ClinicalTrials.Veeva

Menu

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

University of California, Los Angeles (UCLA) logo

University of California, Los Angeles (UCLA)

Status

Completed

Conditions

Trauma, Psychological
Cardiovascular Risk Factors
HIV/AIDS

Treatments

Behavioral: HHMB

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04025463
1U01HL142109 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

"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).

Full 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.

Enrollment

202 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

202 participants in 1 patient group

Intervention
Other group
Description:
Hybrid type II effectiveness/implementation study design - pre-post design with each participant serving as his or her own control.
Treatment:
Behavioral: HHMB

Trial documents
1

Trial contacts and locations

2

Loading...

Central trial contact

Alison Hamilton, PhD, MPH; Arleen F Brown, MD, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems