Self-Managing HIV and Chronic Disease (PRIME)
This study has been completed.
Sponsor:
Group Health Cooperative
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT01032824
First received: December 15, 2009
Last updated: August 16, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV/AIDS |
Behavioral: Individual Telephone Counseling Intervention Other: Group Arm Other: Book Arm |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Community-based Self-management of HIV and Chronic Disease |
Resource links provided by NLM:
Further study details as provided by Group Health Cooperative:
Primary Outcome Measures:
- antiretroviral (ART) adherence [ Time Frame: Pre-treatment Screening and Baseline, 6, 9, and 12 months f/u. ] [ Designated as safety issue: No ]
- health-related quality of life (physical, mental health, and social function) [ Time Frame: Baseline, 6, 9, 12 mo f/u ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- chronic disease treatment adherence [ Time Frame: baseline, 6, 9 and 12 months f/u ] [ Designated as safety issue: No ]
- Self-efficacy and readiness to change [ Time Frame: baseline, 6, 9, 12 months f/u ] [ Designated as safety issue: No ]
- perceived stress and depression [ Time Frame: baseline, 6, 9, and 12 months f/u ] [ Designated as safety issue: No ]
| Enrollment: | 452 |
| Study Start Date: | October 2007 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: telephone counseling
|
|
Group Arm
Attention-matched comparison arm
|
Other: Group Arm
10-session didactic telephone group
Other Name: Attention-matched comparison arm
|
|
Book Arm
Information-matched control arm.
|
Other: Book Arm
Book only.
Other Name: Information-matched comparison 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.
Eligibility| Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032824
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032824
Locations
| United States, Washington | |
| Group Health Research Institute | |
| Seattle, Washington, United States, 98101 | |
Sponsors and Collaborators
Group Health Cooperative
Investigators
| Principal Investigator: | Sheryl L Catz, PhD | Group Health Research Institute |
More Information
| Responsible Party: | Group Health Cooperative |
| ClinicalTrials.gov Identifier: | NCT01032824 History of Changes |
| Other Study ID Numbers: | 5R01MH074380 |
| Study First Received: | December 15, 2009 |
| Last Updated: | August 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Group Health Cooperative:
|
Complementary Therapies |
Additional relevant MeSH terms:
|
Chronic Disease Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on September 26, 2016