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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01662336
First received: August 8, 2012
Last updated: October 10, 2014
Last verified: October 2014

August 8, 2012
October 10, 2014
June 2012
December 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01662336 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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).
  • Change in patient perception of stress as measured by the Perceived Stress Scale [ Time Frame: From 0 months to 12 months ] [ Designated as safety issue: No ]
    The Perceived Stress Sale is a 10-item questionnaire that assesses the degree to which the patient considers situations as stressful.
  • 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 ] [ Designated as safety issue: No ]
    The CES-D is a 20-item questionnaire assessing the presence of depressive state during the previous week.
  • 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 ] [ Designated as safety issue: No ]
    CSE is a 13 item questionnaire that measures perceived self-efficacy in coping with daily psychological challenges.
Same as current
Not Provided
Not Provided
 
Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program
Real Life Effectiveness of KASA: A Prospective Observational Cohort Study

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients will be enrolled from the offices (at clinic or hospital) of primary care physicians across Canada treating HIV (Human Immunodeficiency Virus) positive patients.

Human Immunodeficiency Virus Infection
Not Provided
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

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
165
December 2015
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Jacinthe Lemay, PhD 514-832-7321 jacinthe.lemay@abbvie.com
Contact: Marie-Josee Fournelle 514-832-7307 marie-josee.fournelle@abbvie.com
Canada
 
NCT01662336
P13-566
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Linda Assouline AbbVie Corporation
AbbVie
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP