Self-Managing HIV and Chronic Disease (PRIME)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01032824

First Posted: December 16, 2009

Last Update Posted: October 13, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Kaiser Permanente

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 Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care
Official Title:	Community-based Self-management of HIV and Chronic Disease

Resource links provided by NLM:

MedlinePlus related topics: Coping with Chronic Illness HIV/AIDS

U.S. FDA Resources

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


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

Information from the National Library of Medicine

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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

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


Responsible Party:	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT01032824 History of Changes
Other Study ID Numbers:	5R01MH074380 ( U.S. NIH Grant/Contract )
First Submitted:	December 15, 2009
First Posted:	December 16, 2009
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

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