- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT00582218
Family Access to Care Study (FACS)
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
Tanulmány típusa
Beiratkozás (Várható)
Kapcsolatok és helyek
Tanulmányi helyek
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New York
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New York, New York, Egyesült Államok, 10065
- Memorial Sloan-Kettering Cancer Center
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Együttműködők és nyomozók
Nyomozók
- Kutatásvezető: Bruce Rapkin, PhD, Memorial Sloan Kettering Cancer Center
Publikációk és hasznos linkek
Hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 03-008
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