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Clinical Trials/NCT01032824
NCT01032824
Completed
N/A

Community-based Self-management of HIV and Chronic Disease

Kaiser Permanente1 site in 1 country452 target enrollmentOctober 2007
ConditionsHIV/AIDS

Overview

Phase
N/A
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
Kaiser Permanente
Enrollment
452
Locations
1
Primary Endpoint
health-related quality of life (physical, mental health, and social function)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to conduct a randomized control trial of a behavioral intervention delivered by counselors via telephone to determine if this is an efficacious method for improving medication adherence and health-related quality of life for persons who are 50 and older and living with HIV/AIDS and other chronic conditions.

Detailed Description

450 adult HIV+ patients aged 50 or older will be randomized to one of three arms. 150 will be assigned to receive a series of ten 30-minute phone calls every two weeks from a counselor. 150 will be assigned to an attention-matched comparison arm, and will receive 10 sessions in a didactic telephone group. 150 will be assigned to a information-matched control arm and will receive the book Living Well with HIV \& AIDS. Letters will be sent by AIDS Service Organizations inviting interested clients to call the study's 800 number to learn more about the study and to be screened for enrollment. Posters and brochures will also be posted in public areas of the ASOs. The individualized intervention combines problem-solving, with motivation and self-management. This trial will allow us to evaluate the effectiveness of a multi-component intervention on both specific HIV behavioral outcomes and non-disease-specific outcomes.

Registry
clinicaltrials.gov
Start Date
October 2007
End Date
February 2011
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • age 50 years or older
  • HIV-positive serostatus
  • currently prescribed antiretroviral medication
  • antiretroviral nonadherence reported in past 30 days
  • provision of oral informed consent

Exclusion Criteria

  • hearing problems that preclude participation in a telephone study
  • presence of probable dementia or acute psychosis detectable by screening interview

Outcomes

Primary Outcomes

health-related quality of life (physical, mental health, and social function)

Time Frame: Baseline, 6, 9, 12 mo f/u

antiretroviral (ART) adherence

Time Frame: Pre-treatment Screening and Baseline, 6, 9, and 12 months f/u.

Secondary Outcomes

  • chronic disease treatment adherence(baseline, 6, 9 and 12 months f/u)
  • Self-efficacy and readiness to change(baseline, 6, 9, 12 months f/u)
  • perceived stress and depression(baseline, 6, 9, and 12 months f/u)

Study Sites (1)

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