CompletedPhase 4

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

Peru200 participantsStarted 2009-10

Plain-language 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.

Who can participate

Age range

18 Years – 26 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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.

Timeframe: 6 months

Trial details

NCT IDNCT00925288

SponsorJohns Hopkins Bloomberg School of Public Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-08

Results submitted2012-07-03

View on ClinicalTrials.gov More Human Papillomavirus Infection trials