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

Sponsor

University of California, Los Angeles (Other)

Overall Status

Recruiting

CT.gov ID

NCT04025463

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

260

Enrollment

Locations

Arm

Anticipated Duration (Months)

130

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

"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).

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS Cardiovascular Risk Factors Trauma, Psychological	Behavioral: HHMB	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

260 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Hybrid type II effectiveness/implementation study designHybrid type II effectiveness/implementation study design

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Intervention

Hybrid type II effectiveness/implementation study design - pre-post design with each participant serving as his or her own control.

Behavioral: HHMB

Blended, culturally-congruent, evidence-informed care model to increase patient and clinic participation in CVD risk reduction for patients with HIV

Outcome Measures

Primary Outcome Measures

Experience of workload [Baseline]
Maslach Burnout Inventory - 16-item general survey measuring burnout in the workplace. Scale ranges from 0-6,with 0 = "Never" and 6 = "every day."
Implementation Climate Scale [Baseline]
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."
Implementation Leadership Scale [Baseline]
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.
Implementation Citizenship Behavior Scale [Baseline]
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.
Change from baseline in CVD Risk - Life's Simple Seven [Three-month Follow-up]
Seven risk factors that individuals can improve through lifestyle changes to help achieve ideal cardiovascular health
Change from baseline in PROMIS V1.2 - Global Health [Three-month Follow-up]
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.
Change from baseline in Difficulties in Emotional Regulation (DERS) [Three-month Follow-up]
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.
Change from baseline in Woke Scale [Three-month Follow-up]
Measure of Critical Racial Consciousness

Secondary Outcome Measures

Change from baseline in Hill-Bone Adherence Scale [Three-month Follow-up]
Medication adherence for medications for hypertension, diabetes, or hyperlipidemia
Change from baseline in HIV Adherence Scale [Three-month Follow-up]
Self-reported Rating, Frequency,
Change from baseline in Beck Depression Inventory-II [Three-month Follow-up]
Depression screener
Change from baseline in Overall Anxiety Severity and Impairment Scale (OASIS) [Three-month Follow-up]
Anxiety screener - 5-item
Change from baseline in Post-traumatic Stress (PDS-5) [Three-month Follow-up]
Estimates the severity of a respondent's PTSD symptoms.
Change from baseline in AUDIT-C [Three-month Follow-up]
Brief alcohol screen to identify hazardous drinking or active alcohol use disorders
Change from baseline in CAGE-AID [Three-month Follow-up]
Brief screen for alcohol and drug problems conjointly
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) [Three-month Follow-up]
Measure of quality and patter of sleep in adults
Change from baseline in ASCVD Risk Score [Three-month Follow-up]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.