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
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS Cardiovascular Risk Factors Trauma, Psychological||Behavioral: HHMB||Not Applicable|
|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)|
|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|
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
- 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."
- 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."
- 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.
- 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.
- 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
- 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.
- 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.
- Change from baseline in Woke Scale [ Time Frame: Three-month Follow-up ]Measure of Critical Racial Consciousness
- Change from baseline in Hill-Bone Adherence Scale [ Time Frame: Three-month Follow-up ]Medication adherence for medications for hypertension, diabetes, or hyperlipidemia
- Change from baseline in HIV Adherence Scale [ Time Frame: Three-month Follow-up ]Self-reported Rating, Frequency,
- Change from baseline in Beck Depression Inventory-II [ Time Frame: Three-month Follow-up ]Depression screener
- Change from baseline in Overall Anxiety Severity and Impairment Scale (OASIS) [ Time Frame: Three-month Follow-up ]Anxiety screener - 5-item
- Change from baseline in Post-traumatic Stress (PDS-5) [ Time Frame: Three-month Follow-up ]Estimates the severity of a respondent's PTSD symptoms.
- Change from baseline in AUDIT-C [ Time Frame: Three-month Follow-up ]Brief alcohol screen to identify hazardous drinking or active alcohol use disorders
- Change from baseline in CAGE-AID [ Time Frame: Three-month Follow-up ]Brief screen for alcohol and drug problems conjointly
- Change from baseline in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Three-month Follow-up ]Measure of quality and patter of sleep in adults
- 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.
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
|Contact: Arleen F Brown, MD, PhDfirstname.lastname@example.org|
|Contact: Alison Hamilton, PhD, MPHemail@example.com|
|United States, California|
|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 firstname.lastname@example.org|
|Principal Investigator:||Gail Wyatt, PhD||University of California, Los Angeles|