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Transitioning HIV+ Adolescents to Adult Care: Exploring Adolescent and Adult Medicine Clinics Role in the Process

27 lutego 2017 zaktualizowane przez: University of North Carolina, Chapel Hill

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.

Przegląd badań

Status

Zakończony

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

136

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • California
      • Los Angeles, California, Stany Zjednoczone, 90027
        • Childrens Hospital of Los Angeles
    • Colorado
      • Aurora, Colorado, Stany Zjednoczone, 80045
        • University of Colorado - The Children's Hospital of Denver
    • District of Columbia
      • Washington, District of Columbia, Stany Zjednoczone, 20010
        • Children's Hosp Natinal Med Center
    • Florida
      • Miami, Florida, Stany Zjednoczone, 33101
        • University of Miami
      • Tampa, Florida, Stany Zjednoczone, 33606
        • University of South Florida
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone, 60612
        • Stroger Hospital of Cook County
    • Louisiana
      • New Orleans, Louisiana, Stany Zjednoczone, 70112
        • Tulane Medical Center
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone, 21287
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02215
        • Fenway Institute
    • Michigan
      • Detroit, Michigan, Stany Zjednoczone, 48201
        • Wayne State University
    • New York
      • Bronx, New York, Stany Zjednoczone, 10467
        • Montefiore Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
        • Children's Hopsital of Philadelphia
    • Tennessee
      • Memphis, Tennessee, Stany Zjednoczone, 38105
        • St. Jude Children's Research Hospital
    • Texas
      • Houston, Texas, Stany Zjednoczone, 77030
        • Baylor College of Medicine

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 24 lata (Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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 .

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
Transition Expectations and Experiences as assessed by the ACASI (comparison between pre- and post-transition)
Ramy czasowe: Baseline
Baseline
Transition Expectations and Experiences as assessed by the ACASI (comparison between pre- and post-transition)
Ramy czasowe: 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)
Ramy czasowe: Baseline
Baseline
Patterns of Transition as assessed by the ACASI, as well as medical and appointment records abstraction (comparison between pre- and post-transition)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 39 weeks
39 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Transition Protocols at AMTUs and Adult Clinics
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Krzesło do nauki: Amanda E Tanner, PhD, MPH, University of North Carolina, Greensboro
  • Krzesło do nauki: J. Dennis Fortenberry, MD, MS, Indiana University School of Medicine

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 sierpnia 2015

Zakończenie podstawowe (Rzeczywisty)

1 listopada 2016

Ukończenie studiów (Rzeczywisty)

1 listopada 2016

Daty rejestracji na studia

Pierwszy przesłany

19 października 2015

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 maja 2016

Pierwszy wysłany (Oszacować)

27 maja 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 lutego 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 lutego 2017

Ostatnia weryfikacja

1 grudnia 2016

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • ATN 135

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na HIV

3
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