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

NCT ID: NCT04025463

Last Updated: 2023-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2023-05-31

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.

Conditions

HIV/AIDS; Cardiovascular Risk Factors; Trauma, Psychological

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: OTHER

HHMB

Intervention Type: BEHAVIORAL

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

Interventions

HHMB

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

Patient Eligibility

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Arleen F. Brown, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gail Wyatt, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

OASIS Clinic

Los Angeles, California, United States

Northeast Valley Healthcare Corporation

Van Nuys, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 37384508 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36521110 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37339419 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32109483 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1U01HL142109

Identifier Type: NIH

Identifier Source: secondary_id

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1U01HL142109

Identifier Type: NIH

Identifier Source: org_study_id

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