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| Sponsors and Collaborators: |
University of California, San Francisco University of Utah Massachusetts General Hospital University of Puerto Rico Aga Khan University University of South Africa Universidad del Turabo Texas A&M University |
|---|---|
| Information provided by: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00241202 |
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: | Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | The Efficacy of the HIV/AIDS Symptom Management Manual |
| 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) |
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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: | University of California, San Francisco ( William L. Holzemer ) |
| Study ID Numbers: | H642-27289 |
| Study First Received: | October 13, 2005 |
| Last Updated: | January 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00241202 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
signs and symptoms self care patient compliance quality of life |
|
Virus Diseases Signs and Symptoms Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Quality of Life Retroviridae Infections Immunologic Deficiency Syndromes |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Disease Immune System Diseases Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes |
Virus Diseases Pathologic Processes HIV Infections Syndrome Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |
