The Efficacy of the HIV/AIDS Symptom Management Manual
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
California
-
San Francisco, California, Forenede Stater, 94121
- San Francisco Veteran's Affairs Medical Center
-
San Francisco, California, Forenede Stater, 94143-0378
- PositiveHealth Practice
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-
Illinois
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Chicago, Illinois, Forenede Stater, 60649
- Jackson Park Hospital
-
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02116
- Boston Living Center
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-
Texas
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Harlingen, Texas, Forenede Stater, 78550
- Valley AIDS Clinic - Harlingen
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Houston, Texas, Forenede Stater, 77009
- Thomas Street Health Center
-
-
Utah
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Salt Lake City, Utah, Forenede Stater, 84112
- University of Utah Health Science center
-
-
-
-
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Nairobi, Kenya
- Nazareth Hospital
-
-
-
-
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San Juan, Puerto Rico, 00936
- AIDS Clinical Trials Unit
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Vega Baja, Puerto Rico, 00693
- Casita de Salud Integral Ramón Vicente, Universidad del Turabo
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-
-
-
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Pretoria, Sydafrika, 0001
- PAH ARV Clinic - Tshwane District Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Degree of helpfulness (not at all, somewhat, very, extremely) of the symptom management manual at 1 month and 2 months.
Tidsramme: 1 month and 2 months
|
1 month and 2 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in quality of life.
Tidsramme: 1 month and 2 months
|
1 month and 2 months
|
|
Change in adherence.
Tidsramme: 1 month and 2 months
|
1 month and 2 months
|
|
Change in symptoms.
Tidsramme: 1 month and 2 months
|
1 month and 2 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: William L. Holzemer, RN, PhD, University of California, San Francisco
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Sygdomme i immunsystemet
- Langsomme virussygdomme
- HIV-infektioner
- Erhvervet immundefektsyndrom
- Immunologiske mangelsyndromer
Andre undersøgelses-id-numre
- H642-27289
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