Infections

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Communicable Diseases

Papillomavirus Infections

Congenital Abnormalities

Virus Diseases

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

All Drugs and Chemicals

Antibodies

Vaccines

Immunoglobulins

Immunologic Factors

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

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

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

Gardasil

Neal Halsey, MD

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.

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.

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

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.

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.

Type specific prevalence of HPV6,11,16,18 among study participants, calculated using Linear Array testing.

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.

Merck Sharp & Dohme LLC

NGO Via Libre

Universidad Peruana Cayetano Heredia

Johns Hopkins Bloomberg School of Public Health

Professor of International Health

Regular Schedule

Modified Schedule

Total

Age, Categorical

Age Continuous

Sex: Female, Male

Peru

Region of Enrollment

Small time difference between study arms (0,2,6 and 0,3,6 months); We cannot distinguish between antibodies resulting from vaccination and antibodies resulting from natural HPV infection;

Dr. Brandon Brown

The null hypothesis is that both schedules will provide an equivalent antibody response.

HPV 6

HPV11

HPV16

HPV18

All participants who returned for the final blood draw considered in the final antibody analysis. The analysis applies to antibody levels after vaccination for HPV6, HPV11, HPV16, and HPV18. This is done for each study arm, namely the regular schedule and the modified schedule.

Antibody Response to HPV Vaccine for HPV 6,11,16,18.

Completion rates compared in the 2 study arms

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.

comparison of differences in HPV DNA prevalence by study arm.

All participants were included in the analysis for baseline HPV DNA prevalence

Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers

All participants who listed doubts about the vaccine are counted here.

Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers

Duration: 0,2,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age

Duration: 0,3,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age

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