Clinical trial NCT00241202: The Efficacy of the HIV/AIDS Symptom Management Manual
Official title: The Efficacy of the HIV/AIDS Symptom Management Manual
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Acquired Immunodeficiency Syndrome
Keywords: signs and symptoms
self care
patient compliance
quality of life
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Utah
name: Massachusetts General Hospital
name: University of Puerto Rico
name: Aga Khan University
name: University of South Africa
name: Universidad del Turabo
name: Texas A&M University
First posted: 2005-10-18
Enrollment: 775
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Degree of helpfulness (not at all, somewhat, very, extremely) of the symptom management manual at 1 month and 2 months.
timeFrame: 1 month and 2 months
Secondary outcomes:
measure: Change in quality of life.
timeFrame: 1 month and 2 months
measure: Change in adherence.
timeFrame: 1 month and 2 months
measure: Change in symptoms.
timeFrame: 1 month and 2 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Veteran's Affairs Medical Center
state: California
city: San Francisco
country: United States
facility: PositiveHealth Practice
state: California
city: Chicago
country: United States
facility: Jackson Park Hospital
state: Illinois
city: Boston
country: United States
facility: Boston Living Center
state: Massachusetts
city: Harlingen
country: United States
facility: Valley AIDS Clinic - Harlingen
state: Texas
city: Houston
country: United States
facility: Thomas Street Health Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Science Center
state: Utah
city: Nairobi
country: Kenya
facility: Nazareth Hospital
city: San Juan
country: Puerto Rico
facility: AIDS Clinical Trials Unit
city: Vega Baja
country: Puerto Rico
facility: Casita de Salud Integral Ramón Vicente, Universidad del Turabo
city: Pretoria
country: South Africa
facility: PAH ARV Clinic - Tshwane District Hospital
Study officials:
affiliation: University of California, San Francisco
name: William L. Holzemer, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: