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.

Patient-reported outcome measures in adult HIV care: A rapid scoping review of targeted outcomes and instruments used.

OBJECTIVE: There is international interest in the integration of patient-reported outcome measures (PROMs) into routine HIV care, but little work has synthesized the content of published initiatives. We conducted a rapid scoping review primarily to identify their selected patient-reported outcomes and respective instruments. METHODS: Four databases were searched on 4 May 2022 (Medline, Embase, CINAHL and PsychINFO) for relevant English language documents published from 2005 onwards. Dual review of at least 20% of records, full texts and data extraction was performed. Outcomes and instruments were classified with an adapted 14-domain taxonomy. Instruments with evidence of validation were described. RESULTS: Of 13 062 records generated for review, we retained a final sample of 94 documents, referring to 60 distinct initiatives led mostly in the USA (n = 29; 48% of initiatives), Europe (n = 16; 27%) and Africa (n = 9; 15%). The measured patient-reported outcome domains were: mental health (n = 42; 70%), substance use (n = 23; 38%), self-management (n = 16; 27%), symptoms (n = 12; 20%), sexual/reproductive health (n = 12; 20%), physical health (n = 9; 15%), treatment (n= 8; 13%), cognition (n = 7; 12%), quality of life (n = 7; 12%), violence/abuse (n = 6; 10%), stigma (n = 6; 10%), socioeconomic issues (n = 5; 8%), social support (n = 3; 5%) and body/facial appearance (n = 1; 2%). Initiatives measured 2.6 outcome domains, on average (range = 1-11). In total, 62 distinct validated PROMs were identified, with 53 initiatives (88%) employing at least one (M = 2.2). Overwhelmingly, the most used instrument was any version of the Patient Health Questionnaire to measure symptoms of depression, employed by over a third (26; 43%) of initiatives. CONCLUSION: Published PROM initiatives in HIV care have spanned 19 countries and disproportionately target mental health and substance use.

Interventions, Barriers, and Facilitators to Address the Sexual Problems of Gay, Bisexual and Other Men Who Have Sex with Men Living with HIV: A Rapid Scoping Review.

Sexual problems are common among gay, bisexual, and other men who have sex with men (GBM) after diagnosis with HIV. However, these are often overlooked in care and research, where sexual risk reduction and biomedical aspects of sexual health tend to dominate. We conducted a rapid scoping review to investigate which sexual problems of GBM living with HIV are addressed by interventions, and the barriers and facilitators to their implementation. Literature from high-income countries published in English since 2010 was reviewed. Medline, Embase, PsycInfo, and Scopus databases were searched on July 4, 2022. Targeted sexual problems were categorized according to the ten dimensions of Robinson's Sexual Health Model, and barriers and facilitators, according to the five domains of the Consolidated Framework for Implementation Research (CFIR). Interventions focused solely on the dimension of Sexual Health Care/Safer Sex were excluded. Relevant information was extracted from the qualifying documents with NVivo 12 software for content analysis. Fifty-two documents were included, referring to 37 interventions which mainly took place in the United States (n = 29/37; 78%), were group-based (n = 16; 41%), and used counselling techniques (n = 23; 62%; e.g., motivational interviewing, cognitive-behavioral therapy). Their settings were mostly primary care (n = 15; 40%) or community-based (n = 16; 43%). On average, interventions addressed three sexual health dimensions (SD = 2; range: 1-10). The most targeted dimension was Sexual Health Care/Safer Sex (n = 26; 70%), which concerned sexual risk reduction. Next, Challenges (n = 23; 62%), included substance use (n = 7; 19%), sexual compulsivity (n = 6; 16%), sexual abuse (n = 6; 16%), and intimate partner violence (n = 4; 11%). Third was Talking About Sex (n = 22; 59%) which mostly concerned HIV disclosure. About a third of interventions addressed Culture/Sexual identity (n = 14; 38%), Intimacy/Relationships (n = 12; 33%), and Positive sexuality (n = 11; 30%). Finally, few targeted Body Image (n = 4; 11%), Spirituality (n = 3; 8%), Sexual Anatomy Functioning (n = 2; 5%) or Masturbation/Fantasy (n = 1; 3%). Forty-one documents (79%) mentioned implementation barriers or facilitators, particularly about the characteristics of the interventions (41% and 78%, respectively; e.g., cost, excessive duration, acceptability, feasibility) and of the individuals involved (37% and 46%; e.g., perceived stigmatization, provider expertise). The other three CFIR dimensions were less common (5%-17%). The search strategy of this review may not have captured all eligible documents, due to its limit to English-language publications. Overall, most interventions incorporated a focus on Sexual Health Care/Safer Sex, at the expenses of other prevalent sexual problems among GBM living with HIV, such as intimate partner violence (Challenges), erectile dysfunction (Sexual Anatomy Functioning), and Body Image dissatisfaction. These findings suggest they could receive more attention within clinical care and at the community level. They also highlight the importance of cost-effective and acceptable interventions conducted in non-stigmatizing environments, where patients' needs can be met by providers who are adequately trained on sexuality-related topics.

Impact of social determinants of health on time to antiretroviral therapy initiation and HIV viral undetectability for migrants enrolled in a multidisciplinary HIV clinic with rapid, free, and onsite B/F/TAF: 'The ASAP study'.

OBJECTIVE: Multidisciplinary care with free, rapid, and on-site bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) dispensation may improve health outcomes among migrants living with HIV. However, models for rapid B/F/TAF initiation are not well studied among migrants living with HIV, and an understanding of how social determinants of health (SDH) may affect HIV-related health outcomes for migrants enrolled in such care models is limited. METHODS: Within a 96-week pilot feasibility prospective cohort study at a multidisciplinary HIV clinic, participants received free B/F/TAF rapidly after care linkage. The effects of SDH (i.e., birth region, sexual orientation, living status, education, employment, French proficiency, health coverage, use of a public health facility outside our clinic for free blood tests, and time in Canada) and other covariates (i.e., age, sex) on median time to antiretroviral therapy (ART) initiation and HIV viral undetectability from care linkage were calculated via survival analyses. RESULTS: Thirty-five migrants were enrolled in this study. Median time to ART initiation and HIV undetectability was 5 days (range 0-50) and 57 days (range 5-365), respectively. Those who took significantly longer to initiate ART were aged <35 years, identified as heterosexual, had less than university-level education, or were unemployed. No factor was found to significantly affect time to undetectability. CONCLUSION: Despite the provision of free B/F/TAF, several SDH were linked to delays in ART initiation. However, once initiated and engaged, migrants living with HIV reached HIV undetectability efficiently. Findings provide preliminary support for adopting this care model with migrants living with HIV and suggest that SDH should be considered when designing clinical interventions for more equitable outcomes.

Conceptions of sexual health by gay men living with HIV in serodifferent couples in Montreal, Canada: results from a qualitative analysis.

BACKGROUND: Gay, bisexual, and other men (GBM) who have sex with men living with HIV in serodifferent couples (one partner living with HIV, the other HIV-negative) may encounter unique sexual health challenges. This study aimed to explore their definition of sexual health that could improve service provision. METHODS: We interviewed 10 gay-identified men living with HIV from 2017 to 2019 as part of CTNPT013, a study on the sexual health of HIV serodifferent GBM couples conducted at two HIV-specialised clinics in Montreal, Canada. Participants partook in semi-structured interviews on the meaning of sexual health. We performed a content analysis of interview transcripts, coding them according to the 10 dimensions of Robinson's Sexual Health Model. RESULTS: Mean age of interviewees was 35.4years (s.d.,10.2; range, 20-53). Every dimension of Robinson's model was spontaneously evoked, except for body image and spirituality. All men indicated intimacy/relationships (e.g. sexual agreements) and sexual health care/safer sex (e.g. HIV management, risk behaviours) as relevant aspects of sexual health. Other dimensions included: positive sexuality (n =7), such as pleasure and enjoyment during sex; talking about sex (n =5), which mainly concerned HIV disclosure; sexual functioning (n =4); challenges to sexual health (n =3), including substance abuse; and culture/sexual identity (n =3). Two participants (n =2) cited masturbation/fantasy. CONCLUSIONS: This study emphasises the multi-faceted nature of sexual health for gay men with HIV in serodifferent couples and the pivotal roles of relationships, HIV, risk management (e.g. via health care, knowledge), and positive sexual experiences. These dimensions could be considered in sexual health promotion interventions targeting this population.

Barriers to adherence to antiretroviral therapy: identifying priority areas for people with HIV and healthcare professionals.

BACKGROUND: Challenges to antiretroviral therapy adherence are well-known and continue to be a major hurdle in HIV care. The objective of this paper is to identify barriers to antiretroviral therapy (ART) adherence that are relevant to HIV care from the perspective of people living with HIV and healthcare and social service professionals. METHODS: This study used an online survey design to collect information from the two groups. A total of 100 areas that covered six domains and 20 subdomains were administered to people living with HIV and care professionals in Canada and France. The survey asked participants to rate the importance of each area for HIV care on a four-point Likert scale. Any areas rated 3 or 4 were considered important and ranked. A Chi-square test was conducted for the difference between the groups, people living with HIV and professionals, and between women and men. RESULTS: A response rate of 87% (58/66) in Canada and 65% (38/58) was achieved. 15 of 43 (35%) areas were endorsed as important barriers by both groups, across countries and sex-covering subdomains - drug cost coverage, challenging material circumstances, HIV stigma, and privacy concerns, affect, motivation, beliefs, acceptance of HIV, comorbidity, side effects, and demands and organisation of daily life. People living with HIV identified two, and care professionals identified nine, additional areas as important barriers to HIV care across different domains and subdomains. CONCLUSION: The study identified some common and distinct barriers to ART from the perspective of the people living with HIV and care professionals.

Implementation of Lost & Found, An Intervention to Reengage Patients Out of HIV Care: A Convergent Explanatory Sequential Mixed-Methods Analysis.

Being out of HIV care (OOC) is associated with increased morbidity and mortality. We assessed implementation of Lost & Found, a clinic-based intervention to reengage OOC patients. OOC patients were identified using a nurse-validated, real-time OOC list within the electronic medical records (EMR) system. Nurses called OOC patients. Implementation occurred at the McGill University Health Centre from April 2018 to 2019. Results from questionnaires to nurses showed elevated scores for implementation outcomes throughout, but with lower, more variable scores during pre-implementation to month 3 [e.g., adoption subscales (scale: 1-5): range from pre-implementation to month 3, 3.7-4.9; thereafter, 4.2-4.9]. Qualitative results from focus groups with nurses were consistent with observed quantitative trends. Barriers concerning the EMR and nursing staff shortages explained reductions in fidelity. Strategies for overcoming barriers to implementation were crucial in early months of implementation. Intervention compatibility, information systems support, as well as nurses' team processes, knowledge, and skills facilitated implementation.

Feasibility of a Platform Trial Design for the Development of Mobile Health Applications: A Review.

Background: A novel adaptive trial design called platform trials (PTs) may offer an effective, efficient, and unbiased approach to evaluate different developer versions of mobile health (m-health) apps. However, the feasibility of their use for this purpose is yet to be explored. Objective: This literature review aims to explore the reported challenges associated with the adaptive PT design to assess its feasibility for the development of m-health apps. Methods: A descriptive literature review using two databases (MEDLINE and Embase) was conducted. Documents published in English between 1947 and September 20, 2020, were eligible for inclusion. Results: The titles and abstracts of 758 records were screened after which 179 full-text articles were assessed for eligibility. A total of 41 articles were included in the synthesis, all published after the year 2000. The synthesis yielded eight distinct categories of challenging issues with PTs relevant to their application in m-health app development, along with potential solutions. These categories are ethical issues (e.g., related to informed consent, equipoise, justice) (with 19 articles contributing content), biases (7 articles), temporal drift (4 articles), miscellaneous statistical issues (3 articles), logistical issues (e.g., cost and human resources, frequent amendments; 6 articles), sample size and power conflict (2 articles), generalizability of the results (2 articles), and operational challenges (1 article). Conclusion: Although PT designs are relatively new, they have promising feasibility for the seamless evaluation of interventions that undergo continuous development, including m-health apps; however, various challenges may hinder their successful implementation.

Experiences of Migrant People Living with HIV in a Multidisciplinary HIV Care Setting with Rapid B/F/TAF Initiation and Cost-Covered Treatment: The 'ASAP' Study.

This study aimed to explore the experiences of migrant people living with HIV (MLWH) enrolled in a Montreal-based multidisciplinary HIV care clinic with rapid antiretroviral treatment (ART) initiation and cost-covered ART. Between February 2020 and March 2022, 32 interviews were conducted with 16 MLWH at three time-points (16 after 1 week of ART initiation, 8 after 24 weeks, 8 after 48 weeks). Interviews were analyzed via the Framework Method. Thirty categories were identified, capturing experiences across the HIV care cascade. At diagnosis, most MLWH described "initially experiencing distress". At linkage, almost all MLWH discussed "navigating the health system with difficulty". At treatment initiation, almost all MLWH expressed "being satisfied with treatment", particularly due to a lack of side effects. Regarding care retention, all MLWH noted "facing psychosocial or health-related challenges beyond HIV". Regarding ART adherence, most MLWH expressed "being satisfied with treatment" with emphasis on their taking control of HIV. At viral suppression, MLWH mentioned "finding more peace of mind since becoming undetectable". Regarding their perceived health-related quality of life, most MLWH indicated "being helped by a supportive social network". Efficient, humanizing, and holistic approaches to care in a multidisciplinary setting, coupled with rapid and free ART initiation, seemed to help alleviate patients' concerns, address their bio-psycho-social challenges, encourage their initial and sustained engagement with HIV care and treatment, and ultimately contribute to positive experiences.

Potential interventions to support HCV treatment uptake among HIV co-infected people in Canada: Perceptions of patients and health care providers.

BACKGROUND: Increasing direct-acting antiviral (DAA) treatment uptake is key to eliminating HCV infection as a public health threat in Canada. People living with human immunodeficiency virus (HIV) and hepatitis C (HCV) co-infection face barriers to HCV treatment initiation. We sought to identify interventions that could support HCV treatment initiation based on patient and HCV care provider perspectives. METHODS: Eleven people living with HIV with a history of HCV infection and 12 HCV care providers were recruited for this qualitative descriptive study. Participants created ranked-ordered lists of potential interventions during nominal groups (n = 4) and individual interviews (n = 6). Following the nominal group technique, transcripts and intervention lists underwent thematic analysis and ranking scores were merged to create consolidated and prioritized lists from patient and provider perspectives. RESULTS: Patient participants identified a total of eight interventions. The highest-ranked interventions were multidisciplinary clinics, HCV awareness campaigns and patient education, nurse- or pharmacist-led care, peer involvement, and more and better-prepared health professionals. Provider participants identified 11 interventions. The highest-ranked were mobile outreach, DAA initiation at pharmacies, a simplified process of DAA prescription, integration of primary and specialist care, and patient-centred approaches. CONCLUSION: Participants proposed alternatives to hospital-based specialist HCV care, which require increasing capacity for nurses, pharmacists, primary care providers, and peers to have more direct roles in HCV treatment provision. They also identified the need for structural changes and educational initiatives. In addition to optimizing HCV care, these interventions might result in broader benefits for the health of HIV-HCV co-infected people.

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.

Remote Follow-up of Self-isolating Patients With COVID-19 Using a Patient Portal: Protocol for a Mixed Methods Pilot Study (Opal-COVID Study).

BACKGROUND: People with COVID-19 are instructed to self-isolate at home. During self-isolation, they may experience anxiety and insufficient care. Patient portals can allow patients to self-monitor and remotely share their health status with health care professionals, but little data are available on their feasibility. OBJECTIVE: This paper presents the protocol of the Opal-COVID Study. Its objectives are to assess the implementation of the Opal patient portal for distance monitoring of self-isolating patients with COVID-19, identify influences on the intervention's implementation, and describe service and patient outcomes of this intervention. METHODS: This mixed methods pilot study aims to recruit 50 patient participants with COVID-19 tested at the McGill University Health Centre (Montreal, Canada) for 14 days of follow-up. With access to an existing patient portal through a smartphone app, patients will complete a daily self-assessment of symptoms, vital signs, and mental health monitored by a nurse, and receive teleconsultations as needed. Study questionnaires will be administered to collect data on sociodemographic characteristics, medical background, implementation outcomes (acceptability, usability, and respondent burden), and patient satisfaction. Coordinator logbook entries will inform on feasibility outcomes, namely, on recruitment, retention, and fidelity, as well as on the frequency and nature of contacts with health care professionals. The statistical analyses for objectives 1 (implementation outcomes), 3 (service outcomes), and 4 (patient outcomes) will evaluate the effects of time and sociodemographic characteristics on the outcomes. For objectives 1 (implementation outcomes) and 4 (patient outcomes), the statistical analyses will also examine the attainment of predefined success thresholds. As for the qualitative analyses, for objective 2 (influences on implementation), semistructured qualitative interviews will be conducted with 4 groups of stakeholders (ie, patient participants, health care professionals, technology developers, and study administrators) and submitted for content analysis, guided by the Consolidated Framework for Implementation Research to help identify barriers to and facilitators of implementation. For objective 3 (service outcomes), reasons for contacting health care professionals through Opal will also be submitted for content analysis. RESULTS: Between December 2020 and March 2021, a total of 51 patient participants were recruited. Qualitative interviews were conducted with 39 stakeholders from April to September 2021. Delays were experienced owing to measures taken at the McGill University Health Centre to address COVID-19. The quantitative and qualitative analyses began in May 2022. As of June 2022, a total of 2 manuscripts (on the implementation and the patient outcomes) were being prepared, and 3 conference presentations had been given on the study's methods. CONCLUSIONS: This protocol is designed to generate multidisciplinary knowledge on the implementation of a patient portal-based COVID-19 care intervention and will lead to a comprehensive understanding of feasibility, stakeholder experience, and influences on implementation that may prove useful for scaling up similar interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04978233; https://clinicaltrials.gov/ct2/show/NCT04978233. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35760.

Interventions to Improve Uptake of Direct-Acting Antivirals for Hepatitis C Virus in Priority Populations: A Systematic Review.

Background & Objective: Access to Hepatitis C (HCV) care remains suboptimal. This systematic review sought to identify existing interventions designed to improve direct-acting antiviral (DAA) uptake among HCV infected women, people who inject drugs (PWID), men who have sex with men (MSM), and Indigenous peoples. Methods: Studies published in high- and middle-income countries were retrieved from eight electronic databases and gray literature (e.g., articles, research reports, theses, abstracts) were screened by two independent reviewers. Identified interventions were summarized using textual narrative synthesis. Results: After screening 3,139 records, 39 studies were included (11 controlled comparative studies; 36 from high-income countries). Three groups of interventions were identified: interventions involving patients; providers; or the healthcare system. Interventions directed to patients included care co-ordination, accelerated DAA initiation, and patient education. Interventions involving providers included provider education, telemedicine, multidisciplinary teams, and general practitioner-led care. System-based interventions comprised DAA universal access policies and offering HCV services in four settings (primary care, secondary care, tertiary care, and community settings). Most studies (30/39) described complex interventions, i.e., those with two or more strategies combined. Most interventions (37/39) were tailored to, or studied among, PWID. Only one study described an intervention that was aimed at women. Conclusions: Combining multiple interventions is a common approach for supporting DAA initiation. Three main research gaps were identified, specifically, a lack of: (1) controlled trials estimating the individual or combined effects of interventions on DAA uptake; (2) studies in middle-income countries; and (3) interventions tailored to women, MSM, and Indigenous people.

Content validation of a new measure of patient-reported barriers to antiretroviral therapy adherence, the I-Score: results from a Delphi study.

BACKGROUND: Over a third of people living with HIV (PLHIV) have suboptimal adherence to antiretroviral therapy (ART). Measures of barriers to ART adherence often lack comprehensiveness. To help manage ART adherence barriers in HIV care, we are developing a new patient-reported outcome measure (PROM) of these barriers (the I-Score). METHODS: We assessed the content validity of 100 items (distinct barriers) to retain only those most relevant to both PLHIV and HIV health/social service providers. A web-based Delphi was conducted in Canada and France, collecting data from December 2018 to October 2019. Items were evaluated on relevance (the combined rated importance and actionability for HIV care of items among both PLHIV and providers); comprehensibility (rated item clarity); comprehensiveness (examined against our conceptual framework); cross-cultural equivalence (based on comparisons by questionnaire language (English, French) and country of residence). Pearson's chi-square tests were used for comparisons by language, country, gender, and stakeholder group (PLHIV, providers). RESULTS: Panelists included 40 PLHIV and 57 providers (66% response rate). Thirty-one items were retained based on consensus thresholds for relevance (minimum: 50% for PLHIV, 60% for providers) and showed good comprehensibility and comprehensiveness, when compared to our conceptual framework (representation of: 6/6 domains, 15/20 subdomains). No significant difference in relevance based on language or country was found among retained items, suggestive of cross-cultural equivalence. Among all 100 items, only 6 significant differences on relevance were observed for gender. For 62 items, the relevance ratings of PLHIV and providers differed significantly, with providers showing greater endorsement of all items but one. DISCUSSION: The Delphi led to a much-needed item reduction. Remaining items highlight the panel's multidimensional priorities for the PROM on ART adherence barriers, with few, if any, differences by language, country, and gender. While the analyses may lack generalizability and power, the sample size is considered adequate for a PROM validation study. CONCLUSION: Retained items showed good content validity. The different patterns of item endorsement observed underscore the utility of engaging multiple stakeholder groups in PROM development for use in clinical practice. The greater endorsement of items by providers versus patients merits further investigation, including the implications of such differentials for measure development.

Understanding the Risks and Benefits of a Patient Portal Configured for HIV Care: Patient and Healthcare Professional Perspectives.

BACKGROUND: Like other chronic viral illnesses, HIV infection necessitates consistent self-management and adherence to care and treatment, which in turn relies on optimal collaboration between patients and healthcare professionals (HCPs), including physicians, nurses, pharmacists, and clinical care coordinators. By providing people living with HIV (PLHIV) with access to their personal health information, educational material, and a communication channel with HCPs, a tailored patient portal could support their engagement in care. Our team intends to implement a patient portal in HIV-specialized clinics in Canada and France. We sought to understand the perceived risks and benefits among PLHIV and HCPs of patient portal use in HIV clinical care. METHODS: This qualitative study recruited PLHIV and HIV-specialized HCPs, through maximum variation sampling and purposeful sampling, respectively. Semi-structured focus group discussions (FGDs) were held separately with PLHIV and HCPs between August 2019 and January 2020. FGDs were recorded, transcribed, coded using NVivo 12 software, and analyzed using content analysis. RESULTS: A total of twenty-eight PLHIV participated in four FGDs, and thirty-one HCPs participated in six FGDs. PLHIV included eighteen men, nine women, and one person identifying as other; while, HCPs included ten men, twenty women, and one person identifying as other. A multi-disciplinary team of HCPs were included, involving physicians, nurses, pharmacists, social workers, and clinical coordinators. Participants identified five potential risks: (1) breach of confidentiality, (2) stress or uncertainty, (3) contribution to the digital divide, (4) dehumanization of care, and (5) increase in HCPs' workload. They also highlighted four main benefits of using a patient portal: (1) improvement in HIV self-management, (2) facilitation of patient visits, (3) responsiveness to patient preferences, and (4) fulfillment of current or evolving patient needs. CONCLUSION: PLHIV and HCPs identified both risks and benefits of using a patient portal in HIV care. By engaging stakeholders and understanding their perspectives, the configuration of a patient portal can be optimized for end-users and concerns may be mitigated during its implementation.

Increased reengagement of out-of-care HIV patients using Lost & Found, a clinic-based intervention.

BACKGROUND: Negative health outcomes associated with being out of HIV care (OOC) warrant reengagement strategies. We aimed to assess effectiveness of Lost & Found, a clinic-based intervention to identify and reengage OOC patients. METHODS: Developed and delivered using implementation science, Lost & Found consists of two core elements: identification, operationalized through nurse validation of a real-time list of possible OOC patients; and contact, via nurse-led phone calls. It was implemented over a 12-month period (2018-2019) at the Chronic Viral Illness Service, McGill University Health Centre (CVIS-MUHC) during a type-II implementation-effectiveness hybrid pilot study. Descriptive outcomes of interest were identification as possibly OOC, OOC confirmation, contact, and successful reengagement. We present results from a pre-post analysis comparing overall reengagement to the year prior, using robust Poisson regression controlled for sex, age, and Canadian birth. Time to reengagement is reported using a Cox proportional hazards model. RESULTS: Over half (56%; 1312 of 2354) of CVIS-MUHC patients were identified as possibly OOC. Among these, 44% (n = 578) were followed elsewhere, 19% (n = 249) engaged in care, 3% (n = 33) deceased, 2% (n = 29) otherwise not followed, and 32% (n = 423) OOC. Of OOC patients contacted (85%; 359/423), 250 (70%) reengaged and 40 (11%) had upcoming appointments; the remainder were unreachable, declined care, or missed given appointments. Pre-post results indicate people who received Lost & Found were 1.18 [95% confidence interval (CI) 1.02-1.36] times more likely to reengage, and reengaged a median 55 days (95% CI 14-98) sooner. CONCLUSION: Lost & Found may be a viable clinic-based reengagement intervention for OOC patients. More robust evaluations are needed.

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.

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 systematically capture 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). Four HIV physicians and 32 of their HIV patients with known or suspected adherence problems will participate. The intervention will involve having patients complete the I-Score through a smartphone application (Opal), before meeting with their physician. Both patients and physicians 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04702412; https://clinicaltrials.gov/.

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.

Patient and provider perceived barriers and facilitators to direct acting antiviral hepatitis C treatment among priority populations in high income countries: A knowledge synthesis.

BACKGROUND: Direct acting antivirals (DAAs) have increased cure rates for hepatitis C virus (HCV) infection; however, there are several obstacles to the uptake of DAAs in populations where substance use contributes to HCV risk. This synthesis aimed to identify the patient and provider perceived barriers and facilitators to DAA treatment initiation in key patient subgroups-people who inject drugs (PWID), men who have sex with men (MSM), and Indigenous people. METHODS: We systematically searched seven databases and conducted a gray literature search for studies that qualitatively explored patient and provider perceived barriers and facilitators to DAA treatment in our populations of interest. Selected studies were published after 2013 when second generation DAAs became available. The titles, abstracts, and subsequently full texts were screened by two independent reviewers and critically appraised. Barriers and facilitators to DAA treatment uptake were then extracted and thematically synthesized. RESULTS: 2144 titles and abstracts were identified and screened; 29 full texts were subsequently reviewed. Twelve qualitative studies were finally included. Among providers, perceived barriers to DAA treatment uptake included lack of resources and lack of provider knowledge on HCV while facilitators to treatment provision included simplicity of DAA regimens and professional identity as a doctor to advocate for patients. Among patients, perceived barriers to treatment uptake included current drug use, concerns about side effects of DAAs, stigma, gaps in community care, competing social responsibilities and mental health issues while facilitators included having a trustworthy provider and access to multidisciplinary HCV care. CONCLUSION: Despite simplicity of DAAs, many structural barriers to optimal HCV care continue to be experienced by patients and providers. In highlighting nuanced patient and provider perceived barriers and facilitators, this review underscores the need to involve participatory methods in the design and evaluation of interventions to best improve access to care.

Barriers to Use of Remote Monitoring Technologies Used to Support Patients With COVID-19: Rapid Review.

BACKGROUND: The COVID-19 pandemic has acted as a catalyst for the development and adoption of a broad range of remote monitoring technologies (RMTs) in health care delivery. It is important to demonstrate how these technologies were implemented during the early stages of this pandemic to identify their application and barriers to adoption, particularly among vulnerable populations. OBJECTIVE: The purpose of this knowledge synthesis was to present the range of RMTs used in delivering care to patients with COVID-19 and to identify perceived benefits of and barriers to their use. The review placed a special emphasis on health equity considerations. METHODS: A rapid review of published research was conducted using Embase, MEDLINE, and QxMD for records published from the inception of COVID-19 (December 2019) to July 6, 2020. Synthesis involved content analysis of reported benefits of and barriers to the use of RMTs when delivering health care to patients with COVID-19, in addition to health equity considerations. RESULTS: Of 491 records identified, 48 publications that described 35 distinct RMTs were included in this review. RMTs included use of existing technologies (eg, videoconferencing) and development of new ones that have COVID-19-specific applications. Content analysis of perceived benefits generated 34 distinct codes describing advantages of RMTs, mapped to 10 themes overall. Further, 52 distinct codes describing barriers to use of RMTs were mapped to 18 themes. Prominent themes associated with perceived benefits included a lower burden of care (eg, for hospitals, health care practitioners; 28 records), reduced infection risk (n=33), and support for vulnerable populations (n=14). Prominent themes reflecting barriers to use of RMTs included equity-related barriers (eg, affordability of technology for users, poor internet connectivity, poor health literacy; n=16), the need for quality "best practice" guidelines for use of RMTs in clinical care (n=12), and the need for additional resources to develop and support new technologies (n=11). Overall, 23 of 48 records commented on equity characteristics that stratify health opportunities and outcomes, including general characteristics that vary over time (eg, age, comorbidities; n=17), place of residence (n=11), and socioeconomic status (n=7). CONCLUSIONS: Results of this rapid review highlight the breadth of RMTs being used to monitor and inform treatment of COVID-19, the potential benefits of using these technologies, and existing barriers to their use. Results can be used to prioritize further efforts in the implementation of RMTs (eg, developing "best practice" guidelines for use of RMTs and generating strategies to improve equitable access for marginalized populations).