NCT01788852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

2 years

First QC Date

February 7, 2013

Last Update Submit

March 30, 2015

Conditions

HPV InfectionCervical/Anal Dysplasia

Keywords

HPVHIVcervical/anal dysplasiaintraepithelial neoplasiaE6/E7 biomarkerperinatally HIV-infected adolescentsbehaviorally HIV-infected adolescentsanal and pap smear

Outcome Measures

Primary Outcomes (1)

  • HPV infection

    Prevalence of cervical and anal HPV infection and of oncogenic subtypes, among perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents, and HIv-negative adolescents

    48 weeks

Secondary Outcomes (3)

  • intraepithelial neoplasia

    48 weeks

  • E6/E7

    48 weeks

  • HPV vaccine

    48 weeks

Study Arms (3)

Perinatally HIV-infected adolescents

Perinatally HIV-infected adolescents

behaviorally HIV-infected adolescents

behaviorally HIV-infected adolescents

HIV negative adolescents

HIV negative adolescents

Eligibility Criteria

Age12 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Pediatrics, Chulalongkorn University

Bangkok, 10330, Thailand

Location

HIV-NAT

Bangkok, 10330, Thailand

Location

Thai Red Cross - Anonymous Clinc

Bangkok, 10330, Thailand

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Cervical and anal pap smears specimens will be used for HPV typing. Blood will be collected for STI and immune response to HPV/HIV testing

MeSH Terms

Conditions

Papillomavirus InfectionsCarcinoma in Situ

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Jintanat Ananworanich, MD, PhD

    The HIV Netherlands Australia Thailand Research Collaboration

    PRINCIPAL INVESTIGATOR

  • Nittaya Phanuphak, MD

    Thai Red Cross AIDS Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 11, 2013

Study Start

December 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

TH(3)