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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acceptability and Feasibility of a Modified HPV Vaccine Schedule in Brothel Based Female Sex Workers in Peru

Conditions
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Human Papillomavirus Infection

Intervention / Treatment
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* Biological: Gardasil


Participation Criteria
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Eligibility Criteria
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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: Currently pregnant or planning to get pregnant in the next six months Known immune deficiency disorder Current receipt of immunosuppressive drugs Allergy to yeast or known contraindication to HPV vaccine Women who have had their cervix removed Previous HPV vaccination Current fever over 100 degrees Fahrenheit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regular schedule<br>Duration: Gardasil HPV vaccine administered intramuscularly at 0,2,6 months | Biological: Gardasil<br>* Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses<br>* Other names: Human Papillomavirus Quadrivalent Vaccine;|
| Experimental: Modified Schedule<br>Duration: Gardasil HPV vaccine administered intramuscularly at 0,3,6 months | Biological: Gardasil<br>* Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses<br>* Other names: Human Papillomavirus Quadrivalent Vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody Response to HPV Vaccine for HPV 6,11,16,18. | 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. | Month 7 | 
| 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. | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers | Type specific prevalence of HPV6,11,16,18 among study participants, calculated using Linear Array testing. | Baseline | 
| Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers | 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. | Month 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Female sex worker, Peru, Cervical infection, Cervical abnormality, Serum antibody, Vaccine acceptance, Alternative schedule, Viral infections, Human papillomavirus vaccine, Human papillomavirus (HPV), non inferiority