Acquired Immunodeficiency SyndromeNCT01322217
Managerial Database II
An observational study of Acquired Immunodeficiency Syndrome, run by University of North Carolina, Chapel Hill at 5 sites in United States.
Trial summary
This study will collect information on health status and risk behaviors, as well as basic demographic and biomedical information for a group of HIV positive adolescents receiving care at sites newly participating in ATN III. Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Acquired Immunodeficiency Syndrome
- How many people
- 513 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2011to Jun 2012
- 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: All HIV-infected adolescents and young adults engaged in care at sites newly participating in ATN III and their affiliates who are between 12 and 24 years of age, inclusive, are aware of their HIV status and understand written and/or verbal English will be eligible for inclusion in the study. In addition, new patients who have their initial clinic visit within the enrollment period will also be eligible for participation
Who may be able to join
- Laboratory evidence of HIV-1 infection documented by a positive result on any of the following licensed tests at any time: Any HIV-1 antibody test confirmed by Western blot, HIV-1 culture, HIV-1 DNA PCR, or plasma HIV-1 RNA PCR > 1,000 copies/ml;
- Knowledge of HIV positive diagnoses;
- Age 12 years through 24 years, inclusive, at the time of consent;
- Engaged in care at the AMTU or its affiliate and/or partnering clinic. Individuals will be considered to be engaged in care if they have an AMTU (or its affiliate) clinic visit during the enrollment period;
- Ability to understand written and/or verbal English or Spanish.
Who cannot join
- Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individual's ability to complete the study measures;
- Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior); or
- Intoxicated or under the influence of alcohol or other substances at the time of consent/assent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado Denver
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21287
The Fenway Institute-Fenway Health
Boston, Massachusetts, 02115
Wayne State University-Children's Hospital of Michigan
Detroit, Michigan, 48201
Baylor College of Medicine - Pediatrics Allergy and Immunology
Houston, Texas, 77030
About this study
Official title: Network-Wide Assessment of Current Health Status and Behavioral Risk Factors: An Expanded Study for New Sites in ATN III
This study will collect information on health status and risk behaviors, as well as basic demographic and biomedical information for a group of HIV positive adolescents receiving care at sites newly participating in ATN III.
Read the detailed description
The proposed study is a cross sectional study intended to be conducted at each of the Adolescent Medicine Trials Units (AMTUs) newly participating in ATN III and to enroll all participating patients followed at each site. This approach will allow for the examination of the broad spectrum of youth participating in the ATN, including those newly entered into care.
Psychosocial and risk-taking behavioral data will be collected using Audio Computer-Assisted Self-Interview (ACASI) for English-speaking participants, or a paper-and-pencil Spanish-language survey with identical measures to the ACASI for Spanish-speaking participants; biomedical information will be collected through medical chart abstraction.
- Conditions
- Acquired Immunodeficiency Syndrome
- Keywords
- Medication adherence, Substance use, Sexual risk behaviors
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Medication Adherence, Substance-Related Disorders
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 |
|---|---|---|
| AMTU Clients | All HIV-infected adolescents and young adults engaged in care at sites newly participating in ATN III and their affiliates who are between 12 and 24 years of age, inclusive, are aware of their HIV status and understand written and/or verbal English will be eligible for inclusion in the study. In addition, new patients who have their initial clinic visit within the enrollment period will also be eligible for participation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect information on for adolescents and young adults with HIV infection engaged in care at the AMTUs
Collect information on rates of adherence to medical regimens, sexual risk behavior, substance use and mental health concerns, along with basic demographic and biomedical data for adolescents and young adults with HIV infection engaged in care at the AMTUs to better understand the extent of risk behaviors as well as to understand risk and protective factors in this population.
Measured: 1 year
Secondary outcomes (1)
To better understand the complex relationships between adherence to medical regimens, sexual risk behavior, substance use and mental health concerns, and basic demographic and biomedical data in adolescents and young adults with HIV infection.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 513 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Huszti, PhD, Study chair, Adolescent Trials Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322217
- Sponsor's protocol ID
- ATN 106
- Status last verified
- Mar 2016
- First submitted
- 22 Mar 2011
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Network-Wide Assessment of Current Health Status and Behavioral Risk Factors: An Expanded Study for New Sites in ATN III
- ClinicalTrials.gov ID
- NCT01322217
- Acronym / sponsor ID
- ATN 106
- Conditions
- Acquired Immunodeficiency Syndrome
- Keywords
- Medication adherence, Substance use, Sexual risk behaviors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 24 Mar 2011 (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.
This study will collect information on health status and risk behaviors, as well as basic demographic and biomedical information for a group of HIV positive adolescents receiving care at sites newly participating in ATN III.
Detailed description
The proposed study is a cross sectional study intended to be conducted at each of the Adolescent Medicine Trials Units (AMTUs) newly participating in ATN III and to enroll all participating patients followed at each site. This approach will allow for the examination of the broad spectrum of youth participating in the ATN, including those newly entered into care.
Psychosocial and risk-taking behavioral data will be collected using Audio Computer-Assisted Self-Interview (ACASI) for English-speaking participants, or a paper-and-pencil Spanish-language survey with identical measures to the ACASI for Spanish-speaking participants; biomedical information will be collected through medical chart abstraction.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMTU Clients | – | –All HIV-infected adolescents and young adults engaged in care at sites newly participating in ATN III and their affiliates who are between 12 and 24 years of age, inclusive, are aware of their HIV status and understand written and/or verbal English will be eligible for inclusion in the study. In addition, new patients who have their initial clinic visit within the enrollment period will also be eligible for participation. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All HIV-infected adolescents and young adults engaged in care at sites newly participating in ATN III and their affiliates who are between 12 and 24 years of age, inclusive, are aware of their HIV status and understand written and/or verbal English will be eligible for inclusion in the study. In addition, new patients who have their initial clinic visit within the enrollment period will also be eligible for participation
Key inclusion criteria (5 listed)
- Laboratory evidence of HIV-1 infection documented by a positive result on any of the following licensed tests at any time: Any HIV-1 antibody test confirmed by Western blot, HIV-1 culture, HIV-1 DNA PCR, or plasma HIV-1 RNA PCR > 1,000 copies/ml;
- Knowledge of HIV positive diagnoses;
- Age 12 years through 24 years, inclusive, at the time of consent;
- Engaged in care at the AMTU or its affiliate and/or partnering clinic. Individuals will be considered to be engaged in care if they have an AMTU (or its affiliate) clinic visit during the enrollment period;
- Ability to understand written and/or verbal English or Spanish.
Key exclusion criteria (3 listed)
- Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individual's ability to complete the study measures;
- Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior); or
- Intoxicated or under the influence of alcohol or other substances at the time of consent/assent
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
Collect information on for adolescents and young adults with HIV infection engaged in care at the AMTUs
Time frame: 1 year
Collect information on rates of adherence to medical regimens, sexual risk behavior, substance use and mental health concerns, along with basic demographic and biomedical data for adolescents and young adults with HIV infection engaged in care at the AMTUs to better understand the extent of risk behaviors as well as to understand risk and protective factors in this population.
1 secondary outcome
To better understand the complex relationships between adherence to medical regimens, sexual risk behavior, substance use and mental health concerns, and basic demographic and biomedical data in adolescents and young adults with HIV infection.
Time frame: 1 year
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 28 Feb 2017.
- ATN WebsiteLink provided by the sponsor.
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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.
Heather Huszti, PhD study chair
Adolescent Trials Network
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Immunodeficiency Syndrome, run by University of North Carolina, Chapel Hill at 5 sites in United States.
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 5 inclusion and 3 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Collect information on for adolescents and young adults with HIV infection engaged in care at the AMTUs (time frame: 1 year). 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 28 Feb 2017.