Ignite Creation Date:
2024-05-05 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00643903
Status:
COMPLETED
Last Update Posted:
2023-12-12
First Post:
2008-03-24
Brief Title:
Effectiveness of Coping Training for People With HIV Experiencing Treatment Side Effects The Balance Project
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
The Balance Project - RCT of an HIV Treatment Side Effects Coping Intervention
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DAHBR 9A-ASGA | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH068208 |
| R01MH068208 | NIH | None | None |