HIVNCT02276287
HIV Patients Illness Perception and Adherence
An observational study of HIV, run by University of Milan.
Trial summary
Background: the study aimed to explore HIV positive patients' perceptions toward illness and treatment, and their associations with demographic and clinical variables, in particular with adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- How many people
- 187 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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: HIV positive patients recruited at the outpatients clinic of Infectious Disease, S.Paolo University Hospital, Milan, Italy during their check up visit or blood test
Who may be able to join
- HIV positivity
- age ≥18 years
- to be able to understand and provide informed consent
- to be able to understand a questionnaire in Italian
- not to be psychiatric patient
- not to be alcohol and/or drugs' abuser
Who cannot join
- not HIV positive patients
- age <18 years
- inability to understand and provide informed consent
- inability to understand a questionnaire in Italian
- to be psychiatric patient
- to be alcohol and/or drugs' abuser
About this study
Official title: HIV Positive Patient's Cognitive and Emotional Illness Perception: a Possible Tool for Understanding Adherence?
Background: the study aimed to explore HIV positive patients' perceptions toward illness and treatment, and their associations with demographic and clinical variables, in particular with adherence.
Methods: the study was conducted at the outpatients clinic of Infectious Disease of a University Hospital in the north of Italy. Patients were asked to fill out the Illness Perception Questionnaire-Revised. Patient's adherence was measured by: viral load (HIV-RNA copies/ml) and presence at the check up.
Read the detailed description
Data collection Participants were recruited in the waiting room, before their check up visit or the blood test; a researcher explained them the aim of the study and asked them a written informed consent to participate. The accepting patients were asked to fill out the Illness Perception Questionnaire Revised (IPQ-R). Demographic, clinical and adherence data were also collected.
Measures:
- Demographic and clinical data: demographic information included age, gender, marital status, education, employment status, nationality. Clinical information, extracted from participants' medical records, included: years diagnosed with HIV, patient history of antiretroviral therapy (ART), years of therapy, presence of fix dose combination of antiretroviral drugs, current therapeutic regimen's type, total number of pills per day, presence of other drugs' therapies, HIV acquisition risk.
- Illness representations: measured with the Italian validate version of the IPQ-R24. The questionnaire is divided in three sections: 1) disease identity; 2) opinions and 3) causes. While items on disease identity have dichotomous responses (yes/no), items regarding opinions and causes are constituted by a 5 points Likert scale (from "1=completely disagree" to "5=completely agree"). Identity section explores patients' beliefs about the disease's nature. Fourteen symptoms are listed and patients have to indicate if they have experienced them since being diagnosed with the disease and, if so, if they believe that their symptoms are linked to the disease or not. Opinions section is composed by 38 items exploring how, at the moment, patients perceive their illness condition. Items are grouped into seven factors: 1) Timeline (perception of chronic vs acute duration); 2) Cyclical symptoms (perception of a cyclic vs stable disease); 3) Consequences (perception that the disease has or not serious physical, psychological and social consequences on patients' life); 4) Personal control (perceptions that actions can or cannot be taken to effectively manage the disease); 5) Treatment control (high or low trust in the treatment and its efficacy); 6) Coherence (high or low understanding of the disease); 7) Emotional responses (prevalence of negative emotions vs positive). Causes section lists 18 possible illness causes and patients have to rate their level of agreement with each item as a cause of their disease.
- Adherence indexes : measured by HIV-RNA copies/ml and presence at the check up visits(scheduled every 3 months). Patients were considered "adherent" in case of: undetectable viral load or HIV-RNA <40 copies/ml and regular presence at the check up visits (≤ 3 months). Adherence indexes were collected only for patients under treatment (naïve patients and patients in therapy from <1 month were excluded).
Data analysis Descriptive statistics were used for demographic and clinical characteristics, IPQ-R data and adherence outcomes. Data were analyzed using SPSS® version 21.0 for Windows.
Independent t-tests, one-way ANOVA with LSD post hoc multiple comparisons tests and Pearson correlational analysis were used for the analysis of demographic/clinical variables and IPQ-R Identity and Opinion continuous variables. Mann-Whitney U-test and Kruskal-Wallis Chi-Squared test were used on IPQ-R Cause ordinal variables.
One-way ANOVA with LSD post hoc multiple comparisons tests were also used to compare means between the adherence indexes and IPQ-R Identity and Opinion continuous variables. Kruskal-Wallis Chi-Squared tests were used on IPQ-R Cause ordinal variables. Values of p ≤0.05 were considered statistically significant.
- Conditions
- HIV
- Keywords
- Adherence, HAART, HIV, Illness Perception, IPQ-R
What is being measured
The primary outcome is the main question the study is designed to answer.
Illness representations
Illness Perception Questionnaire Revised (IPQ-R)
Measured: participants will be followed for the duration of their hospital access, an expected average of 2 hours
Secondary outcomes (3)
demographic data
age, gender, marital status, education, employment status, nationality
Measured: participants will be followed for the duration of their hospital access, an expected average of 2 hours
clinical data
years diagnosed with HIV, patient history of antiretroviral therapy, years of therapy (first therapy and current therapy), presence of fix dose combination of antiretroviral drugs, current therapeutic regimen's type (once a day and twice a day), total number of pills per day, presence of other drugs' therapies, HIV acquisition risk.
