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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

December 15, 2009
August 16, 2012
October 2007
February 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01032824 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Self-Managing HIV and Chronic Disease
Community-based Self-management of HIV and Chronic Disease

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
HIV/AIDS
  • Behavioral: Individual Telephone Counseling Intervention
    10-session, 5-month HIV adherence and chronic disease self-management individual telephone counseling intervention.
    Other Name: telephone counseling
  • Other: Group Arm
    10-session didactic telephone group
    Other Name: Attention-matched comparison arm
  • Other: Book Arm
    Book only.
    Other Name: Information-matched comparison arm
  • Experimental: Intervention
    Individual telephone counseling intervention.
    Intervention: Behavioral: Individual Telephone Counseling Intervention
  • Group Arm
    Attention-matched comparison arm
    Intervention: Other: Group Arm
  • Book Arm
    Information-matched control arm.
    Intervention: Other: Book Arm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
452
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01032824
5RO1MH074380
No
Group Health Cooperative
Group Health Cooperative
Not Provided
Principal Investigator: Sheryl L Catz, PhD Group Health Research Institute
Group Health Cooperative
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP