Acquired Immunodeficiency Syndrome, HIV
Conditions
Keywords
signs and symptoms, self care, patient compliance, quality of life
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.
Interventions
BEHAVIORALSymptom Management Manual
Participants receive the Symptom Management Manual, and are shown an example. They are given the Manual to take home with them and use.
Sponsors
University of Utah
Massachusetts General Hospital
University of Puerto Rico
Aga Khan University
University of South Africa
Universidad del Turabo
Texas A&M University
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed HIV/AIDS * Adult (men and women, transgender) * Presence of at least one symptom within the past week * Consent * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of helpfulness (not at all, somewhat, very, extremely) of the symptom management manual at 1 month and 2 months. | 1 month and 2 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Kenya, Puerto Rico, South Africa, United States
Outcome results
None listed