HIV InfectionsCTNPT039NCT04702412
Electronic Capture of Adherence Barriers for HIV Care
A study testing The Opal patient portal and smartphone application combined with the I-Score patient-reported outcome measure in people with HIV Infections, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Adherence to antiretroviral therapy (ART) remains problematic. Our team has thus developed a new patient-reported measure of barriers to ART adherence (the I-Score) which will be completed by HIV patients through the Opal patient portal for routine HIV care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- The Opal patient portal and smartphone application combined with the I-Score patient-reported outcome measure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2021to Jan 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be aged 18 years or older
- be diagnosed with HIV-1 infection
- be treated with a combination antiretroviral therapy (composed of 2 to 3 different drugs)
- be treated for HIV at the Chronic Viral Illness Service of the McGill University Health Centre
- be able to speak and understand either French or English
- possess a smartphone
- be willing to download the smartphone app
Who cannot join
- are participating in a clinical trial at the time of enrollment in this study
- have a cognitive impairment or medical instability that prevents them from participating in the interview
- have insufficient mastery of French or English to participate in the interview and complete the questionnaires
- have insufficient ability to use the app with the technical support provided
- are co-infected with hepatitis C and are being treated for it or have completed treatment 3 months or less ago
- are co-infected with hepatitis B and are either not treated for it or are being treated for it with a medication other than their anti-HIV medication
Trial locations and contacts
1 site in 1 country.
Canada1 site
Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A3T2
About this study
Official title: Implementation of an Electronic Patient-reported Measure of Barriers to Antiretroviral Therapy Adherence With the Opal Patient Portal: a Mixed Method Type 3 Hybrid Pilot Study at a Large Montreal HIV Clinic
Adherence to antiretroviral therapy (ART) remains problematic. Our team has thus developed a new patient-reported measure of barriers to ART adherence (the I-Score) which will be completed by HIV patients through the Opal patient portal for routine HIV care. This 6-month mixed method pilot study will implement the I-Score/Opal intervention with 5 HIV physicians at the McGill University Health Centre (Montreal, Quebec) and 30 of their patients. The study's primary objectives are to assess patient and physician perceptions of the intervention (e.g., acceptability) and evaluate the implementation strategy. The data collected will help plan and determine the feasibility of a definitive effectiveness trial.
Read the detailed description
Background: Adherence to antiretroviral therapy (ART) remains problematic. Regular monitoring of its barriers is clinically recommended, however, patient-provider communication around adherence is often inadequate. Our team thus decided to develop a new electronically administered patient-reported outcome measure (PROM) of barriers to ART adherence (the I-Score) to facilitate the systematic capture of this data for physician consideration in routine HIV care. To prepare for a controlled definitive trial to test the I-Score intervention, a pilot study was designed. Its primary objectives are to evaluate patient and physician perceptions of the I-Score intervention and its implementation strategy.
Methods: This one-arm, 6-month study will adopt a mixed method type 3 implementation-effectiveness hybrid design and be conducted at the Chronic Viral Illness Service of the McGill University Health Centre (Montreal, Canada). Five HIV physicians and 30 of their HIV patients with known or suspected adherence problems will participate. The intervention will involve having patients complete the I-Score in the Opal smartphone application, before meeting with their physician. Both patient and physician will have access to the I-Score results, for consideration during the clinic visits at Times 1, 2 (3 months), and 3 (6 months). The implementation strategy will focus on stakeholder involvement, education, and training; promoting the intervention's adaptability; and hiring an Application Manager to facilitate implementation. Implementation, patient, and service outcomes will be collected (Times 1-2-3). The primary outcome is the intervention's acceptability to patients and physicians. Qualitative data obtained, in part, through physician focus groups (Times 2-3) and patient interviews (Times 2-3) will help evaluate the implementation strategy and inform any methodological adaptations.
Discussion: This study will help plan a definitive trial to test the efficacy of the I-Score intervention. It will generate needed data on electronic PROM interventions in routine HIV care that will help improve understanding of conditions for their successful implementation.
- Conditions
- HIV Infections
- Being tested
- The Opal patient portal and smartphone application combined with the I-Score patient-reported outcome measure
- Keywords
- patient-reported outcomes, adherence, antiretroviral therapy, mHealth, smartphone app, patient portal, implementation science, care
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Opal patient portal and smartphone application combined with the I-Score patient-reported outcome measureOther
HIV patients will complete the I-Score PROM via Opal (patient portal) prior to three consecutive clinic visits with their HIV physician who is expected to access their PROM results in time for the visit. The clinic visits will be held at Time 1, Time 2 (3 months) and Time 3 (6 months).
| Study group | Role | What they receive |
|---|---|---|
| Opal patient portal | Experimental | Exposure to routine use of a patient portal (Opal) through which HIV patients are expected to complete a measure on barriers to ART adherence for screening purposes, before each HIV care visit. Receives: Other: The Opal patient portal and smartphone application combined with the I-Score patient-reported outcome measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the Intervention as assessed with the Acceptability E-scale
Score range: 6-30 (Threshold: M ≥ 24, indicates high acceptability)
Measured: Change from baseline (week 1) to study completion (week 24)
Acceptability of the Intervention as indicated by the percent likely to recommend the I-Score
(Threshold: ≥ 80 percent)
Measured: Change from baseline (week 1) to study completion (week 24)
Acceptability of the Intervention as assessed with the Net Promoter Score
Score range: -100 to 100 (Threshold: > 0, indicates acceptability)
Measured: Change from baseline (week 1) to study completion (week 24)
Secondary outcomes (10)
Appropriateness of the Intervention as assessed with the Perceived Compatibility subscale
Score range: 1 to 7 (Threshold: Score M ≥ 5.5, indicates high compatibility)
Measured: Change from baseline (week 1) to study completion (week 24)
Appropriateness of the Intervention as assessed with the Appropriateness of Intervention Measure
Score range: 1 to 5 (Threshold: Score M ≥ 4, indicates high appropriateness)
Measured: Change from baseline (week 1) to study completion (week 24)
Feasibility of the Intervention as indicated by the consent rate
Reasons for refusal will also be collected (Threshold: ≥ 70 percent)
Measured: At baseline
Feasibility of the Intervention as indicated by the retention rate
(Threshold: ≥ 80 percent)
Measured: Cumulative until study completion (week 24)
Feasibility of the Intervention as indicated by the missing I-Score data rate
e.g., due to non-completion, network failure (Threshold: ≤ 10 percent)
Measured: Cumulative until study completion (week 24)
Feasibility of the Intervention as assessed with the Feasibility of Intervention Measure
Score range: 1 to 5 (Threshold: M ≥ 4, indicates high feasibility)
Measured: Change from baseline (week 1) to study completion (week 24)
Fidelity of the Intervention as indicated by the percentage of patients who complete the I-Score on time
(Threshold: ≥ 90 percent)
Measured: Cumulative until study completion (week 24)
Fidelity of the Intervention as indicated by the percentage of physicians who review the I-Score results on time
(Threshold: ≥ 90 percent)
Measured: Cumulative until study completion (week 24)
Feasibility of the implementation strategy as indicated by the percentage of physicians who participate in the implementation activities
e.g., educational meeting, focus groups (Threshold: ≥ 80 percent)
Measured: Cumulative until study completion (week 24)
Feasibility of the implementation strategy as indicated by the number of technical issues encountered
Based on the Application Manager's notes
Measured: Cumulative until study completion (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study with a mixed method type 3 implementation-effectiveness hybrid design
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- CIHR Canadian HIV Trials Network
- Responsible party
- Principal investigator, Dr. Bertrand Lebouche, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Bertrand Lebouché, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702412
- Sponsor's protocol ID
- 2021-7190
- Acronym
- CTNPT039
- Status last verified
- Jan 2021
- First submitted
- 11 Dec 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Engler K, Ahmed S, Lessard D, Vicente S, Lebouche B. Assessing the Content Validity of a New Patient-Reported Measure of Barriers to Antiretroviral Therapy Adherence for Electronic Administration in Routine HIV Care: Proposal for a Web-Based Delphi Study. JMIR Res Protoc. 2019 Aug 2;8(8):e12836. doi: 10.2196/12836.
PubMed 31376275Lessard D, Engler K, Toupin I; I-Score Consulting Team; Routy JP, Lebouche B. Evaluation of a project to engage patients in the development of a patient-reported measure for HIV care (the I-Score Study). Health Expect. 2019 Apr;22(2):209-225. doi: 10.1111/hex.12845. Epub 2018 Oct 29.
PubMed 30375111Kildea J, Battista J, Cabral B, Hendren L, Herrera D, Hijal T, Joseph A. Design and Development of a Person-Centered Patient Portal Using Participatory Stakeholder Co-Design. J Med Internet Res. 2019 Feb 11;21(2):e11371. doi: 10.2196/11371.
