Human Immunodeficiency Virus InfectionNCT01662336
Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program
An observational study of Human Immunodeficiency Virus Infection, run by AbbVie (prior sponsor, Abbott).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus Infection
- What is being tested?
- Lopinavir / ritonavir and Kaletra Adherence Support Assistance Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 173 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jun 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were enrolled from the offices (at clinic or hospital) of primary care physicians across Canada treating HIV-positive patients.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Real-Life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program: A Prospective Observational Cohort Study (KASA PMOS)
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus Infection
- Being tested
- Lopinavir / ritonavir, Kaletra Adherence Support Assistance Program
- Keywords
- Human Immunodeficiency Virus infection
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir / ritonavirDrug
Also called Kaletra®, LPV/r
Prescribed according to the product monograph and physician's discretion.
Kaletra Adherence Support Assistance ProgramBehavioural
Also called KASA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lopinavir / ritonavir; Behavioral: Kaletra Adherence Support Assistance Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Adherent to Treatment at Month 6
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.
Measured: Baseline and 6 months
Secondary outcomes (19)
Change From Baseline in Adherence Summative Score at Months 6 and 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.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Adherence Integration Subscale Score at Months 6 and 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.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 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.
Measured: Baseline, Month 6 and Month 12
Percentage of Participants Adherent to Treatment at 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). 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.
Measured: Baseline and 12 months
Change From Baseline in Health-related Quality of Life General Health Perception Domain Score
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.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score
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.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Health-related Quality of Life Role Functioning Domain Score
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.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Health-related Quality of Life Social Functioning Domain Score
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.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score
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.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Health-related Quality of Life Pain Domain Score
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.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Health-related Quality of Life Mental Health Domain Score
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.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score
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.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Patient Perception of Stress
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.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Psychological Well-being
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.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Coping Self-Efficacy
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.
Measured: Baseline, Month 6 and Month 12
Health Resource Utilization
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.
Measured: Baseline, Month 6 and Month 12
Viral Load at Each Visit
Measured: Baseline, Month 6 and Month 12
Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit
Measured: Baseline, Month 6 and Month 12
Healthcare Provider Satisfaction
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.
Measured: Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Immunodeficiency Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina Pelizon, MD, Study director, AbbVie Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662336
- Sponsor's protocol ID
- P13-566
- Status last verified
- Jun 2017
- First submitted
- 8 Aug 2012
- Last updated
- 29 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program: A Prospective Observational Cohort Study (KASA PMOS)
- ClinicalTrials.gov ID
- NCT01662336
- Acronym / sponsor ID
- P13-566
- Conditions
- Human Immunodeficiency Virus Infection
- Keywords
- Human Immunodeficiency Virus infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Posted 29 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lopinavir/Ritonavir + KASA | – | Drug: Lopinavir / ritonavir, Behavioral: Kaletra Adherence Support Assistance ProgramPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were enrolled from the offices (at clinic or hospital) of primary care physicians across Canada treating HIV-positive patients.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lopinavir / ritonavirAlso: Kaletra®, LPV/rPrescribed according to the product monograph and physician's discretion. | Drug | Lopinavir/Ritonavir + KASA |
| Kaletra Adherence Support Assistance ProgramAlso: KASAA 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. | Behavioural | Lopinavir/Ritonavir + KASA |
Primary outcome
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.
19 secondary outcomes
Change From Baseline in Adherence Summative Score at Months 6 and 12
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12
Time frame: Baseline, Month 6 and Month 12
Percentage of Participants Adherent to Treatment at Month 12
Time frame: Baseline and 12 months
Change From Baseline in Health-related Quality of Life General Health Perception Domain Score
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Health-related Quality of Life Role Functioning Domain Score
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Health-related Quality of Life Social Functioning Domain Score
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Health-related Quality of Life Pain Domain Score
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Health-related Quality of Life Mental Health Domain Score
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Patient Perception of Stress
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Psychological Well-being
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Coping Self-Efficacy
Time frame: Baseline, Month 6 and Month 12
Health Resource Utilization
Time frame: Baseline, Month 6 and Month 12
Viral Load at Each Visit
Time frame: Baseline, Month 6 and Month 12
Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit
Time frame: Baseline, Month 6 and Month 12
Healthcare Provider Satisfaction
Time frame: Month 6 and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Pelizon, MD study director
AbbVie Corporation
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus Infection, run by AbbVie (prior sponsor, Abbott).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Adherent to Treatment at Month 6 (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.