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

HIV Infections Clinical Trial

Official title:

The Balance Project - RCT of an HIV Treatment Side Effects Coping Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643903
• Other study ID #: R01MH068208
• Secondary ID: R01MH068208DAHBR
• Status: Completed
• Phase: N/A
• Start date: April 2004
• Est. completion date: February 2009

Study information

• Verified date: January 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.
• Standard care
Participants will receive standard of care for HIV infections.
• 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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life		Measured at Month 18
Secondary	Medication adherence		Measured at Month 18