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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00643903
First received: March 24, 2008
Last updated: January 18, 2012
Last verified: January 2012

March 24, 2008
January 18, 2012
April 2004
September 2008   (final data collection date for primary outcome measure)
Quality of life [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00643903 on ClinicalTrials.gov Archive Site
Medication adherence [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Coping Training for People With HIV Experiencing Treatment Side Effects (The Balance Project)
The Balance Project - RCT of an HIV Treatment Side Effects Coping Intervention

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.

HIV is a virus that is transmitted through the exchange of bodily fluids, primarily through sexual intercourse. HIV infections can lead to acquired immunodeficiency syndrome (AIDS), a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. Antiretroviral therapy (ART) has proven to effectively inhibit the replication of HIV and has resulted in a reduction in HIV-related deaths. People infected with HIV who are receiving ART, however, may be confronted with negative physical and emotional side effects. These side effects can impact quality of life (QOL), adherence to medical care, and decisions about health care. Stress and Coping Theory (SCT) is a person-centered approach that considers stressful experiences as person-environment transactions. A cognitive behavioral treatment based upon SCT may help to eliminate or reduce the negative impact of side effects, improve QOL, and maximize benefit from treatment among people living with HIV. This study will evaluate the effectiveness of cognitive behavioral coping training in improving side effect management and treatment adherence in HIV-infected people who are taking ART medications.

This study will involve two phases. Phase 1 will be conducted over 12 months and will include two 1-hour interviews with questions about personal life, family, friends, medications, and medication side effects. After the first interview, participants may be invited to participate in Phase 2, which will last 18 months.

During Phase 2, participants will complete five 2- to 3-hour interviews occurring at baseline and Months 3, 6, 12, and 18. Interviews will include questions about personal life, friends, family, health-related activities, drug-using behaviors, emotions, mental state, and educational background. Participants will be assigned randomly to one of two treatment groups:

  • Group 1 participants will receive five individual sessions of cognitive behavioral coping training, beginning after the Month 3 interview. The 90-minute sessions will focus on coping with stress, dealing with medication side effects, and staying on track with medications.
  • Group 2 participants will receive standard care and one group session of coping training, which will be held after the Month 18 interview. The group session will cover the same material that is covered in the individual sessions.

After the last follow-up interview, some participants may also be asked to complete an exit interview about thoughts and feelings on study participation.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
HIV Infections
  • Behavioral: Cognitive behavioral coping effectiveness training
    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.
  • Behavioral: Standard care
    Participants will receive standard of care for HIV infections.
  • Behavioral: Single group workshop on coping effectiveness training
    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.
  • Experimental: 1
    Participants will receive five individual sessions of coping effectiveness training.
    Intervention: Behavioral: Cognitive behavioral coping effectiveness training
  • Active Comparator: 2
    Participants will receive standard care and one delayed group workshop of coping effectiveness training.
    Interventions:
    • Behavioral: Standard care
    • Behavioral: Single group workshop on coping effectiveness training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
February 2009
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Currently enrolled in another trial
  • Evidence of psychosis or cognitive impairment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00643903
R01 MH068208, R01MH068208, DAHBR 9A-ASGA
No
University of California, San Francisco
University of California, San Francisco
National Institute of Mental Health (NIMH)
Principal Investigator: Mallory O. Johnson, PhD University of California, San Francisco
University of California, San Francisco
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP