Clinical trial NCT00103883: A Novel Method to Determine HIV Incidence Among Youth
Official title: A Novel Method to Determine HIV Incidence Among Youth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: HIV
Detuned Assay
Enzyme Immunoassay (EIA)
HIV Incidence
Laboratory assay
Sensitive/Less sensitive Assay
Acute Infection
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2005-02-16
Enrollment: 440
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Phase I - Serum-based S/LS assay result
timeFrame: 15-20 Months
measure: Phase II - Saliva-based S/LS assay result
timeFrame: 15-20 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: San Diego
country: United States
facility: University of California at San Diego
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Washington, DC
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Children's Diagnostic and Treatment Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Stroger Hospital of Cook County
state: Illinois
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical School
state: Maryland
city: Boston
country: United States
facility: Childrens Hospital Boston
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: San Juan
country: Puerto Rico
facility: University Pediatric Hospital
Study officials:
affiliation: University of Maryland
name: Ligia Peralta, MD
role: STUDY_CHAIR
References: