Recruiting

Patient-Reported Tool

Sponsor:

Dr. Bertrand Lebouche

Code:

NCT02586584

Conditions

HIV/AIDS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

HIV/AIDS

Study ID

NCT02586584

Start date

Apr, 2016

Status verified date

Aug, 2019

Completion date

Jul, 2021

Anticipated

Primary completion date

Apr, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Rosalie Ponte, PhD. Research coordinator

438-831-0037Rosalie.Ponte@MUHC.MCGILL.CA

Bertrand Lebouché, MD PhD

514-843-2090bertrand.lebouche@mcgill.ca

Locations

Chronic Viral illness Service

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Rosalie Ponte

438-831-0037Rosalie.Ponte@MUHC.MCGILL.CA

Diana Salazar

514-9341934diana.salazar@muhc.mcgill.ca

More Information

Sponsor

Dr. Bertrand Lebouche

Last update posted

Aug 14, 2019

Last verified

Aug, 2019

Keywords

  • Patient-Reported Outcome, Antiretroviral Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Bertrand Lebouche on 2019-08-14.