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).

BACKGROUND: Artificial intelligence (AI)-based chatbots could help address some of the challenges patients face in acquiring information essential to their self-health management, including unreliable sources and overburdened health care professionals. Research to ensure the proper design, implementation, and uptake of chatbots is imperative. Inclusive digital health research and responsible AI integration into health care require active and sustained patient and stakeholder engagement, yet corresponding activities and guidance are limited for this purpose. OBJECTIVE: In response, this manuscript presents a master protocol for the development, testing, and implementation of a chatbot family in partnership with stakeholders. This protocol aims to help efficiently translate an initial chatbot intervention (MARVIN) to multiple health domains and populations. METHODS: The MARVIN chatbots study has an adaptive platform trial design consisting of multiple parallel individual chatbot substudies with four common objectives: (1) co-construct a tailored AI chatbot for a specific health care setting, (2) assess its usability with a small sample of participants, (3) measure implementation outcomes (usability, acceptability, appropriateness, adoption, and fidelity) within a large sample, and (4) evaluate the impact of patient and stakeholder partnerships on chatbot development. For objective 1, a needs assessment will be conducted within the setting, involving four 2-hour focus groups with 5 participants each. Then, a co-construction design committee will be formed with patient partners, health care professionals, and researchers who will participate in 6 workshops for chatbot development, testing, and improvement. For objective 2, a total of 30 participants will interact with the prototype for 3 weeks and assess its usability through a survey and 3 focus groups. Positive usability outcomes will lead to the initiation of objective 3, whereby the public will be able to access the chatbot for a 12-month real-world implementation study using web-based questionnaires to measure usability, acceptability, and appropriateness for 150 participants and meta-use data to inform adoption and fidelity. After each objective, for objective 4, focus groups will be conducted with the design committee to better understand their perspectives on the engagement process. RESULTS: From July 2022 to October 2023, this master protocol led to four substudies conducted at the McGill University Health Centre or the Centre hospitalier de l'Université de Montréal (both in Montreal, Quebec, Canada): (1) MARVIN for HIV (large-scale implementation expected in mid-2024), (2) MARVIN-Pharma for community pharmacists providing HIV care (usability study planned for mid-2024), (3) MARVINA for breast cancer, and (4) MARVIN-CHAMP for pediatric infectious conditions (both in preparation, with development to begin in early 2024). CONCLUSIONS: This master protocol offers an approach to chatbot development in partnership with patients and health care professionals that includes a comprehensive assessment of implementation outcomes. It also contributes to best practice recommendations for patient and stakeholder engagement in digital health research. TRIAL REGISTRATION: ClinicalTrials.gov NCT05789901; https://classic.clinicaltrials.gov/ct2/show/NCT05789901. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54668.

Barriers and facilitators related to HCV treatment uptake among HIV coinfected populations in Canada: Patient and treatment provider perceptions.

BACKGROUND: Direct-acting antiviral (DAA) uptake is challenging across HIV-hepatitis C (HCV) coinfected populations. This study sought to identify barriers and facilitators related to DAA uptake in priority populations in Canada. METHODS: This qualitative descriptive study included 11 people living with HIV with a history of HCV and 15 HCV care providers. Participants were part of either nominal groups (n = 4) or individual interviews (n = 6) in which they identified and ranked barriers and facilitators to DAA uptake. Consolidated lists of barriers and facilitators were identified thematically. RESULTS: Patient participants highly ranked the following barriers: competing priorities and needs (ie, social instability and mental health), delays in care, lack of adherence, and polypharmacy. Provider participant top barriers were the following: competing priorities and needs (ie, social chaos), delays in care (eg, systemic barriers, difficulties engaging patients, lack of trained HCV providers), and HCV-related stigma. Patient participants identified having a strong network of health care providers, family, and friends, possessing intrinsic motivation, and DAAs being a simple and tolerable oral treatment as important facilitators. Provider participant top-ranked facilitators were having resources to identify hard-to-reach populations (eg, patient navigation, outreach), holistic care and addiction management, provider HCV education, and a strong network of interprofessional collaboration. CONCLUSION: The barriers to DAA initiation addressed by patients and providers overlapped, with some nuances. Multidisciplinary care fostering a strong supportive network and intrinsically motivated patients along with HCV education emerged as key facilitators. This study provides insights for developing potential strategies to improve DAA uptake among HIV-HCV coinfected people in Canada.

Barriers and Facilitators Affecting the HIV Care Cascade for Migrant People Living with HIV in Organization for Economic Co-Operation and Development Countries: A Systematic Mixed Studies Review.

Migrants in countries affiliated with the Organization for Economic Co-operation and Development (OECD) have a higher risk of acquiring HIV, experience delayed HIV diagnosis, and have variable levels of engagement with HIV care and treatment when compared to native-born populations. A systematic mixed studies review was conducted to generate a multilevel understanding of the barriers and facilitators affecting HIV Care Cascade steps for migrant people living with HIV (MLWH) in OECD countries. Medline, Embase, Scopus, CINAHL, and the Cochrane Library were searched on March 25, 2020. Screening, critical appraisal, and analysis were conducted independently by two authors. We used qualitative content analysis and the five-level Socio-Ecological Model (i.e., individual, interpersonal, organizational, community, and policy) to categorize barriers and facilitators. Fifty-nine studies from 17 OECD countries were included. MLWH faced similar barriers and facilitators regardless of their host country, ethnic and geographic origins, or legal status. Most barriers and facilitators were associated with the individual and organizational levels and centered around retention in HIV care and treatment. Adapting clinical environments to better address MLWH's competing needs via multidisciplinary models would address retention issues across OECD countries.

Acceptability of a Patient Portal (Opal) in HIV Clinical Care: A Feasibility Study.

Opal (opalmedapps.com), a patient portal in use at the Cedars Cancer Centre of the McGill University Health Centre (MUHC) (Montreal, Canada), gives cancer patients access to their medical records, collects information on patient-reported outcome measures (PROMs), and has demonstrated patient satisfaction with care. This feasibility study aims to evaluate Opal's potential acceptability in the context of HIV care. People living with HIV (PLWH) and their healthcare providers (HCPs) completed cross-sectional surveys from August 2019 to February 2020 at large HIV centers, including the Chronic Viral Illness Service of the MUHC, and other HIV clinical sites in Montreal and Paris, France. This study comprised 114 PLWH (mean age 48 years old, SD = 12.4), including 74% men, 24% women, and 2% transgender or other; and 31 HCPs (mean age 46.5 years old, SD = 11.4), including 32% men, 65% women, and 3% other. Ownership of smartphones and tablets was high (93% PLWH, 96% HCPs), and participants were willing to use Opal (74% PLWH, 68% HCPs). Participants were interested in most Opal functions and PROMs, particularly PROMs capturing quality of life (89% PLWH, 77% HCPs), experience of healthcare (86% PLWH, 97% HCPs), and HIV self-management (92% PLWH, 97% HCPs). This study suggests Opal has high acceptability and potential usefulness as perceived by PLWH and HCPs.

Barriers and facilitators associated with steps of the HIV care cascade for migrants in OECD countries: a systematic mixed studies review protocol.

INTRODUCTION: In 2019, the United Nations signalled a substantial rise in the number of international migrants, up to 272 million globally, about half of which move to only 10 countries, including 8 member nations of the Organization for Economic Co-operation and Development (OECD). Migrants in OECD countries are often at higher risk for acquiring HIV and have a higher frequency of delayed HIV diagnosis. The barriers and facilitators that migrant people living with HIV (PLWH) in OECD countries face in relation to HIV care are insufficiently understood. The five-step HIV Care Cascade Continuum (HCCC) is an effective model to identify gaps, barriers and facilitators associated with HIV care. The purpose of this study is to generate a comprehensive, multilevel understanding of barriers and facilitators regarding the five steps of the HCCC model in OECD countries by migration status. METHODS AND ANALYSIS: A systematic mixed studies review using a data-based convergent design will be conducted. Medline, Embase, Scopus, CINAHL and the Cochrane Library will be searched on 25 March 2020. Screening and critical appraisal will be conducted independently by the first author. Authors 3-5 will act as second reviewers, each independently conducting 33% of the screening and appraisal. Quantitative data will be transformed to qualitative data and be synthesised using thematic analysis. The Mixed Methods Appraisal Tool will be used for quality assessment. An advisory committee, composed of four migrant PLWH, will be involved in screening and appraising 5% of articles to build knowledge and experience with systematic reviews. They will also be involved in analysis and dissemination. ETHICS AND DISSEMINATION: Ethics approval was obtained from the McGill University Health Centre (15-188-MUHC, 2016-1697, eReviews 4688). Publications arising from this study will be open-access. PROSPERO REGISTRATION NUMBER: CRD42020172122.

HIV-Positive Patients' Perceptions of Antiretroviral Therapy Adherence in Relation to Subjective Time: Imprinting, Domino Effects, and Future Shadowing.

Antiretroviral treatment adherence barriers are major concerns in HIV care. They are multiple and change over time. Considering temporality in patients' perceptions of adherence barriers could improve adherence management. We explored how temporality manifests itself in patients' perceptions of adherence barriers. We conducted 2 semi-structured focus groups on adherence barriers with 12 adults with HIV which were analyzed with grounded theory. A third focus group served to validate the results obtained. Three temporal categories were manifest in HIV-positive patients' perceptions of barriers: (1) imprinting (events with lasting impacts on patients), (2) domino effects (chain of life events), and (3) future shadowing (apprehension about long-term adherence). An overarching theme, weathering (gradual erosion of abilities to adhere), traversed these categories. These temporalities explain how similar barriers may be perceived differently by patients. They could be useful to providers for adapting their interventions and improving understanding of patients' subjective experience of adherence.

Explaining the Presence of "Heterosexual" Female Clients of a Rapid HIV Testing Site Located in the Gay Village of Montreal, Quebec.

BACKGROUND: Increasing access and uptake of HIV testing among at-risk women is needed. Examining women's motives for visiting a community-based rapid HIV testing site (Actuel sur Rue-AsR) oriented to men who have sex with men (MSM) could offer suggestions. OBJECTIVE: To compare the "heterosexual" female and male clients of AsR, located in Montreal's (Canada) gay village, to better understand the women's particular HIV prevention and sexual health service needs. METHODS: This cross-sectional pilot study analyzed questionnaire data provided by AsR clients and staff (nurse and community agent teams) between July 2012 and November 2013. Women and men reporting only opposite-sex partners were compared with chi-square, Fisher's exact, and Kruskal-Wallis tests, as appropriate, on sociodemographics, HIV-related behaviors, motives for visiting AsR, and health service provision. RESULTS: AsR received 1901 clients. Among these, 55 women and 147 men reported only opposite-sex partners. Women were significantly younger. Significantly greater proportions of women visited AsR because no appointment was necessary (67% vs. 48%), sought testing for condom failure (18% vs. 5%), and had no regular doctor (44% vs. 27%). Both groups mainly chose AsR for the rapid test results (80% and 77%), visited it to receive the rapid HIV test (71% and 76%), and sought testing due to unprotected vaginal sex (44% and 43%). Similar proportions saw the nurse (91% and 89%), received the rapid HIV test (44% and 35%), and were linked to a medical clinic (49% and 52%), especially, to receive complete sexually transmitted infection testing (50% and 44%). CONCLUSIONS: The results of this innovative study highlight the draw of rapid HIV testing for "heterosexual" users of a site mainly targeting MSM. They also suggest that further research is warranted into the importance for this group of women clients of drop-in and linkage services, particularly given their possible lesser access to regular care.

Ability of a rapid HIV testing site to attract and test vulnerable populations: a cross-sectional study on Actuel sur Rue.

Quebec's HIV epidemic persists, particularly among men who have sex with men (MSM) and in Montreal. Increasing access to HIV testing is necessary and community-based rapid testing offers one strategy. This paper examines the clienteles and activities of a rapid HIV testing site in Montreal, the pilot project Actuel sur Rue. Comparative analyses were conducted with 1357 MSM, 147 heterosexual men and 64 women who visited Actuel sur Rue between July 2012 and November 2013 on socio-demographics, health, drug use, sexual practices/infection and HIV testing/prevention. Significant group differences were observed in each category. Actuel sur Rue received 1901 clients, conducted 1417 rapid HIV tests and tested 77 never-tested individuals. Rapid testing produced a high reactive rate (2%). Only 1/28 of those with reactive tests had no previous HIV testing, and 36% had used post-exposure prophylaxis, suggesting missed opportunities for prevention. Findings highlight diverse client vulnerability profiles and the relevance of checkpoints and further prevention efforts.

Explaining the appeal for immigrant men who have sex with men of a community-based rapid HIV-testing site in Montreal (Actuel sur Rue).

Immigrant men who have sex with men (MSM) are vulnerable to HIV. In the last decade, several rapid HIV-testing facilities targeting MSM have been established around the world and seem popular among immigrants. This study analyzes factors contributing to immigrant MSM's use of Actuel sur Rue (AsR), a community-based rapid HIV-testing site in Montreal's gay village, where 31% of clients are immigrants. From October 2013 to January 2014, AsR staff compiled a list of new clients born outside of Canada. With their consent, 40 immigrant MSM were reached among these new clients for a 15-minute phone survey entailing open-ended and multiple-choice questions. The survey sought immigrant MSM's reasons for visiting AsR; satisfaction with service and staff; and open comments. An inductive thematic analysis was conducted with the qualitative data, and descriptive statistics were produced with the quantitative data. The qualitative findings indicate that the main reasons for seeking an HIV test were a recent risk, routine testing, or being in a new relationship. Clients chose AsR mainly because it is easily accessible, service is fast or they heard about it from a friend. The quantitative findings indicate that rates of satisfaction were high (over 90% were satisfied about all aspects except for openings hours) and more than 80% felt comfortable while receiving services at AsR. Nevertheless, this study's findings have implications for improving services. They stress the importance of offering rapid yet comprehensive service and of taking into account immigrant MSM's concerns for confidentiality.

The role of extended-release niacin on immune activation and neurocognition in HIV-infected patients treated with antiretroviral therapy - CTN PT006: study protocol for a randomized controlled trial.

BACKGROUND: Approximately 30% of HIV-1-infected patients receiving antiretroviral therapy who achieve virologic control have unsatisfactory immune reconstitution, with CD4+ T-cell counts persistently below 350 cells/µL. These patients are at elevated risk for clinical progression to AIDS and non-AIDS events. CD4+ T-cell depletion following infection and persistent immune activation can partially explain this low CD4+ T-cell recovery. Recent data suggest a link between the tryptophan oxidation pathway, immune activation and HIV disease progression based on overstimulation of the tryptophan oxidation pathway by HIV antigens and by interferon-gamma. This overstimulation reduces levels of circulating tryptophan, resulting in inflammation which has been implicated in the development of neurocognitive dysfunction. Niacin (vitamin B3) is able to control the excess tryptophan oxidation, correcting tryptophan depletion, and therefore represents an interesting strategy to improve CD4 recovery.We aim to design a crossover proof-of-concept study to assess supplementation with an extended-release form of niacin (Niaspan FCT™) in combination with antiretroviral therapy, compared to antiretroviral therapy alone, on T-cell immune activation as defined by changes in the percentage of CD8+ CD38+ HLA-DR+ T-cells. METHODS/DESIGN: This randomized, open-label, interventional crossover study with an immediate versus deferred use of Niaspan FCT for 24 weeks will assess its ability to reduce immune activation and thus increase CD4 recovery in 20 HIV-infected individuals with suboptimal immune responses despite sustained virologic suppression. A substudy evaluating neurocognitive function will also be conducted. DISCUSSION: This randomized trial will provide an opportunity to evaluate the potential benefit of oral extended-release niacin, a drug that can indirectly increase tryptophan, to reduce immune activation and in turn increase CD4+ T-cell recovery. The study will also allow for the evaluation of the impact of Niaspan FCT on neurocognitive function in HIV-infected individuals with suboptimal immune responses despite sustained virologic suppression. TRIAL REGISTRATION: This study was registered with ClinicalTrials.gov on 17 December 2013 (registration number: NCT02018965).