A Novel Method to Determine HIV Incidence Among Youth
1 other identifier
observational
440
2 countries
15
Brief Summary
Identifying young people with early HIV-1 infection is important for increasing linkage to care, for behavioral counseling, and for enrolling individuals into programs that can provide effective interventions to disease progression and improve outcome. This study will develop and evaluate a saliva-based sensitive/less sensitive (S/LS) assay for differentiating persons with recent HIV-1 infection (less than 133 days) from those with established HIV-1 infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2003
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 15, 2005
CompletedFirst Posted
Study publicly available on registry
February 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedMarch 1, 2017
February 1, 2016
4.1 years
February 15, 2005
February 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase I - Serum-based S/LS assay result
To develop and calibrate a saliva S/LS assay using the FDA licensed OraSure collection device in conjunction with its matched saliva EIA assay to differentiate persons with recent versus established HIV infection (Phase I)
15-20 Months
Phase II - Saliva-based S/LS assay result
To assess that the saliva S/LS method performs equivalently to the reference serum S/LS method for HIV incidence estimates in populations of youth (Phase II)
15-20 Months
Study Arms (3)
HIV Infected Teens -ATN Clinical Sites
HIV infected teens who are referred to or engaged in care at any of the 15 ATN clinical sites during the course of the study.
HIV Positive - ATN Clinical Sites
Youth who test HIV positive at ATN-managed or ATN-affiliated HIV Counseling and Testing Sites (CTS) during the course of the study.
HIV Positive - BCHD STD Clinic
Youth who test HIV positive at the BCHD STD Clinic during the course of the study.
Eligibility Criteria
Two hundred fifty subjects will be recruited from the fifteen sites of the Adolescent Trials Network for HIV/AIDS Interventions (ATN) and 190 from the BCHD STD Clinic, a sexually transmitted disease clinic of the Baltimore City Health Department (BCHD). The age range for subjects from the ATN clinical sites will be 12 through 24 years and those from the BCHD STD Clinic will be 17 through 30 years.
You may qualify if:
- Age 12 through 24 years
- HIV infection determined by routine HIV testing strategies
- Ability to give informed consent or assent with parental permission, where required
You may not qualify if:
- Visibly distraught or emotionally unstable
- Intoxicated or under the influence of psychoactive agents
- First disclosure of sexual, physical, or emotional abuse
- Clinically presents as acutely ill
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of California at San Diego
San Diego, California, 92103, United States
University of California at San Francisco
San Francisco, California, 94118, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33316, United States
University of Miami
Miami, Florida, 33101, United States
University of South Florida
Tampa, Florida, 33606, United States
Stroger Hospital of Cook County
Chicago, Illinois, 60612, United States
Tulane University
New Orleans, Louisiana, 70112, United States
University of Maryland Medical School
Baltimore, Maryland, 21201, United States
Childrens Hospital Boston
Boston, Massachusetts, 02115, United States
Mount Sinai Hospital
New York, New York, 10128, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University Pediatric Hospital
San Juan, 00936, Puerto Rico
Biospecimen
Phenotypic and genotypic testing for antiretroviral drug (ART) resistance will be done on stored samples from all subjects who are identified as recently infected by the serum based DV S/LS reference method. An assay for viral replication fitness will also be done on these same samples. This testing will provide a recent assessment of prevalence of transmitted ART resistant HIV-1 in this population.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ligia Peralta, MD
University of Maryland
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2005
First Posted
February 16, 2005
Study Start
February 1, 2003
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
March 1, 2017
Record last verified: 2016-02