HIVNCT02438592
PHASES: Provision of HIV Treatment at ATN Sites: An Evaluation for Stakeholders
An observational study of HIV, run by University of North Carolina, Chapel Hill at 14 sites in United States.
Trial summary
This is an observational study involving retrospective and prospective medical record review covering a total maximum of 104 weeks (24 months) per subject. An Audio Computer- Assisted Self-Interview (ACASI) at study entry will assess demographic and psychosocial variables of study subjects. Read more about this study
- Who is it for?
- Ages 13 to 24 years
- Conditions the study is for
- HIV
- How many people
- 924 participants
- Where
- 14 sitesUnited States
- Study dates
- Mar 2015to Feb 2016
- 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 13 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 1. Behaviorally-infected, HIV-positive adolescents and young adults who are currently receiving or plan to receive their medical care at any clinical site that is part of the AMTU; 2. Ages 13 through 24, inclusive, at the Baseline visit; 3. Males and females; 4. Ability to understand spoken English; and 5. Ability for the AMTU staff to access the subject's medical records for a maximum of 78 weeks after enrollment or through February 2017, whichever occurs first.
Who may be able to join
- Laboratory evidence of HIV-1 infection per Centers for Disease Control and Prevention (CDC) Surveillance Case Definition for HIV Infection, 2014 (Section 1.1) http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6303a1.htm;
- Behaviorally-acquired HIV after age 9 years;
- Age 13 through 24 years, inclusive, at the baseline visit (Enrollment);
- Planning to receive HIV medical care at an AMTU or at any clinical site that is part of the AMTU for the duration of study follow-up
- If transition to an adult health care provider must occur during the course of study participation, continued AMTU staff accessibility to medical and appointment records;
- Ability for the AMTU staff to access medical and appointment records for a maximum of 78 weeks after enrollment or through February 2017, whichever occurs first;
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- Ability to understand spoken English;
- Willing and able to provide signed informed consent or assent;
- NOTE: If consent/assent is obtained > 4 weeks prior to the enrollment date, reaffirmation of consent must be obtained prior to starting the Baseline visit.
- -Parent or Legal Guardian permission, if applicable; and
- In addition to all the criteria listed above, to be considered eligible for enrollment after August 31, 2015, an individual must also meet the following criterion.
- -Must be considered either: (a) newly engaged in HIV medical care defined as no previous initial comprehensive HIV medical care visit with consent occurring before, at the time of, or within four weeks following that initial comprehensive visit; or (b) newly re-engaged in HIV medical care defined as attending the last medical appointment more than 52 weeks ago.
- NOTE: The initial HIV medical care appointment is defined as a routine HIV medical appointment where the adolescent attends with a medical provider authorized to prescribe medication.
- This HIV medical appointment must be a non-emergency, routine condition-focused exam AND one or more of the following:
- CD4, VL lab draw and/or review of these lab results;
- Discussion around HIV ART options;
- Primary and/or secondary HIV prevention education and counseling; or
- Diagnosis and treatment of complications of HIV, and of AIDS-defining conditions.
Who cannot join
- Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individual's ability to provide true informed consent or participate in the baseline ACASI*;
- Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior) at the time of consent or the baseline ACASI*; or
- Intoxicated or under the influence of alcohol or other substances at the time of consent or the baseline ACASI*
- NOTE: If consent/assent is obtained prior to the enrollment date, assessment for these exclusion criteria must be performed again prior to administration of the baseline ACASI (Enrollment). If any are present, the subject cannot be enrolled; do not administer the ACASI. Reassessment of eligibility and enrollment may take place at a later date per the discretion of the treating clinician.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University of Colorado/The Children's Hospital
Aurora, California, 80045
Johns Hopkins University
Baltimore, Maryland, 21287
Fenway Institute
Boston, Massachusetts, 02215
Stroger Hospital of Cook County
Chicago, Illinois, 60612
Children's Hospital of Michigan
Detroit, Michigan, 48201
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, 77030
Children's Hopsital of Los Angeles
Los Angeles, California, 90027
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
University of Miami School of Medicine
Miami, Florida, 33101
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of South Florida
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
Children's Hospital National Medical Center
Washington D.C., District of Columbia, 20010
About this study
This is an observational study involving retrospective and prospective medical record review covering a total maximum of 104 weeks (24 months) per subject. An Audio Computer- Assisted Self-Interview (ACASI) at study entry will assess demographic and psychosocial variables of study subjects. Data will also be collected to assess clinic level variables. Definitions of engagement, prescription of antiretroviral therapy (ART), and viral suppression in the Continuum of Care (CoC) will utilize common definitions including those by U.S. Department of Health and Human Services (DHHS) and Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB). Data will be collected in a large, simple trial design manner to provide all elements for both the primary and secondary outcomes.
Read the detailed description
This is an observational study involving retrospective and prospective medical record review covering a total maximum of 104 weeks (24 months) per subject. Behavioral data will be collected via ACASI at study entry to assess demographic and psychosocial variables of study subjects. All other data (biomedical, ART, healthcare utilization) at subsequent study visits will be collected via medical record abstraction. Information about missed visits as well as other healthcare utilization data can be abstracted from electronic appointment systems or other electronic systems at the clinical sites. Subject data will be abstracted from medical records for up to a maximum 26 weeks prior to the baseline study visit, as well as up to a maximum 78 weeks after the baseline study visit or through January 31, 2017, whichever occurs first, for a total maximum of 104 weeks or two years per subject. Data will also be collected from each Adolescent Medicine Trials Unit to assess clinic level variables at baseline (within 30 days of protocol registration) and 48 and 96 weeks after baseline. Definitions of engagement, prescription of antiretroviral therapy (ART), and viral suppression in the Continuum of Care (CoC) will utilize common definitions including those by U.S. Department of Health and Human Services (DHHS) and Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB). Data will be collected in a large, simple trial design manner to provide all elements for both the primary and secondary outcomes.
- Conditions
- HIV
- Keywords
- Continuum of care
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects engaged in care at Baseline, per subject year, as defined by the HRSA HAB measure
Measured: Baseline
The proportion of subjects engaged in care at Week 26, per subject year, as defined by the HRSA HAB measure
Measured: Week 26
The proportion of subjects engaged in care at Week 52, per subject year, as defined by the HRSA HAB measure
Measured: Week 52
The proportion of subjects engaged in care at Week 78, per subject year, as defined by the HRSA HAB measure
Measured: Week 78
The proportion of subjects engaged in care at Baseline, per subject year, as defined by the DHHS measure
Measured: Baseline
The proportion of subjects engaged in care at Week 26, per subject year, as defined by the DHHS measure
Measured: Week 26
The proportion of subjects engaged in care at Week 52, per subject year, as defined by the DHHS measure
Measured: Week 52
The proportion of subjects engaged in care at Week 78, per subject year, as defined by the DHHS measure
Measured: Week 78
The proportion of subjects prescribed antiretroviral therapy at Baseline per subject year
Measured: Baseline
The proportion of subjects prescribed antiretroviral therapy at Week 26 per subject year
Measured: Week 26
The proportion of subjects prescribed antiretroviral therapy at Week 52 per subject year
Measured: Week 52
The proportion of subjects prescribed antiretroviral therapy at Week 78 per subject year
Measured: Week 78
The proportion of subjects that have achieved viral suppression at Baseline per subject year
Measured: Baseline
The proportion of subjects that have achieved viral suppression at Week 26 per subject year
Measured: Week 26
The proportion of subjects that have achieved viral suppression at Week 52 per subject year
Measured: Week 52
The proportion of subjects that have achieved viral suppression at Week 78 per subject year
Measured: Week 78
Secondary outcomes (19)
The proportion of subjects with advanced HIV disease at time of first clinical visit defined as a CD4 count < 200 cells/mm3
Measured: Baseline
The incidence of STIs in the study population as an indicator of transmission risk at Baseline
Measured: Baseline
The incidence of STIs in the study population as an indicator of transmission risk at Week 26
Measured: Week 26
The incidence of STIs in the study population as an indicator of transmission risk at Week 52
Measured: Week 52
The incidence of STIs in the study population as an indicator of transmission risk at Week 78
Measured: Week 78
Number of subjects with mental health issues at Baseline
Measured: Baseline
Number of subjects engaging in substance use at Baseline
Measured: Baseline
Number of subjects engaging in sexual risk behaviors at Baseline
Measured: Baseline
ART adherence rate at Baseline
Measured: Baseline
Frequency of missed clinic visits at Baseline
Measured: Baseline
Frequency of missed clinic visits at Week 26
Measured: Week 26
Frequency of missed clinic visits at Week 52
Measured: Week 52
Frequency of missed clinic visits at Week 78
Measured: Week 78
Types of services available at each AMTU at Baseline
Measured: Baseline
Types of services available at each AMTU at 48 weeks after Baseline
Measured: Week 48
Types of services available at each AMTU at 96 weeks after Baseline
Measured: Week 96
Proportion of subjects notifying their sexual partners after learning their HIV status
Measured: Baseline
Timing of subjects notifying their partners after learning about their HIV status
Measured: Baseline
Proportion of subjects with whom partner notification was discussed
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 924 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Bret Rudy, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438592
- Sponsor's protocol ID
- ATN 125
- Status last verified
- Mar 2016
- First submitted
- 2 Apr 2015
- 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
- PHASES: Provision of HIV Treatment at ATN Sites: An Evaluation for Stakeholders
- ClinicalTrials.gov ID
- NCT02438592
- Acronym / sponsor ID
- ATN 125
- Conditions
- HIV
- Keywords
- Continuum of care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 924 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Mar 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 May 2015 (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 is an observational study involving retrospective and prospective medical record review covering a total maximum of 104 weeks (24 months) per subject. An Audio Computer- Assisted Self-Interview (ACASI) at study entry will assess demographic and psychosocial variables of study subjects. Data will also be collected to assess clinic level variables. Definitions of engagement, prescription of antiretroviral therapy (ART), and viral suppression in the Continuum of Care (CoC) will utilize common definitions including those by U.S. Department of Health and Human Services (DHHS) and Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB). Data will be collected in a large, simple trial design manner to provide all elements for both the primary and secondary outcomes.
Detailed description
This is an observational study involving retrospective and prospective medical record review covering a total maximum of 104 weeks (24 months) per subject. Behavioral data will be collected via ACASI at study entry to assess demographic and psychosocial variables of study subjects. All other data (biomedical, ART, healthcare utilization) at subsequent study visits will be collected via medical record abstraction. Information about missed visits as well as other healthcare utilization data can be abstracted from electronic appointment systems or other electronic systems at the clinical sites. Subject data will be abstracted from medical records for up to a maximum 26 weeks prior to the baseline study visit, as well as up to a maximum 78 weeks after the baseline study visit or through January 31, 2017, whichever occurs first, for a total maximum of 104 weeks or two years per subject. Data will also be collected from each Adolescent Medicine Trials Unit to assess clinic level variables at baseline (within 30 days of protocol registration) and 48 and 96 weeks after baseline. Definitions of engagement, prescription of antiretroviral therapy (ART), and viral suppression in the Continuum of Care (CoC) will utilize common definitions including those by U.S. Department of Health and Human Services (DHHS) and Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB). Data will be collected in a large, simple trial design manner to provide all elements for both the primary and secondary outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 1. Behaviorally-infected, HIV-positive adolescents and young adults who are currently receiving or plan to receive their medical care at any clinical site that is part of the AMTU; 2. Ages 13 through 24, inclusive, at the Baseline visit; 3. Males and females; 4. Ability to understand spoken English; and 5. Ability for the AMTU staff to access the subject's medical records for a maximum of 78 weeks after enrollment or through February 2017, whichever occurs first.
Key inclusion criteria (18 listed)
- Laboratory evidence of HIV-1 infection per Centers for Disease Control and Prevention (CDC) Surveillance Case Definition for HIV Infection, 2014 (Section 1.1) http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6303a1.htm;
- Behaviorally-acquired HIV after age 9 years;
- Age 13 through 24 years, inclusive, at the baseline visit (Enrollment);
- Planning to receive HIV medical care at an AMTU or at any clinical site that is part of the AMTU for the duration of study follow-up
- Ability for the AMTU staff to access medical and appointment records for a maximum of 78 weeks after enrollment or through February 2017, whichever occurs first;
Key exclusion criteria (4 listed)
- Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individual's ability to provide true informed consent or participate in the baseline ACASI*;
- Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior) at the time of consent or the baseline ACASI*; or
- Intoxicated or under the influence of alcohol or other substances at the time of consent or the baseline ACASI*
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
The proportion of subjects engaged in care at Baseline, per subject year, as defined by the HRSA HAB measure
Time frame: Baseline
The proportion of subjects engaged in care at Week 26, per subject year, as defined by the HRSA HAB measure
Time frame: Week 26
The proportion of subjects engaged in care at Week 52, per subject year, as defined by the HRSA HAB measure
Time frame: Week 52
The proportion of subjects engaged in care at Week 78, per subject year, as defined by the HRSA HAB measure
Time frame: Week 78
The proportion of subjects engaged in care at Baseline, per subject year, as defined by the DHHS measure
Time frame: Baseline
The proportion of subjects engaged in care at Week 26, per subject year, as defined by the DHHS measure
Time frame: Week 26
The proportion of subjects engaged in care at Week 52, per subject year, as defined by the DHHS measure
Time frame: Week 52
The proportion of subjects engaged in care at Week 78, per subject year, as defined by the DHHS measure
Time frame: Week 78
The proportion of subjects prescribed antiretroviral therapy at Baseline per subject year
Time frame: Baseline
The proportion of subjects prescribed antiretroviral therapy at Week 26 per subject year
Time frame: Week 26
The proportion of subjects prescribed antiretroviral therapy at Week 52 per subject year
Time frame: Week 52
The proportion of subjects prescribed antiretroviral therapy at Week 78 per subject year
Time frame: Week 78
The proportion of subjects that have achieved viral suppression at Baseline per subject year
Time frame: Baseline
The proportion of subjects that have achieved viral suppression at Week 26 per subject year
Time frame: Week 26
The proportion of subjects that have achieved viral suppression at Week 52 per subject year
Time frame: Week 52
The proportion of subjects that have achieved viral suppression at Week 78 per subject year
Time frame: Week 78
19 secondary outcomes
The proportion of subjects with advanced HIV disease at time of first clinical visit defined as a CD4 count < 200 cells/mm3
Time frame: Baseline
The incidence of STIs in the study population as an indicator of transmission risk at Baseline
Time frame: Baseline
The incidence of STIs in the study population as an indicator of transmission risk at Week 26
Time frame: Week 26
The incidence of STIs in the study population as an indicator of transmission risk at Week 52
Time frame: Week 52
The incidence of STIs in the study population as an indicator of transmission risk at Week 78
Time frame: Week 78
Number of subjects with mental health issues at Baseline
Time frame: Baseline
Number of subjects engaging in substance use at Baseline
Time frame: Baseline
Number of subjects engaging in sexual risk behaviors at Baseline
Time frame: Baseline
ART adherence rate at Baseline
Time frame: Baseline
Frequency of missed clinic visits at Baseline
Time frame: Baseline
Frequency of missed clinic visits at Week 26
Time frame: Week 26
Frequency of missed clinic visits at Week 52
Time frame: Week 52
Frequency of missed clinic visits at Week 78
Time frame: Week 78
Types of services available at each AMTU at Baseline
Time frame: Baseline
Types of services available at each AMTU at 48 weeks after Baseline
Time frame: Week 48
Types of services available at each AMTU at 96 weeks after Baseline
Time frame: Week 96
Proportion of subjects notifying their sexual partners after learning their HIV status
Time frame: Baseline
Timing of subjects notifying their partners after learning about their HIV status
Time frame: Baseline
Proportion of subjects with whom partner notification was discussed
Time frame: Baseline
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.
Bret Rudy, MD principal investigator
NYU Langone Health
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by University of North Carolina, Chapel Hill at 14 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 18 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 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 14 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?
The proportion of subjects engaged in care at Baseline, per subject year, as defined by the HRSA HAB measure (time frame: Baseline). The study lists 16 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 28 Feb 2017.