The I-Score Study: Developing a New Patient-Reported Tool for the Routine HIV Care of Patients on Antiretroviral Therapy
The I-Score Study: The Development and Validation of a Patient-Reported Measure of Antiretroviral Therapy's Interference With Life: A Clinical Patient-management Tool for Healthcare Providers
3 other identifiers
observational
160
1 country
1
Brief Summary
The purpose of this Canada-France study is to develop and validate a multidimensional patient-reported measure of perceived barriers to antiretroviral therapy adherence for HIV-positive patients undergoing treatment that will be theoretically founded, easy to use and helpful to clinicians in their medical decision-making, in a clinical or research setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2015
CompletedFirst Posted
Study publicly available on registry
October 26, 2015
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedAugust 14, 2019
August 1, 2019
5 years
October 20, 2015
August 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Interference-Score (I-Score)
The I-Score is the measure to be developed and concerns perceived barriers to antiretroviral therapy adherence
During the field test of Step 3 of the study, the I-Score will be administered at week 0 and then at week 4 to evaluate change (reliability)
Eligibility Criteria
The target population consists of HIV-positive patients on ART recruited from the caseloads of eight participating clinical sites in France and Canada. The clinical sites were selected on a geographical basis to account for different regional contexts not only in terms of the size of the HIV/AIDS epidemics, but also in terms of the sociodemographic, socioeconomic, and organizational HIV care differences that may exist across regions. The sites are similarly heterogeneous in the representation of risk groups composing the caseloads (e.g., women, injection drug user, men who have sex with men, immigrants).
You may qualify if:
- Be a man, woman or transgender person aged 18 years or older
- Be diagnosed HIV-1 positive
- Be treated by a combination of 2 to 3 antiretroviral drugs for at least 3 months
- Ability to speak and understand either French or English
You may not qualify if:
- Participation in a clinical trial at the time of enrollment in this study, in some cases (to be discussed on a site-by-site basis by the scientific committee)
- Having a cognitive impairment or medical instability that prevents their use of the electronic tablet, completion of the questionnaire or participation in the interview
- Insufficient mastery of French or English to complete the questionnaires or participate in the interview
- Refusal to use the electronic tablet to fill out the questionnaire material (not relevant for the qualitative and cognitive interviews)
- Co-infection with hepatitis C and currently under treatment for it or having completed hepatitis C treatment 3 months ago or less
- Co-infection with hepatitis B and either not being treated for it or receiving a treatment for it other than one's antiretroviral therapy for HIV
- Participation in the study's Pilot phase (for the field test and retest)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dr. Bertrand Lebouchelead
- Mitacscollaborator
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (1)
Chronic Viral illness Service
Montreal, Quebec, H4A 3J1, Canada
Related Publications (2)
Lebouche B, Engler K, Levy JJ, Gilmore N, Spire B, Rozenbaum W, Routy JP. Minimal interference: A basis for selecting ART for prevention with positives. AIDS Care. 2013;25(10):1284-90. doi: 10.1080/09540121.2013.764394. Epub 2013 Feb 11.
PMID: 23394079RESULTToupin I, Engler K, Lessard D, Wong L, Lenart A, Spire B, Raffi F, Lebouche B. Developing a patient-reported outcome measure for HIV care on perceived barriers to antiretroviral adherence: assessing the needs of HIV clinicians through qualitative analysis. Qual Life Res. 2018 Feb;27(2):379-388. doi: 10.1007/s11136-017-1711-5. Epub 2017 Oct 13.
PMID: 29027607DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bertrand Lebouché, MD PhD
McGill University Health Centre, Chronic Viral Illness Service, Royal Victoria Hospital - Glen Site D02.4110 - 1001 boul Décarie, Montreal, QC H4A 3J1
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD, Assistant Professor
Study Record Dates
First Submitted
October 20, 2015
First Posted
October 26, 2015
Study Start
April 1, 2016
Primary Completion
April 1, 2021
Study Completion
July 1, 2021
Last Updated
August 14, 2019
Record last verified: 2019-08