Healing Our Hearts Minds and Bodies: CVD Reduction in Persons With HIV
a study on HIV/AIDS Cardiovascular Disease Mental Health Psychological Trauma
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Healthy Volunteers
- healthy people welcome
- Location
- at UCLA
- Dates
- study startedestimated completion
- Principal Investigator
- by Gail Wyatt, PhD (ucla)
Description
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).
Official Title
Enhancing Patient and Organizational Readiness for CVD Risk Reduction Among Persons Living With HIV or AIDS
Details
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.
Keywords
HIV/AIDS, Cardiovascular Risk Factors, Trauma, Psychological, Implementation science, Organizational readiness, African American, Latino, Psychological Trauma, HHMB
Eligibility
For people ages 18 years and up
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.
Locations
- Northeast Valley Healthcare Corporation
accepting new patients
Van Nuys California 91405 United States - OASIS Clinic
accepting new patients
Los Angeles California 90059 United States
Lead Scientist at University of California Health
- Gail Wyatt, PhD (ucla)
Gail Wyatt, Ph.D., holds the Dena Bat-Yaacov Endowed Chair in Psychiatry.
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- University of California, Los Angeles
- ID
- NCT04025463
- Study Type
- Interventional
- Participants
- Expecting 260 study participants
- Last Updated