientist from Columbia University. “There are a number of reasons why. Communications may enhance intimacy, and women want to share the responsibility for protection with their partners.”

“With regular partners, women cited closeness and communication as a reason for telling their partners [about microbicide use]” said Dr Susie Hoffman of Columbia University, who evaluated attitudes about covert use of microbicides among participants in HIV Prevention Trials Network 050 (HPTN 050), a phase I study of tenofovir gel. According to Dr Hoffman, participants in the study made comments like “we tell each other everything, we don’t have no secrets,” and “I think he should know. Because I don’t like keeping nothing from...my partner.”

Others thought that they were obligated to disclose product use because of fears of potential sides effects: “It could give him a reaction. His penis might fall off,” said one study participant.

Perceptions that their partner does not pose a risk to them could also be an barrier to microbicide use. For example, in several studies of microbicide acceptability in India, women reported that they wouldn’t consider using microbicides if they trusted their partner and believe him to be faithful. “In our qualitative data, most women indicated that they would not consider using a microbicide, unless they perceived of themselves to be at some risk of HIV,” said Dr Betsy Tolley of Family Health Internation. “Their perception of risk was related to their perceptions of marital infidelity and marital harmony.”

This may not be as much of an issue in sub-Saharan Africa where women are more likely perceive themselves at risk — especially from partners who spend long periods working away from home working (e.g. in the mines).

Gel microbicide use may disclose itself

But even when women know better than to trust their regular partners, studies suggest it may not be easy to use a gel-based microbicide without him knowing.

“Covert use or the ability to use a prevention method without the explicit knowledge of male partners is one of the main reasons for developing microbicides,” said Dr Hoffman. However, many participants in HPTN 050 (a US trial) felt that it would be difficult to keep using gel-based microbicides a secret. In the study, 86% of the women reported increased vaginal lubrication with the gel and some women were pretty sure that their regular partners would know. “I’m 14 years with my man, so he would know anyway... he would know there was something different,” one women commented in focus group discussions according to Dr Hoffman.

Another woman said “Okay, so with this gel, you’re a lot more lubricated. So if your partner knows you, he’ll know.” When the facilitator asked her what he would say, she responded “What the hell is that? Why the hell are you so wet in there? I know you better.”

While some of these concerns may be particular to the tenofovir gel formulation, other studies with gels also report increased vaginal lubrication. In one African study, even though HIV-positive men were supportive of their partner’s microbicide use, the majority (51%) of the men reported that the women couldn’t hide its use as they were able to feel the gel's wetness during sex.

In Indian studies with Pro 2000, women reported that if the gel was used more than an hour before sex, their partner would be less likely to notice. However, they had concerns about the product being noticeable.

According to Dr Neelam Joglekar, problems with product storage and disposal could make keeping microbicide use difficult.

“In the focus group discussions, some participants reported that the assembly of the applicator required a lot of time and privacy. And as these participants were mostly from the lower socio-economic class, the size of the house was smaller and they were living in conjoined families. Therefore quite a few participants expressed problems for storage and disposal of the study kits at their home and privacy for use,” she said.

Storage and disposal of applicators could pose a problem in other resource-limited settings as well.

“Where does the woman keep this so that he doesn’t find it?” said Dr Ellen Hardy from Sao Paolo, Brazil, in another session. “Because I have been to homes in places, such as the Dominican Republic and other countries, where the only thing that the woman owns is her handbag hanging on a nail.”

Women will disclose out of fear of negative consequences

Audience members at a number of sessions expressed concern about the implications of a woman’s inability to keep microbicide use a secret. “With this excessive lubrication, do you still think it is woman controlled?” one audience member asked Dr Hoffman after her presentation. She responded: “It may be woman controlled but that doesn’t mean that the partner isn’t aware of it and yet, it's okay because it has a positive effective on sexual pleasure.”

But that conclusion may be culture-specific to the United States where HPTN 050 was conducted. In other settings, such as Africa, “male partners may interpret too much lubrication, especially before sexual intercourse, as meaning that the woman is unfaithful, has a sexually transmitted infection, or see it as just a poor indicator of vaginal hygiene,” according to Prof. Mantell.

Thus, since the use of a gel microbicide may be impossible to keep as a secret from their regular partners, studies show that some woman will disclose use “to avert potential negative repercussions, such as preventing accusations of infidelity and avoiding the possibility of being abandoned by partners,” according to Prof. Mantell.

This was certainly the case in the Pro 2000 study in Pune, India. “During focus groups discussions women said that the husband’s permission to use such a product was important to avoid marital disputes and doubts about infidelity,” said Dr Joglekar.

Men also clearly want to know whether their partner is using a microbicides, according to several studies conducted with male partners of trial participants. Even in the study with the HIV-positive male partners, who all believed that a women-controlled microbicide was a good thing, most of the men thought that women would have to tell their regular partners to prevent mistrust in stable relationships.

In another study presented by Dr Joglekar, she said that “Men expressed the need for being informed about women’s microbicide use in order to avoid suspicion. One said the study would have gone unfinished had he not been consulted.”

Indeed, incidents have already occurred in some studies, with microbicides being thrown away in one case.

According to Symon P Wandiembe, scientific officer for the Medical Research Council and the Uganda Research Unit on AIDS, some women reported that their continued participation in the MDP301 study was subject to their partner’s approval. In the same study, partner opposition was the most common reason given for poor adherence to gel use (in eleven out of 26 women). In another study, men expressed preference for multiple use applicators so that they could limit the amount of gel being used — suggesting that adherence to the proper amount of gel used could wind up being determined by the man.

But even when the men do not have a preference for dry sex or do not fear that their partner is being unfaithful, their reactions to the product could lead to poor adherence. For example, in the Indian studies, men were afraid that their partner’s use of the microbicide applicators could be discovered — even though, at this early stage of development, no one could possibly know what the devices are used for.

“One participant said I was worried that everything would come out of the garbage bin -- and it would look very embarrassing.’ Another one said “I collected all the applicators and buried them in a pit near my house,’ said Dr Joglekar. They also said that they didn’t believe women would be able to go to the pharmacy and ask for the product because of the stigma related to HIV.

Involving men

Although several studies at the conference reported success involving male participation and recommended that this be done from early on, it must be noted that many of the participants in the early acceptability studies came from lower risk populations — or had partners who perceived themselves as being high risk. Disclosure and male participation may be more difficult both in the clinical efficacy studies with the general population — and when a product reaches the market.

During one session, Dr Hardy commented, “one point that I think is missing is the emotional cost of covert use - because if you are going to be using something to protect yourself from your husband who you suspect is having sex with other women. If he finds out that you are using this and that you suspect him - what is the impact and how many men are going to react violently? I mean, there’s no explanation for why you would use a microbicide with someone you really trust.”

“How does a women get permission from her partner if she is suspicious of him? — that is a real challenge,” said Dr Joglekar.

Disclosure in such circumstances could possibly be dangerous and Heise believes research teams of the ongoing microbicide trials should expect some men to react violently, “I think we can say with certainty that many of the women who we will be enrolling in microbicide trials will be in violent relationships and that our staff may be ill-prepared to handle this.”

Future directions

Future studies within the community at large will be essential to get the exact picture of how male involvement could affect microbicide use — and what sort of community-based marketing might be necessary to change attitudes. In the meantime, the job might be made easier if the microbicidal products that eventually go to the market have broader applications than simply being anti-HIV or anti-STI (sexually transmitted infections). Combination products that are seen being for female hygiene or contraception might raise fewer eyebrows and allow women more freedom to use a product without raising suspicion. Also, slow-release technologies such as intravaginal rings or even oral drugs that a woman can use without the man knowing may better deliver on the promise of women-controlled devices.

Finally, Heise thinks that the development of microbicides present an opportunity to “begin the discussion about sex and power. But it can’t end there. Successful microbicide introduction also requires working on the underlying gender power imbalances that condition women’s risk. I think we need to embed our work on microbicides into women’s protection strategies [which] also include the need for social power and economic opportunities, and if we don’t [address these other factors], its not going to matter if we have a safe and effective microbide.”

References

Bakoru ZB. Vaginas and applicators: expanding the national discourse on microbicides, sex and sexuality. Microbicides 2006 Conference, Cape Town, Plenary talk, 2006.

Heise L et al. The WHO multi-country study on women's health and domestic violence: implications for microbicide development. Microbicides 2006 Conference, Cape Town, OC12, 2006.

Hoffman S et al. Covert use of a vaginal microbicide: views of women participating in a phase I trial of tenofovir gel (HPTN 050). Microbicides 2006 Conference, Cape Town, OC10, 2006.

Wandiembe SP et al. Potential barriers to adherence to product use and cohort retention in microbicides efficacy trials. Microbicides 2006 Conference, Cape Town, OB9, 2006.

Rutterford C, Nunn A, Wandiembe S. Assessment of adherence to gel and condom use in the Microbicides Development Programme pilot study . Microbicides 2006 Conference, Cape Town, OB10, 2006.

Tolley B et al. Predicting microbicide acceptability: development and validation of scales to measure HIV risk perception, sexual power and couple harmony in India. Microbicides 2006 Conference, Cape Town, OC3, 2006.

Mweemba O, Fylkesnes K, Siziya S. Acceptability of vaginal microbicides among men living on the Nakambala Sugar Estate in Zambia. Microbicides 2006 Conference, Cape Town, OC4, 2006.

Hardy E et al. Devices for the administration of a vaginal microbicide: use difficulties, adherence to use and preferred devices . Microbicides 2006 Conference, Cape Town, PC23, 2006.

Joglekar N et al. Acceptability of PRO 2000 vaginal gel among HIV un-infected women in Pune, India. Microbicides 2006 Conference, Cape Town, OC8, 2006.

Govinden R et al. A double cross-over randomized controlled trial to determine acceptability of two gel volumes and applicators. Microbicides 2006 Conference, Cape Town, OC7, 2006.

Morar N, Gumede S, Ramjee G. HIV positive male partners’ experiences of participating in a microbicide safety study. Microbicides 2006 Conference, Cape Town, OC16, 2006.

Toriesen Kristine et al. Male involvement may improve retention and gel adherence among women participating in a microbicide trial: Lilongwe, Malawi, HPTN 035. Microbicides 2006 Conference, Cape Town, OC18, 2006.

Joglekar N et al. Learning what men feel about microbicides: Experience during Phase I safety study of PRO 2000 Vaginal Gel in Pune, India. Microbicides 2006 Conference, Cape Town, OC20, 2006.

Morrow K et al. Acceptability of vaginal microbicide use in Chennai, India: A qualitative study among low- and high- risk men. Microbicides 2006 Conference, Cape Town, PC45, 2006.

Rosen R et al. The acceptability of vaginal microbicide use among women in Chennai: A qualitative study conducted among low- and high-risk women. Microbicides 2006 Conference, Cape Town, PC67, 2006.