Self-Managing HIV and Chronic Disease

Not Applicable

Completed

• Conditions: HIV/AIDS
• Interventions: Behavioral: Individual Telephone Counseling Intervention; Other: Book Arm; Other: Group Arm

• Registration Number: NCT01032824
• Lead Sponsor: Kaiser Permanente

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 452

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Individual Telephone Counseling Intervention	Individual telephone counseling intervention.
Book Arm	Book Arm	Information-matched control arm.
Group Arm	Group Arm	Attention-matched comparison arm

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Group Health Research Institute; 🇺🇸 Seattle, Washington, United States