PubMed 30741643Engler K, Vicente S, Ma Y, Hijal T, Cox J, Ahmed S, Klein M, Achiche S, Pant Pai N, de Pokomandy A, Lacombe K, Lebouche B. Implementation of an electronic patient-reported measure of barriers to antiretroviral therapy adherence with the Opal patient portal: Protocol for a mixed method type 3 hybrid pilot study at a large Montreal HIV clinic. PLoS One. 2021 Dec 30;16(12):e0261006. doi: 10.1371/journal.pone.0261006. eCollection 2021.
PubMed 34969046
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Electronic Patient-reported Measure of Barriers to Antiretroviral Therapy Adherence With the Opal Patient Portal: a Mixed Method Type 3 Hybrid Pilot Study at a Large Montreal HIV Clinic
- ClinicalTrials.gov ID
- NCT04702412
- Acronym / sponsor ID
- CTNPT039 / 2021-7190
- Conditions
- HIV Infections
- Keywords
- patient-reported outcomes, adherence, antiretroviral therapy, mHealth, smartphone app, patient portal, implementation science, care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- CIHR Canadian HIV Trials Network
- Study start
- Jan 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 8 Jan 2021 (actual)
- 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.
Adherence to antiretroviral therapy (ART) remains problematic. Our team has thus developed a new patient-reported measure of barriers to ART adherence (the I-Score) which will be completed by HIV patients through the Opal patient portal for routine HIV care. This 6-month mixed method pilot study will implement the I-Score/Opal intervention with 5 HIV physicians at the McGill University Health Centre (Montreal, Quebec) and 30 of their patients. The study's primary objectives are to assess patient and physician perceptions of the intervention (e.g., acceptability) and evaluate the implementation strategy. The data collected will help plan and determine the feasibility of a definitive effectiveness trial.
Detailed description
Background: Adherence to antiretroviral therapy (ART) remains problematic. Regular monitoring of its barriers is clinically recommended, however, patient-provider communication around adherence is often inadequate. Our team thus decided to develop a new electronically administered patient-reported outcome measure (PROM) of barriers to ART adherence (the I-Score) to facilitate the systematic capture of this data for physician consideration in routine HIV care. To prepare for a controlled definitive trial to test the I-Score intervention, a pilot study was designed. Its primary objectives are to evaluate patient and physician perceptions of the I-Score intervention and its implementation strategy.
Methods: This one-arm, 6-month study will adopt a mixed method type 3 implementation-effectiveness hybrid design and be conducted at the Chronic Viral Illness Service of the McGill University Health Centre (Montreal, Canada). Five HIV physicians and 30 of their HIV patients with known or suspected adherence problems will participate. The intervention will involve having patients complete the I-Score in the Opal smartphone application, before meeting with their physician. Both patient and physician will have access to the I-Score results, for consideration during the clinic visits at Times 1, 2 (3 months), and 3 (6 months). The implementation strategy will focus on stakeholder involvement, education, and training; promoting the intervention's adaptability; and hiring an Application Manager to facilitate implementation. Implementation, patient, and service outcomes will be collected (Times 1-2-3). The primary outcome is the intervention's acceptability to patients and physicians. Qualitative data obtained, in part, through physician focus groups (Times 2-3) and patient interviews (Times 2-3) will help evaluate the implementation strategy and inform any methodological adaptations.
Discussion: This study will help plan a definitive trial to test the efficacy of the I-Score intervention. It will generate needed data on electronic PROM interventions in routine HIV care that will help improve understanding of conditions for their successful implementation.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study with a mixed method type 3 implementation-effectiveness hybrid design
| Arm | Type | Receives |
|---|---|---|
| Opal patient portal | Experimental | Other: The Opal patient portal and smartphone application combined with the I-Score patient-reported outcome measureExposure to routine use of a patient portal (Opal) through which HIV patients are expected to complete a measure on barriers to ART adherence for screening purposes, before each HIV care visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- be aged 18 years or older
- be diagnosed with HIV-1 infection
- be treated with a combination antiretroviral therapy (composed of 2 to 3 different drugs)
- be treated for HIV at the Chronic Viral Illness Service of the McGill University Health Centre
- be able to speak and understand either French or English
Key exclusion criteria (6 listed)
- are participating in a clinical trial at the time of enrollment in this study
- have a cognitive impairment or medical instability that prevents them from participating in the interview
- have insufficient mastery of French or English to participate in the interview and complete the questionnaires
- have insufficient ability to use the app with the technical support provided
- are co-infected with hepatitis C and are being treated for it or have completed treatment 3 months or less ago
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 |
|---|---|---|
| The Opal patient portal and smartphone application combined with the I-Score patient-reported outcome measureHIV patients will complete the I-Score PROM via Opal (patient portal) prior to three consecutive clinic visits with their HIV physician who is expected to access their PROM results in time for the visit. The clinic visits will be held at Time 1, Time 2 (3 months) and Time 3 (6 months). | Other | Opal patient portal |
Primary outcome
Acceptability of the Intervention as assessed with the Acceptability E-scale
Time frame: Change from baseline (week 1) to study completion (week 24)
Score range: 6-30 (Threshold: M ≥ 24, indicates high acceptability)
Acceptability of the Intervention as indicated by the percent likely to recommend the I-Score
Time frame: Change from baseline (week 1) to study completion (week 24)
(Threshold: ≥ 80 percent)
Acceptability of the Intervention as assessed with the Net Promoter Score
Time frame: Change from baseline (week 1) to study completion (week 24)
Score range: -100 to 100 (Threshold: > 0, indicates acceptability)
10 secondary outcomes
Appropriateness of the Intervention as assessed with the Perceived Compatibility subscale
Time frame: Change from baseline (week 1) to study completion (week 24)
Appropriateness of the Intervention as assessed with the Appropriateness of Intervention Measure
Time frame: Change from baseline (week 1) to study completion (week 24)
Feasibility of the Intervention as indicated by the consent rate
Time frame: At baseline
Feasibility of the Intervention as indicated by the retention rate
Time frame: Cumulative until study completion (week 24)
Feasibility of the Intervention as indicated by the missing I-Score data rate
Time frame: Cumulative until study completion (week 24)
Feasibility of the Intervention as assessed with the Feasibility of Intervention Measure
Time frame: Change from baseline (week 1) to study completion (week 24)
Fidelity of the Intervention as indicated by the percentage of patients who complete the I-Score on time
Time frame: Cumulative until study completion (week 24)
Fidelity of the Intervention as indicated by the percentage of physicians who review the I-Score results on time
Time frame: Cumulative until study completion (week 24)
Feasibility of the implementation strategy as indicated by the percentage of physicians who participate in the implementation activities
Time frame: Cumulative until study completion (week 24)
Feasibility of the implementation strategy as indicated by the number of technical issues encountered
Time frame: Cumulative until study completion (week 24)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Background: PubMed 31376275Engler K, Ahmed S, Lessard D, Vicente S, Lebouche B. Assessing the Content Validity of a New Patient-Reported Measure of Barriers to Antiretroviral Therapy Adherence for Electronic Administration in Routine HIV Care: Proposal for a Web-Based Delphi Study. JMIR Res Protoc. 2019 Aug 2;8(8):e12836. doi: 10.2196/12836.
- Background: PubMed 30375111Lessard D, Engler K, Toupin I; I-Score Consulting Team; Routy JP, Lebouche B. Evaluation of a project to engage patients in the development of a patient-reported measure for HIV care (the I-Score Study). Health Expect. 2019 Apr;22(2):209-225. doi: 10.1111/hex.12845. Epub 2018 Oct 29.
- Background: PubMed 30741643Kildea J, Battista J, Cabral B, Hendren L, Herrera D, Hijal T, Joseph A. Design and Development of a Person-Centered Patient Portal Using Participatory Stakeholder Co-Design. J Med Internet Res. 2019 Feb 11;21(2):e11371. doi: 10.2196/11371.
- Derived from this study: PubMed 34969046Engler K, Vicente S, Ma Y, Hijal T, Cox J, Ahmed S, Klein M, Achiche S, Pant Pai N, de Pokomandy A, Lacombe K, Lebouche B. Implementation of an electronic patient-reported measure of barriers to antiretroviral therapy adherence with the Opal patient portal: Protocol for a mixed method type 3 hybrid pilot study at a large Montreal HIV clinic. PLoS One. 2021 Dec 30;16(12):e0261006. doi: 10.1371/journal.pone.0261006. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Bertrand Lebouché, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Opal patient portal and smartphone application combined with the I-Score patient-reported outcome measure in people with HIV Infections, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 7 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: status not confirmed, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bertrand Lebouché, MD (514-843-2090, bertrand.lebouche@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the Intervention as assessed with the Acceptability E-scale (time frame: Change from baseline (week 1) to study completion (week 24)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04702412, which also lists 4 linked publications.
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 8 Jan 2021.