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Completed

NCT Number: NCT04025463

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

"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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HHMB

Behavioral

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

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

Registry information

Official study title

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

Acronym: HHMB

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jul 19, 2019
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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