A Disability-Inclusive Healthcare-to-Well-Being Translational Science Framework.

The recent World Health Organization report on disability noted that people with disabilities (PWD) have many unmet health and rehabilitation needs, face numerous barriers to accessing healthcare and specialized services, and have overall worse health than people without disability. In view of this urgency to better identify and address health inequities systematically, we convened an expert panel of 14 stakeholders to develop a strategic plan that addresses this issue. The panel identified two major obstacles to quality healthcare services for PWD: (1) lack of coordination between the various healthcare sectors and community well-being programs and (2) substantial challenges finding and accessing healthcare services that meet their specific needs. The expert stakeholder panel noted that well-being self-management programs (both online and in person) that are easily accessible to PWD are critically needed. PWD must transition from being cared for as patients to individuals who are able to self-manage and self-advocate for their own health and well-being plans and activities. The proposed strategic plan offers providers and local communities a framework to begin addressing accessible and appropriate healthcare-to-well-being services and programs for PWD in managing their health in partnership with their healthcare providers.

Effects of an intervention on internalized HIV-related stigma for individuals newly entering HIV care.

OBJECTIVE: Considering the association between internalized HIV-related stigma and treatment adherence, an intervention addressing HIV treatment adherence may have the added benefit of reducing internalized stigma. The 'integrating ENGagement and Adherence Goals upon Entry' (iENGAGE) intervention was developed to facilitate adjustment to living with HIV among individuals newly engaged in HIV care. We evaluated the effects of this intervention on internalized stigma and examined whether the effect is moderated by depressive symptoms and coping styles. DESIGN: The iENGAGE intervention was tailored individually to improve information, motivation, and behavioral skills to promote treatment adherence and viral suppression. Three hundred and seventy-one participants initiating HIV care at four sites in the United States were randomly assigned to either the intervention receiving four face-to-face sessions or standard of care control arm. METHODS: Baseline and 48-week follow-up assessments were conducted, which included validated measures of internalized HIV-related stigma, depressive symptoms, and coping mechanisms (behavioral disengagement and self-blame) as secondary outcomes. A repeated measures ANOVA evaluated the effect of the intervention on change in internalized HIV stigma. Furthermore, the moderating effects of depressive symptoms and coping mechanisms on the decrease in internalized stigma were examined. RESULTS: The decrease in internalized stigma from baseline to 48 weeks was significantly larger in the intervention arm compared with the control arm. This effect was significantly moderated by baseline levels of depressive symptoms and self-blame. CONCLUSION: The multifaceted iENGAGE intervention is effective in reducing internalized stigma for new-to-HIV care individuals, especially with higher depressive symptoms or when using higher levels of self-blame coping.

Factors Associated with HIV Disclosure Status Among iENGAGE Cohort of New to HIV Care Patients.

HIV disclosure is an important behavior with implications for HIV treatment and prevention but understudied among new to HIV care patients who face unique challenges adjusting to a new diagnosis. This study evaluated the factors associated with HIV disclosure status and patterns of HIV disclosure among new to HIV care patients. A cross-sectional study was conducted evaluating the iENGAGE (integrating ENGagement and Adherence Goals upon Entry) cohort. Participants were enrolled in this randomized behavioral trial between December 2013 and June 2016. The primary and secondary outcomes included HIV disclosure status (Yes/No) and patterns of disclosure (Broad, Selective and Nondisclosure), respectively. Logistic and Multinomial Logistic Regression were used to evaluate the association of participant factors with HIV disclosure and patterns of HIV disclosure, respectively. Of 371 participants, the average age was 37 ± 12 years, 79.3% were males, and 62.3% were African Americans. A majority of participants (78.4%) disclosed their HIV status at baseline, 63.1% were broad disclosers and 15.2% were selective disclosers. In multivariable regression, black race, emotional support, and unmet needs predicted any HIV and broad disclosure, whereas males, emotional support, active coping, and acceptance were associated with selective disclosure. Interventions to promote early disclosure should focus on coping strategies and unmet needs, particularly among black and male people living with HIV initiating care.

A Web-Based Data Collection Platform for Multisite Randomized Behavioral Intervention Trials: Development, Key Software Features, and Results of a User Survey.

BACKGROUND: Meticulous tracking of study data must begin early in the study recruitment phase and must account for regulatory compliance, minimize missing data, and provide high information integrity and/or reduction of errors. In behavioral intervention trials, participants typically complete several study procedures at different time points. Among HIV-infected patients, behavioral interventions can favorably affect health outcomes. In order to empower newly diagnosed HIV positive individuals to learn skills to enhance retention in HIV care, we developed the behavioral health intervention Integrating ENGagement and Adherence Goals upon Entry (iENGAGE) funded by the National Institute of Allergy and Infectious Diseases (NIAID), where we deployed an in-clinic behavioral health intervention in 4 urban HIV outpatient clinics in the United States. To scale our intervention strategy homogenously across sites, we developed software that would function as a behavioral sciences research platform. OBJECTIVE: This manuscript aimed to: (1) describe the design and implementation of a Web-based software application to facilitate deployment of a multisite behavioral science intervention; and (2) report on results of a survey to capture end-user perspectives of the impact of this platform on the conduct of a behavioral intervention trial. METHODS: In order to support the implementation of the NIAID-funded trial iENGAGE, we developed software to deploy a 4-site behavioral intervention for new clinic patients with HIV/AIDS. We integrated the study coordinator into the informatics team to participate in the software development process. Here, we report the key software features and the results of the 25-item survey to evaluate user perspectives on research and intervention activities specific to the iENGAGE trial (N=13). RESULTS: The key features addressed are study enrollment, participant randomization, real-time data collection, facilitation of longitudinal workflow, reporting, and reusability. We found 100% user agreement (13/13) that participation in the database design and/or testing phase made it easier to understand user roles and responsibilities and recommended participation of research teams in developing databases for future studies. Users acknowledged ease of use, color flags, longitudinal work flow, and data storage in one location as the most useful features of the software platform and issues related to saving participant forms, security restrictions, and worklist layout as least useful features. CONCLUSIONS: The successful development of the iENGAGE behavioral science research platform validated an approach of early and continuous involvement of the study team in design development. In addition, we recommend post-hoc collection of data from users as this led to important insights on how to enhance future software and inform standard clinical practices. TRIAL REGISTRATION: Clinicaltrials.gov NCT01900236; (https://clinicaltrials.gov/ct2/show/NCT01900236 (Archived by WebCite at http://www.webcitation.org/6qAa8ld7v).

Venous thromboembolism among HIV-positive patients and anticoagulation clinic outcomes integrated within the HIV primary care setting.

The purpose of this study was to explore factors associated with venous thromboembolism (VTE) among a cohort of HIV-infected patients and to describe early outcomes of warfarin anticoagulation therapy treated in a pharmacist-based anticoagulation clinic (ACC). A nested case-control study was conducted using the University of Alabama at Birmingham 1917 HIV Clinic Cohort. Conditional logistic regression was used to estimate factors associated with VTE. Among HIV-infected VTE cases, ACC-managed patients were compared to primary care provider (PCP)-managed patients to determine Time within Therapeutic INR Range (TTR). CD4 < 200 cells/µl (OR = 4.50; 95% CI = 1.52, 13.37; p = 0.007) and prior surgical procedures (13.20; 1.56; 111.4; p = 0.018) demonstrated positive associations with VTE, whereas longer HIV duration demonstrated a negative association (0.87; 0.78, 0.98; p = 0.019). TTR was 56.2% among ACC-managed patients compared to 30.5% of PCP-managed patients (p = 0.174). Overall, prior surgical procedures and low CD4 count were associated with an increased risk of VTE among HIV-infected patients. Despite small sample size, patients managed in ACC tend to achieve greater proportion of TTR compared to those managed by PCPs, suggesting that this model of therapy may provide additional benefits to HIV-infected patients.