Clinical trial NCT04025463: Healing Our Hearts Minds and Bodies: CVD Reduction in Persons With HIV
Official title: Enhancing Patient and Organizational Readiness for CVD Risk Reduction Among Persons Living With HIV or AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Cardiovascular Risk Factors
Trauma, Psychological
Keywords: Implementation science
Organizational readiness
African American
Latino
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-07-19
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Hybrid type II effectiveness/implementation study design
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Experience of workload
timeFrame: Baseline
measure: Implementation Climate Scale
timeFrame: Baseline
measure: Implementation Leadership Scale
timeFrame: Baseline
measure: Implementation Citizenship Behavior Scale
timeFrame: Baseline
measure: Change from baseline in CVD Risk - Life's Simple Seven
timeFrame: Three-month Follow-up
measure: Change from baseline in PROMIS V1.2 - Global Health
timeFrame: Three-month Follow-up
measure: Change from baseline in Difficulties in Emotional Regulation (DERS)
timeFrame: Three-month Follow-up
measure: Change from baseline in Woke Scale
timeFrame: Three-month Follow-up
Secondary outcomes:
measure: Change from baseline in Hill-Bone Adherence Scale
timeFrame: Three-month Follow-up
measure: Change from baseline in HIV Adherence Scale
timeFrame: Three-month Follow-up
measure: Change from baseline in Beck Depression Inventory-II
timeFrame: Three-month Follow-up
measure: Change from baseline in Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Three-month Follow-up
measure: Change from baseline in Post-traumatic Stress (PDS-5)
timeFrame: Three-month Follow-up
measure: Change from baseline in AUDIT-C
timeFrame: Three-month Follow-up
measure: Change from baseline in CAGE-AID
timeFrame: Three-month Follow-up
measure: Change from baseline in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Three-month Follow-up
measure: Change from baseline in ASCVD Risk Score
timeFrame: Three-month Follow-up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: OASIS Clinic
state: California
city: Van Nuys
country: United States
facility: Northeast Valley Healthcare Corporation
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Gail Wyatt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
citation: 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.