Clinical trial NCT01788852: HPV in Adolescents
Official title: Prevalence of HPV and Intraepithelial Neoplasia Biomarkers in Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV Infection
Cervical/Anal Dysplasia
Keywords: HPV
HIV
cervical/anal dysplasia
intraepithelial neoplasia
E6/E7 biomarker
perinatally HIV-infected adolescents
behaviorally HIV-infected adolescents
anal and pap smear
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: Thai Red Cross AIDS Research Centre
name: Chulalongkorn University
name: SEARCH Research Foundation
name: We Understand Group
name: TREAT Asia
First posted: 2013-02-11
Enrollment: 27
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 60 sexually active adolescents (perinatally and behaviorally HIV-infected adolescents, HIV negative adolescents) aged 12-24 will be recruited from the HIV-NAT and TRC Anonymous Clinic

Brief summary: This study will assess the prevalence of HPV infection in perinatally HIV-infected adolescents, intraepithelial neoplasia, and E6E7 biomarker at cervical and anal sites.

Detailed description: Human Papillomavirus (HPV) is the most common sexually transmitted disease and it causes cervical and anal cancer. Prevalence and incidence of HPV infection among young adults who are sexually experienced is high. No data exist for HIV-positive adolescents in regards to HPV infection, cervical and anal intraepithelial neoplasia. This study will compare the prevalence of HPV infection, intraepithelial neoplasia and E6/E7 biomarker at cervical and anal sites among perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents, and HIV-negative adolescents.

Eligibility criteria: Inclusion Criteria:

* Perinatally-infected (documented positive HIV enzyme immunoassay (EIA) or nucleic acid testing (NAT) at any time and history of maternal HIV infection)
* behaviorally-infected (documented positive HIV enzyme immunoassay (EIA) or nucleic acid testing (NAT) at any time after sexual debut without history of maternal HIV infection)
* female with vaginal or receptive anal intercourse with a male OR male with receptive rectal intercourse with another male
* Signed informed consent. Volunteers aged 12-17 years can decide whether they wish for their parents to consent for their participation. Due to the confidential nature of the issues being studied, parental consent may be exempted

Exclusion Criteria:

* Have any conditions that may interfer with subjects' ability to understand and consent to the study

Primary outcomes:
measure: HPV infection
timeFrame: 48 weeks
Secondary outcomes:
measure: intraepithelial neoplasia
timeFrame: 48 weeks
measure: E6/E7
timeFrame: 48 weeks
measure: HPV vaccine
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Pediatrics, Chulalongkorn University
city: Bangkok
country: Thailand
facility: HIV-NAT
city: Bangkok
country: Thailand
facility: Thai Red Cross - Anonymous Clinc
Study officials:
affiliation: The HIV Netherlands Australia Thailand Research Collaboration
name: Jintanat Ananworanich, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thai Red Cross AIDS Research Centre
name: Nittaya Phanuphak, MD
role: PRINCIPAL_INVESTIGATOR
References: