A Novel Method to Determine HIV Incidence Among Youth

NCT ID: NCT00103883

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 440 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2007-03-31

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.

Detailed Description

HIV infection incidence estimates are important, not only for determining specific populations where community HIV education sessions can have the most benefit or where changes in infection patterns are occurring, but also to target these populations for therapeutic interventions and measure their effect in the community. It is estimated that half of all new HIV infections in the United States occur in persons under the age of 25 each year, translating to approximately 20,000 new HIV-infected young people annually.

Incidence can be estimated by testing a cohort of individuals for antibody at two different time periods and observing the number of new infections, or by demonstrating the presence of HIV p24 or viral RNA in antibody-negative persons. Since these strategies are logistically difficult, expensive, and/or require significant laboratory infrastructure, new laboratory-based strategies were devised that can classify individuals as recently infected or with established infection. These serologic assays are known as "sensitive/less sensitive (S/LS) assays". They are based on either the concept of antibody titer or the concept of antibody avidity. There are several S/LS tests available but all of them are performed on serum collected via venipuncture. Based on several studies showing that obtaining saliva is a more desirable method of collection for adolescents receiving HIV testing, it is anticipated that the collection of saliva and its use for determining HIV incidence by S/LS methods among adolescents would be a valuable adjunct for population studies and for increasing compliance for testing and enrollment.

The aim of this study is to prove equivalence between the serum S/LS reference method (CDC validated serum S/LS Dilutional Vironostika (DV) from Organon Teknika) and the experimental method that uses an FDA approved saliva collection device (OraSure Technologies). Our rationale follows a syllogism, i.e., if the serum S/LS EIA (DV) is the best serologic method to determine incidence estimates and a saliva S/LS method is found to perform equivalently, then it follows that the saliva S/LS method can be used effectively to determine incidence. Therefore, our purpose is to show equivalence between the two assays. To address the issue of accuracy, further studies are planned to assess the saliva S/LS test against seroconversion panels where the exact time of acquisition of HIV infection is known.

This is a cross-sectional, laboratory-based study designed to develop and evaluate a saliva-based S/LS assay for differentiating individuals with recent HIV infection (less than 133 days) from those with established HIV infection. A total of 440 subjects will be recruited in the study. A serum and two saliva samples will be obtained from every subject. The first 40 patient samples will be used to develop and calibrate the saliva-based S/LS method. The remaining patient samples will be tested using the calibrated saliva based S/LS assay and the reference serum S/LS assay and concordance between the two methods will be analyzed.

Conditions

HIV Infection

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

HIV Positive - BCHD STD Clinic

Youth who test HIV positive at the BCHD STD Clinic during the course of the study.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ligia Peralta, MD

Role: STUDY_CHAIR

University of Maryland

Locations

Children's Hospital of Los Angeles

Los Angeles, California, United States

University of California at San Diego

San Diego, California, United States

University of California at San Francisco

San Francisco, California, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Children's Diagnostic and Treatment Center

Fort Lauderdale, Florida, United States

University of Miami

Miami, Florida, United States

University of South Florida

Tampa, Florida, United States

Stroger Hospital of Cook County

Chicago, Illinois, United States

Tulane University

New Orleans, Louisiana, United States

University of Maryland Medical School

Baltimore, Maryland, United States

Childrens Hospital Boston

Boston, Massachusetts, United States

Mount Sinai Hospital

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

University Pediatric Hospital

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

Other Identifiers

ATN 022

Identifier Type: -

Identifier Source: org_study_id