Self-Managing HIV and Chronic Disease

Study Overview
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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.

Official Title
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Community-based Self-management of HIV and Chronic Disease

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: Individual Telephone Counseling Intervention
* Other: Group Arm
* Other: Book Arm


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Individual telephone counseling intervention. | Behavioral: Individual Telephone Counseling Intervention<br>* 10-session, 5-month HIV adherence and chronic disease self-management individual telephone counseling intervention.<br>* Other names: telephone counseling;|
| Other: Group Arm<br>Attention-matched comparison arm | Other: Group Arm<br>* 10-session didactic telephone group<br>* Other names: Attention-matched comparison arm;|
| Other: Book Arm<br>Information-matched control arm. | Other: Book Arm<br>* Book only.<br>* Other names: Information-matched comparison arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complementary Therapies