A recent federal report suggested that rigorous tests of condom effectiveness against sexually transmitted infections (STIs) are urgently needed. 1 To date, published studies have not described tests of condom effectiveness. Further, a search of the CRISP database revealed that studies of condom effectiveness have not yet been funded. The proposed study uses an innovative approach to testing condom effectiveness against penile-vaginal acquisition of a) Chlamydia, b) trichomoniasis, and c) any of three non-viral STIs (Chlamydia, trichomoniasis, and gonorrhea) (Aim 1). The negative sequelae of these infections are well documented. The infections also increase the odds of HIV acquisition and transmission. Because the protective value is highly likely to vary between men and women, the study will also test for moderating effects of sex (gender) on condom effectiveness (Aim 2). Based on a substantial amount of research conducted by the PI of the proposed study, it is also quite apparent that various forms of condom failure must be accounted for in tests of condom effectiveness. Therefore the study will quantify the loss of protective value attributable to these sources of failure (Aim 3). A final study aim is to determine the loss of protective value incurred as the frequency of condom use decreases from 100% (Aim 4). The sample will be 625 men and 625 women (>15 years of age) attending one of two clinics for the evaluation and treatment of an STI. Participants will be followed over 6 months. After initially being tested (using DNA amplification) and treated (using single-dose, directly observed therapy) for existing non-viral STIs, participants will learn how to use a Personal Digital Assistant to keep an electronic coital diary over the subsequent 6 months. This innovative method of data collection helps assure optimal validity of the assessed behaviors. A brief education session will also be provided. This session will promote the correct and consistent use of condoms during the study period thereby helping to ensure that an adequate number of participants are classified as """"""""100%"""""""" users in the analyses. A 3-month follow-up screening will detect early reinfections or new infections. A 6-month follow-up period will also include re-screening for the three STIs. The study is adequately powered (>80%) to detect even modest effect sizes. Findings will be disseminated to inform public health policy and programs related to the use of condoms in the prevention of these common, non-viral STIs.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project (R01)
Project #
5R01AI068119-05
Application #
7858335
Study Section
Behavioral and Social Science Approaches to Preventing HIV/AIDS Study Section (BSPH)
Program Officer
David, Hagit S
Project Start
2006-06-15
Project End
2013-05-31
Budget Start
2010-06-01
Budget End
2013-05-31
Support Year
5
Fiscal Year
2010
Total Cost
$357,336
Indirect Cost
Name
University of Kentucky
Department
Type
Schools of Public Health
DUNS #
939017877
City
Lexington
State
KY
Country
United States
Zip Code
40506
Crosby, Richard; Graham, Cynthia; Milhausen, Robin et al. (2015) Associations between rushed condom application and condom use errors and problems. Sex Transm Infect 91:275-7
Wallace, Amanda R; Blood, Emily A; Crosby, Richard A et al. (2015) Differences in correlates of condom use between young adults and adults attending sexually transmitted infection clinics. Int J STD AIDS 26:526-33
Crosby, Richard A; Charnigo, Richard; Shrier, Lydia A (2014) Prospective associations between perceived barriers to condom: use and ""perfect use"". Am J Prev Med 47:70-2
Crosby, Richard A; Milhausen, Robin R; Graham, Cynthia A et al. (2014) Likelihood of Condom Use When Sexually Transmitted Diseases Are Suspected: Results From a Clinic Sample. Health Educ Behav 41:449-54
Crosby, Richard; Shrier, Lydia A (2013) A partner-related risk behavior index to identify people at elevated risk for sexually transmitted infections. J Prim Prev 34:81-7
Crosby, R; Charnigo, R J (2013) A comparison of condom use perceptions and behaviours between circumcised and intact men attending sexually transmitted disease clinics in the United States. Int J STD AIDS 24:175-8
Crosby, R; Shrier, L A; Charnigo, R et al. (2013) Negative perceptions about condom use in a clinic population: comparisons by gender, race and age. Int J STD AIDS 24:100-5
Crosby, Richard; Shrier, Lydia A; Charnigo, Richard J et al. (2012) A prospective event-level analysis of condom use experiences following STI testing among patients in three US cities. Sex Transm Dis 39:756-60
Crosby, Richard A; Charnigo, Richard A; Weathers, Chandra et al. (2012) Condom effectiveness against non-viral sexually transmitted infections: a prospective study using electronic daily diaries. Sex Transm Infect 88:484-9