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Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program

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ClinicalTrials.gov Identifier: NCT01662336
Recruitment Status : Completed
First Posted : August 10, 2012
Last Update Posted : September 2, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:

The study will assess the effectiveness of KASA (Kaletra Patient Support Program) on improving or maintaining treatment adherence in HIV positive patients that have been initiated on treatment with Kaletra®. This will be a purely observational study conducted on patients that will be on treatment with Kaletra®. All treatments will be as per routine care including the use of KASA which will be determined exclusively by the physician and the patient without consideration of the study.

The efficacy of disease management programs as assessed in randomized clinical trials is not representative of real - life effectiveness observed under routine clinical practice. In real - life settings the utilization of and compliance with disease management programs by physicians and patients is not uniform. Therefore assessment of their true effectiveness is ideally conducted under a pure observational setting without any interference from the investigators with respect to making the programs available to patients and enforcing their adherence to them.

Condition or disease
Human Immunodeficiency Virus Infection

Detailed Description:
This is a 12-month, multi-center, Canadian Post Marketing Observational Study utilizing a prospective single cohort design. Patients that are treated with Kaletra® including those that are initiated on treatment with Kaletra® will be eligible to participate. All treatments including participation in the KASA (Kaletra Adherence Support Assistance) program will be according to the decision of the treating physician and the patients and will not be affected in any way by their decision to participate in the study. Follow-up will be for 12 months with visits conducted according to the physician judgment. However, assessments every six months will be recommended.

Study Design

Study Type : Observational
Actual Enrollment : 173 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Real Life Effectiveness of KASA: A Prospective Observational Cohort Study
Study Start Date : June 2012
Primary Completion Date : June 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

HIV (Human Immunodeficiency Virus) positive subjects

Subjects participating in this purely observational study will be HIV-infected adults, who are currently being treated with Kaletra® or those who are initiated on treatment with Kaletra® and willing to be enrolled in the KASA program.

All treatments will be as per routine care which will be determined exclusively by the physician and the patient without consideration of the study

Outcome Measures

Primary Outcome Measures :
  1. Adherence will be measured by the Adherence Self - Efficacy Scale (ASES) .The primary outcome measure of the current study will be adherence with KALETRA treatment at 6 months after enrollment in the KASA program. [ Time Frame: 6 months ]
    The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen but also diet and exercise.

Secondary Outcome Measures :
  1. Change in patient Quality of Life as measured by the QOL 601-2 (Health Status Assessment Questionnaire) [ Time Frame: From Month 0 to Month 12 ]
    The QOL 601-2 ("Health Status Assessment" ) survey is a brief, comprehensive measure of health-related quality of life used extensively in Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS).

  2. Change in patient perception of stress as measured by the Perceived Stress Scale [ Time Frame: From 0 months to 12 months ]
    The Perceived Stress Sale is a 10-item questionnaire that assesses the degree to which the patient considers situations as stressful.

  3. Change in psychological well-being as measured by the Center for Epidemiologic studies depression scale (CES-D) [ Time Frame: From 0 months to 12 months ]
    The CES-D is a 20-item questionnaire assessing the presence of depressive state during the previous week.

  4. Change in Coping Self-Efficacy will be measured the change in the Coping Self - Efficacy Scale (CSE) [ Time Frame: From 0 months to 12 months ]
    CSE is a 13 item questionnaire that measures perceived self-efficacy in coping with daily psychological challenges.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be enrolled from the offices (at clinic or hospital) of primary care physicians across Canada treating HIV (Human Immunodeficiency Virus) positive patients.

Inclusion Criteria:

  • Subject is HIV+ (positive for Human Immunodeficiency Virus)
  • On treatment with Kaletra® or currently initiated on treatment with Kaletra®.
  • Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel.
  • Willing to be enrolled in the Kaletra Adherence Support Assistance (KASA) program.

Exclusion Criteria:

  • Not willing to sign an informed consent.
  • In the opinion of the treating physician is unlikely to be available for the 12-month follow-up duration of the study.
  • Is currently participating in a clinical trial of an investigational product.
  • Not willing to participate in the KASA program.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662336

Site Reference ID/Investigator# 75444
Montreal, Canada, H2I 4P9
Site Reference ID/Investigator# 75442
Montreal, Canada, H3H 1V1
Site Reference ID/Investigator# 77613
Ottawa, Canada, K1N 6N5
Site Reference ID/Investigator# 126514
Prince George, Canada, V2L 2P6
Site Reference ID/Investigator# 79793
Toronto, Canada, M5G 1N8
Site Reference ID/Investigator# 75438
Vancouver, Canada, V6Z 2C7
Site Reference ID/Investigator# 75439
Vancouver, Canada, V6Z 2T1
Site Reference ID/Investigator# 75440
Victoria, Canada, V8W 1M8
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Christina Pelizon, MD AbbVie Corporation
More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01662336     History of Changes
Other Study ID Numbers: P13-566
First Posted: August 10, 2012    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2016

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Human Immunodeficiency Virus infection

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Virus Diseases
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases