NCT00241202

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
775

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Oct 2005

Shorter than P25 for not_applicable hiv

Geographic Reach
4 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

January 17, 2008

Status Verified

January 1, 2008

Enrollment Period

1.2 years

First QC Date

October 13, 2005

Last Update Submit

January 14, 2008

Conditions

HIVAcquired Immunodeficiency Syndrome

Keywords

signs and symptomsself carepatient compliancequality of life

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Change in quality of life.

    1 month and 2 months

  • Change in adherence.

    1 month and 2 months

  • Change in symptoms.

    1 month and 2 months

Interventions

Symptom Management ManualBEHAVIORAL

Participants receive the Symptom Management Manual, and are shown an example. They are given the Manual to take home with them and use.

Also known as: HIV/AIDS Symptom Management Strategies: A Manual for PLWHA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

San Francisco Veteran's Affairs Medical Center

San Francisco, California, 94121, United States

Location

PositiveHealth Practice

San Francisco, California, 94143-0378, United States

Location

Jackson Park Hospital

Chicago, Illinois, 60649, United States

Location

Boston Living Center

Boston, Massachusetts, 02116, United States

Location

Valley AIDS Clinic - Harlingen

Harlingen, Texas, 78550, United States

Location

Thomas Street Health Center

Houston, Texas, 77009, United States

Location

University of Utah Health Science Center

Salt Lake City, Utah, 84112, United States

Location

Nazareth Hospital

Nairobi, Kenya

Location

AIDS Clinical Trials Unit

San Juan, 00936, Puerto Rico

Location

Casita de Salud Integral Ramón Vicente, Universidad del Turabo

Vega Baja, 00693, Puerto Rico

Location

PAH ARV Clinic - Tshwane District Hospital

Pretoria, 0001, South Africa

Location

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSigns and SymptomsPatient Compliance

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • William L. Holzemer, RN, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 18, 2005

Study Start

October 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

January 17, 2008

Record last verified: 2008-01

Locations

PR(2)ZA(1)US(7)KE(1)