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.

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.

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.

Patient-reported outcomes and experiences of migrants enrolled in a multidisciplinary HIV clinic with rapid, free, and onsite treatment dispensation: the 'ASAP' study.

BACKGROUND: Scholars recommend providing migrants living with HIV (MLWH) with free treatment, rapidly, once linked to care to optimize their HIV-related experiences and health outcomes. Quantitative evaluations of patient-reported measures for MLWH in such models are necessary to explore the viability of these recommendations. METHODS: Within a 96-week prospective cohort study at a multidisciplinary HIV clinic, participants received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for free and rapidly following care linkage. Eight patient-reported measures were administered at weeks 4, 24, and 48: (1) mMOS-SS to measure perceived social support; (2) IA-RSS to measure internalized stigma; (3) K6 to measure psychological distress; (4) PROMIS to measure self-efficacy with treatment taking; (5) G-MISS to measure perceived compliance with clinicians' treatment plans; (6) HIVTSQ to measure treatment satisfaction; (7) CARE to measure perceived provider empathy; and (8) PRPCC to measure perceived clinician cultural competence. Linear mixed modelling with bootstrapping was conducted to identify significant differences by sociodemographics and time. RESULTS: Across weeks 4, 24, and 48, results suggest that MLWH enrolled in this study experienced moderate levels of social support; elevated levels of HIV-related stigma; moderate levels of distress; high self-efficacy with daily medication self-management; great compliance with clinicians' treatment plans; high treatment satisfaction; high perceived empathy; and high perceived cultural competence. Experience of social support (i.e., mMOS-SS scores) differed significantly by birth region. Experience of HIV-related stigma (i.e., IA-RSS scores) differed significantly by birth region, age, and language. Experience of distress (i.e., K6 scores) differed significantly by sexual orientation. Experience of treatment satisfaction (i.e., HIVTSQ scores) differed significantly by birth region and age. No significant differences were identified by time for any measure. CONCLUSION: Overall, participants expressed positive experiences around treatment and care, alongside comparably lower perceptions of social support, internalized stigma, and distress, potentially underscoring a need to embed targeted, well-funded, and accessible mental health support within HIV care models.

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.

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.

The involvement of people living with HIV in the development of HIV-specific or inclusive health instruments: a mixed methods review.

Given recent emphasis on patient engagement in the choice and development of health measures to ensure their relevance, we examined the involvement of people living with HIV (PLHIV) in the creation of health measurement instruments that are HIV-specific or inclusive. A mixed studies review was conducted describing: 1) the sampling, recruitment and characteristics of involved PLHIV; 2) the methods and extent of their involvement; and 3) study author characterizations of this involvement. Five databases were searched in November 2015. Content and thematic analyses and a patient engagement framework guided the synthesis. Forty-one studies describing the development of thirty-nine instruments were reviewed. For many instruments, there was no reporting of the sampling method used for PLHIV involvement (87%), the recruitment setting (62%), the number of PLHIV involved (44%) or their characteristics (38%). Focus groups (38%) and interviews (36%) were the most common involvement methods. Involvement typically occurred at the patient engagement level of consultation (79%). Authors primarily characterized involvement as "contributing to instrument development" and, less frequently, as "a collaboration," "integral to instrument development" or "challenging." Patient engagement frameworks and standards for the content validation of patient-reported measures offer resources for systematic reporting, contextualizing involvement, diversifying approaches, and documenting their potentialities.

Evaluation of a project to engage patients in the development of a patient-reported measure for HIV care (the I-Score Study).

BACKGROUND: Patient engagement (PE), patients' meaningful involvement in research through partnerships and sensitivity to their expertise, is receiving attention. However, PE initiatives are poorly reported and little is known about patients' perspective on PE. OBJECTIVE: To document and evaluate the first phase (22 months) of a PE Project for the I-Score Study which is developing a patient-reported measure of HIV treatment adherence barriers, we describe the nature of PE conducted, determine the level of PE achieved and present its impacts from the engaged patients' perspective. SETTING AND PARTICIPANTS: A Montreal-based committee of ten people with HIV was recruited from community and clinical settings and participated in: I-Score study decision making, knowledge dissemination, research on the experience of people with HIV and the PE project's evaluation. METHODS: The evaluation followed a convergent parallel mixed-methods design. Data collection included participant observation, a satisfaction survey and meeting minutes/transcriptions. Analysis entailed reporting PE activities, generating descriptive statistics and thematically analysing qualitative material. RESULTS: PE consisted of twelve meetings, including two focus groups (needs assessment), in addition to four knowledge dissemination activities. PE levels showed an increase: the first four regular meetings entailed information/consultation, while subsequent meetings reached implication/collaboration. Regarding impacts, patients indicated high and stable satisfaction rates (M = 4.4/5; SD = 0.76). Furthermore, thematic analysis identified "positive interactions," "co-learning," "self-determination," and "the collective management of confidentiality" as important PE impacts for engaged patients. CONCLUSION: This PE Project evaluation highlighted growing engagement levels, high satisfaction rates and the importance of a patient-centric approach to PE.

Decision-making about motherhood among women living with HIV in Canada: a negotiation of multidimensional risks.

Little research in Canada has examined the perspectives of women living with HIV on decision-making across the stages of motherhood. In 2004-2005, semi-structured interviews were conducted with 42 African, Caucasian and Haitian HIV-positive women recruited in Montreal. All were or wished to be biological mothers. Transcripts underwent thematic analysis organised by three culturally informed models of motherhood described by the participants, which influenced decision-making and perceived risks. For women who saw motherhood as 'self-fulfilment and completeness', vertical HIV transmission was a primary concern. It threatened their identity as a 'good mother', which also meant adhering to antiretrovirals. For women who viewed motherhood as a 'social realisation' (all African or Haitian), fears of compromised fertility dominated. Not becoming pregnant threatened their social status and presumed health within their community. Antiretrovirals were abandoned after delivery, fearing they would reveal their HIV status. For women endorsing a 'personal growth' model of motherhood (all Caucasian), threats to personal health were paramount. Pregnancy meant purifying body and soul. Antiretrovirals, seen as pollutants, were stopped after delivery. These findings can inform current research and sensitise health providers to the complex biological, psychological, social and spiritual risks that HIV-positive women negotiate in motherhood-related decision-making, towards more patient-centred care.

Barriers to antiretroviral therapy adherence in developed countries: a qualitative synthesis to develop a conceptual framework for a new patient-reported outcome measure.

Suboptimal adherence to antiretroviral therapy (ART) remains common. Patient-centered tools are needed to comprehensively assess adherence barriers in HIV clinical practice. Thus, we conducted a research synthesis to produce a conceptual framework for a new patient-reported outcome measure (PRO) for use in routine HIV care in Canada and France. A PRO's conceptual framework graphically represents the concepts to be measured and the potential relationships between them. Towards ensuring the framework's relevance to the target populations' concerns, qualitative studies with HIV-positive adults on barriers to ART adherence in developed countries were synthesized with thematic analysis, attending to the cross-study prevalence and interrelationships of barrier themes. In March 2016, searches within Medline, PsychINFO, and Embase produced 5,284 records. Two reviewers determined the final sample (n = 41). Analysis generated three levels of ART adherence barrier themes. Twenty Level 2 themes and their component subthemes (Level 3) were organized into 6 higher-order themes (Level 1): Cognitive and emotional aspects (100% of studies contributing content -prevalence), Lifestyle factors (95%), Social and material context (95%), Characteristics of ART (90%), Health experience and state (73%), and Healthcare services and system (66%). As to interrelationships, study authors articulated relationships between all higher-order themes (Level 3). Linkages between Level 2 barrier themes showed great variability, from 21% to 95%. Overall, this synthesis contributes an exceptionally detailed conceptual framework and report of ART adherence barriers, applicable to a wide range of PLHIV. It suggests that a key to understanding many barriers is through their interconnections. It also identifies gaps in barrier research. Concerning the new PRO's development, comprehensiveness will need to be weighed against other concerns (e.g., respondent burden) and the provision of barrier-specific guidance for clinically addressing its scores seems essential.

Patient profiles as organizing HIV clinicians' ART adherence management: a qualitative analysis.

