The Efficacy of the HIV/AIDS Symptom Management Manual

January 14, 2008 updated by: University of California, San Francisco

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

775

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Nairobi, Kenya
        • Nazareth Hospital
  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • AIDS Clinical Trials Unit
      • Vega Baja, Puerto Rico, 00693
        • Casita de Salud Integral Ramón Vicente, Universidad del Turabo
  • South Africa
      • Pretoria, South Africa, 0001
        • PAH ARV Clinic - Tshwane District Hospital
  • United States
    • California
      • San Francisco, California, United States, 94121
        • San Francisco Veteran's Affairs Medical Center
      • San Francisco, California, United States, 94143-0378
        • PositiveHealth Practice
    • Illinois
      • Chicago, Illinois, United States, 60649
        • Jackson Park Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02116
        • Boston Living Center
    • Texas
      • Harlingen, Texas, United States, 78550
        • Valley AIDS Clinic - Harlingen
      • Houston, Texas, United States, 77009
        • Thomas Street Health Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 month and 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in quality of life.
Time Frame: 1 month and 2 months
1 month and 2 months
Change in adherence.
Time Frame: 1 month and 2 months
1 month and 2 months
Change in symptoms.
Time Frame: 1 month and 2 months
1 month and 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Massachusetts General Hospital
Aga Khan University
University of Utah
Texas A&M University
University of Puerto Rico
University of South Africa
Universidad del Turabo

Investigators

  • Principal Investigator: William L. Holzemer, RN, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

October 13, 2005

First Submitted That Met QC Criteria

October 14, 2005

First Posted (Estimate)

October 18, 2005

Study Record Updates

Last Update Posted (Estimate)

January 17, 2008

Last Update Submitted That Met QC Criteria

January 14, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H642-27289

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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