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The Efficacy of the HIV/AIDS Symptom Management Manual
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Purpose
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.
| Condition | Intervention |
|---|---|
| HIV Acquired Immunodeficiency Syndrome | Behavioral: Symptom Management Manual |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | The Efficacy of the HIV/AIDS Symptom Management Manual |
- 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 ]
- Change in quality of life. [ Time Frame: 1 month and 2 months ]
- Change in adherence. [ Time Frame: 1 month and 2 months ]
- Change in symptoms. [ Time Frame: 1 month and 2 months ]
| Enrollment: | 775 |
| Study Start Date: | October 2005 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
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Behavioral: Symptom Management Manual
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00241202
| United States, California | |
| San Francisco Veteran's Affairs Medical Center | |
| San Francisco, California, United States, 94121 | |
| PositiveHealth Practice | |
| San Francisco, California, United States, 94143-0378 | |
| United States, Illinois | |
| Jackson Park Hospital | |
| Chicago, Illinois, United States, 60649 | |
| United States, Massachusetts | |
| Boston Living Center | |
| Boston, Massachusetts, United States, 02116 | |
| United States, Texas | |
| Valley AIDS Clinic - Harlingen | |
| Harlingen, Texas, United States, 78550 | |
| Thomas Street Health Center | |
| Houston, Texas, United States, 77009 | |
| United States, Utah | |
| University of Utah Health Science Center | |
| Salt Lake City, Utah, United States, 84112 | |
| Kenya | |
| Nazareth Hospital | |
| Nairobi, Kenya | |
| Puerto Rico | |
| AIDS Clinical Trials Unit | |
| San Juan, Puerto Rico, 00936 | |
| Casita de Salud Integral Ramón Vicente, Universidad del Turabo | |
| Vega Baja, Puerto Rico, 00693 | |
| South Africa | |
| PAH ARV Clinic - Tshwane District Hospital | |
| Pretoria, South Africa, 0001 | |
| Principal Investigator: | William L. Holzemer, RN, PhD | University of California, San Francisco |
More Information
| Responsible Party: | William L. Holzemer, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00241202 History of Changes |
| Other Study ID Numbers: |
H642-27289 |
| Study First Received: | October 13, 2005 |
| Last Updated: | January 14, 2008 |
Keywords provided by University of California, San Francisco:
|
signs and symptoms self care patient compliance quality of life |
Additional relevant MeSH terms:
|
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on July 21, 2017