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Project 3 Summary & Aims

Project 3 Summary

Rectal health, behaviors and product acceptability.

Anal intercourse is a widely practiced behavior. There is substantial epidemiological data on its practice and association with sexually transmitted infections (STI) for men. Substantially less is known about heterosexual anal intercourse practices, but it is highly prevalent. Development of rectal microbicides will be guided by providing descriptive data on anal sex, anal health, and the acceptability of carrier methods for rectal microbicides. Such fundamental information is crucial for understanding anal microbicide acceptability and use effectiveness.
Specific Aim #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. The physical and mechanical details of behaviors surrounding anal intercourse of 224 men who report practice of receptive anal intercourse (RAI) in the past month and 224 women who report practice of RAI in the past 12 months, including both HIV-positive and negative subjects, will be described. All subjects will undergo a computer assisted interview to assess behaviors such as physical position, preparation activities, and post-coital movements involved in anal intercourse as well as peri-sexual behaviors such as anal hygiene practices, penetration site sequencing, and lubrication usage. These aspects of anal intercourse will be compared by gender, partner type, location of sex, and HIV status.

Specific Aim #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. Little research has been conducted during the AIDS era on the relationship of sexual practices to anorectal symptoms and clinical diagnoses, including infections. This information will be critical in discriminating between anal symptoms related to RAI and those caused by adverse effects of microbicides. We propose to assess these relationships among 896 women and men (the 448 men and women described in Aim #1 as well as an additional 224 men and 224 women who do not report practice of RAI). We will establish baseline anorectal symptomatology and compare reports between groups and correlate with diagnoses. It is hypothesized that: (i) individuals who report RAI will report more anal symptoms than individuals who do not practice RAI; (ii) more individuals who report RAI will have clinical signs of anorectal conditions than individuals who do not report RAI and (iii) individuals who report RAI will have a higher prevalence of anorectal STI’s than individuals who do not report RAI.

Specific Aim #3.

Quantify the acceptability of five different formulation types of anorectal products among target populations to prioritize formulation options for delivering a potential rectal microbicide in a pre-sex context. A subset of individuals recruited for Aims 1 and 2 who report regular RAI will be recruited for a study of acceptability of microbicide carrier formulation, application methods and mechanical aspects of microbicide use. They will be asked to sequentially experiment with different candidate microbicide delivery devices and application techniques and report on their use.

Project 3 Aims: Milestones

Project Specific Aim Milestone Date Completion Anticipated Before Year 2.5 Review (10/06)
Project 3      
  Aims 1 & 2: Anal health and behavior study    
  Subject enrollment starts 04/05 Yes
  Last subject out 07/08  
  Preliminary study report completed 06/09  
  Aim 3: Microbicide acceptability study    
  Subject enrollment starts 08/07  
  Last subject out 11/08  
  Preliminary study report completed 05/09