NCT00183781

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P25-P50 for phase_3 hiv-infections

Timeline
Completed

Started Sep 2000

Typical duration for phase_3 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

August 22, 2013

Status Verified

August 1, 2013

First QC Date

September 14, 2005

Last Update Submit

August 20, 2013

Conditions

HIV Infections

Keywords

HIVTelephone intervention

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

FITT: Family Intervention - Telephone TrackingBEHAVIORAL

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (2)

  • 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.

    PMID: 15987325BACKGROUND

  • 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.

    PMID: 15897729BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Michael Stein, MD

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

  • Penelope Dennehy, MD

    Rhode Island Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

September 1, 2000

Study Completion

June 1, 2004

Last Updated

August 22, 2013

Record last verified: 2013-08

Locations

US(1)