Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04025463
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : December 9, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Arleen F. Brown, MD, PhD, University of California, Los Angeles

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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Hybrid 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 : August 1, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Experience of workload [ Time Frame: 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."

  2. Implementation Climate Scale [ Time Frame: 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."

  3. Implementation Leadership Scale [ Time Frame: 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.

  4. Implementation Citizenship Behavior Scale [ Time Frame: 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.

  5. Change from baseline in CVD Risk - Life's Simple Seven [ Time Frame: Three-month Follow-up ]
    Seven risk factors that individuals can improve through lifestyle changes to help achieve ideal cardiovascular health

  6. Change from baseline in PROMIS V1.2 - Global Health [ Time Frame: 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.

  7. Change from baseline in Difficulties in Emotional Regulation (DERS) [ Time Frame: 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.

  8. Change from baseline in Woke Scale [ Time Frame: Three-month Follow-up ]
    Measure of Critical Racial Consciousness


Secondary Outcome Measures :
  1. Change from baseline in Hill-Bone Adherence Scale [ Time Frame: Three-month Follow-up ]
    Medication adherence for medications for hypertension, diabetes, or hyperlipidemia

  2. Change from baseline in HIV Adherence Scale [ Time Frame: Three-month Follow-up ]
    Self-reported Rating, Frequency,

  3. Change from baseline in Beck Depression Inventory-II [ Time Frame: Three-month Follow-up ]
    Depression screener

  4. Change from baseline in Overall Anxiety Severity and Impairment Scale (OASIS) [ Time Frame: Three-month Follow-up ]
    Anxiety screener - 5-item

  5. Change from baseline in Post-traumatic Stress (PDS-5) [ Time Frame: Three-month Follow-up ]
    Estimates the severity of a respondent's PTSD symptoms.

  6. Change from baseline in AUDIT-C [ Time Frame: Three-month Follow-up ]
    Brief alcohol screen to identify hazardous drinking or active alcohol use disorders

  7. Change from baseline in CAGE-AID [ Time Frame: Three-month Follow-up ]
    Brief screen for alcohol and drug problems conjointly

  8. Change from baseline in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Three-month Follow-up ]
    Measure of quality and patter of sleep in adults

  9. Change from baseline in ASCVD Risk Score [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025463


Contacts
Layout table for location contacts
Contact: Arleen F Brown, MD, PhD 310-794-6047 abrown@mednet.ucla.edu
Contact: Alison Hamilton, PhD, MPH alisonh@ucla.edu

Locations
Layout table for location information
United States, California
OASIS Clinic Recruiting
Los Angeles, California, United States, 90059
Contact: Wilbert Jordan, MD    424-338-2929      
Northeast Valley Healthcare Corporation Recruiting
Van Nuys, California, United States, 91405
Contact: Ardis Moe, MD    818-988-6335    amoe@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Gail Wyatt, PhD University of California, Los Angeles
  Study Documents (Full-Text)

Documents provided by Arleen F. Brown, MD, PhD, University of California, Los Angeles:

Layout table for additonal information
Responsible Party: Arleen F. Brown, MD, PhD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04025463    
Other Study ID Numbers: 1U01HL142109 ( U.S. NIH Grant/Contract )
1U01HL142109 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arleen F. Brown, MD, PhD, University of California, Los Angeles:
Implementation science
Organizational readiness
African American
Latino
Additional relevant MeSH terms:
Layout table for MeSH terms
Psychological Trauma
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders