PROJECT
Microbicides Acceptability Research

Background
Acceptability research has featured prominently in the Population Council’s microbicides program, both in the context of Phase 2 and 3 clinical trials of the Council’s lead candidate microbicide Carraguard®, as well as in freestanding studies. A five-country study examined three different vaginal formulations of an over-the-counter spermicide to gauge women's preferences for gel, film, or suppositories. Results showed that preferences varied within and among countries, highlighting the need for a variety of formulations of microbicides to be developed and made available.

Researchers explored rural and urban men’s attitudes toward a potential microbicide in Mexico, Zimbabwe, and the United States through a series of focus group discussions. One issue that was discussed was covert use of potential microbicides. While these men were generally supportive of the idea, most felt strongly that women should not use microbicides without their partners’ knowledge. A number of men also expressed concern about the effect a microbicide might have on their own health and future fertility. Focus groups were also conducted with women in four cities in the United States to explore their attitudes toward a potential microbicide. Most of the women preferred a product that would protect against pregnancy and HIV/STIs.

One particular aspect of acceptability involves the amount of lubrication that a microbicide might provide. Because most potential products currently being tested are formulated as gels, Council researchers are conducting a study to better understand women's and men's perceptions of type, amount, and significance of vaginal lubrication and people's preferences related to lubrication during sex. Results of this qualitative research were published in "Cultural norms and behavior regarding vaginal lubrication during sex: Implications for the acceptability of vaginal microbicides for the prevention of HIV/STIs."

Because even a highly efficacious microbicide will not be effective if it is not used, acceptability research is a critical component of the product development process. While research has been undertaken to explore the hypothetical acceptability of microbicides once they become available, it is necessary to develop understandings of people’s experiences with actual microbicide products.

Current research
The Population Council is currently undertaking a qualitative research study in conjunction with the Phase 3 Carraguard efficacy trial, which will be conducted among women and their partners who participated in the Phase 3 trial.

The study will explore the ways in which sociocultural values—such as sexual norms and practices, partner relationships, reproductive intentions, the importance of covert use—and product characteristics affect adherence to and the feasibility and acceptability of a microbicide. The research also aims to determine how relationships between study staff (as health care providers) and trial participants may have an impact on participants’ perceptions, experiences, and use of a microbicide. Additional objectives of the research are identifying the issues that may affect future microbicide use from the point of view of service providers, improving data collection instruments and educational materials related to behavioral aspects of microbicide trials, and informing messages for product introduction.

At each of the three study sites, in-depth interviews and focus group discussions will be conducted with a sample of women who participated in the Carraguard trial. Male partners will also be asked to participate in focus group discussions to gauge men's perception about microbicides in the context of actual use. In-depth interviews will also be conducted with study nurses and counselors to explore their perceptions about talking to women about their sexual behavior and practices; understanding of issues that trial participants may find difficult to raise with study staff and why; and perceptions of challenges participants faced with regard to study product compliance.

The need to conduct research with actual microbicide users that will provide insight into the complexities of use of a real microbicide is of paramount importance to the field of microbicide development and to HIV-prevention strategies generally. This study will provide an opportunity to explore the dynamics of use and the attributes of actual microbicide products; the social, cultural, and sexual norms and practices that may have an impact on the acceptability and use of microbicides; and the potential impact of relationships with service providers. The experiences of participants will provide important insights to inform the microbicide field broadly about what attributes are more acceptable for microbicide formulations, and also will assist in the appropriate choice of placebos for trials.

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Population Council researchers

Sharon Abbott, Barbara Friedland

Non-Council collaborators

Alana de Kock, Phyllis Orner (School of Public Health and Family Medicine, University of Cape Town, Women’s Health Research Unit)

Neetha Morar (Medical Research Council, HIV Prevention Research Unit, Durban)

Vuyelwa Mtimkulu, University of Limpopo/Medunsa campus, Setshaba Research Center, Soshanguve

Donor

International Partnership for Microbicides

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