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The Efficacy of the HIV/AIDS Symptom Management Manual

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00241202
First received: October 13, 2005
Last updated: January 14, 2008
Last verified: January 2008

October 13, 2005
January 14, 2008
October 2005
December 2006   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Degree of helpfulness (not at all, somewhat, very, extremely) of the symptom management manual at 1 month and 2 months.
Complete list of historical versions of study NCT00241202 on ClinicalTrials.gov Archive Site
  • Change in quality of life. [ Time Frame: 1 month and 2 months ] [ Designated as safety issue: No ]
  • Change in adherence. [ Time Frame: 1 month and 2 months ] [ Designated as safety issue: No ]
  • Change in symptoms. [ Time Frame: 1 month and 2 months ] [ Designated as safety issue: No ]
  • Change in quality of life.
  • Change in adherence.
  • Change in symptoms.
Not Provided
Not Provided
 
The Efficacy of the HIV/AIDS Symptom Management Manual
The Efficacy of the HIV/AIDS Symptom Management Manual

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • HIV
  • Acquired Immunodeficiency Syndrome
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
775
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Kenya,   Puerto Rico,   South Africa
 
NCT00241202
H642-27289
No
William L. Holzemer, University of California, San Francisco
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
Principal Investigator: William L. Holzemer, RN, PhD University of California, San Francisco
University of California, San Francisco
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP