Table 3:

Clinical Trial Designs from the PRECluDE Consortium.

Intervention Name	National Clinical Trail Number	Target				Control	Study Aims	Effectiveness-Implementation Hybrid Design99	Primary Outcomes	Secondary Outcomes
		HIV+ Patients			Other Participants
		Age	Inclusion Criteria	Race/ Ethnicity
EXTRA-CVD	NCT0364370521	≥18 years	Suppressive ART with co-morbid hypertension and hyperlipidemia/ hypercholesterolemia	White, Black/African American, Hispanic/Latino, American Indian/Alaska Native, Asian, Native Hawaiian/Other Pacific Islander, and more than one race	-	Same criteria as target participants, but does not receive the intervention (receives generic prevention education)	Examine ASCVD preventive care and perceptions of ASCVD risk in clinics at baseline Adapt the EXTRA-CVD intervention to clinic context with respect to baseline assessments and key stakeholder input Evaluate 12-month intervention efficacy to improve BP and cholesterol control in PLWH Perform process evaluation of the intervention	Type II	12-month change in systolic blood pressure	12-month change in non-HDL-C and extended HIV treatment cascade
GREAT 2	NCT0390243123	40–79 years	≥5% CVD risk	White, Black/African American, Hispanic/Latino, American Indian/Alaska Native, Asian, and Native Hawaiian/Other Pacific Islander	Clinicians who provide direct HIV care to patients and work at a participating study site that serves at least 100 HIV+ patients and has an EHR system	Same criteria as target participants, except both patients and clinicians will not receive or access the intervention	Evaluate the impact of implementing the GREAT 2 intervention among PLWH with respect to reducing ASCVD risk Evaluate the implementation process of the intervention	Type II	12-month change in 10-year CVD risk	6-month pre-post changes in appropriate medications for the ABCS, patient adherence to ABCS, a healthy lifestyle, and patient-clinician shared decision making, and no adverse impact on suppressive ART
HHMB (Healing Our Hearts, Minds, and Bodies)	NCT0402546325	18–60 years	1 or more CVD risk factors and greater than 0 on UCLA Life Adversities Screener	Black/African American and Hispanic/Latino	Employees of the participating clinics	Each participant in the study serves as his or her own control in a pre-post design	Assess and enhance organizational readiness for addressing trauma and CVD risk among people of color living with HIV Assess use and effectiveness of the HHMB intervention’s implementation strategies Identify barriers and facilitator to organizational adoption, adherence to, feasibility of, and sustainability of guidelines Assess effect of intervention on cognitive-behavioral, emotional, and clinical outcomes of patients	Type II	Baseline: workplace burnout and climate, and implementation leadership and citizenship behavior 3-month follow-up: change from baseline in CVD risk, physical, mental, and social health, emotional regulation difficulties, and critical racial consciousness	3-month follow-up: medication for hypertension, diabetes, or hyperlipidemia and HIV adherence, signs of depression, anxiety, severity of PTSD symptoms, alcohol misuse and disorders, and drug problems, quality and patterns of sleep, and ASCVD risk score
INSPIRE	NCT0368706027	40–75 years	At-risk for CVD and eligible to receive statin therapy	White, Black/African American, Asian, and Hispanic/Latino	Medical directors/clinic leadership from participating HIV clinics and providers that work at participating clinics and care for HIV+ patients at least 1/2 day each week	Same criteria as target participants, except none will receive or have access to the intervention	Assess the knowledge of clinical leadership and all participating providers about facilitators and barriers to prescribing statin therapy to PLWH Evaluate the effectiveness of the education intervention and peer comparison intervention (called INSPIRE) on adoption Assess outcomes from the intervention’s implementation process	Type III	12-month change in rates of prescribing statins to eligible PLWH	12-month change in responses to knowledge survey questions before and after interventions
ACHIEVE	NCT0385687929	18–89 years	COPD and must be a patient of a participating provider	White, Black/African American, Hispanic/Latino, American Indian/Alaska Native, Asian, Native Hawaiian/Other Pacific Islander, and more than one race	Providers with 2 or more patients that received intervention recommendation	Same criteria as target participants, except patients do not receive intervention recommendations from their respective provider and providers do not have patients that received intervention recommendation	Test the ACHIEVE intervention for improvement in quality of care and health-related quality of life in PLWH and co-occurring COPD Identify factors that influence the process adoption, implementation, and maintenance of the E-consults	Type II	Quality of COPD care at 6 months after patient/provider appointment	Patient health-related quality of life at 6 weeks after patient/provider appointment