- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02785302
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
Přehled studie
Postavení
Podmínky
Detailní popis
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 studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
California
-
Los Angeles, California, Spojené státy, 90027
- Childrens Hospital of Los Angeles
-
-
Colorado
-
Aurora, Colorado, Spojené státy, 80045
- University of Colorado - The Children's Hospital of Denver
-
-
District of Columbia
-
Washington, District of Columbia, Spojené státy, 20010
- Children's Hosp Natinal Med Center
-
-
Florida
-
Miami, Florida, Spojené státy, 33101
- University of Miami
-
Tampa, Florida, Spojené státy, 33606
- University of South Florida
-
-
Illinois
-
Chicago, Illinois, Spojené státy, 60612
- Stroger Hospital of Cook County
-
-
Louisiana
-
New Orleans, Louisiana, Spojené státy, 70112
- Tulane Medical Center
-
-
Maryland
-
Baltimore, Maryland, Spojené státy, 21287
- Johns Hopkins University
-
-
Massachusetts
-
Boston, Massachusetts, Spojené státy, 02215
- Fenway Institute
-
-
Michigan
-
Detroit, Michigan, Spojené státy, 48201
- Wayne State University
-
-
New York
-
Bronx, New York, Spojené státy, 10467
- Montefiore Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Spojené státy, 19104
- Children's Hopsital of Philadelphia
-
-
Tennessee
-
Memphis, Tennessee, Spojené státy, 38105
- St. Jude Children's Research Hospital
-
-
Texas
-
Houston, Texas, Spojené státy, 77030
- Baylor College of Medicine
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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 .
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Transition Expectations and Experiences as assessed by the ACASI (comparison between pre- and post-transition)
Časové okno: Baseline
|
Baseline
|
Transition Expectations and Experiences as assessed by the ACASI (comparison between pre- and post-transition)
Časové okno: 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)
Časové okno: Baseline
|
Baseline
|
Patterns of Transition as assessed by the ACASI, as well as medical and appointment records abstraction (comparison between pre- and post-transition)
Časové okno: 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)
Časové okno: 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)
Časové okno: 39 weeks
|
39 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Transition Protocols at AMTUs and Adult Clinics
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Amanda E Tanner, PhD, MPH, University of North Carolina, Greensboro
- Studijní židle: J. Dennis Fortenberry, MD, MS, Indiana University School of Medicine
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- ATN 135
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na HIV
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthNáborHIV | Testování HIV | HIV vazba na péči | Léčba HIVSpojené státy
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement a další spolupracovníciNeznámýHIV | Děti neinfikované HIV | Děti vystavené HIVKamerun
-
University of MinnesotaStaženoHIV infekce | HIV/AIDS | Hiv | AIDS | Problém AIDS/Hiv | AIDS a infekceSpojené státy
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationDokončenoPartnerské HIV testování | Poradenství pro pár HIV | Párová komunikace | Výskyt HIVKamerun, Dominikánská republika, Gruzie, Indie
-
CDC FoundationGilead SciencesNeznámýPreexpoziční profylaxe HIV | Chemoprofylaxe HIVSpojené státy
-
Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University... a další spolupracovníciNábor
-
Erasmus Medical CenterZatím nenabírámeHIV infekce | Hiv | HIV-1-infekce | HIV I infekceHolandsko
-
Hospital Clinic of BarcelonaDokončenoInhibitory integrázy, HIV; HIV PROTEASE INHIBŠpanělsko
-
University of WashingtonNational Institute of Mental Health (NIMH)NáborPrevence HIV | Preexpoziční profylaxe HIV | ImplementaceKeňa
-
University of Maryland, BaltimoreStaženoHiv | Transplantace ledvin | Zásobník HIV | CCR5Spojené státy