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
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94105
- University of California, San Francisco
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 1
Participants will receive five individual sessions of coping effectiveness training.
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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.
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Active Comparator: 2
Participants will receive standard care and one delayed group workshop of coping effectiveness training.
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Participants will receive standard of care for HIV infections.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Quality of life
Time Frame: Measured at Month 18
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Measured at Month 18
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Medication adherence
Time Frame: Measured at Month 18
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Measured at Month 18
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mallory O. Johnson, PhD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
Other Study ID Numbers
- R01MH068208 (U.S. NIH Grant/Contract)
- DAHBR 9A-ASGA
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