Effectiveness of Coping Training for People With HIV Experiencing Treatment Side Effects (The Balance Project)

NCT00643903 | Completed

• 2 other identifiers: R01MH068208DAHBR 9A-ASGA
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of cognitive behavioral coping training in improving side effect management and treatment adherence in HIV-infected patients who are taking antiretroviral medications.

Conditions

HIV Infections

Keywords

Side Effects; Adherence; Coping; HIV; AIDS; Complementary Therapies

Outcome Measures

Primary Outcomes (1)

• Quality of life

  Measured at Month 18

Secondary Outcomes (1)

• Medication adherence

  Measured at Month 18

Study Arms (2)

1

EXPERIMENTAL

Participants will receive five individual sessions of coping effectiveness training.

Behavioral: Cognitive behavioral coping effectiveness training

2

ACTIVE COMPARATOR

Participants will receive standard care and one delayed group workshop of coping effectiveness training.

Behavioral: Standard care; Behavioral: Single group workshop on coping effectiveness training

Interventions

Cognitive behavioral coping effectiveness training BEHAVIORAL

Coping effectiveness training will include five individual 90-minute counseling sessions. The sessions will focus on coping with stress, dealing with medication side effects, and staying on track with medications.

1

Standard care BEHAVIORAL

Participants will receive standard of care for HIV infections.

2

Single group workshop on coping effectiveness training BEHAVIORAL

Participants will attend one group workshop covering the same material as in the individual sessions. The workshop will be delivered after completion of the Month 18 final assessment.

2

Eligibility Criteria

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

You may qualify if:

• Confirmed presence of HIV infection
• Currently receiving ART
• Experiencing ART side effects

You may not qualify if:

• Currently enrolled in another trial
• Evidence of psychosis or cognitive impairment

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94105, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mallory O. Johnson, PhD

  University of California, San Francisco

  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: March 24, 2008
• First Posted: March 26, 2008
• Study Start: April 1, 2004
• Primary Completion: September 1, 2008
• Study Completion: February 1, 2009
• Last Updated: December 12, 2023

Record last verified: 2012-01

Locations

US (1)