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Translating the ABCSs into HIV Care: A Stepped Wedge Cluster Randomized Clinical Trial
Kevin Fiscella1,2, Amneris Luque3, Brent A Johnson4
1University of Rochester Medical Center, Rochester, NY, USA. Kevin_Fiscella@urmc.rochester.edu.
Insights
A multilevel intervention significantly reduced atherosclerotic cardiovascular disease risk in people with HIV (PLWH) by addressing aspirin use, blood pressure, cholesterol, and smoking. The strategy proved effective despite COVID-19 pandemic delays.
Area of Science:
- Cardiovascular Health
- Infectious Disease Management
- Public Health Interventions
Background:
- People living with HIV (PLWH) exhibit elevated atherosclerotic cardiovascular disease (ASCVD) risk compared to the general population.
- Understanding and mitigating ASCVD risk factors in PLWH is critical for improving long-term health outcomes.
Purpose of the Study:
- To evaluate the "Million Hearts" multilevel strategy's impact on estimated 10-year ASCVD risk in PLWH.
- The strategy focused on aspirin use (A), blood pressure management (B), cholesterol reduction (C) with statins, and smoking cessation (S) – collectively known as ABCS.
Main Methods:
- A stepped-wedge cluster randomized clinical trial (SW-CRCT) was conducted across nine practices serving PLWH from 2019 to 2022.
- 485 PLWH aged 40-75 with a baseline 10-year ASCVD risk of ≥5% were enrolled.
- Interventions included patient coaching, automated texting, academic detailing for clinicians, and risk/adoption feedback.
Main Results:
- Analysis adjusted for COVID-19 pandemic delays showed a statistically significant reduction in 10-year ASCVD risk (-0.47; 95% CI -0.93 to -0.01).
- This risk reduction was primarily driven by significant decreases in cholesterol levels and smoking rates.
- No significant worsening of HIV viral load suppression was observed (p=0.6).
Conclusions:
- The "Million Hearts" multicomponent intervention effectively reduced ASCVD risk in PLWH.
- Despite implementation challenges due to the COVID-19 pandemic, the strategy demonstrated significant benefits.
- The intervention improved cardiovascular health markers without negatively impacting HIV viral suppression.
Background:
People living with HIV (PLWH) experience higher atherosclerotic cardiovascular disease (ASCVD) risk and events than people living without HIV.
Objective:
We evaluated a multilevel strategy, "Million Hearts," based on appropriate daily low-dose aspirin (A) use, blood pressure management (B), cholesterol (C) reduction with a statin, and smoking (S) cessation ("ABCS") on estimated 10-year ASCVD risk among PLWH.
Design:
Stepped-wedge cluster randomized clinical trial (SW-CRCT) involved nine practices caring for PLWH between 2019 and 2022.
Participants:
Within participating sites of randomized wedges, we consented and enrolled 485 PLWH ages 40-75 with a 10-year baseline ASCVD risk ≥ 5% clustered within their consented treating clinician.
Intervention:
Patient-directed interventions included (1) patient coaching on ASCVD risk and patient goal-setting selection of ABCS and (2) automated bidirectional texting to reinforce selected ABCS. Clinician-directed interventions included (1) academic detailing on ABCS and (2) feedback on patient risk and ABCS adoption.
Main Measures:
Ten-year ASCVD risk (primary outcome) and HIV viral load suppression (primary safety outcome).
Key Results:
The intervention spanned the time of peak COVID-19 closures and reduced access for many health systems, and delayed intervention startup. While analysis based on the initially assigned start dates revealed no statistically significant effect on ASCVD risk, analysis based on actual start dates resulting from the COVID-19 pandemic showed a statistically significant reduction in ASCVD risk of -0.47 (95% CI -0.93 to -0.01) without evidence of any worsening of viral suppression (p = 0.6). This effect was driven by statistically significant reductions in cholesterol and smoking.
Conclusion:
While delayed by COVID, the multicomponent intervention delivered based on actual start dates yielded statistically significant reductions in ASCVD risk among PLWH without increasing detectable viral load.
Trial Registration:
NCT05488795; April 1, 2019.
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