Self-Managing HIV and Chronic Disease

HIV/AIDS Clinical Trial

— PRIME  

Official title:

Community-based Self-management of HIV and Chronic Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032824
• Other study ID #: 5R01MH074380
• Status: Completed
• Phase: N/A
• First received: December 15, 2009
• Last updated: October 11, 2017
• Start date: October 2007
• Est. completion date: February 2011

Study information

• Verified date: October 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• HIV/AIDS

Intervention

Behavioral:
• Individual Telephone Counseling Intervention
10-session, 5-month HIV adherence and chronic disease self-management individual telephone counseling intervention.

Other:
• Group Arm
10-session didactic telephone group
• Book Arm
Book only.

Locations

Country	Name	City	State
United States	Group Health Research Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	antiretroviral (ART) adherence		Pre-treatment Screening and Baseline, 6, 9, and 12 months f/u.
Primary	health-related quality of life (physical, mental health, and social function)		Baseline, 6, 9, 12 mo f/u
Secondary	chronic disease treatment adherence		baseline, 6, 9 and 12 months f/u
Secondary	Self-efficacy and readiness to change		baseline, 6, 9, 12 months f/u
Secondary	perceived stress and depression		baseline, 6, 9, and 12 months f/u