Healing Our Hearts Minds and Bodies: CVD Reduction in Persons With HIV (HHMB)
Primary Purpose
HIV/AIDS, Cardiovascular Risk Factors, Trauma, Psychological
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HHMB
Sponsored by
About this trial
This is an interventional treatment trial for HIV/AIDS focused on measuring Implementation science, Organizational readiness, African American, Latino
Eligibility Criteria
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.
Sites / Locations
- OASIS ClinicRecruiting
- Northeast Valley Healthcare CorporationRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention
Arm Description
Hybrid type II effectiveness/implementation study design - pre-post design with each participant serving as his or her own control.
Outcomes
Primary Outcome Measures
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."
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."
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.
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.
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
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.
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.
Change from baseline in Woke Scale
Measure of Critical Racial Consciousness
Secondary Outcome Measures
Change from baseline in Hill-Bone Adherence Scale
Medication adherence for medications for hypertension, diabetes, or hyperlipidemia
Change from baseline in HIV Adherence Scale
Self-reported Rating, Frequency,
Change from baseline in Beck Depression Inventory-II
Depression screener
Change from baseline in Overall Anxiety Severity and Impairment Scale (OASIS)
Anxiety screener - 5-item
Change from baseline in Post-traumatic Stress (PDS-5)
Estimates the severity of a respondent's PTSD symptoms.
Change from baseline in AUDIT-C
Brief alcohol screen to identify hazardous drinking or active alcohol use disorders
Change from baseline in CAGE-AID
Brief screen for alcohol and drug problems conjointly
Change from baseline in Pittsburgh Sleep Quality Index (PSQI)
Measure of quality and patter of sleep in adults
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.
Full Information
NCT ID
NCT04025463
First Posted
June 27, 2019
Last Updated
April 11, 2022
Sponsor
University of California, Los Angeles
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT04025463
Brief Title
Healing Our Hearts Minds and Bodies: CVD Reduction in Persons With HIV
Acronym
HHMB
Official Title
Enhancing Patient and Organizational Readiness for CVD Risk Reduction Among Persons Living With HIV or AIDS
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Cardiovascular Risk Factors, Trauma, Psychological
Keywords
Implementation science, Organizational readiness, African American, Latino
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Hybrid type II effectiveness/implementation study design
Masking
None (Open Label)
Allocation
N/A
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Arm Description
Hybrid type II effectiveness/implementation study design - pre-post design with each participant serving as his or her own control.
Intervention Type
Behavioral
Intervention Name(s)
HHMB
Intervention Description
Blended, culturally-congruent, evidence-informed care model to increase patient and clinic participation in CVD risk reduction for patients with HIV
Primary Outcome Measure Information:
Title
Experience of workload
Description
Maslach Burnout Inventory - 16-item general survey measuring burnout in the workplace. Scale ranges from 0-6,with 0 = "Never" and 6 = "every day."
Time Frame
Baseline
Title
Implementation Climate Scale
Description
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."
Time Frame
Baseline
Title
Implementation Leadership Scale
Description
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.
Time Frame
Baseline
Title
Implementation Citizenship Behavior Scale
Description
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.
Time Frame
Baseline
Title
Change from baseline in CVD Risk - Life's Simple Seven
Description
Seven risk factors that individuals can improve through lifestyle changes to help achieve ideal cardiovascular health
Time Frame
Three-month Follow-up
Title
Change from baseline in PROMIS V1.2 - Global Health
Description
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.
Time Frame
Three-month Follow-up
Title
Change from baseline in Difficulties in Emotional Regulation (DERS)
Description
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.
Time Frame
Three-month Follow-up
Title
Change from baseline in Woke Scale
Description
Measure of Critical Racial Consciousness
Time Frame
Three-month Follow-up
Secondary Outcome Measure Information:
Title
Change from baseline in Hill-Bone Adherence Scale
Description
Medication adherence for medications for hypertension, diabetes, or hyperlipidemia
Time Frame
Three-month Follow-up
Title
Change from baseline in HIV Adherence Scale
Description
Self-reported Rating, Frequency,
Time Frame
Three-month Follow-up
Title
Change from baseline in Beck Depression Inventory-II
Description
Depression screener
Time Frame
Three-month Follow-up
Title
Change from baseline in Overall Anxiety Severity and Impairment Scale (OASIS)
Description
Anxiety screener - 5-item
Time Frame
Three-month Follow-up
Title
Change from baseline in Post-traumatic Stress (PDS-5)
Description
Estimates the severity of a respondent's PTSD symptoms.
Time Frame
Three-month Follow-up
Title
Change from baseline in AUDIT-C
Description
Brief alcohol screen to identify hazardous drinking or active alcohol use disorders
Time Frame
Three-month Follow-up
Title
Change from baseline in CAGE-AID
Description
Brief screen for alcohol and drug problems conjointly
Time Frame
Three-month Follow-up
Title
Change from baseline in Pittsburgh Sleep Quality Index (PSQI)
Description
Measure of quality and patter of sleep in adults
Time Frame
Three-month Follow-up
Title
Change from baseline in ASCVD Risk Score
Description
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.
Time Frame
Three-month Follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arleen F Brown, MD, PhD
Phone
310-794-6047
Email
abrown@mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alison Hamilton, PhD, MPH
Email
alisonh@ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Wyatt, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
OASIS Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wilbert Jordan, MD
Phone
424-338-2929
Facility Name
Northeast Valley Healthcare Corporation
City
Van Nuys
State/Province
California
ZIP/Postal Code
91405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ardis Moe, MD
Phone
818-988-6335
Email
amoe@mednet.ucla.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32109483
Citation
Hamilton AB, Brown A, Loeb T, Chin D, Grills C, Cooley-Strickland M, Liu HH, Wyatt GE. Enhancing patient and organizational readiness for cardiovascular risk reduction among Black and Latinx patients living with HIV: Study protocol. Prog Cardiovasc Dis. 2020 Mar-Apr;63(2):101-108. doi: 10.1016/j.pcad.2020.02.014. Epub 2020 Feb 25.
Results Reference
derived
Learn more about this trial
Healing Our Hearts Minds and Bodies: CVD Reduction in Persons With HIV
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