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
|
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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 |
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 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 |
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Behavioral: 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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

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
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 |
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 |