The Efficacy of the HIV/AIDS Symptom Management Manual
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV
- Sponsor
- University of California, San Francisco
- Enrollment
- 775
- Locations
- 11
- Primary Endpoint
- Degree of helpfulness (not at all, somewhat, very, extremely) of the symptom management manual at 1 month and 2 months.
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
The goals of this research are: 1) To test the efficacy of a self-care symptom management manual by examining whether people who use the manual find it to be useful; 2) To examine symptom and demographic data related to self-care behaviors, symptom control, medication adherence and enhanced quality of life.
The University of California, San Francisco is the coordinating site for this multi-site international study.
Detailed Description
People living with HIV/AIDS encounter many psychological, physiological, and cognitive symptoms, such as pain, diarrhea, fever, fatigue, depression, and confusion. These symptoms have been found to restrict a person's daily life significantly. Self-management of multiple HIV and medication side effects symptoms and maintaining optimal quality of life have, therefore, become major daily tasks for people living with HIV/AIDS. This study is a randomized controlled trial with a two-group repeated measures design to test the efficacy of the symptom management manual. Two groups (experimental and control) will be assessed in a repeated measures design at 3 time points: baseline (time 0), one month (time 1), and two months (time 2). Data will be analyzed using longitudinal mixture modeling. Comparison(s): HIV-positive patients receiving a symptom management manual and orientation to the manual, compared to HIV-positive patients receiving a nutrition manual and orientation to the manual.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosed HIV/AIDS
- •Adult (men and women, transgender)
- •Presence of at least one symptom within the past week
- •May or may not be pregnant
- •May or may not be on ART
- •Able to use the manual with or without family support
Exclusion Criteria
- •Documented diagnosis of dementia
- •Unable to understand consent procedure as judged by the person getting consent
- •Self-reporting no symptoms within the past week
- •Self-reports having had experience with a self-care Symptom Management Manual
Outcomes
Primary Outcomes
Degree of helpfulness (not at all, somewhat, very, extremely) of the symptom management manual at 1 month and 2 months.
Time Frame: 1 month and 2 months
Secondary Outcomes
- Change in quality of life.(1 month and 2 months)
- Change in adherence.(1 month and 2 months)
- Change in symptoms.(1 month and 2 months)