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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) )

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Human Immunodeficiency Virus Infection
Interventions: Drug: Lopinavir / ritonavir
Behavioral: Kaletra Adherence Support Assistance Program

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from the practices of 8 physicians in Canada between 29 June 2012 and 06 August 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lopinavir/Ritonavir + KASA Patients were treated according to the standard of care provided by their respective study sites. Treatments with lopinavir / ritonavir (LPV/r; Kaletra®) and participation in the Kaletra Adherence Support Assistance (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.

Participant Flow:   Overall Study
    Lopinavir/Ritonavir + KASA
STARTED   173 
Completed Month 6 Visit   142 
Completed Month 12 Visit   109 
COMPLETED   107 
NOT COMPLETED   66 
Adverse Event                1 
No longer on LPV/r                30 
Other                29 
Withdrawal by Subject                6 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
   Lopinavir/Ritonavir + KASA 
Overall Participants Analyzed 
[Units: Participants]
 173 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 173 
   50.7  (10.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 173 
Female      24  13.9% 
Male      149  86.1% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 173 
American Indian/ Alaska      7   4.0% 
Asian      13   7.5% 
Black      15   8.7% 
Hispanic or Latino      1   0.6% 
Other      5   2.9% 
White      130  75.1% 
Missing      2   1.2% 
Adherence Self-Efficacy Scale (ASES) Scores [1] [2] 
[Units: Units on a scale]
Mean (Standard Deviation)
 
Adherence Summative Score   
Participants Analyzed 
[Units: Participants]
 164 
Adherence Summative Score   102.5  (17.3) 
Adherence Integration Subscale Score   
Participants Analyzed 
[Units: Participants]
 168 
Adherence Integration Subscale Score   77.1  (13.2) 
Adherence Perseverance Subscale Score   
Participants Analyzed 
[Units: Participants]
 164 
Adherence Perseverance Subscale Score   25.0  (5.0) 
[1] The ASES is a 12 item tool that measures 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 ranges from 0 to 120, with higher scores indicating higher treatment self-efficacy. The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence integration subscale score ranges from 0 to 90 and the adherence perseverance subscale score ranges from 0 to 30.
[2] Intent-to-treat population included all enrolled participants who received at least 1 dose of lopinavir/ritonavir; data are reported for participants with non-missing data at baseline.
Health Status Assessment (HSA) [1] [2] 
[Units: Units on a scale]
Mean (Standard Deviation)
 
General Health Perception   
Participants Analyzed 
[Units: Participants]
 166 
General Health Perception   58.2  (23.2) 
Physical Functioning   
Participants Analyzed 
[Units: Participants]
 169 
Physical Functioning   67.8  (26.2) 
Role Functioning   
Participants Analyzed 
[Units: Participants]
 168 
Role Functioning   68.3  (29.5) 
Social Functioning   
Participants Analyzed 
[Units: Participants]
 165 
Social Functioning   67.8  (26.4) 
Cognitive Functioning   
Participants Analyzed 
[Units: Participants]
 167 
Cognitive Functioning   64.0  (24.3) 
Pain   
Participants Analyzed 
[Units: Participants]
 167 
Pain   64.4  (24.8) 
Mental Health   
Participants Analyzed 
[Units: Participants]
 168 
Mental Health   61.3  (22.6) 
Energy/ Fatigue   
Participants Analyzed 
[Units: Participants]
 168 
Energy/ Fatigue   54.8  (21.6) 
[1] Quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA), a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The survey includes 21 items assessing 8 domains of health-related QoL 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.
[2] Intent-to-treat population with non-missing data at baseline
Patient Perception of Stress [1] [2] 
[Units: Units on a scale]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 166 
   16.3  (7.5) 
[1] 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.
[2] Intent-to-treat population with non-missing data at baseline
Psychological Well-being [1] [2] 
[Units: Units on a scale]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 169 
   18.4  (11.6) 
[1] 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.
[2] Intent-to-treat population with non-missing data at baseline
Coping Self-Efficacy Scale [1] [2] 
[Units: Units on a scale]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 168 
   187.0  (42.6) 
[1] 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.
[2] Intent-to-treat population with non-missing data at baseline


  Outcome Measures

1.  Primary:   Percentage of Participants Adherent to Treatment at Month 6   [ Time Frame: Baseline and 6 months ]

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

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

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

5.  Secondary:   Percentage of Participants Adherent to Treatment at Month 12   [ Time Frame: Baseline and 12 months ]

6.  Secondary:   Change From Baseline in Health-related Quality of Life General Health Perception Domain Score   [ Time Frame: Baseline, Month 6 and Month 12 ]

7.  Secondary:   Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score   [ Time Frame: Baseline, Month 6 and Month 12 ]

8.  Secondary:   Change From Baseline in Health-related Quality of Life Role Functioning Domain Score   [ Time Frame: Baseline, Month 6 and Month 12 ]

9.  Secondary:   Change From Baseline in Health-related Quality of Life Social Functioning Domain Score   [ Time Frame: Baseline, Month 6 and Month 12 ]

10.  Secondary:   Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score   [ Time Frame: Baseline, Month 6 and Month 12 ]

11.  Secondary:   Change From Baseline in Health-related Quality of Life Pain Domain Score   [ Time Frame: Baseline, Month 6 and Month 12 ]

12.  Secondary:   Change From Baseline in Health-related Quality of Life Mental Health Domain Score   [ Time Frame: Baseline, Month 6 and Month 12 ]

13.  Secondary:   Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score   [ Time Frame: Baseline, Month 6 and Month 12 ]

14.  Secondary:   Change From Baseline in Patient Perception of Stress   [ Time Frame: Baseline, Month 6 and Month 12 ]

15.  Secondary:   Change From Baseline in Psychological Well-being   [ Time Frame: Baseline, Month 6 and Month 12 ]

16.  Secondary:   Change From Baseline in Coping Self-Efficacy   [ Time Frame: Baseline, Month 6 and Month 12 ]

17.  Secondary:   Health Resource Utilization   [ Time Frame: Baseline, Month 6 and Month 12 ]

18.  Secondary:   Viral Load at Each Visit   [ Time Frame: Baseline, Month 6 and Month 12 ]

19.  Secondary:   Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit   [ Time Frame: Baseline, Month 6 and Month 12 ]

20.  Secondary:   Healthcare Provider Satisfaction   [ Time Frame: Month 6 and Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: AbbVie (prior Sponsor Abbott)
phone: 800-633-9110



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01662336     History of Changes
Other Study ID Numbers: P13-566
First Submitted: August 8, 2012
First Posted: August 10, 2012
Results First Submitted: June 19, 2017
Results First Posted: January 29, 2018
Last Update Posted: January 29, 2018