Acceptability studies have important role in microbicide clinical trials
Researchers also look to improve female condom use
Although obstacles remain before any one of the five microbicides in Phase III clinical trials are approved by the FDA, public health officials are grateful that at least one challenge has already been addressed, and that is the acceptability of the products.
Acceptability studies are fully integrated into the microbicide study process, even as investigators design and initiate research into finding a microbicide that will prove efficacious against HIV infection.
Research demonstrates a need for microbicides among women, particularly in the developing world. The Global Campaign for Microbicides of Washington, DC, has developed predictions of sales potential that indicate that a third-generation microbicide could have international sales figures that are nearly as high as the sales of male condoms.
Studying acceptability of the new product has been crucial to its development, experts say.
"One of our goals is to bring the behavioral side into the pre-development clinical pipeline, so we have acceptability very early in the pipeline," says Jim A. Turpin, PhD, microbiologist with NIH’s National Institute of Allergies and Infectious Diseases (NIAID). He also is part of the Prevention Sciences Branch and the Topical Microbicide Group, both of NIH.
Turpin and other NIH scientists discussed at the recent HIV Prevention Conference the behavioral and social data regarding acceptability of microbicides and how these can be integrated very early in the microbicide development process. Sponsored by the CDC, the 2005 HIV Prevention Conference was held June 13-17, 2005, in Atlanta.
"If you look across the board, you will find almost all clinical trials, whether for vaccines or microbicide treatments, have something about acceptability of the treatment," Turpin says.
Turpin says he’s optimistic about the eventual commercial use of an HIV microbicide since there are five microbicides in Phase III or efficacy trials, ready to determine the major obstacle of proof of concept for efficacy.
"I’m very optimistic that if we have that many in, we’ll have a broad assessment of a microbicide that’s efficacious and what conditions under which it will be efficacious," Turpin says. "The other part that makes me optimistic is that for microbicides there is a robust pipeline, a broad base of compounds advanced and a broad base even further back in the development pipeline."
A drawback to microbicides is that it will likely be a few years before one makes it to the market, and even then researchers expect that the first microbicides to be approved by the FDA will be far less effective at preventing HIV than either the male or female condom, says Theresa Exner, PhD, research scientist with the HIV Center for Clinical and Behavioral Studies and an assistant professor of medical psychology, department of psychiatry, at Columbia University in New York City.
"The best guess is that early microbicides may only be about 60% effective," she says.
Nonetheless, public health officials and researchers are very enthusiastic about the prospect of microbicides being used for HIV prevention, Exner says.
"Everyone I talk to is very enthused conceptually about the idea of a product that is lubricant in format," she says.
Also, some public health officials argue that if the HIV prevention arsenal includes a product that is less effective, but more widely used, then it will increase the overall protection of the population, says Susie Hoffman, DrPH, research scientist for the HIV Center for Clinical and Behavioral Studies and assistant professor of clinical epidemiology at the Mailman School of Public Health in New York City.
"It can increase the overall level of population protection if more people are using it who have never used anything," Hoffman explains. "So even if the product has lower efficacy than condoms, if it has a high acceptability, and if people who were not using condoms begin to use it then the overall protection for a population can be increased."
The biggest challenge facing microbicide research is reaching the goal of proof of concept, Turpin says.
"And what will that be — a 100% efficacious microbicide, 80% or 50%?" he says. "That incorporates not only basic science, but also applied sciences, formulations, manufacturing, and social and behavioral sciences of whether it’s acceptable, and if it is, how do we make it more acceptable."
Another challenge is convincing a major pharmaceutical company to buy in to the microbicide business, Turpin notes.
So far most of the money spent on microbicide research has come from NIH, other government entities, and nonprofit organizations, he says.
"We are actively through our initiatives and grant programs trying to fund and bring the big pharma into the microbicide business," Turpin says. "So we are providing through multiple programs money for basic research and pipeline development."
Case in point
Meantime, some scientists are frustrated by the lack of interest among the world media, health officials, and the public for the very effective and readily available female condom.
When it first came on the market, it was derided in media reports, and now it is never mentioned, Exner notes.
"The female condom provides an option beyond the male condom, and the marginalization of this method — people acting like it doesn’t exist — is extremely frustrating when it’s so badly needed," Exner explains.
The lack of popularity and acceptance for the female condom could be a good example of what happens when acceptability studies aren’t incorporated into clinical research early on in the development of a prevention method.
"Acceptability of the female condom is an issue that was explored in more depth only after its development," Exner says. "So when this method was introduced it wasn’t really carefully introduced with an eye toward acceptance by health care providers, and then the word of mouth and the press have been quite poor."
Exner and Hoffman were involved in research about health care providers’ perceptions of the female condom, and they, along with colleagues, discovered there were enormous prejudices against the method, based on word-of-mouth reports and not based on direct experience.1
"It’s a method that’s gotten a really bad rap, and it’s one that I think is constraining what providers do when they’re counseling on issues of use," they say.
For example, a study about the acceptability of the female condom among New York City health care providers found that they were skeptical about the condom’s contraceptive efficacy, with only a little more than one-third of the providers reporting they would recommend the female condom as a primary contraceptive.2
South African providers were concerned about the female condom’s appearance and its affects on sexual pleasure.2
Another reason the female condom has not caught on internationally is because of its cost and structural issues, such as too few national programs promoting its use and the lack of provider training to introduce the female condom to women, Hoffman says.
Its benefits are many, Exner notes. First, it provides women with a way to protect themselves, rather than convincing or relying on their male partners to wear a condom, she says. Secondly, studies have shown the female condom offers a more pleasurable sexual experience than the male condom.3,4
"The female condom doesn’t require a man’s penis to be erect, and a woman can put it in before sex, and it can stay in her as long as she likes before sex," Hoffman says. "Polyurethane, which is what it’s made of, transmits heat better than latex, and it doesn’t cause allergies."
The transmission of heat has been reported by women who use the condom as being quite important, and the female condom presents less of a barrier between bodies than does the male condom, Hoffman adds.
Drawbacks to the female condom are similar to those of any barrier method of birth control, which mainly is that people are not as fond of these devices. Also, the female condom costs about nine to 10 times more than the male condom in developing nations, even in places where the World Health Organization (WHO) and others are distributing them at a reduced cost, Hoffman notes.
In the United States, the female condom costs around $3.50, but some Medicaid programs are offering reimbursements for its use, Exner reports.
"One of the biggest indications that the female condom is not even penetrating the consciousness of people working with women is in the year 2002 there were only 500 Medicaid reimbursements in the entire year for New York state," she says. "That’s enough prevention for about four people, so that speaks to the need for education to consumers about the condom’s availability for reimbursement."
Also, although WHO has not yet endorsed the reuse of female condoms, there is ample evidence that these can be reused a number of times, Exner says. "They’ve basically tortured female condoms washing them in bleach and all kinds of substances, and they’re incredibly hardy."
Prevention scientists have addressed the issue of improving the use and acceptability of the female condom through training of health care workers, Hoffman says.
"Many health care workers believe it’s not a good method for women to use because it doesn’t protect against pregnancy — but this is inaccurate," she says. "It does protect against pregnancy better than diaphragms."
In South Africa, where the female condom program was integrated into all family planning settings, the use of the female condom has increased, Hoffman reports.
While there have not been clinical trials to prove the female condom’s HIV prevention efficacy, it has been proven highly efficacious against infection by sexually transmitted diseases, Exner says. "And while people are talking about an undeveloped microbicide, the female condom is here, and there is considerable evidence that the availability of this method is an important part of the methods that can empower women to negotiate with their partners in new ways," she says. "And it provides an option beyond the male condom."
References
- Kaler A. The female condom in North America: Selling the technology of empowerment.’ J Gend Stuf 2004; 13(2):139-152.
- Mantell JE, Hoffman S, Weiss E, et al. The acceptability of the female condom: Perspectives of family planning providers in New York City, South Africa, and Nigeria. J Urban Health 2001; 78(4):658-668.
- Mantell JE, Myer L, Carballo-Dieguez A, et al. Microbicide acceptability research: Current approaches and future directions. Soc Sci & Med 2005; 60:319-330.
- Susser I, Stein ZA. Culture, sexuality, and women’s agency in the prevention of HIV/AIDS in southern Africa. Am J Pub Health 2000; 90(7):1,042-1,048.
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