The objective of this study is to evaluate acceptability of topical microbicide use for STD prevention among young women from middle adolescence to early adulthood. This project has an integrated methodological approach and makes use of the Biostatistical and Clinical Cores of the CRC proposal. This proposal examines developmental, behavioral, and attitudinal issues relevant to microbicide acceptability.
Specific Aims : 1. To assess acceptability as a function of relationship status and different age cohorts across adolescence and young adulthood, including examinations of relationship quality, self-efficacy, and microbicide characteristics as predictors of acceptability. 2. To assess developmental changes in acceptability of topical microbicides over a 4-year time span. 3. To assess acceptability through field trials of a vaginal moisturizer among older adolescents and young adults. Methods: The first specific aim will involve cross-sectional analyses of in-person interviews with partner-specific questions about microbicide acceptability. The second specific aim trill involve longitudinal analysis of the same interview data. Microbicide acceptability will be measured by participant ratings of 14 described microbicides, each uniquely defined along 4 dimensions: 1) timing of application in relation to coitus; 2) vehicle texture; 3) contraceptive action; and efficacy. The third specific aim will be accomplished through the use of daily diary collection in which participants will indicate their reactions to the use of the vaginal moisturizer. 150 young women at high risk for STD are expected to participate for lims 1 and 2 and 100 women to participate for aim 3. The study protocol involves baseline and quarterly in-person interviews for 48 months, baseline and yearly self-report questionnaires, and two 1-month diary periods per year for 3 years. Significance: the work has the potential to inform, methodologically, the structure and development of Phase 2 and 3 clinical trials for microbicides among adolescents.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
5U19AI031494-16
Application #
7270407
Study Section
Special Emphasis Panel (ZAI1)
Project Start
Project End
Budget Start
2006-08-01
Budget End
2007-07-31
Support Year
16
Fiscal Year
2006
Total Cost
$134,504
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Type
DUNS #
603007902
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
Hensel, Devon J; Nance, Jennifer; Fortenberry, J Dennis (2016) The Association Between Sexual Health and Physical, Mental, and Social Health in Adolescent Women. J Adolesc Health 59:416-21
Hensel, Devon J; Selby, Sarah; Tanner, Amanda E et al. (2016) A Daily Diary Analysis of Condom Breakage and Slippage During Vaginal Sex or Anal Sex Among Adolescent Women. Sex Transm Dis 43:531-6
Hensel, Devon J; Tanner, Amanda E; Sherrow, Ashley et al. (2016) A longitudinal daily diary analysis of condom use during bleeding-associated vaginal sex among adolescent females. Sex Transm Infect 92:337-9
Singer, Martin; Li, Wei; Morré, Servaas A et al. (2016) Host Polymorphisms in TLR9 and IL10 Are Associated With the Outcomes of Experimental Haemophilus ducreyi Infection in Human Volunteers. J Infect Dis 214:489-95
van Rensburg, Julia J; Lin, Huaiying; Gao, Xiang et al. (2015) The Human Skin Microbiome Associates with the Outcome of and Is Influenced by Bacterial Infection. MBio 6:e01315-15
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Li, Zhuokai; Liu, Hai; Tu, Wanzhu (2015) A sexually transmitted infection screening algorithm based on semiparametric regression models. Stat Med 34:2844-57
Janowicz, Diane M; Zwickl, Beth W; Fortney, Kate R et al. (2014) Outer membrane protein P4 is not required for virulence in the human challenge model of Haemophilus ducreyi infection. BMC Microbiol 14:166
Best, Candace; Tanner, Amanda E; Hensel, Devon J et al. (2014) Young women's contraceptive microbicide preferences: associations with contraceptive behavior and sexual relationship characteristics. Perspect Sex Reprod Health 46:15-22
Batteiger, Byron E; Wan, Raymond; Williams, James A et al. (2014) Novel Chlamydia trachomatis strains in heterosexual sex partners, Indianapolis, Indiana, USA. Emerg Infect Dis 20:1841-7

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