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Self-Managing HIV and Chronic Disease

NCT ID: NCT01032824

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

452 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-02-28

Brief Summary

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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

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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.

Conditions

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HIV/AIDS

Keywords

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Complementary Therapies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

Individual telephone counseling intervention.

Group Type EXPERIMENTAL

Individual Telephone Counseling Intervention

Intervention Type BEHAVIORAL

10-session, 5-month HIV adherence and chronic disease self-management individual telephone counseling intervention.

Group Arm

Attention-matched comparison arm

Group Type OTHER

Group Arm

Intervention Type OTHER

10-session didactic telephone group

Book Arm

Information-matched control arm.

Group Type OTHER

Book Arm

Intervention Type OTHER

Book only.

Interventions

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Individual Telephone Counseling Intervention

10-session, 5-month HIV adherence and chronic disease self-management individual telephone counseling intervention.

Intervention Type BEHAVIORAL

Group Arm

10-session didactic telephone group

Intervention Type OTHER

Book Arm

Book only.

Intervention Type OTHER

Other Intervention Names

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telephone counseling Attention-matched comparison arm Information-matched comparison arm

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sheryl L Catz, PhD

Role: PRINCIPAL_INVESTIGATOR

Group Health Research Institute

Locations

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Group Health Research Institute

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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5R01MH074380

Identifier Type: NIH

Identifier Source: org_study_id

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