- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00582218
Family Access to Care Study (FACS)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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New York
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New York, New York, États-Unis, 10065
- Memorial Sloan-Kettering Cancer Center
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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:
Inclusion Criteria for Sampling AIDS Care Settings: Our goal in sampling is to identify and recruit the kinds of organizations that might ultimately be targets for Phase IV trials and other Memorial Sloan-Kettering Cancer Center dissemination efforts. For purposes of this research, we define an "AIDS Care Setting" as any setting which:
- Provides primary medical care, case management, day treatment, mental health or substance use treatment for people living with HIV/AIDS.
- Includes two or more full-time professional staff (e.g., social workers, nurses, clergy, physicians, or psychologists) with primary responsibility for an HIV/AIDS population.
- Has an active caseload of at least 50 people with HIV/AIDS.
- Has been in operation as an HIV/AIDS provider for at least two years.
- Has leadership and staff who are agreeable to participate in the work plan outlined in the Memorandum of Understanding (MOU).
Inclusion Criteria for Providers:
- Working as an administrator of HIV/AIDS care services, or a direct provider of services to HIV+ patients/clients.
- Working at the agency for at least 6 months.
- Working at the agency at least 20 hours a week.
- Able to converse in English or Spanish.
- Identified by agency leadership as staff who meet above criteria and can be approached, or want to volunteer to be interviewed.
Inclusion Criteria for Sampling Patients/Clients:
- Identified as HIV+ (according to identification by setting staff and/or by virtue of receiving services in a program exclusively designated for people infected with HIV/AIDS).
- Receiving services at an HIV/AIDS Care Setting sampled for this study, at the time of recruitment.
- Identified as a setting client for at least three months (in order to answer questions about the setting).
- Age 18 or older or emancipated minors over age 16.
- Able to converse in English or Spanish.
- Physically and mentally capable of providing informed consent, as determined by a trained interviewer.
Inclusion Criteria for Patients'/Clients' Family Members: In keeping with the definition of family as "networks of mutual commitment" adopted by the NIMH Family and AIDS Consortium, and in recognition of the diverse types of family situations of people affected by HIV/AIDS, we will include anyone designated as a "family member" by the index client/patient who meets our other inclusion criteria:
- Identified by index patient client as "one of the people in my family most likely to participate in programs with me" at the HIV/AIDS Care Setting sampled for this study.
- Age 18 or older or emancipated minors over age 16.
- Able to converse in English or Spanish.
- Physically and mentally capable of providing informed consent, as determined by a trained interviewer.
Exclusion Criteria:
Exclusion Criteria for AIDS Care Settings: Note that two or more AIDS Care Settings may exist within a single institution or agency. For example, hospitals may have separate programs for adult and pediatric HIV. A community AIDS service organization may have multiple distinct programs for different populations. Also, two settings may be closely coordinated. In order to ensure independence among settings, we will adopt the following exclusionary criteria:
- Only one AIDS Care Setting administered or governed by a given institution will be included in the study. If one setting from a particular institution agrees to participate, other settings from that institution will be ineligible.
- Multi-site programs or programs of a single agency that are working together in a coordinated fashion for purposes of this study will be treated as a single "AIDS Care Setting." If we discover that programs are affiliated, we will remove them from the list. In general, we will attempt to carry out this project at the site initially identified, although involvement of multiple sites may be necessary.
Exclusion Consideration for Providers: All providers who are identified by the agency leadership will be approached. However, a provider will not be able to participate if he/she has already participated in the study as a provider from another agency.
Exclusion Considerations for Patients and Families: All patients/clients of settings identified for this study and meeting above inclusion criteria are eligible. Patients/clients will be able to participate regardless of whether or not they nominate a family member to participate in the study with them.
Patients/clients will not be able to participate if they:
- Are not HIV+.
- Have been receiving services at the HIV/AIDS care setting for less than three months.
- Are under the age of 18, or are not emancipated minors.
- Are not able to converse in either English or Spanish.
- Are physically and mentally incapable of providing informed consent, as determined by a trained interviewer.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Bruce Rapkin, PhD, Memorial Sloan Kettering Cancer Center
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
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
- Syndromes d'immunodéficience
- Maladies du système immunitaire
- Infections à VIH
Autres numéros d'identification d'étude
- 03-008
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 .
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