Healing Our Hearts Minds and Bodies: CVD Reduction in Persons With HIV

Study Overview
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Brief Summary
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Healing our Minds and Bodies (HHMB) uses a a hybrid type II effectiveness/implementation study design to increase both patient and organizational readiness to address trauma and CVD risk among African American and Latino persons living with HIV or AIDS (PLWHIV).

Detailed Description
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Cardiovascular disease (CVD) has emerged as an increasingly important cause of morbidity and mortality among people living with HIV (PLWHIV). Now that HIV is considered a manageable chronic disease, the identification and treatment of comorbid medical conditions including CVD are increasingly the focus of research and clinical attention. What is missing, however, is yet another critical component of care for PLWHIV: integrated care for histories of trauma. Experiences of trauma increase the likelihood of HIV infection as well as CVD risk, yet health care for PLWHIV is rarely coordinated to address these three intersecting issues of HIV, CVD, and trauma, particularly among those disproportionately affected by HIV, i.e., ethnic minority patients. Histories of trauma among PLWHIV are associated with inconsistent treatment adherence and non-adherence, and trauma history alone is associated with poor CVD outcomes. Failure to address trauma poses significant barriers to the adoption of CVD risk strategies among PLWHIV. Health systems that coordinate and integrate care across HIV and chronic conditions such as CVD may provide the infrastructure needed to address the complex interplay of these conditions and their therapies. The investigators have designed a novel blended, culturally-congruent, evidence-informed care model, Healing our Minds and Bodies (HHMB), to address patients' trauma histories and barriers to care, and to prepare patients to engage in CVD risk reduction. Recognizing the need to ensure that PLWHIV receive CVD guideline-concordant care, the investigators have also identified implementation strategies to prepare providers and clinics for addressing CVD risk among their HIV-positive patients. Therefore, using a hybrid type II effectiveness/implementation study design, the goal of this study is to increase both patient and organizational readiness to address trauma and CVD risk among PLWHIV. The Specific Aims are: (1) to assess and enhance organizational readiness for addressing trauma and CVD risk among ethnic minority PLWHIV; specifically, a phased approach will drive the use of implementation strategies designed to educate, monitor, and support providers and staff in adhering to CVD care guidelines; (2) using mixed methods, to (a) evaluate the use and effectiveness of implementation strategies over time, and (b) identify barriers and facilitators to organizational adoption of guidelines, provider adherence to guidelines, feasibility, and sustainability; and (3) To evaluate the effect of HHMB on cognitive-behavioral, emotional, and clinical outcomes among 260 African American and Latino PLWHIV. The investigators will use the Replicating Effective Programs (REP) framework to guide the use of implementation strategies and the tailoring of the HHMB intervention within our participating implementation settings, and the Consolidated Framework for Implementation Research to guide the evaluation analyses.

Official Title
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Enhancing Patient and Organizational Readiness for CVD Risk Reduction Among Persons Living With HIV or AIDS

Conditions
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HIV/AIDS, Cardiovascular Risk Factors, Trauma, Psychological

Intervention / Treatment
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* Behavioral: HHMB


Participation Criteria
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Eligibility Criteria
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Organizational/Staff Eligibility Inclusion Criteria: staff employed by the participating agencies Exclusion Criteria: non-employees of the participating agencies Patient Eligibility Inclusion Criteria African American and Latino Patient cared for in a participating agency 18 to 60 years of age Living with HIV or AIDS Speak English or Spanish Screen greater than 0 on the UCLA Life Adversities Screener (LADS) Identify at least one self-reported CVD risk factor Exclusion Criteria - Potential participants will be screened by the Project Coordinator, who will be trained to assess the following exclusion criteria: Known psychiatric, physical or neurological impairment that would limit their effective participation; Recent history of a severe illness, sexual or physical abuse that might require sudden medical, psychological and/or legal intervention Unwilling or unable to give consent or to commit to participate in the study through completion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Hybrid type II effectiveness/implementation study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>Hybrid type II effectiveness/implementation study design - pre-post design with each participant serving as his or her own control. | Behavioral: HHMB<br>* Blended, culturally-congruent, evidence-informed care model to increase patient and clinic participation in CVD risk reduction for patients with HIV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experience of workload | Maslach Burnout Inventory - 16-item general survey measuring burnout in the workplace. Scale ranges from 0-6,with 0 = Never and 6 = every day. | Baseline | 
| Implementation Climate Scale | This 18-item measure assesses the degree to which there is a strategic organizational climate supportive of evidence-based practice implementation. Implementation climate is defined as employees' shared perceptions of the policies, practices, procedures, and behaviors that are rewarded, supported, and expected in order to facilitate effective EBP implementation. The scale ranges from 0-4, with 0 = not at all and 4 = very great extent. | Baseline | 
| Implementation Leadership Scale | The ILS assesses the degree to which a leader is Proactive, Knowledgeable, Supportive, and Perseverant in implementing evidence-based practice. The score for each subscale is created by computing a mean score for each set of items that load on a given subscale. For example, items 1, 2, and 3 constitute Scale 1. A mean of the scale scores may be computed to yield the mean score for the total ILS. | Baseline | 
| Implementation Citizenship Behavior Scale | This measure assesses the behaviors employees perform that exceed their expected job tasks to support the implementation of evidence-based practices (EBPs). The score for each subscale is created by computing a mean score for each set of items that load on a given subscale. For example, items 1, 2, and 3 constitute Scale 1 (Helping Others). A mean of the scale scores may be computed to yield the mean score for the total ICBS. | Baseline | 
| Change from baseline in CVD Risk - Life's Simple Seven | Seven risk factors that individuals can improve through lifestyle changes to help achieve ideal cardiovascular health | Three-month Follow-up | 
| Change from baseline in PROMIS V1.2 - Global Health | Assessment of generic (not condition-specific) physical, mental, and social health. The adult PROMIS Global Health measure produces two scores: Physical Health and Mental Health. | Three-month Follow-up | 
| Change from baseline in Difficulties in Emotional Regulation (DERS) | Self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 (almost never [0-10%]) to 5 (almost always [91-100%]). Higher scores indicate more difficulty in emotion regulation. | Three-month Follow-up | 
| Change from baseline in Woke Scale | Measure of Critical Racial Consciousness | Three-month Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Hill-Bone Adherence Scale | Medication adherence for medications for hypertension, diabetes, or hyperlipidemia | Three-month Follow-up | 
| Change from baseline in HIV Adherence Scale | Self-reported Rating, Frequency, | Three-month Follow-up | 
| Change from baseline in Beck Depression Inventory-II | Depression screener | Three-month Follow-up | 
| Change from baseline in Overall Anxiety Severity and Impairment Scale (OASIS) | Anxiety screener - 5-item | Three-month Follow-up | 
| Change from baseline in Post-traumatic Stress (PDS-5) | Estimates the severity of a respondent's PTSD symptoms. | Three-month Follow-up | 
| Change from baseline in AUDIT-C | Brief alcohol screen to identify hazardous drinking or active alcohol use disorders | Three-month Follow-up | 
| Change from baseline in CAGE-AID | Brief screen for alcohol and drug problems conjointly | Three-month Follow-up | 
| Change from baseline in Pittsburgh Sleep Quality Index (PSQI) | Measure of quality and patter of sleep in adults | Three-month Follow-up | 
| Change from baseline in ASCVD Risk Score | Estimate of 10-year and lifetime risks for atherosclerotic cardiovascular disease (ASCVD), defined as coronary death or nonfatal myocardial infarction, or fatal or nonfatal stroke. Sensitivity analyses will be conducted including and excluding those on a statin. | Three-month Follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implementation science, Organizational readiness, African American, Latino