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Self-Managing HIV and Chronic Disease (PRIME)

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ClinicalTrials.gov Identifier: NCT01032824
Recruitment Status : Completed
First Posted : December 16, 2009
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Individual Telephone Counseling Intervention Other: Group Arm Other: Book Arm Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Community-based Self-management of HIV and Chronic Disease
Study Start Date : October 2007
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
Individual telephone counseling intervention.
 Behavioral: Individual Telephone Counseling Intervention
10-session, 5-month HIV adherence and chronic disease self-management individual telephone counseling intervention.
Other Name: telephone counseling
Group Arm
Attention-matched comparison arm
 Other: Group Arm
10-session didactic telephone group
Other Name: Attention-matched comparison arm
Book Arm
Information-matched control arm.
 Other: Book Arm
Book only.
Other Name: Information-matched comparison arm


Outcome Measures
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Primary Outcome Measures :
  1. antiretroviral (ART) adherence [ Time Frame: Pre-treatment Screening and Baseline, 6, 9, and 12 months f/u. ]
  2. health-related quality of life (physical, mental health, and social function) [ Time Frame: Baseline, 6, 9, 12 mo f/u ]

Secondary Outcome Measures :
  1. chronic disease treatment adherence [ Time Frame: baseline, 6, 9 and 12 months f/u ]
  2. Self-efficacy and readiness to change [ Time Frame: baseline, 6, 9, 12 months f/u ]
  3. perceived stress and depression [ Time Frame: baseline, 6, 9, and 12 months f/u ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032824


Locations
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Sheryl L Catz, PhD Group Health Research Institute
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01032824     History of Changes
Other Study ID Numbers: 5R01MH074380 ( U.S. NIH Grant/Contract )
First Posted: December 16, 2009    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by Kaiser Permanente:
Complementary Therapies

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes