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

27 февраля 2017 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Подробное описание

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.

Тип исследования

Наблюдательный

Регистрация (Действительный)

136

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 24 года (Взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

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 .

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Временное ограничение
Transition Expectations and Experiences as assessed by the ACASI (comparison between pre- and post-transition)
Временное ограничение: Baseline
Baseline
Transition Expectations and Experiences as assessed by the ACASI (comparison between pre- and post-transition)
Временное ограничение: 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)
Временное ограничение: Baseline
Baseline
Patterns of Transition as assessed by the ACASI, as well as medical and appointment records abstraction (comparison between pre- and post-transition)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 39 weeks
39 weeks

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Transition Protocols at AMTUs and Adult Clinics
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Следователи

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

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 августа 2015 г.

Первичное завершение (Действительный)

1 ноября 2016 г.

Завершение исследования (Действительный)

1 ноября 2016 г.

Даты регистрации исследования

Первый отправленный

19 октября 2015 г.

Впервые представлено, что соответствует критериям контроля качества

26 мая 2016 г.

Первый опубликованный (Оценивать)

27 мая 2016 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

28 февраля 2017 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

27 февраля 2017 г.

Последняя проверка

1 декабря 2016 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • ATN 135

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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