HIV InfectionNCT00103883
A Novel Method to Determine HIV Incidence Among Youth
An observational study of HIV Infection, run by University of North Carolina, Chapel Hill at 15 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- HIV Infection
- How many people
- 440 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Feb 2003to Mar 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
University of Maryland Medical School
Baltimore, Maryland, 21201
Childrens Hospital Boston
Boston, Massachusetts, 02115
Stroger Hospital of Cook County
Chicago, Illinois, 60612
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33316
Children's Hospital of Los Angeles
Los Angeles, California, 90027
University of Miami
Miami, Florida, 33101
Tulane University
New Orleans, Louisiana, 70112
Mount Sinai Hospital
New York, New York, 10128
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of California at San Diego
San Diego, California, 92103
University of California at San Francisco
San Francisco, California, 94118
University of South Florida
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
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.
Read the 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
- Keywords
- HIV, Detuned Assay, Enzyme Immunoassay (EIA), HIV Incidence, Laboratory assay, Sensitive/Less sensitive Assay, Acute Infection
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 15-20 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2005 (estimated)
- Study startFeb 2003
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ligia Peralta, MD, Study chair, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103883
- Sponsor's protocol ID
- ATN 022
- Status last verified
- Feb 2016
- First submitted
- 15 Feb 2005
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Method to Determine HIV Incidence Among Youth
- ClinicalTrials.gov ID
- NCT00103883
- Acronym / sponsor ID
- ATN 022
- Conditions
- HIV Infection
- Keywords
- HIV, Detuned Assay, Enzyme Immunoassay (EIA), HIV Incidence, Laboratory assay, Sensitive/Less sensitive Assay, Acute Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 16 Feb 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ligia Peralta, MD study chair
University of Maryland
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by University of North Carolina, Chapel Hill at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I - Serum-based S/LS assay result (time frame: 15-20 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.