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The I-Score Study: Developing a New Patient-Reported Tool for the Routine HIV Care of Patients on Antiretroviral Therapy

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ClinicalTrials.gov Identifier: NCT02586584
Recruitment Status : Unknown
Verified August 2019 by Dr. Bertrand Lebouche, McGill University Health Centre/Research Institute of the McGill University Health Centre.
Recruitment status was:  Recruiting
First Posted : October 26, 2015
Last Update Posted : August 14, 2019
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Bertrand Lebouche, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Condition or disease

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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
Study Start Date : April 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Change in the Interference-Score (I-Score) [ Time Frame: 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) ]
    The I-Score is the measure to be developed and concerns perceived barriers to antiretroviral therapy adherence

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

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): NCT02586584

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Contact: Rosalie Ponte, PhD. Research coordinator 438-831-0037 Rosalie.Ponte@MUHC.MCGILL.CA
Contact: Bertrand Lebouché, MD PhD 514-843-2090 bertrand.lebouche@mcgill.ca

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Canada, Quebec
Chronic Viral illness Service Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Rosalie Ponte    438-831-0037    Rosalie.Ponte@MUHC.MCGILL.CA   
Contact: Diana Salazar    514-9341934 ext 32547    diana.salazar@muhc.mcgill.ca   
Sponsors and Collaborators
Dr. Bertrand Lebouche
Canadian Institutes of Health Research (CIHR)
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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
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Bertrand Lebouche, MD, PhD, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT02586584    
Other Study ID Numbers: MUHC Study Code 14-229-PSY
Merck-IIS-53538 ( Other Identifier: Merck Inc )
CTN283 ( Other Identifier: CIHR's Canadian HIV Trials Network )
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by Dr. Bertrand Lebouche, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Patient-Reported Outcome, Antiretroviral Therapy
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases