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Disclosure is an issue with microbicides testing
Cultural, family, other issues may pose obstacle
Microbicide products remain in the testing stages and have not been approved by the Food and Drugs Administration; but as some move closer to market, investigators are looking at how likely it is that women will use these products for protection against HIV infection.
"We don’t know yet whether women can use them for protection," says Margaret Bentley, PhD, professor of nutrition and associate dean for global health at the School of Public Health at the University of North Carolina in Chapel Hill.
However, assuming that at least some of these products will prove potent against HIV infection, the next big question is: Will women use them?
No need for women to consult partner
Microbicides evolved with the idea that women could use them privately without the consent of a partner," Bentley says. "We wanted to check out the acceptability; did women think it would be possible, and what did men say?"
One such product is BufferGel, a vaginal microbicide, that was studied by Bentley and co-investigators to determine acceptability of vaginal microbicides among women and their partners.1
The study found that 73% of the 98 low-risk, HIV-negative women who participated in the project approved of the microbicide. The women in the study were from Malawi, Zimbabwe, India, and Thailand.1
"The primary BufferGel study was for safety and toxicity, and investigators added acceptability research to a Phase I trial, which is a unique strategy, Bentley adds.
"We believe having acceptability data early in the pipeline of testing is important and will help in Phase II/III trials as well as in the post-marketing phase," she says.
The results were more ambiguous when the question was asked whether they could use the product without letting their partners know they were using it, Bentley notes.
The results were mixed, she continues. "The issue that came out more than anything — and it reflects the low-risk population we enrolled — was that both men and women thought women should talk to their partners about using it."
An earlier study of the product used by women in Rhode Island also had mixed results as to whether women felt they could use the product without their partner’s knowledge, Bentley adds.
The women who participated in the international study were all married; and within their cultures, it is common for the men to make all of the decisions, she says.
"So it did come out that trust would be broken if women would use this product without their partners knowing," Bentley notes. "This needs to be explored in the context of the population we’re exploring."
For instance, if women in some regions avoid using a microbicide product because of the disclosure issue, then this could contribute to their HIV risk.
"These are married women who could be considered low risk, but they are not because their partners are having multiple partners, and this is very common in Africa, India, and Thailand," Bentley says.
"In other literature, it shows that women very much suspect this and they know they’re at risk, but they don’t know what to do about it," she points out.
The women recruited for the BufferGel study were considered low risk, and they had not had a sexually transmitted disease within the past six months, Bentley explains.
Marital status is a risk factor
The women who participated in the study said they believed that if a woman felt she was at HIV risk, she should have access to a microbicide product and that she shouldn’t necessarily have to tell her partner about it, Bentley adds.
"In India and many other settings, the most important HIV risk factor for women is being married," she says.
When vaginal microbicides are marketed, it would be helpful to develop a strategy that takes into account the local culture and traditions, adds Bentley.
For instance, it’s important to know whether a particular region has a high condom use and to know how empowered women are in that region, she explains.
"All we need to do is look at this in context and know enough about what’s going on in the area to figure out how to market these products to both women and their partners, if we feel that men need to know about it," Bentley adds.
"In a nutshell, acceptability needs a broad definition and should not be focused just on product characteristics or use," she concludes. "Microbicide acceptability research needs to be embedded in the social and cultural context and should include both women and men."
1. Bentley ME, Fullem AM, Tolley EE, et al. Acceptability of a microbicide among women and their partners in a 4-country phase I trial. Am J Pub Health 2004; 94(7):1,159-1,164.