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Self-Managing HIV and Chronic Disease (PRIME)

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Individual Telephone Counseling Intervention
Group Arm
Book Arm
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV/AIDS focused on measuring Complementary Therapies

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Group Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Other

Arm Label

Intervention

Group Arm

Book Arm

Arm Description

Individual telephone counseling intervention.

Attention-matched comparison arm

Information-matched control arm.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

chronic disease treatment adherence
Self-efficacy and readiness to change
perceived stress and depression

Full Information

First Posted
December 15, 2009
Last Updated
October 11, 2017
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT01032824
Brief Title
Self-Managing HIV and Chronic Disease
Acronym
PRIME
Official Title
Community-based Self-management of HIV and Chronic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
Complementary Therapies

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
452 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Individual telephone counseling intervention.
Arm Title
Group Arm
Arm Type
Other
Arm Description
Attention-matched comparison arm
Arm Title
Book Arm
Arm Type
Other
Arm Description
Information-matched control arm.
Intervention Type
Behavioral
Intervention Name(s)
Individual Telephone Counseling Intervention
Other Intervention Name(s)
telephone counseling
Intervention Description
10-session, 5-month HIV adherence and chronic disease self-management individual telephone counseling intervention.
Intervention Type
Other
Intervention Name(s)
Group Arm
Other Intervention Name(s)
Attention-matched comparison arm
Intervention Description
10-session didactic telephone group
Intervention Type
Other
Intervention Name(s)
Book Arm
Other Intervention Name(s)
Information-matched comparison arm
Intervention Description
Book only.
Primary Outcome Measure Information:
Title
antiretroviral (ART) adherence
Time Frame
Pre-treatment Screening and Baseline, 6, 9, and 12 months f/u.
Title
health-related quality of life (physical, mental health, and social function)
Time Frame
Baseline, 6, 9, 12 mo f/u
Secondary Outcome Measure Information:
Title
chronic disease treatment adherence
Time Frame
baseline, 6, 9 and 12 months f/u
Title
Self-efficacy and readiness to change
Time Frame
baseline, 6, 9, 12 months f/u
Title
perceived stress and depression
Time Frame
baseline, 6, 9, and 12 months f/u

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheryl L Catz, PhD
Organizational Affiliation
Group Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

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Self-Managing HIV and Chronic Disease

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