The Efficacy of the HIV/AIDS Symptom Management Manual

Study 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.

Official Title
-----------------
The Efficacy of the HIV/AIDS Symptom Management Manual

Conditions
-----------------
HIV, Acquired Immunodeficiency Syndrome

Intervention / Treatment
-----------------
* Behavioral: Symptom Management Manual


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Symptom 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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
signs and symptoms, self care, patient compliance, quality of life