The Efficacy of the HIV/AIDS Symptom Management Manual

HIV Clinical Trial

Official title:

The Efficacy of the HIV/AIDS Symptom Management Manual

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241202
• Other study ID #: H642-27289
• Status: Completed
• Phase: N/A
• First received: October 13, 2005
• Last updated: January 14, 2008
• Start date: October 2005
• Est. completion date: December 2006

Study information

• Verified date: January 2008
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 775
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

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.

Locations

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

Sponsors (8)

Lead Sponsor	Collaborator
University of California, San Francisco	Aga Khan University, Massachusetts General Hospital, Texas A&M University, Universidad del Turabo, University of Puerto Rico, University of South Africa, University of Utah

Countries where clinical trial is conducted

United States,  Kenya,  Puerto Rico,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in quality of life.		1 month and 2 months	No
Secondary	Change in adherence.		1 month and 2 months	No
Secondary	Change in symptoms.		1 month and 2 months	No

External Links

•   Sponsor's website