HIV InfectionsNCT00582218
Family Access to Care Study (FACS)
An observational study of HIV Infections, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to find ways to get services to families living with HIV. New services for families living with HIV have been tried in places around the country. They seem to benefit many families. We will work with places in New York City that provide HIV services to find out more about family services. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 3,200 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Feb 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients/clients and their families at HIV/AIDS care centers
Who may be able to join
- 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).
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- 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.
- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to find ways to get services to families living with HIV. New services for families living with HIV have been tried in places around the country. They seem to benefit many families. We will work with places in New York City that provide HIV services to find out more about family services. There, we will talk with people living with HIV, their family members, and their providers. Many questions need to be answered. For example: What kinds of services do families want? What would make it easier for families to come in for services? What would get in the way?
Read the detailed description
Families affected by HIV and AIDS require access to a comprehensive continuum of services. Findings from our own and other recently completed federally sponsored intervention trials and other studies could be used to help expand and enhance these services. However, a number of fundamental questions must first be answered about the feasibility of "technology transfer." This study will address this issue by conducting individual interviews and focus groups with providers from 64 medical care and social service settings. Data will also be obtained through a comprehensive assessment of providers' capacities to serve families and to participate in technology transfer, including dimensions of organizational mission and leadership, availability of resources, and connections in the community. Thirty patients/clients served by each setting along with approximately twenty of their family members will also be individually interviewed to assess their needs for services, factors that affect their desire for family-oriented services, and their willingness to take part in psychosocial intervention studies. Data analysis will determine how initial setting readiness and setting capacities, and feedback about patient and family needs and willingness to participate in research, influence change in readiness, interest in capacity building and participation in research partnership activities. We will also conduct hierarchical data analyses to better understand how providers' readiness and capacities are related to clients'and families' service needs, barriers to participation, and willingness to participate in research. Study findings will guide efforts to implement family-oriented intervention research in frontline community service settings, and will help to establish a scientific framework for studying the process of technology transfer. Additionally, this project will lay the groundwork for sustained research collaboration with the network of community providers participating in this study to further explore ways to address the needs of families affected by HIV/AIDS.
- Conditions
- HIV Infections
- Keywords
- HIV/AIDS, Access to care
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startFeb 2003
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Bruce Rapkin, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582218
- Sponsor's protocol ID
- 03-008
- Status last verified
- Jan 2009
- First submitted
- 21 Dec 2007
- Last updated
- 14 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Access to Care Study (FACS)
- ClinicalTrials.gov ID
- NCT00582218
- Acronym / sponsor ID
- 03-008
- Conditions
- HIV Infections
- Keywords
- HIV/AIDS, Access to care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find ways to get services to families living with HIV. New services for families living with HIV have been tried in places around the country. They seem to benefit many families. We will work with places in New York City that provide HIV services to find out more about family services. There, we will talk with people living with HIV, their family members, and their providers. Many questions need to be answered. For example: What kinds of services do families want? What would make it easier for families to come in for services? What would get in the way?
Detailed description
Families affected by HIV and AIDS require access to a comprehensive continuum of services. Findings from our own and other recently completed federally sponsored intervention trials and other studies could be used to help expand and enhance these services. However, a number of fundamental questions must first be answered about the feasibility of "technology transfer." This study will address this issue by conducting individual interviews and focus groups with providers from 64 medical care and social service settings. Data will also be obtained through a comprehensive assessment of providers' capacities to serve families and to participate in technology transfer, including dimensions of organizational mission and leadership, availability of resources, and connections in the community. Thirty patients/clients served by each setting along with approximately twenty of their family members will also be individually interviewed to assess their needs for services, factors that affect their desire for family-oriented services, and their willingness to take part in psychosocial intervention studies. Data analysis will determine how initial setting readiness and setting capacities, and feedback about patient and family needs and willingness to participate in research, influence change in readiness, interest in capacity building and participation in research partnership activities. We will also conduct hierarchical data analyses to better understand how providers' readiness and capacities are related to clients'and families' service needs, barriers to participation, and willingness to participate in research. Study findings will guide efforts to implement family-oriented intervention research in frontline community service settings, and will help to establish a scientific framework for studying the process of technology transfer. Additionally, this project will lay the groundwork for sustained research collaboration with the network of community providers participating in this study to further explore ways to address the needs of families affected by HIV/AIDS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients/clients and their families at HIV/AIDS care centers
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2009.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Rapkin, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2009.