Self-Managing HIV and Chronic Disease

NCT01032824 | Completed

• 1 other identifier: 5R01MH074380
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

Complementary Therapies

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (3)

Intervention

EXPERIMENTAL

Individual telephone counseling intervention.

Behavioral: Individual Telephone Counseling Intervention

Group Arm

OTHER

Attention-matched comparison arm

Other: Group Arm

Book Arm

OTHER

Information-matched control arm.

Other: Book Arm

Interventions

Individual Telephone Counseling Intervention BEHAVIORAL

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

Also known as: telephone counseling

Intervention

Group Arm OTHER

10-session didactic telephone group

Also known as: Attention-matched comparison arm

Group Arm

Book Arm OTHER

Book only.

Also known as: Information-matched comparison arm

Book Arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 50 years or older
• HIV-positive serostatus
• currently prescribed antiretroviral medication
• antiretroviral nonadherence reported in past 30 days
• provision of oral informed consent

You may not qualify if:

• hearing problems that preclude participation in a telephone study
• presence of probable dementia or acute psychosis detectable by screening interview

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Sheryl L Catz, PhD

  Group Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: October 1, 2007
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: October 13, 2017

Record last verified: 2017-10

Locations

US (1)