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
  Purpose

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
Human Immunodeficiency Virus Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Real Life Effectiveness of KASA: A Prospective Observational Cohort Study

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 165
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/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


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662336

Contacts
Contact: Jacinthe Lemay, PhD 514-832-7321 jacinthe.lemay@abbvie.com
Contact: Marie-Josee Fournelle 514-832-7307 marie-josee.fournelle@abbvie.com

Locations
Canada
Site Reference ID/Investigator# 84273 Not yet recruiting
Brampton, Canada, L6R 3J7
Principal Investigator: Site Reference ID/Investigator# 84273         
Site Reference ID/Investigator# 75437 Not yet recruiting
Montreal, Canada, H2L 5B1
Principal Investigator: Site Reference ID/Investigator# 75437         
Site Reference ID/Investigator# 75444 Recruiting
Montreal, Canada, H2L 4P9
Principal Investigator: Site Reference ID/Investigator# 75444         
Site Reference ID/Investigator# 75441 Not yet recruiting
Montreal, Canada, H2X 2P4
Principal Investigator: Site Reference ID/Investigator# 75441         
Site Reference ID/Investigator# 75442 Recruiting
Montreal, Canada, H3H 1V1
Principal Investigator: Site Reference ID/Investigator# 75442         
Site Reference ID/Investigator# 75443 Not yet recruiting
Montreal, Canada, H2L 4M1
Principal Investigator: Site Reference ID/Investigator# 75443         
Site Reference ID/Investigator# 77613 Recruiting
Ottawa, Canada, K1N 6N5
Principal Investigator: Site Reference ID/Investigator# 77613         
Site Reference ID/Investigator# 126514 Not yet recruiting
Prince George, Canada, V2L 2P6
Principal Investigator: Site Reference ID/Investigator# 126514         
Site Reference ID/Investigator# 122455 Not yet recruiting
St-Jerome, Canada, J7Z 4B8
Principal Investigator: Site Reference ID/Investigator# 122455         
Site Reference ID/Investigator# 107135 Not yet recruiting
Toronto, Canada, M5B 1L6
Principal Investigator: Site Reference ID/Investigator# 107135         
Site Reference ID/Investigator# 79793 Active, not recruiting
Toronto, Canada, M5G 1N8
Site Reference ID/Investigator# 75438 Recruiting
Vancouver, Canada, V6Z 2C7
Principal Investigator: Site Reference ID/Investigator# 75438         
Site Reference ID/Investigator# 75439 Recruiting
Vancouver, Canada, V6Z 2T1
Principal Investigator: Site Reference ID/Investigator# 75439         
Site Reference ID/Investigator# 75440 Recruiting
Victoria, Canada, V8W 1M8
Principal Investigator: Site Reference ID/Investigator# 75440         
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Linda Assouline AbbVie Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01662336     History of Changes
Other Study ID Numbers: P13-566
Study First Received: August 8, 2012
Last Updated: October 10, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by AbbVie:
Human Immunodeficiency Virus infection

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

ClinicalTrials.gov processed this record on October 21, 2014