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

Johns Hopkins Bloomberg School of Public Health200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

200

Conditions

Human Papillomavirus Infection

Interventions

GardasilBIOLOGICAL

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 26 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

NGO Via Libre

Lima, Lima Province, Peru

Outcomes

Primary Outcomes

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.

Time frame: 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.

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: Baseline

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.

Time frame: Month 0

Data from ClinicalTrials.gov

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