Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04025463
Study type Interventional
Source University of California, Los Angeles
Contact
Status Completed
Phase N/A
Start date October 1, 2019
Completion date May 31, 2023

See also
  Status Clinical Trial Phase
Completed NCT03413696 - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed NCT03215901 - Life Plans Intervention Study N/A
Completed NCT03289676 - Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV Phase 1
Completed NCT03268551 - MEMO-Medical Marijuana and Opioids Study
Active, not recruiting NCT04064567 - Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK N/A
Completed NCT04121962 - A Pilot Peer Mentor Intervention That Trains Black Men Who Have Sex With Men (BMSM) to Use and Promote Uptake of HIV/STI Self-Testing to Peers and Sex Partners: STAR Study (Self-Testing at Your Residence) N/A
Completed NCT04013295 - Prize-linked Savings Initiatives for Promoting Better Health and Economic Outcomes in Kenya N/A
Recruiting NCT04405700 - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting NCT03984136 - HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM N/A
Completed NCT02928900 - Patient Actor Training to Improve HIV Services for Adolescents in Kenya N/A
Recruiting NCT03268109 - COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
Not yet recruiting NCT05813964 - Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France. Phase 3
Completed NCT02797262 - Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System N/A
Completed NCT02376582 - Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS Phase 1
Completed NCT01957865 - Real-Time Antiretroviral Therapy Adherence Intervention in Uganda N/A
Completed NCT01616940 - Minority AIDS Initiative Retention and Re-Engagement Project N/A
Terminated NCT01443923 - Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV Phase 4
Completed NCT01910714 - Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth N/A
Completed NCT01084421 - A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos N/A
Completed NCT01596322 - International HIV Antiretroviral Adherence, Resistance and Survival N/A