We propose a three-year multidimensional project that includes a short-term, prospective study of women randomly assigned to two forms of spermicides (gel and suppository), and of women who participate and decline to participate in an STD clinical trial of a spermicidal gel. Prior to the randomized study, we will conduct qualitative research (N=216) to explore the factors related to choice and use of vaginal spermicides and microbicides, to identify the factors relevant to the choice of microbicides versus condoms or nonuse, and to help construct more valid instruments to be used in quantitative studies. The questionnaires will be used to measure the acceptability of vaginal microbicides and associated factors before women use their randomly assigned method and a month afterwards. We will enroll three groups whose future microbicide use could have major impact on the incidence of STDs: higher risk adult women from an STD clinic (N=460); lower risk adults from a public family planning clinic (N=460); and sexually active teenagers from both clinics (N=460). Comparing these groups on various acceptability measures and associated factors will give us a broader understanding of the likelihood of use in a larger at-risk population. The proposed research has six specific aims: To increase understanding of the factors affecting choice and use of methods, including vaginal gels and suppositories and condoms, to protect against STDs and HIV/AIDS; To develop better measures for studying acceptability of STD prevention methods and construct a more valid instrument for measuring acceptability; To measure the acceptability of vaginal spermicides (a gel and suppository) before use (t1) and after use (t2), compare their acceptability at both time points across the three risk groups, and examine change in acceptability after actual use; To determine whether the gel or suppository is the preferred delivery system for each of the three risk groups, using both attitudinal and behavioral measures; To investigate direct comparisons of the gel and suppository, and probe in-depth the reason for their likely use or nonuse; and , To determine the extent to which women participating in a typical STD clinical trial represent a broader population of potential microbicide users.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD040141-02
Application #
6388272
Study Section
Special Emphasis Panel (ZHD1-DRG-D (05))
Program Officer
Newcomer, Susan
Project Start
2000-09-30
Project End
2003-08-31
Budget Start
2001-09-01
Budget End
2002-08-31
Support Year
2
Fiscal Year
2001
Total Cost
$699,964
Indirect Cost
Name
Research Triangle Institute
Department
Type
DUNS #
131606022
City
Research Triangle Park
State
NC
Country
United States
Zip Code
27709