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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01HL142109 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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"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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | Hybrid type II effectiveness/implementation study design - pre-post design with each participant serving as his or her own control. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HHMB | Behavioral | Blended, culturally-congruent, evidence-informed care model to increase patient and clinic participation in CVD risk reduction for patients with HIV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Hill-Bone Adherence Scale | Medication adherence for medications for hypertension, diabetes, or hyperlipidemia | Three-month Follow-up |
| Change from baseline in HIV Adherence Scale |
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Organizational/Staff Eligibility
Patient Eligibility
Inclusion Criteria
Exclusion Criteria - Potential participants will be screened by the Project Coordinator, who will be trained to assess the following exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Wyatt, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OASIS Clinic | Los Angeles | California | 90059 | United States | ||
| Northeast Valley Healthcare Corporation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37384508 | Background | 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. | |
| 36521110 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 8, 2024 | |
| Unrelease | Apr 9, 2024 | |
| Release | Apr 9, 2024 | |
| Reset | May 1, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2018 | Jul 17, 2019 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 8, 2024 | Apr 9, 2024 | |||
| Apr 9, 2024 |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D000067073 | Psychological Trauma |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Hybrid type II effectiveness/implementation study design
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| Three-month Follow-up |
| 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 |
| 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 |
| Change from baseline in Woke Scale | Measure of Critical Racial Consciousness | Three-month Follow-up |
Self-reported Rating, Frequency,
| Three-month Follow-up |
| Change from baseline in Beck Depression Inventory-II | Depression screener | Three-month Follow-up |
| Change from baseline in Overall Anxiety Severity and Impairment Scale (OASIS) | Anxiety screener - 5-item | Three-month Follow-up |
| Change from baseline in Post-traumatic Stress (PDS-5) | Estimates the severity of a respondent's PTSD symptoms. | Three-month Follow-up |
| Change from baseline in AUDIT-C | Brief alcohol screen to identify hazardous drinking or active alcohol use disorders | Three-month Follow-up |
| Change from baseline in CAGE-AID | Brief screen for alcohol and drug problems conjointly | Three-month Follow-up |
| Change from baseline in Pittsburgh Sleep Quality Index (PSQI) | Measure of quality and patter of sleep in adults | Three-month Follow-up |
| 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 |
| Van Nuys |
| California |
| 91405 |
| United States |
| 37339419 | Background | 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. |
| 32109483 | Derived | 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. |
| May 1, 2024 |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |