None listed
Conditions
Interventions
Regular scheme Type of group
Gardasil HPV 0.5ml suspension administered intramuscularly at 0,2,6 months
Group name:Modified Scheme Type of group
Gardasil HPV 0.5ml suspension administered intramuscularly at 0, 3, 6 months
Sponsors
Johns Hopkins University,
Eligibility
Sex/Gender
Female
Age
18 Years to 26 Years
Inclusion criteria
Inclusion criteria: • Be between 18 and 26 years old, • Be a registered sex worker who lives in Lima, • Be in good health and not have an immune deficiency, • Be willing to participate in an HPV vaccine study that will include the Pap test, three pregnancy tests, blood shots, and three vaccine administrations for 7 months • Be willing to give informed consent.
Exclusion criteria
Exclusion criteria: • Being pregnant or planning to get pregnant in the next seven months, • Have a known immune deficiency or be a current recipient of immunosuppressive drugs, • Have a known yeast allergy or some other contraindication for the HPV vaccine, • Not have a cervix • Have received HPV vaccination, and • Have a temperature greater than 38 degrees Celsius
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Antibody Response to HPV Vaccine for HPV 6,11,16,18. Timepoints:Month 7 ; Outcome name: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. Measure: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. Timepoints:6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Type specific prevalence of HPV6,11,16,18 among study participants, calculated using Linear Array testing. Measure:Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers Timepoints:Baseline ; Outcome name: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. Measure:Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers Timepoints:Month 0 | — |
Countries
Peru
Contacts
Public ContactMagaly Blas
Asociacion VIA LIBRE
Outcome results
None listed