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

Human Papillomavirus Infection Clinical Trial

— Girasol  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925288
• Other study ID #: Merck IISP 35706
• Secondary ID: IRB00001625
• Status: Completed
• Phase: Phase 4
• First received: June 3, 2009
• Last updated: September 10, 2012
• Start date: October 2009
• Est. completion date: August 2011

Study information

• Verified date: September 2012
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 26 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

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

Locations

Country	Name	City	State
Peru	NGO Via Libre	Lima

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Merck Sharp & Dohme Corp., NGO Via Libre, Universidad Peruana Cayetano Heredia

Country where clinical trial is conducted

Peru, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No