HIVNCT00241202
The Efficacy of the HIV/AIDS Symptom Management Manual
A study testing Symptom Management Manual in people with HIV and Acquired Immunodeficiency Syndrome, run by University of California, San Francisco at 11 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Acquired Immunodeficiency Syndrome
- What is being tested?
- Symptom Management Manual
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 775 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Oct 2005to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United States7 sites
Boston Living Center
Boston, Massachusetts, 02116
Jackson Park Hospital
Chicago, Illinois, 60649
Valley AIDS Clinic - Harlingen
Harlingen, Texas, 78550
Thomas Street Health Center
Houston, Texas, 77009
University of Utah Health Science Center
Salt Lake City, Utah, 84112
San Francisco Veteran's Affairs Medical Center
San Francisco, California, 94121
PositiveHealth Practice
San Francisco, California, 94143-0378
Puerto Rico2 sites
AIDS Clinical Trials Unit
San Juan, 00936
Casita de Salud Integral Ramón Vicente, Universidad del Turabo
Vega Baja, 00693
South Africa1 site
PAH ARV Clinic - Tshwane District Hospital
Pretoria, 0001
About this study
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.
Read the 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.
- Conditions
- HIV, Acquired Immunodeficiency Syndrome
- Being tested
- Symptom Management Manual
- Keywords
- signs and symptoms, self care, patient compliance, quality of life
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Signs and Symptoms, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom Management ManualBehavioural
Also called HIV/AIDS Symptom Management Strategies: A Manual for PLWHA
Participants receive the Symptom Management Manual, and are shown an example. They are given the Manual to take home with them and use.
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of helpfulness (not at all, somewhat, very, extremely) of the symptom management manual at 1 month and 2 months.
Measured: 1 month and 2 months
Secondary outcomes (3)
Change in quality of life.
Measured: 1 month and 2 months
Change in adherence.
Measured: 1 month and 2 months
Change in symptoms.
Measured: 1 month and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 775 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, Massachusetts General Hospital, University of Puerto Rico, Aga Khan University, University of South Africa, Universidad del Turabo, Texas A&M University
- Investigators
- William L. Holzemer, RN, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241202
- Sponsor's protocol ID
- H642-27289
- Status last verified
- Jan 2008
- First submitted
- 13 Oct 2005
- Last updated
- 17 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the HIV/AIDS Symptom Management Manual
- ClinicalTrials.gov ID
- NCT00241202
- Acronym / sponsor ID
- H642-27289
- Conditions
- HIV, Acquired Immunodeficiency Syndrome
- Keywords
- signs and symptoms, self care, patient compliance, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 775 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Utah, Massachusetts General Hospital, University of Puerto Rico, Aga Khan University, University of South Africa, Universidad del Turabo, Texas A&M University
- Study start
- Oct 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 18 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptom Management ManualAlso: HIV/AIDS Symptom Management Strategies: A Manual for PLWHAParticipants receive the Symptom Management Manual, and are shown an example. They are given the Manual to take home with them and use. | Behavioural | – |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William L. Holzemer, RN, PhD principal investigator
University of California, San Francisco
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symptom Management Manual in people with HIV and Acquired Immunodeficiency Syndrome, run by University of California, San Francisco at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Puerto Rico, Kenya, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2008.