HPV in Adolescents

NCT ID: NCT01788852

Last Updated: 2015-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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HPV Infection Cervical/Anal Dysplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Perinatally HIV-infected adolescents

Perinatally HIV-infected adolescents

No interventions assigned to this group

behaviorally HIV-infected adolescents

behaviorally HIV-infected adolescents

No interventions assigned to this group

HIV negative adolescents

HIV negative adolescents

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Thai Red Cross AIDS Research Centre

OTHER

Sponsor Role collaborator

Chulalongkorn University

OTHER

Sponsor Role collaborator

SEARCH Research Foundation

OTHER

Sponsor Role collaborator

We Understand Group

UNKNOWN

Sponsor Role collaborator

TREAT Asia

UNKNOWN

Sponsor Role collaborator

The HIV Netherlands Australia Thailand Research Collaboration

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jintanat Ananworanich, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The HIV Netherlands Australia Thailand Research Collaboration

Nittaya Phanuphak, MD

Role: PRINCIPAL_INVESTIGATOR

Thai Red Cross AIDS Research Centre

Locations

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Department of Pediatrics, Chulalongkorn University

Bangkok, , Thailand

Site Status

HIV-NAT

Bangkok, , Thailand

Site Status

Thai Red Cross - Anonymous Clinc

Bangkok, , Thailand

Site Status

Countries

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Thailand

Related Links

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http://www.hivnat.org

HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)'s website

Other Identifiers

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HIV-NAT 139

Identifier Type: -

Identifier Source: org_study_id

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