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

NCT04025463 | Completed DMC

• 1 other identifier: 1U01HL142109
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

HIV/AIDS; Cardiovascular Risk Factors; Trauma, Psychological

Keywords

Implementation science; Organizational readiness; African American; Latino

Outcome Measures

Primary Outcomes (8)

• 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

  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

Secondary Outcomes (9)

• Change from baseline in Hill-Bone Adherence Scale

  Three-month Follow-up

• Change from baseline in HIV Adherence Scale

  Three-month Follow-up

• Change from baseline in Beck Depression Inventory-II

  Three-month Follow-up

• Change from baseline in Overall Anxiety Severity and Impairment Scale (OASIS)

  Three-month Follow-up

• Change from baseline in Post-traumatic Stress (PDS-5)

  Three-month Follow-up

Study Arms (1)

Intervention

OTHER

Hybrid type II effectiveness/implementation study design - pre-post design with each participant serving as his or her own control.

Behavioral: HHMB

Interventions

HHMB BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patient Eligibility
• African American and Latino
• Patient cared for in a participating agency
• 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
• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

OASIS Clinic

Los Angeles, California, 90059, United States

Location

Northeast Valley Healthcare Corporation

Van Nuys, California, 91405, United States

Location

Related Publications (4)

• 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.

  PMID: 37384508 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.

  PMID: 36521110 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.

  PMID: 37339419 BACKGROUND

• 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.

  PMID: 32109483 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Psychological Trauma

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Gail Wyatt, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Hybrid type II effectiveness/implementation study design

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 19, 2019
• Study Start: October 1, 2019
• Primary Completion: November 30, 2022
• Study Completion: May 31, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)