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Completed

NCT Number: NCT00241202

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Slow Virus Diseases Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nazareth Hospital, Nairobi, Kenya

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Symptom Management Manual

Behavioral

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

Other names: HIV/AIDS Symptom Management Strategies: A Manual for PLWHA

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in quality of life.

    Time frame: 1 month and 2 months

  2. Change in adherence.

    Time frame: 1 month and 2 months

  3. Change in symptoms.

    Time frame: 1 month and 2 months

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Aga Khan University
  • Massachusetts General Hospital
  • Texas A&M University
  • Universidad del Turabo
  • University of Puerto Rico
  • University of South Africa
  • University of Utah

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 18, 2005
Registry last updated
Jan 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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