NCT00925288

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: Female
• Age: 18 Years – 26 Years
• Healthy volunteers: Accepted

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.

Conditions

• Human Papillomavirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Gardasil	Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2009-06-22
• Last updated: 2012-10-11
• Results posted: 2012-10-11

Locations

1 site across 1 country: Peru