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OpenTrials
Completed

NCT Number: NCT00925288

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

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.

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Key information

Conditions

Human Papillomavirus Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year–26 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

NGO Via Libre

Lima, Lima Province, Peru

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GARDASIL

Biological

Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses

Other names: Human Papillomavirus Quadrivalent Vaccine

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Girasol

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 22, 2009
Registry last updated
Oct 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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