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The Efficacy of the HIV/AIDS Symptom Management Manual

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ClinicalTrials.gov Identifier: NCT00241202
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : January 17, 2008
Sponsor:
Collaborators:
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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
HIV Acquired Immunodeficiency Syndrome Behavioral: Symptom Management Manual Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 775 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Efficacy of the HIV/AIDS Symptom Management Manual
Study Start Date : October 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    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.
    Other Name: HIV/AIDS Symptom Management Strategies: A Manual for PLWHA

Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in quality of life. [ Time Frame: 1 month and 2 months ]
  2. Change in adherence. [ Time Frame: 1 month and 2 months ]
  3. Change in symptoms. [ Time Frame: 1 month and 2 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241202


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
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
Investigators
Principal Investigator: William L. Holzemer, RN, PhD University of California, San Francisco
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: January 17, 2008
Last Verified: January 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