HIVNCT02785302
Transitioning HIV+ Adolescents to Adult Care: Exploring Adolescent and Adult Medicine Clinics Role in the Process
An observational study of HIV, run by University of North Carolina, Chapel Hill at 14 sites in United States.
Trial summary
This is a multi-site, longitudinal study and it describes the transition process of behaviorally-infected HIV-positive youth as they move from pediatric- and adolescent-specific care to adult care. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- How many people
- 136 participants
- Where
- 14 sitesUnited States
- Study dates
- Aug 2015to Nov 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Behaviorally-infected HIV-positive adolescents and young adults between the ages of 18 and 24 years, are recruited to complete computer assisted interviews to characterize the transition process and outcomes. AMTU staff and partner adult clinic staff are recruited to complete quantitative surveys and semi-structured interviews over the phone to explore transition processes and protocols. There are no minimum or maximum age criteria that staff must meet .
Who may be able to join
- To be considered eligible to participate in 135, behaviorally-infected HIV-positive adolescents and young adults must be:
- Enrolled in ATN 125
- Be transition eligible. Transition eligible means that the youth are either (a) age 18 through 24 years old and planning to transition to adult medical care within six months after ATN 135 enrollment or (b) 24 years old and not actively planning to transition to adult medical care.
- Willing and able to provide consent to participate.
Who cannot join
- To be considered eligible for enrollment, an individual must not meet any of the criteria listed below.
- 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;
- At the time of consent, intoxicated or under the influence of alcohol or other substances to such an extent that in the opinion of the study staff, the ability to give true informed consent is impaired; or
- At the time of the baseline ACASI, intoxicated or under the influence of alcohol or other substances to such an extent that in the opinion of the study staff, the subject's ability to understand and answer the questions may be impaired and negatively impact the integrity of the research data.
- AMTU and Partner Adult Clinic Staff
Show all 10Show fewer
- To be considered eligible to complete the AMTU and partner adult clinic surveys and semi-structured interviews, an individual must meet all of the criteria listed below.
- Being a clinical staff (e.g., healthcare providers, social workers, case managers, transition person) at either an AMTU or AMTU-affiliated site or partner adult clinic;
- Supporting (in any capacity) transition efforts for HIV-positive adolescents; and
- Willing and able to provide verbal consent for surveys and semi-structured interviews.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University of Colorado - The Children's Hospital of Denver
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21287
Fenway Institute
Boston, Massachusetts, 02215
Stroger Hospital of Cook County
Chicago, Illinois, 60612
Wayne State University
Detroit, Michigan, 48201
Baylor College of Medicine
Houston, Texas, 77030
Childrens Hospital of Los Angeles
Los Angeles, California, 90027
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
University of Miami
Miami, Florida, 33101
Tulane Medical Center
New Orleans, Louisiana, 70112
Children's Hopsital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of South Florida
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
Children's Hosp Natinal Med Center
Washington D.C., District of Columbia, 20010
About this study
Official title: CATCH: Comprehensive Assessment of Transition and Coordination for HIV-Positive Youth as They Move From Adolescent to Adult Care
This is a multi-site, longitudinal study and it describes the transition process of behaviorally-infected HIV-positive youth as they move from pediatric- and adolescent-specific care to adult care. To achieve this goal, the transition process is characterized from the perspectives of HIV-positive youth, Adolescent Medicine Trials Unit (AMTU) clinic staff, and receiving adult clinic staff.
Read the detailed description
The changes associated with transition to adult clinical care may increase the likelihood that an adolescent will drop out of care, which results in poorer outcomes. Disengagement from care has implications for health. Disruption in medication can increase viral load (VL), and intensify the potential for co-morbidities and transmission efficiency . Thus, successful transition to adult care is especially important for HIV-positive adolescents (compared to other chronic diseases) as they will need to maintain clinic visits and medication adherence across their lifespan to remain healthy and maintain a low VL to reduce the potential for transmission in the context of other developmental and psychosocial changes and challenges. The ultimate goal of this study is to represent the key places - youth, adolescent clinic and adult clinic - where transition interventions could be targeted and to collect data to capture the key elements and modifiable variables at each level. This study will contribute to existing research by providing transition research on HIV, which differs from other congenital or acquired chronic conditions due to it being an infectious disease; by prospectively following youth as they transition; and by providing transition research from the perspective of receiving adult clinics. It will also illustrate how each level- youth, adolescent clinic and adult clinic - is situated within a specific context and how these levels interact to affect transition outcomes.
