MICROBICIDE DEVELOPMENT PROGRAM

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Introduction: The proposed research study is a cross-sectional, observational, single-visit study of 896 men and women in Los Angeles, California, and Baltimore, Maryland, including: (1) a computer-assisted interview focusing on the behavioral repertoire surrounding receptive anal intercourse (RAI), anal symptomology, and a multidimensional assessment of behaviors, (2) an anorectal examination, and (3) testing for HIV and sexually transmitted infections (STIs). The overall aim of the study is to collect descriptive data regarding anal sexual behaviors and anal health for both women and men in order to provide baseline information for the future study and development of rectal microbicides. Background & Rationale: Los Angeles and Baltimore are cities with large epidemics of STIs and HIV that are in need of alternative methods of prevention to condom use. Rectal microbicides have great potential in these environments to impact their thriving HIV epidemics. Anal intercourse is a sexual practice with high probability of transmission of STIs and HIV, however, there is little descriptive data about factors that may affect infection transmissibility during intercourse. Descriptive baseline data will be needed in order to adequately design interventions that aim to reduce infection transmissibility through the use of novel prevention methods, such as rectal microbicides. There have been few clinical trials on rectal microbicides and mixed findings from the few existing studies. Research may better characterize the different circumstances that may arise given the types of partnerships in which the product is used (i.e. steady partners vs. non-steady partners), physical locations (home vs. outside the home), and circumstances in which sex is performed, that may restrict methods of administration of the product. Formative research is needed to explore perceptions of the utility and self-efficacy of using rectal microbicides outside of an ongoing partnership and the dynamics of situations in which sex occurs. Study Questions (Objectives): Objective 1: To describe behavioral features of anal intercourse that will affect microbicide utilization and administration. There is a dearth of observational data on the behaviors surrounding anal intercourse. We propose to describe physical and mechanical details of behaviors surrounding anal intercourse of 448 men who report practice of receptive anal intercourse (RAI) in the past month and 448 women who report practice of RAI in the past 12 months, including both HIV-positive and negative subjects. Objective 2: To assess the level of and predictive accuracy of reported anal symptomology among women and men who practice anal intercourse and the effect of anal coitus on symptoms. Study Population: 896 adults will be recruited for participation in Baltimore, Maryland, and Los Angeles, California, over a four year period. The sample will include 448 men and 448 women aged 18 or older. Subjects meeting study eligibility criteria will be sorted into 1 of 8 study groups, based on gender, sexual practice, and HIV status. Outcome Measures: This is an observational study. We will establish baseline anorectal symptomology related to sexual activity, compare reports between groups and correlate with clinical diagnoses, including infections. Aspects of anal intercourse will be compared by gender, partner type, location of sex, and HIV status.