이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2017년 2월 27일 업데이트: 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.

연구 개요

상태

완전한

정황

상세 설명

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.

연구 유형

관찰

등록 (실제)

136

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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 .

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

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

2차 결과 측정

결과 측정
측정값 설명
기간
Transition Protocols at AMTUs and Adult Clinics
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of North Carolina, Chapel Hill

협력자

National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2015년 8월 1일

기본 완료 (실제)

2016년 11월 1일

연구 완료 (실제)

2016년 11월 1일

연구 등록 날짜

최초 제출

2015년 10월 19일

QC 기준을 충족하는 최초 제출

2016년 5월 26일

처음 게시됨 (추정)

2016년 5월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 2월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 2월 27일

마지막으로 확인됨

2016년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • ATN 135

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

에이즈에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Uruguay

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다