The Efficacy of the HIV/AIDS Symptom Management Manual

Not Applicable

Completed

• Conditions: HIV; Acquired Immunodeficiency Syndrome

• Registration Number: NCT00241202
• Lead Sponsor: University of California, San Francisco

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.

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 Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-13
• Study First Submitted QC: 2005-10-14
• Study First Posted: 2005-10-18
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-14
• Last Update Posted: 2008-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 775

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Degree of helpfulness (not at all, somewhat, very, extremely) of the symptom management manual at 1 month and 2 months.	1 month and 2 months

Secondary Outcome Measures

Name	Time	Method
Change in quality of life.	1 month and 2 months
Change in adherence.	1 month and 2 months
Change in symptoms.	1 month and 2 months

Trial Locations

Locations (11)

Jackson Park Hospital; 🇺🇸 Chicago, Illinois, United States

PositiveHealth Practice; 🇺🇸 San Francisco, California, United States

Casita de Salud Integral Ramón Vicente, Universidad del Turabo; 🇵🇷 Vega Baja, Puerto Rico

San Francisco Veteran's Affairs Medical Center; 🇺🇸 San Francisco, California, United States

AIDS Clinical Trials Unit; 🇵🇷 San Juan, Puerto Rico

Valley AIDS Clinic - Harlingen; 🇺🇸 Harlingen, Texas, United States

University of Utah Health Science Center; 🇺🇸 Salt Lake City, Utah, United States

PAH ARV Clinic - Tshwane District Hospital; 🇿🇦 Pretoria, South Africa

Nazareth Hospital; 🇰🇪 Nairobi, Kenya

Boston Living Center; 🇺🇸 Boston, Massachusetts, United States

Thomas Street Health Center; 🇺🇸 Houston, Texas, United States