Women's Attitudes Towards Microbicides And Clinical Trials

Marjan Hezareh, AIDS Research Alliance; Joelle Brown, UC Los Angeles
Basic-Applied Clinical

Relevance of Proposed Project to HIV/AIDS prevention Early in the epidemic, HIV infection and AIDS were diagnosed for relatively few women. Today, women account for more than one quarter of all new HIV/AIDS diagnoses in the United States (U.S.). While HIV/AIDS affects people of all racial and ethnic populations, HIV/AIDS continues to disproportionately affect minorities. Understanding the social context for sexual risk taking behaviors among women, particularly women of diverse ethnicities, will help investigators design appropriate HIV prevention interventions.

In the U.S. and in California, more than three-quarters of all adult HIV infections have resulted from heterosexual intercourse. Women are particularly vulnerable - both biologically and socially - to heterosexual transmission of HIV and thus, microbicide products that women could electively use, instead of depending on male use of condoms, hold great promise as an HIV prevention strategy.

The majority of candidate microbicides are currently being formulated as gels, which will act as lubricants when used during sex. Preferences and practices regarding lubrication during sex, therefore, will likely influence microbicide acceptability and use. Currently, little data are available on women's use of lubricants during sex. Data regarding women's willingness and ability to use lubricants, perceptions of risk and concerns about or experiences with side effects, behavioral choices, cost, and access are needed to identify factors that will facilitate or discourage effective microbicide use in diverse settings.

For that reason, and in the absence of an approved microbicidal product, the primary purpose of this proposed collaboration between the AIDS Research Alliance (ARA) and the University of California, Los Angeles (UCLA) will be to investigate vaginal and rectal lubricant use among an ethnically diverse population of women in Los Angeles, and to simultaneously enhance HIV prevention research capacity at ARA.

Specific Aims: This collaboration aims to enhance ARA's capacity to conduct HIV prevention research in the following ways: (1) Development of specific strategies to recruit and retain an ethnically diverse population of women; (2) Experience conducting qualitative research and analyses; (3) Proficiency in Interactive Voice Recognition (IVR) telephone surveys; and (4) Development of expertise in STI testing and counseling.

In addition to the above capacity-strengthening objectives, this proposed collaboration will simultaneously enable researchers at ARA and UCLA to answer timely and important questions relevant to HIV prevention research among women. Specifically, we will measure the (1) Frequency of vaginal and rectal lubricant use; (2) Cultural, interpersonal, and individual issues that influence the practice of lubricant use; (3) Frequency and distribution of high risk sexual behaviors; (4) Feasibility of conducting a microbicide trial in this population, measured by the incidence of HIV and STIs, participant retention, and attitudes toward study-related procedures.

Methods: This proposed study consists of a cross-sectional qualitative evaluation among 30 ethnically diverse women who will participate in an in-depth interviews (IDI), and an observational cohort of 200 women followed once every four months for one year who will complete quantitative assessments at each study visit, and will be tested for HIV and STIs at enrollment and after one year.