Measured: from date of HIV diagnosis until the date of the visit in which patients were recruited for the study , assessed from 1984 to 2014
Adherence
HIV-RNA copies/ml, and presence at the check up visits
Measured: Adherence indexes assessed at the last check up visit (from 2 weeks up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startMar 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Leone, University of Milan
- Investigators
- Elena Vegni, Professor, Study director, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276287
- Sponsor's protocol ID
- UMilan
- Status last verified
- Oct 2014
- First submitted
- 23 Oct 2014
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Positive Patient's Cognitive and Emotional Illness Perception: a Possible Tool for Understanding Adherence?
- ClinicalTrials.gov ID
- NCT02276287
- Acronym / sponsor ID
- UMilan
- Conditions
- HIV
- Keywords
- Adherence, HAART, HIV, Illness Perception, IPQ-R
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 28 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: the study aimed to explore HIV positive patients' perceptions toward illness and treatment, and their associations with demographic and clinical variables, in particular with adherence.
Methods: the study was conducted at the outpatients clinic of Infectious Disease of a University Hospital in the north of Italy. Patients were asked to fill out the Illness Perception Questionnaire-Revised. Patient's adherence was measured by: viral load (HIV-RNA copies/ml) and presence at the check up.
Detailed description
Data collection Participants were recruited in the waiting room, before their check up visit or the blood test; a researcher explained them the aim of the study and asked them a written informed consent to participate. The accepting patients were asked to fill out the Illness Perception Questionnaire Revised (IPQ-R). Demographic, clinical and adherence data were also collected.
Measures:
- Demographic and clinical data: demographic information included age, gender, marital status, education, employment status, nationality. Clinical information, extracted from participants' medical records, included: years diagnosed with HIV, patient history of antiretroviral therapy (ART), years of therapy, presence of fix dose combination of antiretroviral drugs, current therapeutic regimen's type, total number of pills per day, presence of other drugs' therapies, HIV acquisition risk.
- Illness representations: measured with the Italian validate version of the IPQ-R24. The questionnaire is divided in three sections: 1) disease identity; 2) opinions and 3) causes. While items on disease identity have dichotomous responses (yes/no), items regarding opinions and causes are constituted by a 5 points Likert scale (from "1=completely disagree" to "5=completely agree"). Identity section explores patients' beliefs about the disease's nature. Fourteen symptoms are listed and patients have to indicate if they have experienced them since being diagnosed with the disease and, if so, if they believe that their symptoms are linked to the disease or not. Opinions section is composed by 38 items exploring how, at the moment, patients perceive their illness condition. Items are grouped into seven factors: 1) Timeline (perception of chronic vs acute duration); 2) Cyclical symptoms (perception of a cyclic vs stable disease); 3) Consequences (perception that the disease has or not serious physical, psychological and social consequences on patients' life); 4) Personal control (perceptions that actions can or cannot be taken to effectively manage the disease); 5) Treatment control (high or low trust in the treatment and its efficacy); 6) Coherence (high or low understanding of the disease); 7) Emotional responses (prevalence of negative emotions vs positive). Causes section lists 18 possible illness causes and patients have to rate their level of agreement with each item as a cause of their disease.
- Adherence indexes : measured by HIV-RNA copies/ml and presence at the check up visits(scheduled every 3 months). Patients were considered "adherent" in case of: undetectable viral load or HIV-RNA <40 copies/ml and regular presence at the check up visits (≤ 3 months). Adherence indexes were collected only for patients under treatment (naïve patients and patients in therapy from <1 month were excluded).
Data analysis Descriptive statistics were used for demographic and clinical characteristics, IPQ-R data and adherence outcomes. Data were analyzed using SPSS® version 21.0 for Windows.
Independent t-tests, one-way ANOVA with LSD post hoc multiple comparisons tests and Pearson correlational analysis were used for the analysis of demographic/clinical variables and IPQ-R Identity and Opinion continuous variables. Mann-Whitney U-test and Kruskal-Wallis Chi-Squared test were used on IPQ-R Cause ordinal variables.
One-way ANOVA with LSD post hoc multiple comparisons tests were also used to compare means between the adherence indexes and IPQ-R Identity and Opinion continuous variables. Kruskal-Wallis Chi-Squared tests were used on IPQ-R Cause ordinal variables. Values of p ≤0.05 were considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV positive patients recruited at the outpatients clinic of Infectious Disease, S.Paolo University Hospital, Milan, Italy during their check up visit or blood test
Key inclusion criteria (6 listed)
- HIV positivity
- age ≥18 years
- to be able to understand and provide informed consent
- to be able to understand a questionnaire in Italian
- not to be psychiatric patient
Key exclusion criteria (6 listed)
- not HIV positive patients
- age <18 years
- inability to understand and provide informed consent
- inability to understand a questionnaire in Italian
- to be psychiatric patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Illness representations
Time frame: participants will be followed for the duration of their hospital access, an expected average of 2 hours
Illness Perception Questionnaire Revised (IPQ-R)
3 secondary outcomes
demographic data
Time frame: participants will be followed for the duration of their hospital access, an expected average of 2 hours
clinical data
Time frame: from date of HIV diagnosis until the date of the visit in which patients were recruited for the study , assessed from 1984 to 2014
Adherence
Time frame: Adherence indexes assessed at the last check up visit (from 2 weeks up to 12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
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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.
Elena Vegni, Professor study director
University of Milan
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by University of Milan.
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 6 inclusion and 6 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 28 Oct 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Illness representations (time frame: participants will be followed for the duration of their hospital access, an expected average of 2 hours). 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 28 Oct 2014.