Clinical trial · Interventional
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
NCT00925288CI-TRIAL-00008250GirasolcompletedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gardasil | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Regular schedule
- description
- Duration: Gardasil HPV vaccine administered intramuscularly at 0,2,6 months
- interventionNames
- Biological: Gardasil
- type
- EXPERIMENTAL
- label
- Modified Schedule
- description
- Duration: Gardasil HPV vaccine administered intramuscularly at 0,3,6 months
- interventionNames
- Biological: Gardasil
Primary outcomes (2)
- measure
- Antibody Response to HPV Vaccine for HPV 6,11,16,18.
- timeFrame
- Month 7
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 26 Years
Show eligibility criteria text
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
References
Publications (33)
- BACKGROUNDde Sanjose S, Diaz M, Castellsague X, Clifford G, Bruni L, Munoz N, Bosch FX. Worldwide prevalence and genotype distribution of cervical human papillomavirus DNA in women with normal cytology: a meta-analysis. Lancet Infect Dis. 2007 Jul;7(7):453-9. doi: 10.1016/S1473-3099(07)70158-5. PMID 17597569
- BACKGROUNDMak R, Van Renterghem L, Cuvelier C. Cervical smears and human papillomavirus typing in sex workers. Sex Transm Infect. 2004 Apr;80(2):118-20. doi: 10.1136/sti.2002.003749. PMID 15054172
- BACKGROUNDJuarez-Figueroa LA, Wheeler CM, Uribe-Salas FJ, Conde-Glez CJ, Zampilpa-Mejia LG, Garcia-Cisneros S, Hernandez-Avila M. Human papillomavirus: a highly prevalent sexually transmitted disease agent among female sex workers from Mexico City. Sex Transm Dis. 2001 Mar;28(3):125-30. doi: 10.1097/00007435-200103000-00001. PMID 11289192
- BACKGROUNDFord K, Reed BD, Wirawan DN, Muliawan P, Sutarga M, Gregoire L. The Bali STD/AIDS study: human papillomavirus infection among female sex workers. Int J STD AIDS. 2003 Oct;14(10):681-7. doi: 10.1258/095646203322387947. PMID 14596772
- BACKGROUNDdel Amo J, Gonzalez C, Losana J, Clavo P, Munoz L, Ballesteros J, Garcia-Saiz A, Belza MJ, Ortiz M, Menendez B, del Romero J, Bolumar F. Influence of age and geographical origin in the prevalence of high risk human papillomavirus in migrant female sex workers in Spain. Sex Transm Infect. 2005 Feb;81(1):79-84. doi: 10.1136/sti.2003.008060. PMID 15681729
- BACKGROUNDCanadas MP, Bosch FX, Junquera ML, Ejarque M, Font R, Ordonez E, de Sanjose S. Concordance of prevalence of human papillomavirus DNA in anogenital and oral infections in a high-risk population. J Clin Microbiol. 2004 Mar;42(3):1330-2. doi: 10.1128/JCM.42.3.1330-1332.2004. PMID 15004111
- BACKGROUNDKjaer SK, Svare EI, Worm AM, Walboomers JM, Meijer CJ, van den Brule AJ. Human papillomavirus infection in Danish female sex workers. Decreasing prevalence with age despite continuously high sexual activity. Sex Transm Dis. 2000 Sep;27(8):438-45. doi: 10.1097/00007435-200009000-00003.