Effectiveness of an Interactive, Highly Tailored "Video Doctor" Intervention to Suppress Viral Load and Retain Patients With HIV in Clinical Care: A Randomized Clinical Trial.

BACKGROUND: To determine whether Positive Health Check, a highly tailored video doctor intervention, can improve viral suppression and retention in care. SETTING: Four clinics that deliver HIV primary care. METHODS: A hybrid type 1 effectiveness-implementation randomized trial design was used to test study hypotheses. Participants (N = 799) who were not virally suppressed, were new to care, or had fallen out of care were randomly assigned to receive Positive Health Check or the standard of care alone. The primary endpoint was viral load suppression, and the secondary endpoint was retention in care, both assessed at 12 months, using an intention-to-treat approach. A priori subgroup analyses based on sex assigned at birth and race were examined as well. RESULTS: There were no statistically significant differences between Positive Health Check (N = 397) and standard of care (N = 402) for either endpoint. However, statistically significant group differences were identified from a priori subgroup analyses. Male participants receiving Positive Health Check were more likely to achieve suppression at 12 months than male participants receiving standard of care adjusted risk ratio [aRR] [95% confidence interval (CI)] = 1.14 (1.00 to 1.29), P = 0.046}. For retention in care, there was a statistically significant lower risk for a 6-month visit gap in the Positive Health Check arm for the youngest participants, 18-29 years old [aRR (95% CI) = 0.55 (0.33 to 0.92), P = 0.024] and the oldest participants, 60-81 years old [aRR (95% CI) = 0.49 (0.30 to 0.81), P = 0.006]. CONCLUSIONS: Positive Health Check may help male participants with HIV achieve viral suppression, and younger and older patients consistently attend HIV care. REGISTRY NAME: Positive Health Check Evaluation Trial. Trial ID: 1U18PS004967-01. URL: https://clinicaltrials.gov/ct2/show/NCT03292913.

A Longitudinal Mixed-Methods Examination of Positive Health Check: Implementation Results From a Type 1 Effectiveness-Implementation Hybrid Trial.

BACKGROUND: Positive Health Check is an evidence-based video doctor intervention developed for improving the medication adherence, retention in care, and viral load suppression of people with HIV receiving clinical care. SETTING: Four HIV primary care clinics within the United States. METHODS: As part of a type 1 hybrid trial, a mixed-methods approach was used to longitudinally assess the following 3 key implementation constructs over a 23-month period: innovation-values fit (ie, the extent to which staff perceive innovation use will foster the fulfillment of their values), organizational readiness for change (ie, the extent to which organizational members are psychologically and behaviorally prepared to implement organizational change), and implementation climate (ie, the extent to which implementation is expected, supported, and rewarded). Quantitative mixed-effects regression analyses were conducted to assess changes over time in these constructs. Qualitative analyses were integrated to help provide validation and understanding. RESULTS: Innovation-values fit and organizational readiness for change were found to be high and relatively stable. However, significant curvilinear change over time was found for implementation climate. Based on the qualitative data, implementation climate declined toward the end of implementation because of decreased engagement from clinic champions and differences in priorities between research and clinic staff. CONCLUSIONS: The Positive Health Check intervention was found to fit within HIV primary care service settings, but there were some logistical challenges that needed to be addressed. Additionally, even within the context of an effectiveness trial, significant and nonlinear change in implementation climate should be expected over time.

Challenges of and Solutions for Developing Tailored Video Interventions That Integrate Multiple Digital Assets to Promote Engagement and Improve Health Outcomes: Tutorial.

BACKGROUND: Video is a versatile and popular medium for digital health interventions. As mobile device and app technology advances, it is likely that video-based interventions will become increasingly common. Although clinic waiting rooms are complex and busy environments, they offer the opportunity to facilitate engagement with video-based digital interventions as patients wait to see their providers. However, to increase efficiency in public health, leverage the scalability and low cost of implementing digital interventions, and keep up with rapidly advancing technology and user needs, more design and development guidance is needed for video-based tailored interventions. OBJECTIVE: We provide a tutorial for digital intervention researchers and developers to efficiently design and develop video-based tailored digital health interventions. We describe the challenges and solutions encountered with Positive Health Check (PHC), a hybrid app used to deliver a brief, interactive, individually tailored video-based HIV behavioral counseling intervention. PHC uses video clips and multimedia digital assets to deliver intervention content, including interactive tailored messages and graphics, a repurposed animated video, and patient and provider handouts generated in real time by PHC. METHODS: We chronicle multiple challenges and solutions for the following: (1) using video as a medium to enhance user engagement, (2) navigating the complexity of linking a database of video clips with other digital assets, and (3) identifying the main steps involved in building an app that will seamlessly deliver to users individually tailored messages, graphics, and handouts. RESULTS: We leveraged video to enhance user engagement by featuring "video doctors," full-screen video, storyboards, and streamlined scripts. We developed an approach to link the database of video clips with other digital assets through script coding and flow diagrams of algorithms to deliver a tailored user experience. We identified the steps to app development by using keyframes to design the integration of video and digital assets, using agile development methods to gather iterative feedback from multidisciplinary teams, and creating an intelligent data-driven back-end solution to tailor message delivery to individual users. CONCLUSIONS: Video-based digital health interventions will continue to play an important role in the future of HIV prevention and treatment, as well as other clinical health practices. However, facilitating the adoption of an HIV video intervention in HIV clinical settings is a work in progress. Our experience in designing and developing PHC presented unique challenges due to the extensive use of a large database of videos tailored individually to each user. Although PHC focuses on promoting the health and well-being of persons with HIV, the challenges and solutions presented in this tutorial are transferable to the design and development of video-based digital health interventions focused on other areas of health.

The Effectiveness of mHealth and eHealth Tools in Improving Provider Knowledge, Confidence, and Behaviors Related to Cancer Detection, Treatment, and Survivorship Care: a Systematic Review.

Mobile health (mHealth) and eHealth interventions have demonstrated potential to improve cancer care delivery and disease management by increasing access to health information and health management skills. However, there is a need to better understand the overall impact of these interventions in improving cancer care and to identify best practices to support intervention adoption. Overall, this review intended to systematically catalogue the recent body of cancer-based mHealth and eHealth education and training interventions and assess the effectiveness of these interventions in increasing health care professionals' knowledge, confidence, and behaviors related to the delivery of care along the cancer continuum. Our initial search yielded 135 articles, and our full review included 23 articles. We abstracted descriptive data for each of the 23 studies, including an overview of interventions (i.e., intended intervention recipients, location of delivery, topic of focus), study methods (i.e., design, sampling approach, sample size), and outcome measures. Almost all the studies reported knowledge gain as an outcome of the education interventions, whereas only half assessed provider confidence or behavior change. We conclude that there is some evidence that mHealth and eHealth interventions lead to improvements in cancer care delivery, but this is not a consistent finding across the studies reviewed. Our findings also identify gaps that should be addressed in future research, offer guidance on the utility of mHealth and eHealth interventions, and provide a roadmap for addressing these gaps.

Identifying Implementation Strategies That Address Barriers and Facilitate Implementation of Digital Interventions in HIV Primary Care Settings: Results from the Pilot Implementation of Positive Health Check.

We used the 1-month pilot implementation of Positive Health Check, a brief web-based video counseling intervention that supports patients with HIV attending HIV primary care clinics, to exemplify how studying implementation strategies earlier in the evidence-generation process can improve implementation outcomes in later pragmatic trials. We identified how implementation strategies were operationalized and the barriers and facilitators these strategies addressed using multiple data sources, including adapted implementation procedures and weekly structured interviews conducted with 9 key stakeholders in 4 HIV primary care clinics. Nineteen of 73 discrete implementation strategies for clinical innovations were used in the pilot implementation of Positive Health Check. Clinic staff reported 17 barriers and facilitators related to the clinic environment, patient population, intervention characteristics, and training and technical assistance. Identifying the link between strategies, barriers, and facilitators helped plan for a subsequent larger multisite pragmatic trial.

Health communication campaigns to drive demand for evidence-based practices and reduce stigma in the HEALing communities study.

BACKGROUND: The HEALing Communities Study (HCS) is testing whether the Communities that Heal (CTH) intervention can decrease opioid overdose deaths through the implementation of evidence-based practices (EBPs) in highly impacted communities. One of the CTH intervention components is a series of communications campaigns to promote the implementation of EBPs, increase demand for naloxone and medications for opioid use disorder (MOUD), and decrease stigma toward people with opioid use disorder and the use of EBPs, especially MOUD. This paper describes the approach to developing and executing these campaigns. METHODS: The HCS communication campaigns are developed and implemented through a collaboration between communication experts, research site staff, and community coalitions using a three-stage process. The Prepare phase identifies priority groups to receive campaign messages, develops content for those messages, and identifies a "call to action" that asks people to engage in a specific behavior. In the Plan phase, campaign resources are produced, and community coalitions develop plans to distribute campaign materials. During the Implement stage, these distribution plans guide delivery of content to priority groups. Fidelity measures assess how community coalitions follow their distribution plan as well as barriers and facilitators to implementation. An evaluation of the communication campaigns is planned. CONCLUSIONS: If successful, the Prepare-Plan-Implement process, and the campaign materials, could be adapted and used by other communities to address the opioid crisis. The campaign evaluation will extend the evidence base for how communication campaigns can be developed and implemented through a community-engaged process to effectively address public health crises.

Positive Health Check evaluation: A type 1 hybrid design randomized trial to decrease HIV viral loads in patients seen in HIV primary care.

For people with HIV, important transmission prevention strategies include early initiation and adherence to antiretroviral therapy and retention in clinical care with the goal of reducing viral loads as quickly as possible. Consequently, at this point in the HIV epidemic, innovative and effective strategies are urgently needed to engage and retain people in health care to support medication adherence. To address this gap, the Positive Health Check Evaluation Trial uses a type 1 hybrid randomized trial design to test whether the use of a highly tailored video doctor intervention will reduce HIV viral load and retain people with HIV in health care. Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only. The primary aim is to determine the effectiveness of the intervention. A second aim is to understand the implementation potential of the intervention in clinic workflows, and a third aim is to assess the costs of intervention implementation. The trial findings will have important real-world applicability for understanding how digital interventions that take the form of video doctors can be used to decrease viral load and to support retention in care among diverse patients attending HIV primary care clinics.

Unintended Effects of Communicating About Drug Safety Issues: A Critical Review of the Literature.

Communications about the safety and effectiveness of human drugs can influence patients' and prescribers' perceptions and behaviors, which in turn can affect the public's health more broadly. We conducted a critical review of the literature on the unintended effects from communicating information to the public about safety issues with prescription and over-the-counter drugs. We searched PubMed for peer-reviewed studies published from 1990 to 2017 where study authors reported probable unintended effects of communicating drug safety. The types of communications included in these studies were news reports, direct-to-consumer advertisements, and those released by government agencies. Among the 26 studies identified, the most commonly reported unintended effects were decreased drug use or discontinuation. Other unintended effects included spillover to populations not targeted by the communications (e.g., discontinuation of antidepressants among adults following communications concerning use among youth), shifts in clinical diagnoses (e.g., fewer diagnoses of depression), increased use of alternative therapies, and other undesirable behaviors (e.g., possible increased suicide attempts because antidepressants were discontinued). Limitations to the literature include the inability to establish causation or to isolate the effects of multiple communication sources and messages. Further, because the intended effect of many communications was not known, our study was limited by challenges in defining some effects as unintended. Most studies used health insurer claims data to identify unintended effects of communications, which provide an incomplete picture; few used self-reported or other methodologies that could help illuminate the reasons underlying the effects observed in the claims data. Best practices for communicating about the potential benefits and harms of drugs in a manner that minimizes negative unintended effects are needed to protect and improve public health.

Implementing Web-Based Interventions in HIV Primary Care Clinics: Pilot Implementation Evaluation of Positive Health Check.

BACKGROUND: Web-based interventions can help people living with HIV achieve better clinical outcomes and behaviors, but integrating them into clinical practice remains challenging. There is a gap in understanding the feasibility of implementing these interventions in HIV clinic settings from the clinicians' perspective. OBJECTIVE: The goal of the research was to determine whether Positive Health Check (PHC)-a Web-based, tailored video counseling tool focused on increasing patient adherence and retention in care and reducing HIV risk among HIV-positive patients-was acceptable, appropriate, and feasible for HIV primary care clinic staff to implement in clinic workflows. METHODS: A multiple-case study design was used to evaluate the pilot implementation. Four primary care clinics located in the southeastern United States implemented PHC over a 1-month period. Nine clinic staff across the clinics participated in structured interviews before, during, and after the implementation. In total, 54 interviews were conducted. We used a framework analysis approach to code the data and identify themes related to implementation outcomes, including acceptability, appropriateness, and feasibility. We also analyzed patient intervention use metrics (n=104) to quantify patient intervention completion rates (n=68). RESULTS: Overall, clinicians viewed PHC as acceptable and appropriate. Themes that emerged related to these implementation outcomes include the ability for PHC to increase provider-patient communication and its ability to engage patients due to the tailored and interactive design. While generally feasible to implement, challenges to the clinic workflow and physical environment were areas that clinics needed to manage to make PHC work in their clinics. CONCLUSIONS: Findings from this pilot implementation suggest that clinical staff viewed PHC as acceptable and appropriate, especially as more patients used the intervention over the pilot period. Feasibility of implementation was challenging in some cases, and lessons learned from this pilot implementation can provide information for larger scale tests of the intervention that include assessment of both implementation outcomes and clinical outcomes.