HIV InfectionsNCT05789901
The MARVIN Chatbots to Provide Information for Different Health Conditions
A study testing MARVIN, MARVIN-Pharma and MARVINA in people with HIV Infections and Breast Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
Trial summary
This research is a continuation of a usability study with the MARVIN chatbot. The investigators aim to adapt the MARVIN chatbot to open it to other health domains (e.g. breast cancer) and populations (e.g. pharmacists). Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Breast Cancer, Pediatric Emergency Medicine
- What is being tested?
- MARVIN, MARVIN-Pharma and MARVINA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Mar 2024to 31 Dec 2034
- Phase
- Interventional
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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- being 14 years or older;
- being fluent in English and/or French;
- being able to understand the requirements of study participation and provide informed consent during the duration of the study;
- having access to a smartphone, tablet, or computer at home/at workplace;
- having access to an internet connection at home or data plan on their device.
- accept to use a Facebook Messenger-based Chatbot;
- accept to use or create a personal Facebook account;
- accept Facebook's privacy and data security policies.
Who cannot join
- not meeting the inclusion criteria
- any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving a chatbot (e.g., cognitive deficit)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
Marie-Pacale Pomey, MD, PhD, 514 890 8000 ext. 14302, marie-pascale.pomey@umontreal.ca
- Recruiting
McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3J1
Bertrand Lebouché, MD, PhD, 5148432090, bertrand.lecbouche@mcgill.ca
Esli Osmanlliu, MDCM, MSc
About this study
Official title: A Master Research Protocol to Adapt and Evaluate an Artificial Intelligence Based Conversational Agent to Provide Information for Different Health Conditions: the MARVIN Chatbots
This research is a continuation of a usability study with the MARVIN chatbot. The investigators aim to adapt the MARVIN chatbot to open it to other health domains (e.g. breast cancer) and populations (e.g. pharmacists). Therefore, this protocol constitutes a master research protocol that will englobe different research projects with individual chatbots. The investigators adopt an adaptive platform trial design, which will allow flexibility in handling multiple interventions adapted to different populations while retaining the characteristics of a platform trial design allowing early withdrawal of ineffective trial arms based on interim data (implementation outcomes) and introduction of new trial arms.
Read the detailed description
From 2020, the Principal Investigator's team has developed an innovative chatbot named Minimal AntiretRoViral INterference (MARVIN), for people with HIV. The primary objectives with this master protocol are to: 1) develop or adapt the MARVIN chatbots for different healthcare contexts through co-construction; 2) evaluate the global usability of individual chatbots in their respective use scenarios with a small sample of research participants; 3) evaluate the implementation and user outcomes (e.g., fidelity, appropriateness) of individual chatbots in their respective use scenarios with a larger sample of research participants. This includes also documentation of factors that inhibit or enhance the utilization of the chatbots and outcomes; and 4) establish and evaluate, through the previous objectives, different partnerships with research participants and research team members to co-construct chatbots that will respond to their needs and encourage continued use of the tool.
- Conditions
- HIV Infections, Breast Cancer, Pediatric Emergency Medicine
- Being tested
- MARVIN, MARVIN-Pharma, MARVINA, MARVIN-CHAMP
- Keywords
- Chatbot, Intelligent Conversational Agent, Co-Construction, Adherence, Antiretroviral Therapy, mHealth, Implementation Science, Care, Breast Cancer, HIV, Self-Management, Adaptive Platform Trial Design, Telehealth, Digital Health, Artificial Intelligence, Pediatric Emergency Medicine, Patient and Stakeholder Engagement, Pediatric Infection, Large Language Models
- Medical subject headings
- HIV Infections, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARVINOther
Chatbot on Meta (Facebook) Messenger for HIV Patients
MARVIN-PharmaOther
Chatbot on Meta (Facebook) Messenger for community pharmacists
MARVINAOther
Chatbot on Meta (Facebook) Messenger for breast cancer patients
MARVIN-CHAMPOther
Also called CHatbot to Assist the Management of Pediatric patients with infectious conditions, CHAMP, CHAMPIONS
CHatbot to Assist the Management of Pediatric patients with infectious conditions (CHAMP)
| Study group | Role | What they receive |
|---|---|---|
| MARVIN: a Chatbot for HIV patients | Other | Co-construction of the chatbot, Usability study, Implementation, Evaluation of outcomes and Continuous improvements Receives: Other: MARVIN |
| MARVIN: a Chatbot for Community Pharmacists | Other | Co-construction of the chatbots, Usability study, Implementation, Evaluation of outcomes and Continuous improvements Receives: Other: MARVIN-Pharma |
| MARVINA: a Chatbot for Breast Cancer Patients | Other | Co-construction of the chatbots, Usability study, Implementation, Evaluation of outcomes and Continuous improvements Receives: Other: MARVINA |
| MARVIN CHAMP: a Chatbot for Pediatric Infectious Conditions | Other | Co-construction of the chatbots, Usability study, Implementation, Evaluation of outcomes and Continuous improvements Receives: Other: MARVIN-CHAMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability Metric for User eXperience (UMUX-Lite)
The UMUX-Lite is a 2-item questionnaire, answered on a 7-point Likert scale (1 = strongly disagree to 5 = strongly agree), that was deemed appropriate for evaluating medical technology. The items ask whether the chatbot meets the user's needs and the user's perceived ease of use. Scores range from 0 to 100, with more than 68 being considered high usability according to the literature.
Measured: Immediately, after 1-month of testing - objective 2
Acceptability E-Scale (AES)
The AES contains 6 items rated with different 5-point Likert scales (e.g., 1=very difficult to 5=very easy). It is a validated measure of acceptability and usability of computer-based interventions for health populations. Scores range from 0 to 30, and according to the literature, scores above 24 are considered high acceptability.
Measured: Immediately after 1-month of testing - objective 2
Change in Acceptability E-Scale (AES) over 12 months
The AES contains 6 items rated with different 5-point Likert scales (e.g., 1=very difficult to 5=very easy). It is a validated measure of acceptability and usability of computer-based interventions for health populations. Scores range from 0 to 30, and according to the literature, scores above 24 are considered high acceptability.
Measured: Once every 3 months within 12 months
Change in Intervention Appropriateness Measure (IAM) over 12 months
Appropriateness relates to the relevance or compatibility of the innovation to address a particular issue or problem. The compatibility of an information technology innovation is the extent of which it is considered consistent with users' values, needs, and past experiences. The Compatibility Subscale is a validated tool that contains three items and evaluates on 7-points Likert scales (1 = extremely disagree to 7 = extremely agree) how an IT innovation "fits" with the user's work style. A modified version could be used by healthcare professionals, such as pharmacists.
Measured: Once every 3 months within 12 months
Change in Compatibility Subscale over 12 months
Appropriateness relates to the relevance or compatibility of the innovation to address a particular issue or problem. The compatibility of an information technology innovation is the extent of which it is considered consistent with users' values, needs, and past experiences. A validated tool that could be used by patients is the Intervention Appropriateness Measure (IAM). It also contains 4 items scored on a five-point Likert scale (1=strongly disagree to 5=strongly agree) of agreement evaluating how the innovation is suitable for users.
Measured: Once every 3 months within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Mar 2024
- Primary completion31 Dec 2033 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The investigators adopt a platform trial design, which is defined as "a study designed to evaluate multiple interventions in the context of a single disease in a perpetual manner, with therapies allowed to enter or leave the platform on the basis of a decision algorithm.". Platform trials can also integrate elements of basket trial design, which aims to study a single intervention for different diseases. In the current case, with different healthcare settings and diseases or conditions under study, the investigators would have a mix of platform trial and basket trial designs for an adaptative platform trial design. Such will allow flexibility in handling multiple interventions adapted to different populations while retaining platform trial characteristics, such as early withdrawal of ineffective trial arms based on interim data (implementation outcomes) and introduction of new trial arms. Meanwhile, there is no initial fixed duration or sample size for each arm.
- Masking
- None (open label)
- Enrolment
- 400 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
- Centre hospitalier de l'Université de Montréal (CHUM)
- 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
- NCT05789901
- Sponsor's protocol ID
- MP-37-2023-9333
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma Y, Achiche S, Pomey MP, Paquette J, Adjtoutah N, Vicente S, Engler K; MARVIN chatbots Patient Expert Committee; Laymouna M, Lessard D, Lemire B, Asselah J, Therrien R, Osmanlliu E, Zawati MH, Joly Y, Lebouche B. Adapting and Evaluating an AI-Based Chatbot Through Patient and Stakeholder Engagement to Provide Information for Different Health Conditions: Master Protocol for an Adaptive Platform Trial (the MARVIN Chatbots Study). JMIR Res Protoc. 2024 Feb 13;13:e54668. doi: 10.2196/54668.
PubMed 38349734Lin J, Jaiswal N, Ma Y, Lebouche B, Villanueva S, Achiche S, Lessard D, Engler K, Berthelot S, Buckeridge D, Celi LA, Gagnon I, Gravel J, Plotnick LH, Poenaru D, Pomey MP, Vang ZM; CHAMP Co-Construction Committee; Osmanlliu E. Coconstructing CHAMP, an Artificial Intelligence Chatbot for Pediatric Infectious Symptoms Management: Protocol for a Multiphase Participatory Study. JMIR Res Protoc. 2026 May 26;15:e89852. doi: 10.2196/89852.
PubMed 42189574