The effectiveness of antiretroviral therapy (ART) depends on optimal clinical management and patient adherence. Little is known about patient characteristics that clinicians consider in the management of ART adherence. Exploring this issue, five focus groups were conducted with 31 HIV-clinicians from across France. A qualitative typological analysis suggests that clinician management of patient adherence is based on characteristics that coalesce into seven patient profiles. For the "passive" patient, described as taking ART exactly as prescribed without questioning their doctor's expertise, a directive and simple management style was preferred. The "misleading" patient is characterized as concerned with social desirability and as reporting no adherence difficulties for fear of displeasing their doctor. If clinical outcomes are suboptimal, the clinicians' strategy is to remind them of the importance of open patient-clinician communication. The "stoic" patient is described as requesting and adequately taking the most potent ART available. Here, clinicians emphasize assessment of side effects, which the patient may minimize. The "hedonistic" patient's festive lifestyle and sexual risk-taking are seen as compromising adherence; with them, clinicians stress the patient's responsibility for their own health and that of their sexual partners. The "obsessive" patient is portrayed as having an irrational fear of ART failure and an inability to distinguish illusory from genuine adherence barriers. With this patient, clinicians seek to identify the latter. The "overburdened" patient is recognized as coping with life priorities that interfere with adherence and, with them, a forgiving ART is favored. The "underprivileged" patient is presented as having limited education, income and housing. In this case, clinicians seek to improve the patient's living conditions and access to care. These results shed light on HIV clinicians' ART adherence management. The value of these profiles for HIV care and patients should be investigated.

Developing a patient-reported outcome measure for HIV care on perceived barriers to antiretroviral adherence: assessing the needs of HIV clinicians through qualitative analysis.

PURPOSE: To identify HIV clinicians' needs for the clinical use of a new patient-reported outcome measure (PRO) on barriers to antiretroviral therapy (ART) adherence. METHODS: In 2015, five focus groups with 31 clinicians from France were transcribed, coded with Atlas.ti, and submitted to a typological analysis. RESULTS: The analysis identified seven patient profiles, each tied to distinct barriers to adherence and to specific needs for the PRO's content, data collection and transmission. Clinicians preferred, for the patient who is: (1) 'passive,' that the PRO collect information on ART knowledge, to ensure that the prescription's instructions are being respected; (2) 'misleading,' that it be able to detect adherence to ART and socially desirable responses; (3) 'stoic,' that questions challenge the patient to recognize treatment-specific side effects; (4) 'hedonistic,' that the PRO contains content on lifestyle and risk-taking; (5) 'obsessive,' that the PRO captures quality of life and stressful life events; (6) 'overburdened,' that the PRO provides information on the person's home environment, socioeconomic status and cultural constraints. For all or most patient profiles, the clinicians wished that the PRO be completed, minimally, prior to the medical consultation and to receive alerts, under varying conditions, when problematic scores were detected. Depending on the profile, there was preference for the inclusion of open-ended questions and transmission of cross-sectional, periodic or longitudinal PRO data. CONCLUSION: Overall, this study's findings suggest that to support the clinical management of ART adherence, our PRO must meet the needs of a wide variety of patients and must perform multiple functions.

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.

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.

Minimal interference: A basis for selecting ART for prevention with positives.

Given international interest in "treatment as prevention" (TasP) and the pertinence of optimizing antiretroviral treatment (ART) regimens for TasP, 19 French HIV experts were interviewed on their criteria for ART if used specifically for prevention with HIV-positive persons. Through content analysis of the interview material, nine criteria were identified. The most endorsed criteria, collectively, suggest a choice of treatment based on "minimal interference" where negative impacts of ART are minimized and ease of treatment integration maximized in the lives of people living with HIV/AIDS (PLHIV) for both the short and long term. These criteria were the tolerance, side effects, and/or toxicity profile of ART, simplicity (e.g., of treatment schedule, dosage form) and the individualization of treatment (e.g., adapted to lifestyle). While virologic efficacy (i.e., a durable, undetectable viral load) was also deemed important, several experts specified that it was virtually assured with current treatments. To a much lesser extent, experts endorsed diffusion of ART into the genital compartments, a strong genetic barrier (against resistance), validated treatments (as opposed to new classes of ART), a rapid reduction in HIV viral load, and treatment cost. Pharmacologically, minimal interference calls for further improvements in the tolerance, side effects and toxicity profile of ART and in the simplicity of ART administration. Clinically, it means avoiding a one-size-fits-all approach to ART in TasP and engagement with and of PLHIV in ART selection and side effects management. Strategically, it emphasises keeping the health and quality of life of PLHIV at the forefront of a TasP-oriented public health intervention.

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.

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.

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.