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

Primary Purpose

Human Papillomavirus Infection

Status
Completed
Phase
Phase 4
Locations
Peru
Study Type
Interventional
Intervention
Gardasil
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Papillomavirus Infection focused on measuring Female sex worker, Peru, Cervical infection, Cervical abnormality, Serum antibody, Vaccine acceptance, Alternative schedule, Viral infections, Human papillomavirus vaccine, Human papillomavirus (HPV), non inferiority

Eligibility Criteria

18 Years - 26 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • NGO Via Libre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Regular schedule

Modified Schedule

Arm Description

Duration: Gardasil HPV vaccine administered intramuscularly at 0,2,6 months

Duration: Gardasil HPV vaccine administered intramuscularly at 0,3,6 months

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 3, 2009
Last Updated
September 10, 2012
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Merck Sharp & Dohme LLC, NGO Via Libre, Universidad Peruana Cayetano Heredia
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1. Study Identification

Unique Protocol Identification Number
NCT00925288
Brief Title
Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers
Acronym
Girasol
Official Title
Acceptability and Feasibility of a Modified HPV Vaccine Schedule in Brothel Based Female Sex Workers in Peru
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Merck Sharp & Dohme LLC, NGO Via Libre, Universidad Peruana Cayetano Heredia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papillomavirus Infection
Keywords
Female sex worker, Peru, Cervical infection, Cervical abnormality, Serum antibody, Vaccine acceptance, Alternative schedule, Viral infections, Human papillomavirus vaccine, Human papillomavirus (HPV), non inferiority

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regular schedule
Arm Type
Active Comparator
Arm Description
Duration: Gardasil HPV vaccine administered intramuscularly at 0,2,6 months
Arm Title
Modified Schedule
Arm Type
Experimental
Arm Description
Duration: Gardasil HPV vaccine administered intramuscularly at 0,3,6 months
Intervention Type
Biological
Intervention Name(s)
Gardasil
Other Intervention Name(s)
Human Papillomavirus Quadrivalent Vaccine
Intervention Description
Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses
Primary Outcome Measure Information:
Title
Antibody Response to HPV Vaccine for HPV 6,11,16,18.
Description
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.
Time Frame
Month 7
Title
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.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers
Description
Type specific prevalence of HPV6,11,16,18 among study participants, calculated using Linear Array testing.
Time Frame
Baseline
Title
Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers
Description
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.
Time Frame
Month 0

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Halsey, MD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NGO Via Libre
City
Lima
Country
Peru

12. IPD Sharing Statement

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

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