Self-Managing HIV and Chronic Disease (PRIME)

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: Individual Telephone Counseling Intervention; Other: Group Arm; Other: Book 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.

• Study Type: Interventional
• Enrollment (Actual): 452
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Group Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: telephone counseling
Other: Group Arm; Attention-matched comparison arm	Other: Group Arm; 10-session didactic telephone group; Other Names: Attention-matched comparison arm
Other: Book Arm; Information-matched control arm.	Other: Book Arm; Book only.; Other Names: Information-matched comparison arm

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Sheryl L Catz, PhD, Group Health Research Institute

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: December 15, 2009
• First Submitted That Met QC Criteria: December 15, 2009
• First Posted (Estimate): December 16, 2009

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Complementary Therapies
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 5R01MH074380 (U.S. NIH Grant/Contract)