The primary objectives of this study are to determine the acceptance and potential for the effective use of HPV vaccine in the standard and in a modified schedule in female sex workers of different ages. Secondary objectives include ascertaining the prevalence of HPV types among female sex workers by age and sexual experience. We will identify concerns or problems that could interfere with the acceptance and effectiveness of HPV vaccine in this underserved population. In order to achieve these goals we will undertake a combination of a cross-sectional study of HPV prevalence in brothel based FSWs and a prospective open label randomized trial of the acceptance of HPV vaccine administered at different times. At baseline, HPV prevalence and cytology will be measured by Thin prep Pap test among participating females attending STI clinics with a physician administered Pap smear and collection of serum antibody. Correlation of HPV infection with history of sexual partners will be examined. Women with abnormal cytology will be referred to an Obstetrics and Gynecology specialist. Participants will be randomized to receive HPV vaccine according to-the standard schedule (0, 2, 6 months) or the modified schedule (0, 3, 6 months). Antibody to HPV types 6, 11, 16 and 1 a will De measured among FSWs at baseline and at one month follow-up (month seven), then stratified by age to determine the subtype prevalence and estimated prevalence of infection by age. Geometric mean titer of antibody will be measured at month 7 and compared between the two schedules. A behavioral survey will be administered at baseline and upon follow-up at month 7 to collect information on barriers to vaccination and other relevant data including awareness of HPV, STI history, age, condom use, reported pregnancies, contraceptive use, time in sex work, and number of clients per week. FSWs are at higher risk of HPV infection and presumably cervical cancer, and now a vaccine is available that has been shown to protect against persistent infection. Assuming the vaccine induces high response rates, offering vaccination at the time of beginning sex work in the brothels could substantially decrease HPV risk among FSWs and their clients. This study will help us determine the practicality of HPV vaccination in FSWs and evaluate the effectiveness of administering vaccine at the convenient (0, 3, 6 month) schedule.

Public Health Relevance

My overall career goal is to work in disease control and prevention at both the domestic and international level. In order to accomplish this, I understand that both coursework and direct experience are required. As a second year doctoral student in global disease epidemiology and control, I have already completed my classroom preparation to conduct independent research studies. I would like to concentrate on working with vulnerable and underserved populations, and most recently my main interests have included the use of vaccines. This training will enable me to gain experience in leading a scientific study whose outcome is to increase the health and well being of vulnerable individuals. In preparation for the study, I have written a draft of my full application, as well as a budget and considered staffing issues all of which I will encounter in my career as a principal investigator of my own studies. Even applying for the NRSA application has given me experience in grant writing. Since my study will include formation of a survey, and working with a community advisory board, I will gain much more experience in behavioral health, which has been a continued interest. During this study, I will develop further my management, analysis, and teamwork skills that I will need to excel and conduct research projects both domestically and overseas. It is my hope to complete the PhD program in approximately 4 years time, by early 2010, and subsequently begin writing several grants and managing my own studies. These projects will include HPV and other health related areas of interest including drug use, HIV, HTLV, condom use, male circumcision and obesity. My current desire is to conduct unique research and be the member of a team as a public health advisor at the World Health Organization, but I understand there will be several opportunities open to me at the completion of my degree.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Predoctoral Individual National Research Service Award (F31)
Project #
1F31AI080187-01A1
Application #
7754759
Study Section
Special Emphasis Panel (ZRG1-RPHB-K (29))
Program Officer
Adger-Johnson, Diane S
Project Start
2009-09-04
Project End
2011-09-03
Budget Start
2009-09-04
Budget End
2010-09-03
Support Year
1
Fiscal Year
2009
Total Cost
$41,176
Indirect Cost
Name
Johns Hopkins University
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218