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Self-Managing HIV and Chronic Disease (PRIME)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT01032824
First received: December 15, 2009
Last updated: August 16, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
HIV/AIDS
 Behavioral: Individual Telephone Counseling Intervention
Other: Group Arm
Other: Book Arm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Community-based Self-management of HIV and Chronic Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • antiretroviral (ART) adherence [ Time Frame: Pre-treatment Screening and Baseline, 6, 9, and 12 months f/u. ] [ Designated as safety issue: No ]
  • health-related quality of life (physical, mental health, and social function) [ Time Frame: Baseline, 6, 9, 12 mo f/u ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • chronic disease treatment adherence [ Time Frame: baseline, 6, 9 and 12 months f/u ] [ Designated as safety issue: No ]
  • Self-efficacy and readiness to change [ Time Frame: baseline, 6, 9, 12 months f/u ] [ Designated as safety issue: No ]
  • perceived stress and depression [ Time Frame: baseline, 6, 9, and 12 months f/u ] [ Designated as safety issue: No ]
Enrollment: 452
Study Start Date: October 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032824

Locations
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
Investigators
Principal Investigator: Sheryl L Catz, PhD Group Health Research Institute
  More Information

No publications provided

Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT01032824     History of Changes
Other Study ID Numbers: 5RO1MH074380
Study First Received: December 15, 2009
Last Updated: August 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Group Health Cooperative:
Complementary Therapies

ClinicalTrials.gov processed this record on March 03, 2015