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

September 10, 2012 updated by: Neal Halsey, Johns Hopkins Bloomberg School of Public Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
      • Lima, Peru
        • NGO Via Libre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 26 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody Response to HPV Vaccine for HPV 6,11,16,18.
Time Frame: 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.
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.
Time Frame: 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.
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
Time Frame: Baseline
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
Time Frame: 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.
Month 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Merck Sharp & Dohme LLC
Universidad Peruana Cayetano Heredia
NGO Via Libre

Investigators

  • Principal Investigator: Neal Halsey, MD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 3, 2009

First Submitted That Met QC Criteria

June 19, 2009

First Posted (Estimate)

June 22, 2009

Study Record Updates

Last Update Posted (Estimate)

October 11, 2012

Last Update Submitted That Met QC Criteria

September 10, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Merck IISP 35706
  • IRB00001625

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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