This is a multi-method, longitudinal design research study. Subjects must be enrolled in ATN 125 at the time of the ATN 135 baseline visit. There will be no randomization procedures. During the 39-week study, surveys will be administered to adolescents and young adults transitioning to adult care via Audio Computer Assisted Self Interviews (ACASIs), which will collect data on individual (e.g., psychosocial and behavioral) and clinical factors affecting transition at 0 and 39 weeks. Demographic, biomedical, antiretroviral therapy (ART) and healthcare utilization visit information collected through ATN 125 medical chart abstraction will also become part of the ATN 135 subject dataset. One-time phone surveys and interviews with AMTU and adult clinic staff will also be conducted to collect information on transition protocols as well as review of any documentation of existing transition protocols (e.g., transitioning SOP). Outcome measures will include pre- and post-transition VL and other measures of physical and psychosocial health status to compare individuals with different patterns and outcomes of transition.
- Conditions
- HIV
- Keywords
- Pediatric, HIV, Transition, Adult Care
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 |
|---|---|---|
| Adolescents and Young Adults: | Behaviorally-infected, HIV-positive, adolescents and young adults enrolled in ATN 125, aged 18 through 24, inclusive who are transition eligible. All subjects with available endpoint data will be included in the analysis. | |
| AMTU and Adult Clinic Staff | Clinical staff at the Adolescent Medical Trials Units (AMTUs) and at adult clinics where the AMTUs refer their transitioning patients will be recruited to complete quantitative surveys and semi-structured interviews. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transition Expectations and Experiences as assessed by the ACASI (comparison between pre- and post-transition)
Measured: Baseline
Transition Expectations and Experiences as assessed by the ACASI (comparison between pre- and post-transition)
Measured: 39 weeks
Patterns of Transition as assessed by the ACASI, as well as medical and appointment records abstraction (comparison between pre- and post-transition)
Measured: Baseline
Patterns of Transition as assessed by the ACASI, as well as medical and appointment records abstraction (comparison between pre- and post-transition)
Measured: 39 weeks
Patterns of Engagement in Care as assessed by the ACASI, as well as medical and appointment records abstraction (assessment over time from point of transition)
Measured: Baseline
Patterns of Engagement in Care as assessed by the ACASI, as well as medical and appointment records abstraction (assessment over time from point of transition)
Measured: 39 weeks
Secondary outcomes (3)
Transition Protocols at AMTUs and Adult Clinics
Transition protocols will be assessed by one-time interviews with AMTU Clinic staff where youth from AMTUs transition their care within one year of site registration.
Measured: 1 day
Transition Processes at AMTUs and Adult Clinics
Transition processes will be assessed by one-time interviews with AMTU Clinic staff where youth from AMTUs transition their care within one year of site registration.
Measured: 1 day
Preparedness of Adult Clinics to Receive Behaviorally-Infected HIV-Positive Youth Transitioning from Adolescent Clinics
Preparedness will be assessed by one-time interviews with Adult Clinic staff where youth from AMTUs transition their care within one year of site registration.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startAug 2015
- Primary completionNov 2016
- Study completionNov 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
- Prospective
- Enrolment
- 136 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
- Amanda E Tanner, PhD, MPH, Study chair, University of North Carolina, GreensboroJ. Dennis Fortenberry, MD, MS, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785302
- Sponsor's protocol ID
- ATN 135
- Status last verified
- Dec 2016
- First submitted
- 19 Oct 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
- CATCH: Comprehensive Assessment of Transition and Coordination for HIV-Positive Youth as They Move From Adolescent to Adult Care
- ClinicalTrials.gov ID
- NCT02785302
- Acronym / sponsor ID
- ATN 135
- Conditions
- HIV
- Keywords
- Pediatric, HIV, Transition, Adult Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 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
- Aug 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 27 May 2016 (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 a multi-site, longitudinal study and it describes the transition process of behaviorally-infected HIV-positive youth as they move from pediatric- and adolescent-specific care to adult care. To achieve this goal, the transition process is characterized from the perspectives of HIV-positive youth, Adolescent Medicine Trials Unit (AMTU) clinic staff, and receiving adult clinic staff.
Detailed description
The changes associated with transition to adult clinical care may increase the likelihood that an adolescent will drop out of care, which results in poorer outcomes. Disengagement from care has implications for health. Disruption in medication can increase viral load (VL), and intensify the potential for co-morbidities and transmission efficiency . Thus, successful transition to adult care is especially important for HIV-positive adolescents (compared to other chronic diseases) as they will need to maintain clinic visits and medication adherence across their lifespan to remain healthy and maintain a low VL to reduce the potential for transmission in the context of other developmental and psychosocial changes and challenges. The ultimate goal of this study is to represent the key places - youth, adolescent clinic and adult clinic - where transition interventions could be targeted and to collect data to capture the key elements and modifiable variables at each level. This study will contribute to existing research by providing transition research on HIV, which differs from other congenital or acquired chronic conditions due to it being an infectious disease; by prospectively following youth as they transition; and by providing transition research from the perspective of receiving adult clinics. It will also illustrate how each level- youth, adolescent clinic and adult clinic - is situated within a specific context and how these levels interact to affect transition outcomes.
This is a multi-method, longitudinal design research study. Subjects must be enrolled in ATN 125 at the time of the ATN 135 baseline visit. There will be no randomization procedures. During the 39-week study, surveys will be administered to adolescents and young adults transitioning to adult care via Audio Computer Assisted Self Interviews (ACASIs), which will collect data on individual (e.g., psychosocial and behavioral) and clinical factors affecting transition at 0 and 39 weeks. Demographic, biomedical, antiretroviral therapy (ART) and healthcare utilization visit information collected through ATN 125 medical chart abstraction will also become part of the ATN 135 subject dataset. One-time phone surveys and interviews with AMTU and adult clinic staff will also be conducted to collect information on transition protocols as well as review of any documentation of existing transition protocols (e.g., transitioning SOP). Outcome measures will include pre- and post-transition VL and other measures of physical and psychosocial health status to compare individuals with different patterns and outcomes of transition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents and Young Adults: | – | –Behaviorally-infected, HIV-positive, adolescents and young adults enrolled in ATN 125, aged 18 through 24, inclusive who are transition eligible. All subjects with available endpoint data will be included in the analysis. |
| AMTU and Adult Clinic Staff | – | –Clinical staff at the Adolescent Medical Trials Units (AMTUs) and at adult clinics where the AMTUs refer their transitioning patients will be recruited to complete quantitative surveys and semi-structured interviews. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Behaviorally-infected HIV-positive adolescents and young adults between the ages of 18 and 24 years, are recruited to complete computer assisted interviews to characterize the transition process and outcomes. AMTU staff and partner adult clinic staff are recruited to complete quantitative surveys and semi-structured interviews over the phone to explore transition processes and protocols. There are no minimum or maximum age criteria that staff must meet .
Key inclusion criteria (4 listed)
- To be considered eligible to participate in 135, behaviorally-infected HIV-positive adolescents and young adults must be:
- Enrolled in ATN 125
- Be transition eligible. Transition eligible means that the youth are either (a) age 18 through 24 years old and planning to transition to adult medical care within six months after ATN 135 enrollment or (b) 24 years old and not actively planning to transition to adult medical care.
- Willing and able to provide consent to participate.
Key exclusion criteria (10 listed)
- To be considered eligible for enrollment, an individual must not meet any of the criteria listed below.
- 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;
- At the time of consent, intoxicated or under the influence of alcohol or other substances to such an extent that in the opinion of the study staff, the ability to give true informed consent is impaired; or
- At the time of the baseline ACASI, intoxicated or under the influence of alcohol or other substances to such an extent that in the opinion of the study staff, the subject's ability to understand and answer the questions may be impaired and negatively impact the integrity of the research data.
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
Transition Expectations and Experiences as assessed by the ACASI (comparison between pre- and post-transition)
Time frame: Baseline
Transition Expectations and Experiences as assessed by the ACASI (comparison between pre- and post-transition)
Time frame: 39 weeks
Patterns of Transition as assessed by the ACASI, as well as medical and appointment records abstraction (comparison between pre- and post-transition)
Time frame: Baseline
Patterns of Transition as assessed by the ACASI, as well as medical and appointment records abstraction (comparison between pre- and post-transition)
Time frame: 39 weeks
Patterns of Engagement in Care as assessed by the ACASI, as well as medical and appointment records abstraction (assessment over time from point of transition)
Time frame: Baseline
Patterns of Engagement in Care as assessed by the ACASI, as well as medical and appointment records abstraction (assessment over time from point of transition)
Time frame: 39 weeks
3 secondary outcomes
Transition Protocols at AMTUs and Adult Clinics
Time frame: 1 day
Transition Processes at AMTUs and Adult Clinics
Time frame: 1 day
Preparedness of Adult Clinics to Receive Behaviorally-Infected HIV-Positive Youth Transitioning from Adolescent Clinics
Time frame: 1 day
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.
Amanda E Tanner, PhD, MPH study chair
University of North Carolina, Greensboro
J. Dennis Fortenberry, MD, MS study chair
Indiana University
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 4 inclusion and 10 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?
Transition Expectations and Experiences as assessed by the ACASI (comparison between pre- and post-transition) (time frame: Baseline). The study lists 6 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.