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. Trichomonas vaginalis (TV) is a common and understudied STI. Its detection and treatment in HIV infected women can aid in reducing vaginal viral loads and possible subsequent partner infection. While treatment is currently available to patients, the preliminary results of recent studies suggest that the recurrence rate of TV in HIV infected women is roughly 3 times that of non-HIV infected women. Recurrence can result from many factors, but one factor may be treatment failure. This study aims to determine if the 2 gram STAT dose of metronidazole is as effective as the 7 day 500 mg BID dose for treatment for trichomoniasis among HIV-infected women, and to describe the clinical and behavioral issues that are associated with reinfection. With these study goals in mind, TV infected women will be randomized to two treatment arms in an unblinded randomized control trial. The standard of care for TV treatment is a one time dose of 2 grams of metronidazole. If this treatment fails, patients are treated with a 7 day 500mg BID dose of metronidazole. In this study, the two treatments will be compared and evaluated for effectiveness. Demographic and behavioral information will also be collected through CASI interviews, and a description of clinical and behavioral issues that are associated with reinfection will be examined. Intent-to-treat analysis will be used to assess the outcome 'treatment failure' at the 7 day follow-up, and a two-tailed analysis will be used to determine if the treatment arms are equivalent. Multivariable models will be developed to examine the second study aim, and will examine factors such as partner number, women's age, drug and alcohol usage, female dependency on a partner economically or phychologically, existence of sexual or physical violence, partner TV treatment, etc. This model will be used to describe factors associated with reinfection.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR005096-17
Application #
7376326
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2005-12-01
Project End
2006-11-30
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
17
Fiscal Year
2006
Total Cost
$16,119
Indirect Cost
Name
Tulane University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
053785812
City
New Orleans
State
LA
Country
United States
Zip Code
70118
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