HIV InfectionsPhase 3NCT00183781
Effectiveness of a Telephone Intervention Program in Improving Depression, Coping, and Family Functioning in HIV-Infected Individuals and Caregivers
A Phase 3 study testing FITT: Family Intervention - Telephone Tracking in people with HIV Infections, run by Butler Hospital at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of the Family Intervention: Telephone Tracking (FITT) program in improving depression, coping, and family functioning in HIV-infected individuals and their caregivers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- FITT: Family Intervention - Telephone Tracking
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Jun 2004
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recently began HIV care
- Currently undergoing HIV care in one of the BRUNAP clinics
- Ability to co-enroll with a primary HIV informal caregiver
- English- or Spanish-speaking
Who cannot join
- Schizophrenia
- Lacks regular access to a telephone to receive calls
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Adapting to HIV Disease - A Family Intervention
This study will evaluate the effectiveness of the Family Intervention: Telephone Tracking (FITT) program in improving depression, coping, and family functioning in HIV-infected individuals and their caregivers.
Read the detailed description
Individuals who are newly diagnosed with HIV often experience a variety of social and psychological problems, which can leave them depressed and unable to cope with their disease. The complex financial, legal, and psychiatric issues that many HIV-infected individuals must face can be stressful and can negatively affect their health; they may miss doctors' appointments or fail to adhere to a strict HIV medication regimen. The combination of stress and inconsistent medical care can affect the immune system and potentially worsen HIV symptoms.
Because of the multitude of stressors associated with HIV, HIV-infected individuals often rely on a network of family and friends for support; these caregivers, however, are often overwhelmed by their caregiver roles. They may experience helplessness, fear, and depression as a result of their added responsibilities. Family Intervention: Telephone Tracking (FITT) is a telephone-based intervention program that assists in identifying problems and resolving them through referrals to medical and community organizations that provide HIV-related support and services. It is also an educational resource that provides information on the many medical and psychological aspects of HIV infection. The main goal of FITT is to alleviate stress in both the HIV-infected individual and their support network by providing information and resources to help cope with HIV. The purpose of this study is to evaluate the effectiveness of FITT in improving family functioning, enhancing coping skills, and reducing depression in HIV-infected individuals and their caregivers.
This 12-month study will enroll recently diagnosed HIV-infected individuals and one family member or friend who is identified as their primary caregiver. Each pair will be randomly assigned to either the FITT intervention group or to an assessment-only group that will not receive FITT. Individuals who are assigned to receive FITT will utilize the service for Months 1 through 6. HIV-infected participants in both groups will also receive regular medical care throughout the study. Outcome measurements will include self-assessments of depression, coping, and family functioning. In addition, participants receiving FITT will be asked to evaluate the effectiveness of the telephone intervention. All measurements will be assessed at baseline, and Months 3, 6, and 12.
- Conditions
- HIV Infections
- Being tested
- FITT: Family Intervention - Telephone Tracking
- Keywords
- HIV, Telephone intervention
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FITT: Family Intervention - Telephone TrackingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased depression; measured at baseline, and Months 3, 6, and 12
Improved coping; measured at baseline, and Months 3, 6, and 12
Improved family functioning; measured at baseline, and Months 3, 6, and 12
Secondary outcomes (1)
Efficacy of FITT intervention; measured at baseline, and Months 3, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2000
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Michael Stein, MD, Principal investigator, Rhode Island HospitalPenelope Dennehy, MD, Study director, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183781
- Sponsor's protocol ID
- R01MH063051
- Other IDs
- R01MH063051, DAHBR AZ-A
- Status last verified
- Aug 2013
- First submitted
- 14 Sep 2005
- Last updated
- 22 Aug 2013
- Results posted
- No
Publications
Pirraglia PA, Bishop D, Herman DS, Trisvan E, Lopez RA, Torgersen CS, Van Hof AM, Anderson BJ, Miller I, Stein MD. Caregiver burden and depression among informal caregivers of HIV-infected individuals. J Gen Intern Med. 2005 Jun;20(6):510-4. doi: 10.1111/j.1525-1497.2005.0073.x.
PubMed 15987325Stein M, Herman DS, Trisvan E, Pirraglia P, Engler P, Anderson BJ. Alcohol use and sexual risk behavior among human immunodeficiency virus-positive persons. Alcohol Clin Exp Res. 2005 May;29(5):837-43. doi: 10.1097/01.alc.0000164363.40533.e0.
PubMed 15897729
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting to HIV Disease - A Family Intervention
- ClinicalTrials.gov ID
- NCT00183781
- Acronym / sponsor ID
- R01MH063051
- Conditions
- HIV Infections
- Keywords
- HIV, Telephone intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2000
- Study completion
- Jun 2004 (actual)
- First posted
- 16 Sep 2005 (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.
This study will evaluate the effectiveness of the Family Intervention: Telephone Tracking (FITT) program in improving depression, coping, and family functioning in HIV-infected individuals and their caregivers.
Detailed description
Individuals who are newly diagnosed with HIV often experience a variety of social and psychological problems, which can leave them depressed and unable to cope with their disease. The complex financial, legal, and psychiatric issues that many HIV-infected individuals must face can be stressful and can negatively affect their health; they may miss doctors' appointments or fail to adhere to a strict HIV medication regimen. The combination of stress and inconsistent medical care can affect the immune system and potentially worsen HIV symptoms.
Because of the multitude of stressors associated with HIV, HIV-infected individuals often rely on a network of family and friends for support; these caregivers, however, are often overwhelmed by their caregiver roles. They may experience helplessness, fear, and depression as a result of their added responsibilities. Family Intervention: Telephone Tracking (FITT) is a telephone-based intervention program that assists in identifying problems and resolving them through referrals to medical and community organizations that provide HIV-related support and services. It is also an educational resource that provides information on the many medical and psychological aspects of HIV infection. The main goal of FITT is to alleviate stress in both the HIV-infected individual and their support network by providing information and resources to help cope with HIV. The purpose of this study is to evaluate the effectiveness of FITT in improving family functioning, enhancing coping skills, and reducing depression in HIV-infected individuals and their caregivers.
This 12-month study will enroll recently diagnosed HIV-infected individuals and one family member or friend who is identified as their primary caregiver. Each pair will be randomly assigned to either the FITT intervention group or to an assessment-only group that will not receive FITT. Individuals who are assigned to receive FITT will utilize the service for Months 1 through 6. HIV-infected participants in both groups will also receive regular medical care throughout the study. Outcome measurements will include self-assessments of depression, coping, and family functioning. In addition, participants receiving FITT will be asked to evaluate the effectiveness of the telephone intervention. All measurements will be assessed at baseline, and Months 3, 6, and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recently began HIV care
- Currently undergoing HIV care in one of the BRUNAP clinics
- Ability to co-enroll with a primary HIV informal caregiver
- English- or Spanish-speaking
Key exclusion criteria (2 listed)
- Schizophrenia
- Lacks regular access to a telephone to receive calls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FITT: Family Intervention - Telephone Tracking | Behavioural | – |
Primary outcome
Decreased depression; measured at baseline, and Months 3, 6, and 12
Improved coping; measured at baseline, and Months 3, 6, and 12
Improved family functioning; measured at baseline, and Months 3, 6, and 12
1 secondary outcome
Efficacy of FITT intervention; measured at baseline, and Months 3, 6, and 12
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 22 Aug 2013.
- Background: PubMed 15987325Pirraglia PA, Bishop D, Herman DS, Trisvan E, Lopez RA, Torgersen CS, Van Hof AM, Anderson BJ, Miller I, Stein MD. Caregiver burden and depression among informal caregivers of HIV-infected individuals. J Gen Intern Med. 2005 Jun;20(6):510-4. doi: 10.1111/j.1525-1497.2005.0073.x.
- Background: PubMed 15897729Stein M, Herman DS, Trisvan E, Pirraglia P, Engler P, Anderson BJ. Alcohol use and sexual risk behavior among human immunodeficiency virus-positive persons. Alcohol Clin Exp Res. 2005 May;29(5):837-43. doi: 10.1097/01.alc.0000164363.40533.e0.
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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.
Michael Stein, MD principal investigator
Rhode Island Hospital
Penelope Dennehy, MD study director
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FITT: Family Intervention - Telephone Tracking in people with HIV Infections, run by Butler Hospital 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 4 inclusion and 2 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 22 Aug 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Decreased depression; measured at baseline, and Months 3, 6, and 12. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00183781, which also lists 2 linked publications.
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 22 Aug 2013; AzTrials last refreshed its copy on 30 Oct 2026.