Transitioning HIV+ Adolescents to Adult Care: Exploring Adolescent and Adult Medicine Clinics Role in the Process
CATCH: Comprehensive Assessment of Transition and Coordination for HIV-Positive Youth as They Move From Adolescent to Adult Care
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
California
-
Los Angeles, California, Stati Uniti, 90027
- Childrens Hospital of Los Angeles
-
-
Colorado
-
Aurora, Colorado, Stati Uniti, 80045
- University of Colorado - The Children's Hospital of Denver
-
-
District of Columbia
-
Washington, District of Columbia, Stati Uniti, 20010
- Children's Hosp Natinal Med Center
-
-
Florida
-
Miami, Florida, Stati Uniti, 33101
- University of Miami
-
Tampa, Florida, Stati Uniti, 33606
- University of South Florida
-
-
Illinois
-
Chicago, Illinois, Stati Uniti, 60612
- Stroger Hospital of Cook County
-
-
Louisiana
-
New Orleans, Louisiana, Stati Uniti, 70112
- Tulane Medical Center
-
-
Maryland
-
Baltimore, Maryland, Stati Uniti, 21287
- Johns Hopkins University
-
-
Massachusetts
-
Boston, Massachusetts, Stati Uniti, 02215
- Fenway Institute
-
-
Michigan
-
Detroit, Michigan, Stati Uniti, 48201
- Wayne State University
-
-
New York
-
Bronx, New York, Stati Uniti, 10467
- Montefiore Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Stati Uniti, 19104
- Children's Hopsital of Philadelphia
-
-
Tennessee
-
Memphis, Tennessee, Stati Uniti, 38105
- St. Jude Children's Research Hospital
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- Baylor College of Medicine
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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 .
Descrizione
Adolescents and young adults
Inclusion Criteria
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.
Exclusion Criteria
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
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Transition Expectations and Experiences as assessed by the ACASI (comparison between pre- and post-transition)
Lasso di tempo: Baseline
|
Baseline
|
|
Transition Expectations and Experiences as assessed by the ACASI (comparison between pre- and post-transition)
Lasso di tempo: 39 weeks
|
39 weeks
|
|
Patterns of Transition as assessed by the ACASI, as well as medical and appointment records abstraction (comparison between pre- and post-transition)
Lasso di tempo: Baseline
|
Baseline
|
|
Patterns of Transition as assessed by the ACASI, as well as medical and appointment records abstraction (comparison between pre- and post-transition)
Lasso di tempo: 39 weeks
|
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)
Lasso di tempo: Baseline
|
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)
Lasso di tempo: 39 weeks
|
39 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Transition Protocols at AMTUs and Adult Clinics
Lasso di tempo: 1 day
|
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.
|
1 day
|
|
Transition Processes at AMTUs and Adult Clinics
Lasso di tempo: 1 day
|
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.
|
1 day
|
|
Preparedness of Adult Clinics to Receive Behaviorally-Infected HIV-Positive Youth Transitioning from Adolescent Clinics
Lasso di tempo: 1 day
|
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.
|
1 day
|
Collaboratori e investigatori
Investigatori
- Cattedra di studio: Amanda E Tanner, PhD, MPH, University of North Carolina, Greensboro
- Cattedra di studio: J. Dennis Fortenberry, MD, MS, Indiana University School of Medicine
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- ATN 135
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su HIV
-
Federal University of São PauloGilead SciencesCompletato
-
University of MinnesotaRitiratoInfezioni da HIV | HIV/AIDS | HIV | AIDS | Problema di Aids/Hiv | AIDS e infezioniStati Uniti
-
National Institute of Allergy and Infectious Diseases...Duke University; Department of Health and Human Services (HHS)Non ancora reclutamento
-
Jecho Biopharmaceuticals Co., Ltd.Non ancora reclutamento
-
Boston UniversityBill and Melinda Gates Foundation; HE2RO, University of the WitwatersrandReclutamento
-
National Institute of Allergy and Infectious Diseases...National Institutes of Health (NIH); Department of Health and Human ServicesReclutamento
-
University of California, Los AngelesNational Institute of Mental Health (NIMH); Partners in Hope, Inc.Reclutamento
-
Kelley-Ross & Associates, Inc.Gilead SciencesAttivo, non reclutante
-
Center for Innovative Public Health ResearchNational Institute of Mental Health (NIMH); Makerere University; Internet Solutions...Non ancora reclutamento