- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01322217
Managerial Database II
Network-Wide Assessment of Current Health Status and Behavioral Risk Factors: An Expanded Study for New Sites in ATN III
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The proposed study is a cross sectional study intended to be conducted at each of the Adolescent Medicine Trials Units (AMTUs) newly participating in ATN III and to enroll all participating patients followed at each site. This approach will allow for the examination of the broad spectrum of youth participating in the ATN, including those newly entered into care.
Psychosocial and risk-taking behavioral data will be collected using Audio Computer-Assisted Self-Interview (ACASI) for English-speaking participants, or a paper-and-pencil Spanish-language survey with identical measures to the ACASI for Spanish-speaking participants; biomedical information will be collected through medical chart abstraction.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Colorado
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Aurora, Colorado, États-Unis, 80045
- University of Colorado Denver
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Maryland
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Baltimore, Maryland, États-Unis, 21287
- Johns Hopkins University
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- The Fenway Institute-Fenway Health
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Michigan
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Detroit, Michigan, États-Unis, 48201
- Wayne State University-Children's Hospital of Michigan
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Texas
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Houston, Texas, États-Unis, 77030
- Baylor College of Medicine - Pediatrics Allergy and Immunology
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Laboratory evidence of HIV-1 infection documented by a positive result on any of the following licensed tests at any time: Any HIV-1 antibody test confirmed by Western blot, HIV-1 culture, HIV-1 DNA PCR, or plasma HIV-1 RNA PCR > 1,000 copies/ml;
- Knowledge of HIV positive diagnoses;
- Age 12 years through 24 years, inclusive, at the time of consent;
- Engaged in care at the AMTU or its affiliate and/or partnering clinic. Individuals will be considered to be engaged in care if they have an AMTU (or its affiliate) clinic visit during the enrollment period;
- Ability to understand written and/or verbal English or Spanish.
Exclusion Criteria:
- Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individual's ability to complete the study measures;
- Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior); or
- Intoxicated or under the influence of alcohol or other substances at the time of consent/assent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Transversale
Cohortes et interventions
Groupe / Cohorte |
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AMTU Clients
All HIV-infected adolescents and young adults engaged in care at sites newly participating in ATN III and their affiliates who are between 12 and 24 years of age, inclusive, are aware of their HIV status and understand written and/or verbal English will be eligible for inclusion in the study.
In addition, new patients who have their initial clinic visit within the enrollment period will also be eligible for participation.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Collect information on for adolescents and young adults with HIV infection engaged in care at the AMTUs
Délai: 1 year
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Collect information on rates of adherence to medical regimens, sexual risk behavior, substance use and mental health concerns, along with basic demographic and biomedical data for adolescents and young adults with HIV infection engaged in care at the AMTUs to better understand the extent of risk behaviors as well as to understand risk and protective factors in this population.
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1 year
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
To better understand the complex relationships between adherence to medical regimens, sexual risk behavior, substance use and mental health concerns, and basic demographic and biomedical data in adolescents and young adults with HIV infection.
Délai: 1 year
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1 year
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Collaborateurs et enquêteurs
Les enquêteurs
- Chaise d'étude: Heather Huszti, PhD, Adolescent Trials Network
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections à lentivirus
- Infections à rétroviridae
- Maladies du système immunitaire
- Maladies à virus lents
- Infections à VIH
- Syndrome immunodéficitaire acquis
- Syndromes d'immunodéficience
Autres numéros d'identification d'étude
- ATN 106
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .