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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
Results First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
The overall purpose of the study was to describe the real-life adherence, effectiveness and safety of the Kaletra Adherence Support Assistance (KASA) Program in human immunodeficiency virus (HIV)-positive patients who were receiving treatment with lopinavir / ritonavir (LPV/r; Kaletra®) in Canada.

Condition or disease Intervention/treatment
Human Immunodeficiency Virus Infection Drug: Lopinavir / ritonavir Behavioral: Kaletra Adherence Support Assistance Program

Detailed Description:

The Kaletra Adherence Support Assistance (KASA) Program is a customized support network that has been offered to patients treated with lopinavir / ritonavir (LPV/r; Kaletra®). KASA offers individual counseling with an HIV experienced nurse who assists patients with various aspects of their therapy including life-style changes, emotional stress, and adverse events. Patients enrolled in KASA may also have access to various healthcare professionals (dietician, social worker, psychologist, etc.) or may be offered other types of support (transportation, exercise, etc.), which may help improve their quality of life as well as adherence or compliance while taking LPV/r.

This was a 12-month, multi-center, Canadian Post Marketing Observational Study utilizing a prospective single cohort design. All treatments including participation in the KASA program were according to the decision of the treating physician and the patients and were not affected in any way by their decision to participate in the study. Follow-up was for 12 months at an interval of every six months.


Study Type : Observational
Actual Enrollment : 173 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Real-Life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program: A Prospective Observational Cohort Study (KASA PMOS)
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

Group/Cohort Intervention/treatment
Lopinavir/Ritonavir + KASA
Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Drug: Lopinavir / ritonavir
Prescribed according to the product monograph and physician's discretion.
Other Names:
  • Kaletra®
  • LPV/r
Behavioral: Kaletra Adherence Support Assistance Program
A customized support network for patients treated with lopinavir / ritonavir that offers individual counseling with an HIV experienced nurse who assists patients with various aspects of their therapy including life-style changes, emotional stress, and adverse events, and may provide access to various healthcare professionals or may offer other types of support such as transportation, exercise, etc.
Other Name: KASA



Primary Outcome Measures :
  1. Percentage of Participants Adherent to Treatment at Month 6 [ Time Frame: Baseline and 6 months ]
    Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question is answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 6 relative to Baseline was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.


Secondary Outcome Measures :
  1. Change From Baseline in Adherence Summative Score at Months 6 and 12 [ Time Frame: Baseline, Month 6 and Month 12 ]
    Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the participant's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy.

  2. Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12 [ Time Frame: Baseline, Month 6 and Month 12 ]

    Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do).

    The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence integration subscale score ranges from 0 to 90, with higher scores indicating higher treatment self-efficacy.


  3. Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12 [ Time Frame: Baseline, Month 6 and Month 12 ]
    Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence perseverance subscale score ranges from 0 to 30, with higher scores indicating higher treatment self-efficacy.

  4. Percentage of Participants Adherent to Treatment at Month 12 [ Time Frame: Baseline and 12 months ]
    Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 12 was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.

  5. Change From Baseline in Health-related Quality of Life General Health Perception Domain Score [ Time Frame: Baseline, Month 6 and Month 12 ]
    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.

  6. Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score [ Time Frame: Baseline, Month 6 and Month 12 ]
    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.

  7. Change From Baseline in Health-related Quality of Life Role Functioning Domain Score [ Time Frame: Baseline, Month 6 and Month 12 ]
    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.

  8. Change From Baseline in Health-related Quality of Life Social Functioning Domain Score [ Time Frame: Baseline, Month 6 and Month 12 ]
    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.

  9. Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score [ Time Frame: Baseline, Month 6 and Month 12 ]
    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.

  10. Change From Baseline in Health-related Quality of Life Pain Domain Score [ Time Frame: Baseline, Month 6 and Month 12 ]
    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.

  11. Change From Baseline in Health-related Quality of Life Mental Health Domain Score [ Time Frame: Baseline, Month 6 and Month 12 ]
    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.

  12. Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score [ Time Frame: Baseline, Month 6 and Month 12 ]
    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.

  13. Change From Baseline in Patient Perception of Stress [ Time Frame: Baseline, Month 6 and Month 12 ]
    Change in perception of stress was measured by the Perceived Stress Scale (PSS), a 10-item questionnaire that assesses the degree to which the participant considered situations as stressful. The PSS score ranges from 0 to 40, with higher scores indicating higher levels of perceived stress.

  14. Change From Baseline in Psychological Well-being [ Time Frame: Baseline, Month 6 and Month 12 ]
    Change in psychological well-being was measured by the Center for Epidemiologic Studies Depression scale (CES-D), a 20-item questionnaire assessing the presence of depressive state during the previous week. The possible range of scores is 0 to 60, with higher scores indicating the presence of more symptomatology.

  15. Change From Baseline in Coping Self-Efficacy [ Time Frame: Baseline, Month 6 and Month 12 ]
    Change in coping self-efficacy was measured by the Coping Self-Efficacy Scale (CSE), a 26-item questionnaire that measures perceived self-efficacy in coping with daily psychological challenges. A summative score ranging from 0 to 260 was calculated, with higher scores indicating higher coping self-efficacy.

  16. Health Resource Utilization [ Time Frame: Baseline, Month 6 and Month 12 ]
    Health resource utilization (HRU) was measured by a self-administered questionnaire that contained a series of questions aimed at measuring the patient's utilization of healthcare resources and economic impact of the disease.

  17. Viral Load at Each Visit [ Time Frame: Baseline, Month 6 and Month 12 ]
  18. Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit [ Time Frame: Baseline, Month 6 and Month 12 ]
  19. Healthcare Provider Satisfaction [ Time Frame: Month 6 and Month 12 ]
    For each participant, healthcare provider (HCP) satisfaction with the KASA program was measured by three questions assessing 1) the overall satisfaction with the KASA program, 2) subjective assessment on whether the KASA program was beneficial in maintaining adherence with HIV treatments, and 3) the likelihood of recommending KASA in the future. The scores for each question ranged from 0 to 100, with higher scores indicating higher satisfaction.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Subject is HIV-positive
  • On treatment with LPV/r or currently initiated on treatment with LPV/r.
  • 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.
  • Prescribed LPV/r as part of his/her treatment by the treating physician.

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.

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


Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Christina Pelizon, MD AbbVie Corporation

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
Results First Posted: January 29, 2018
Last Update Posted: January 29, 2018
Last Verified: June 2017

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Virus Diseases
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors