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CompletedNCT00183781Updated Aug 22, 2013

Effectiveness of a Telephone Intervention Program in Improving Depression, Coping, and Family Functioning in HIV-Infected Individuals and Caregivers

A Phase 3 interventional study of FITT: Family Intervention - Telephone Tracking in HIV Infections, sponsored by Butler Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-08-22.

Sponsored by Butler Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
270
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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 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.

02

Conditions studied

  • HIV Infections

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Keywords

  • HIV
  • Telephone intervention
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 270 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Butler Hospital is the lead sponsor of 113 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Schizophrenia
  • Lacks regular access to a telephone to receive calls
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
270 participants

Interventions

  • BehavioralFITT: Family Intervention - Telephone Tracking
06

What researchers measure

Primary outcomes

  1. Decreased depression; measured at baseline, and Months 3, 6, and 12

  2. Improved coping; measured at baseline, and Months 3, 6, and 12

  3. 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

07

Study locations

1 site
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
08

References and documents

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 15987325 ↗
  • Stein 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00183781
Lead sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)
First posted
Sep 16, 2005
Start date
Sep 2000
Completion
Jun 2004
Last update
Aug 22, 2013

Study contacts

Michael Stein, MD
principal investigator · Rhode Island Hospital
Penelope Dennehy, MD
study director · Rhode Island Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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