Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers

Phase 4

Completed

Brief Summary: The primary objectives of this study are to determine the acceptance and potential for the effective use of HPV vaccine in the standard and a modified schedule in female sex workers. Secondary objectives include ascertaining the prevalence of HPV types among female sex workers by age and sexual experience.

Detailed Description: FSWs are at higher risk of HPV infection and presumably cervical cancer, and the recently available vaccine has been shown to protect against persistent infection from these types. If this study gives evidence showing the vaccine is acceptable in preventing cervical HPV infection by types 16 and 18 in this population, then the burden of cervical cancer and cancer precursors could be drastically decreased through widespread vaccination of this target group. Vaccination at the point of entry of brothel based sex work may become a requirement to lower the burden of cervical cancer among FSWs and also among all other sex partners of clients of FSWs. A modified schedule may prove beneficial for FSWs in Peru to complete the vaccine regimen.

Recruitment & Eligibility

Inclusion Criteria

Between the age of 18 and 26 years
Registered female sex worker living in Lima
Healthy with no known immune deficiency
Willing to participate in a study of HPV vaccine including a Pap smear, three pregnancy tests, blood draws, and three vaccine administrations over 7 months
Willing to provide informed consent

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Modified Schedule	Gardasil	Duration: Gardasil HPV vaccine administered intramuscularly at 0,3,6 months
Regular schedule	Gardasil	Duration: Gardasil HPV vaccine administered intramuscularly at 0,2,6 months

Primary Outcome Measures

Name	Time	Method
Antibody Response to HPV Vaccine for HPV 6,11,16,18.	Month 7	We measured anitbody response to HPV vaccine for HPV subtypes 6,11,16, and 18. This was compared by study arm, namely the regular and modified vaccination schedules.
Proportion of Female Sex Workers Who Complete the Three Dose (0, 2, 6 Month) HPV Schedule in a Timely Manner Compared to the Modified (0, 3, 6 Month) Schedule.	6 months	Completion of 3 doses of HPV4 vaccine was measured at 6 months for women receiving the vaccine in 0,2,6 month regimen or the modified 0,3,6 month regimen. Completion was measured as receiving dose 3 of the vaccine during the study.

Secondary Outcome Measures

Name	Time	Method
Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers	Month 0	Listed doubts about the HPV vaccine. Participants were asked if they had any doubts about the vaccine prior to learning about it from the health professional. Herein we present the total number of participants who reported doubts by study arm.
Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers	Baseline	Type specific prevalence of HPV6,11,16,18 among study participants, calculated using Linear Array testing.