A Novel Method to Determine HIV Incidence Among Youth
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ClinicalTrials.gov Identifier: NCT00103883 |
Recruitment Status
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Completed
First Posted
: February 16, 2005
Last Update Posted
: March 1, 2017
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Condition or disease |
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HIV Infection |
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.
Study Type : | Observational |
Actual Enrollment : | 440 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
Official Title: | A Novel Method to Determine HIV Incidence Among Youth |
Study Start Date : | February 2003 |
Actual Primary Completion Date : | March 2007 |
Actual Study Completion Date : | March 2007 |

Group/Cohort |
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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.
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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.
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HIV Positive - BCHD STD Clinic
Youth who test HIV positive at the BCHD STD Clinic during the course of the study.
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- Phase I - Serum-based S/LS assay result [ Time Frame: 15-20 Months ]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)
- Phase II - Saliva-based S/LS assay result [ Time Frame: 15-20 Months ]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)
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 12 Years to 24 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00103883
United States, California | |
Children's Hospital of Los Angeles | |
Los Angeles, California, United States, 90027 | |
University of California at San Diego | |
San Diego, California, United States, 92103 | |
University of California at San Francisco | |
San Francisco, California, United States, 94118 | |
United States, District of Columbia | |
Children's National Medical Center | |
Washington, DC, District of Columbia, United States, 20010 | |
United States, Florida | |
Children's Diagnostic and Treatment Center | |
Fort Lauderdale, Florida, United States, 33316 | |
University of Miami | |
Miami, Florida, United States, 33101 | |
University of South Florida | |
Tampa, Florida, United States, 33606 | |
United States, Illinois | |
Stroger Hospital of Cook County | |
Chicago, Illinois, United States, 60612 | |
United States, Louisiana | |
Tulane University | |
New Orleans, Louisiana, United States, 70112 | |
United States, Maryland | |
University of Maryland Medical School | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Childrens Hospital Boston | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 | |
Mount Sinai Hospital | |
New York, New York, United States, 10128 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
Puerto Rico | |
University Pediatric Hospital | |
San Juan, Puerto Rico, 00936 |
Study Chair: | Ligia Peralta, MD | University of Maryland |
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00103883 History of Changes |
Other Study ID Numbers: |
ATN 022 |
First Posted: | February 16, 2005 Key Record Dates |
Last Update Posted: | March 1, 2017 |
Last Verified: | February 2016 |
Keywords provided by University of North Carolina, Chapel Hill:
HIV Detuned Assay Enzyme Immunoassay (EIA) HIV Incidence |
Laboratory assay Sensitive/Less sensitive Assay Acute Infection |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |