- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04025463
Healing Our Hearts Minds and Bodies: CVD Reduction in Persons With HIV (HHMB)
November 22, 2023 updated by: Arleen F. Brown, MD, PhD, University of California, Los Angeles
Enhancing Patient and Organizational Readiness for CVD Risk Reduction Among Persons Living With HIV or AIDS
"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).
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
202
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arleen F Brown, MD, PhD
- Phone Number: 310-794-6047
- Email: abrown@mednet.ucla.edu
Study Contact Backup
- Name: Alison Hamilton, PhD, MPH
- Email: alisonh@ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90059
- OASIS Clinic
-
Van Nuys, California, United States, 91405
- Northeast Valley Healthcare Corporation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Blended, culturally-congruent, evidence-informed care model to increase patient and clinic participation in CVD risk reduction for patients with HIV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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."
|
Baseline
|
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."
|
Baseline
|
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.
|
Baseline
|
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.
|
Baseline
|
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
|
Three-month Follow-up
|
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.
|
Three-month Follow-up
|
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.
|
Three-month Follow-up
|
Change from baseline in Woke Scale
Time Frame: Three-month Follow-up
|
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
Time Frame: Three-month Follow-up
|
Medication adherence for medications for hypertension, diabetes, or hyperlipidemia
|
Three-month Follow-up
|
Change from baseline in HIV Adherence Scale
Time Frame: Three-month Follow-up
|
Self-reported Rating, Frequency,
|
Three-month Follow-up
|
Change from baseline in Beck Depression Inventory-II
Time Frame: Three-month Follow-up
|
Depression screener
|
Three-month Follow-up
|
Change from baseline in Overall Anxiety Severity and Impairment Scale (OASIS)
Time Frame: Three-month Follow-up
|
Anxiety screener - 5-item
|
Three-month Follow-up
|
Change from baseline in Post-traumatic Stress (PDS-5)
Time Frame: Three-month Follow-up
|
Estimates the severity of a respondent's PTSD symptoms.
|
Three-month Follow-up
|
Change from baseline in AUDIT-C
Time Frame: Three-month Follow-up
|
Brief alcohol screen to identify hazardous drinking or active alcohol use disorders
|
Three-month Follow-up
|
Change from baseline in CAGE-AID
Time Frame: Three-month Follow-up
|
Brief screen for alcohol and drug problems conjointly
|
Three-month Follow-up
|
Change from baseline in Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Three-month Follow-up
|
Measure of quality and patter of sleep in adults
|
Three-month Follow-up
|
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.
|
Three-month Follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Gail Wyatt, PhD, University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Wyatt GE, Loeb TB, Cooley-Strickland M, Chin D, Wyatt LE, Smith-Clapham AM. Novel methodologies using history to document the effects of African American sexual trauma: Perspectives of Gail E. Wyatt, PhD. Am Psychol. 2023 May-Jun;78(4):563-575. doi: 10.1037/amp0001132.
- Loeb TB, Viducich I, Smith-Clapham AM, Adkins-Jackson P, Zhang M, Cooley-Strickland M, Davis T, Pemberton JV, Wyatt GE. Unmet need for mental health services utilization among under-resourced Black and Latinx adults. Fam Syst Health. 2023 Jun;41(2):149-159. doi: 10.1037/fsh0000750. Epub 2022 Dec 15.
- Loeb TB, Banks D, Ramm K, Viducich I, Beasley Q, Barron J, Chen EL, Norwood-Scott E, Fuentes K, Zhang M, Brown AF, Wyatt GE, Hamilton AB. Achieving Health Equity and Continuity of Care for Black and Latinx People Living With HIV. Am J Public Health. 2023 Jun;113(S2):S107-S109. doi: 10.2105/AJPH.2023.307222. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
November 30, 2022
Study Completion (Actual)
May 31, 2023
Study Registration Dates
First Submitted
June 27, 2019
First Submitted That Met QC Criteria
July 17, 2019
First Posted (Actual)
July 19, 2019
Study Record Updates
Last Update Posted (Actual)
November 28, 2023
Last Update Submitted That Met QC Criteria
November 22, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1U01HL142109 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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