Cost Analysis of the Positive Health Check Intervention to Suppress HIV Viral Load and Retain Patients in HIV Clinical Care.

CONTEXT: Digital video-based behavioral interventions are effective tools for improving HIV care and treatment outcomes. OBJECTIVE: To assess the costs of the Positive Health Check (PHC) intervention delivered in HIV primary care settings. DESIGN, SETTING, AND INTERVENTION: The PHC study was a randomized trial evaluating the effectiveness of a highly tailored, interactive video-counseling intervention delivered in 4 HIV care clinics in the United States in improving viral suppression and retention in care. Eligible patients were randomized to either the PHC intervention or the control arm. Control arm participants received standard of care (SOC), and intervention arm participants received SOC plus PHC. The intervention was delivered on computer tablets in the clinic waiting rooms. The PHC intervention improved viral suppression among male participants. A microcosting approach was used to assess the program costs, including labor hours, materials and supplies, equipment, and office overhead. PARTICIPANTS: Persons with HIV infection, receiving care in participating clinics. MAIN OUTCOME MEASURES: The primary outcome was the number of patients virally suppressed, defined as having fewer than 200 copies/mL by the end of their 12-month follow-up. RESULTS: A total of 397 (range across sites [range], 95-102) participants were enrolled in the PHC intervention arm, of whom 368 participants (range, 82-98) had viral load data at baseline and were included in the viral load analyses. Of those, 210 (range, 41-63) patients were virally suppressed at the end of their 12-month follow-up visit. The overall annual program cost was $402 274 (range, $65 581-$124 629). We estimated the average program cost per patient at $1013 (range, $649-$1259) and the cost per patient virally suppressed at $1916 (range, $1041-$3040). Recruitment and outreach costs accounted for 30% of PHC program costs. CONCLUSIONS: The costs of this interactive video-counseling intervention are comparable with other retention in care or reengagement interventions.

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.

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.

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.

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.

Safe in the city: effective prevention interventions for human immunodeficiency virus and sexually transmitted infections.

BACKGROUND: The public health literature documents the efficacy-effectiveness gap between research and practice resulting from the research priority of demonstrating efficacy at the expense of testing for effectiveness. PURPOSE: The Safe in the City video-based HIV/sexually transmitted infection (STI) prevention intervention designed for sexually transmitted disease (STD) clinic waiting rooms is presented as a case study to demonstrate the application of a new framework to bridge efficacy and effectiveness. The goal of the study is to determine the extent to which clinics are implementing the intervention. METHODS: As part of the case study, data were collected from a convenience sample of 81 publicly funded STD clinics during program implementation to determine whether clinics were showing the video. A baseline telephone survey was administered to clinic directors from November to December 2008, and a follow-up was conducted from March to May 2009. Data analysis was completed in 2009. RESULTS: At baseline, 41% of STD clinics were showing Safe in the City, which increased to 58% at follow-up. None reported previous implementation of behavioral interventions delivered in waiting rooms. Almost one fourth of clinics adapted the intervention by showing the video on laptop computers in examination rooms or in other venues with different audiences. CONCLUSIONS: The Safe in the City intervention was implemented by the majority of STD clinics and adapted for implementation. The framework for HIV/STI prevention intervention illustrates how measures of effectiveness were increased in the development, evaluation, dissemination, implementation and sustainability phases of research and program.

Operational research to improve HIV prevention in the United States.

The HIV/AIDS epidemic in the United States continues despite several recent noteworthy advances in HIV prevention. Contemporary approaches to HIV prevention involve implementing combinations of biomedical, behavioral, and structural interventions in novel ways to achieve high levels of impact on the epidemic. Methods are needed to develop optimal combinations of approaches for improving efficiency, effectiveness, and scalability. This article argues that operational research offers promise as a valuable tool for addressing these issues. We define operational research relative to domestic HIV prevention, identify and illustrate how operational research can improve HIV prevention, and pose a series of questions to guide future operational research. Operational research can help achieve national HIV prevention goals of reducing new infections, improving access to care and optimization of health outcomes of people living with HIV, and reducing HIV-related health disparities.

The diffusion of effective behavioral interventions project: development, implementation, and lessons learned.

Implementation of evidence-based HIV/STD prevention interventions can play an important role in reducing HIV and sexually transmitted diseases. This article describes the development, implementation, and lessons learned of the Diffusion of Effective Behavioral Interventions (DEBI) project, a strategy funded by the Centers for Disease Control and Prevention to diffuse evidence-based, group- and community-level HIV/STD prevention interventions to health departments and community-based organizations nationwide. The article specifically provides an overview of the rationale, description, and theoretical foundation of the project; a review of marketing efforts, including assessment of interests, needs, and capacities relative to the project; a description of project products, their purpose, approach employed to develop them, and their use by implementers; a description of the project's training coordination functions and activities; technical assistance issues; an overview of process and outcome evaluation components; new developments in response to feedback; and a discussion of future directions for DEBI. Project successes and challenges are addressed to inform future efforts to diffuse prevention interventions.

Adapting evidence-based behavioral interventions for new settings and target populations.

Many HIV prevention funding agencies require the use of evidence-based behavioral interventions (EBIs) previously shown to be effective through rigorous outcome evaluation. Often, the implementing agency's setting or target population is different than those in the original implementation and evaluation. The Centers for Disease Control and Prevention Division of HIV/AIDS Prevention, in collaboration with internal and external partners, developed draft guidance to adapt an EBI to fit the cultural context, risk determinants, risk behaviors, and unique circumstances of the agency without competing with or contradicting the core elements and internal logic. The guidance described in this article provides a systematic approach to help agencies identify the most appropriate intervention for their target population and agency capacity, monitor the process, and evaluate the outcomes of the adapted intervention. This guidance, currently being piloted with five community-based organizations, will be revised and disseminated at the conclusion of project activities.

An empirical assessment of implementation, adaptation, and tailoring: the evaluation of CDC's National Diffusion of VOICES/VOCES.

The Centers for Disease Control and Prevention (CDC), through its Diffusion of Effective Behavioral Interventions (DEBI) program, trained over 260 agencies on VOICES/VOCES between August 2003 and April 2005. ORC Macro conducted interviews with agency staff 3 months after receiving VOICES/VOCES training. This article discusses the diffusion of VOICES/VOCES; agencies' adoption, adaptation, and implementation of this intervention; and needs for ongoing proactive technical assistance (TA) for agencies to successfully integrate behavioral interventions into their programs. The vastmajority of agencies implemented VOICES/VOCES with fidelity to the core elements, and agencies successfully adapted the intervention to make it more appealing to target populations. TA is needed for interventions to be successfully adapted and implemented with fidelity to the core elements, and to ensure program sustainability. More effective interventions of short duration and minimum complexity to easily match with existing resources and conditions of agency capacity among HIV prevention providers in the community are needed.