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

HIV/AIDS Clinical Trial

— HHMB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04025463
• Other study ID #: 1U01HL142109
• Secondary ID: 1U01HL142109
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: May 31, 2023

Study information

• Verified date: November 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: May 31, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	OASIS Clinic	Los Angeles	California
United States	Northeast Valley Healthcare Corporation	Van Nuys	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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