​​​​​​​​​​​​​​Ongoing and Completed Projects, All Funding Mechanisms

Infectious Diseases

024-A Phase III Multicenter, Open-Label, Randomized Study to Evaluate a Switch to MK-1439A in HIV-1-Infected Subjects Virologically Suppressed on a Regimen of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors (NR
Brad Hare | Industry | Ongoing

2/3 COMpAAAS Tripartite: ART-CC, KP, and VA
Michael Silverberg, Derek Satre | NIH | Ongoing

A new approach to an old problem: Redesigning latent tuberculosis screening and treatment
Jacek Skarbinski, Sara Tartof | NIH | Ongoing

A phase 3 randomized study to evaluate the safety and antiviral activity of remdesivir (GS-5734™) in participants with moderate COVID-19 GS-US-540 -5774
Jacek Skarbinski; Brad Hare | Industry | Ongoing

A phase 3 randomized study to evaluate the safety and antiviral activity of remdesivir (GS-5734™) in participants with severe COVID-19 GS-US-540 -5773
Jacek Skarbinski; Brad Hare | Industry | Ongoing

A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary Peo
Jacek Skarbinski | Industry | Ongoing

A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults in the Era of Coronavirus Disease 2019 (MITIGATE COVID-19)
Alan Go, Jacek Skarbinski | Industry | Ongoing

Analysis to evaluate the effectiveness of a serogroup B outer membrane vesicle meningococcal vaccine against gonorrhea
Ousseny Zerbo    | Other | Ongoing

ATLAS-2M / ViiV 207966: A Phase IIIb, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every 8 Weeks or Eve
Brad Hare | Industry | Ongoing

California  Emerging Infections Program: SARS-CoV-2 Surveillance in Hospitalized Children and Adults
Jacek Skarbinski | Other | Ongoing

California Emerging Infections Program: HPV Vaccine Impact Monitoring Through Surveillance of Cervical Precancerous Lesions
Michael Silverberg | Other | Ongoing

California Emerging Infections Program: Population-Based Influenza Hospitalization Surveillance
Jacek Skarbinski | Other | Ongoing

California Emerging Infections Program: Respiratory Syncytial Virus (RSV)
Jacek Skarbinski | Other | Ongoing

Community – associated Clostridium difficile
Tara Greenhow | CH | Ongoing

COVID and Influenza Near Real-Time Surveillance
Ousseny Zerbo    | Other | Ongoing

COVID surveillance (CDC Vaccine Safety Datalink population-based surveillance)
Nicole Klein | Other | Ongoing

Development of a clinical-decision-making tool on the ‘Approach of the Febrile Infant 7 – 365 days
Tara Greenhow | Other | Ongoing

DSICOVER / GS-US-412-2055: A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who H
Brad Hare | Industry | Ongoing

Effect of Maternal Influenza Vaccination During Pregnancy on Risk of Infant Influenza
Ousseny Zerbo    | Other | Ongoing

Electronic Health Record-Based Dementia Prediction for HIV Primary Care
Jennifer Lam | Other | Ongoing

Establishment of group B streptococcal immunologic endpoints reasonably likely to predict clinical benefit against invasive disease among young infants: a multi-state case-control study
Jacek Skarbinski, Kristi Vanwinden | Other | Ongoing

Evaluation of electronic health-record based frailty indices in people with HIV
Jennifer Lam | Other | Ongoing

GS-US-283-1062: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS-9620 in combination with Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects with Chronic Hepatitis B and
Brad Hare | Industry | Ongoing

GS-US-380-4030: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combi
Brad Hare | Industry | Ongoing

Healthcare Utilization Patterns Post-acute COVID-19
Ousseny Zerbo    | Other | Ongoing

HIV Drug Resistance Mutation as Predictors of Clinical Outcome
Brad Hare | Other | Ongoing

HIV Infection, Use of Tenofovir and Other Antiretrovirals, and Risk of Fatal and Non-Fatal Comorbidities: Cohort Study in Kaiser Permanente
Michael Silverberg | Industry | Ongoing

HIV Status and Incidence and Outcomes of Heart Failure
Michael Silverberg, Alan Go | NIH | Ongoing

HPV self-collection
Betty Suh-Burgmann | PRP | Ongoing

Identification and description of dementia among patients with and without HIV using electronic health records data
Jennifer Lam | Other | Ongoing

Immunity and patterns of disease exposure for COVID-19 across Kaiser Permanente Northern California
Jacek Skarbinski | PRP | Ongoing

Impact of COVID-19 Epidemic on Transgender People Risk of acute thrombotic events such as venous thromboembolism (VTE) and ischemic stroke (IS) in transgender women receiving hormone therapy was addressed in our longitudinal Study of Transition, Outcome
Michael Silverberg | PCORI | Ongoing

Implementing Computerized Substance Use and Depression Screening and Evidence-Based Treatments in an HIV Primary Care Population
Michael Silverberg, Derek Satre | NIH | Ongoing

Improving screening and treatment of latent tuberculosis infection in a large, integrated health system
Jacek Skarbinski | Other | Ongoing

Innovative Methods to Inform Estimates of Vaccine Effectiveness Using Information on the Epidemiology and Incidence of Influenza and Other Acute Respiratory Illnesses
Nicola Klein, Ousseny Zerbo | Other | Ongoing

ME/CFS – Surveillance to Optimize Protocols for Early identification and Subgrouping of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Jacek Skarbinski, Jamila Champsi | Other | Ongoing

North American Aids Cohort Collaboration on Research and Design (NA-ACCORD) COVID-19 Supplement
Michael Silverberg | NIH | Ongoing

North American AIDS Cohorts on Collaboration and Design (NAACCORD)
Michael Silverberg | NIH | Ongoing

Optimizing Cardiovascular Risk Prediction in HIV
Michael Silverberg | NIH | Ongoing

Optimizing identification of frailty among older adults with HIV infection
Jennifer Lam | CH | Ongoing

Optimizing Lung Cancer Treatment in HIV Infected Persons
Michael Silverberg | NIH | Ongoing

Pilot to assess vaccine effectiveness (PAVE) against laboratory confirmed influenza hospitalizations among pregnant women in FluSurv-NET and Enhanced surveillance for influenza
Jacek Skarbinski | Other | Ongoing

PURPOSE 2:  A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Non-binary Peo
Brad Hare | Industry | Ongoing

Risk of COVID-19 pandemic on immunosuppressed populations
Fernando Velayos, Julie Schmittdiel, Bradley Frueh | RAU | Ongoing

SARS-CoV-2 Serological Antibody Testing for Disease Surveillance and Clinical Use
Jacek Skarbinski, Larry Kushi, Douglas Corle | NIH | Ongoing

Study the epidemiology of non-typhoidal Salmonella bacteremia and gastroenteritis in children
Tara Greenhow | CH | Ongoing

Test and Be Treated: Faster and Easier Entry to HIV Care; California HIV/AIDS Research Program
Brad Hare | Other | Ongoing

Using Information on the Epidemiology and Incidence of Influenza and Other Acute Respiratory Illnesses
Nicole Klein | Other | Ongoing

Vaccine Enhanced COVID-19 Disease monitoring
Nicole Klein | Other | Ongoing

Vancomycin area under the curve-guided dosing and monitoring in the outpatient setting
Meredith Silverman, Cynthia Campbell, Rika Alavi | RAU | Ongoing

XPORT-CoV-1001: A phase 2 randomized single-blind study to evaluate the activity and safety of low dose oral selinexor (KPT-330) in patients with severe COVID-19 infection
Jacek Skarbinski | Industry | Ongoing

A multicenter, randomized, placebo-controlled, pragmatic Phase 3 study investigating the efficacy and safety of rivaroxaban to reduce the risk of major venous and arterial thrombotic events, hospitalization and death in medically ill outpatients with acut
Alan Go, Jacek Skarbinski | Industry | Completed

A Phase 1, Open-Label Dose-Finding Study To Evaluate Safety, Tolerability, and Immunogenicity and Phase 2/3 Placebo Controlled, Observer-Blinded Safety, Tolerability, and Immunogenicity Study of SARS-CoV-2 RNA Vaccine Candidate Against COVID-19 In Healt
Nicole Klein | Other | Completed

A Phase 3 Master Protocol to Evaluate Additional Dose(s) of BNT162B2 in Health Individuals Previously Vaccinated with BNT162B2
Nicole Klein, Elizabeth McGlynn | Other | Completed

A Phase 3, Randomized, Observer-Blind Study to Evlauate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of the Vaccine Candidate BNT162b2 Against COVID-19 in Healthy Participants 12 Through 50 Years of Age
Nicole Klein | Other | Completed

A phase 3b, multicenter, open-label study to evaluate switching from a regimen of two nucleos(t)ide reverse transcriptase inhibitors (NRTI) plus a third agent to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF),
Jacek Skarbinski | Industry | Completed

An Assessment of the Status and Impact of Influenza and Influenza Vaccination on Patients with Acute Myocardial Infarction in Kaiser Permanente Northern California
David Miller | CH | Completed

California Emerging Infections Program: Comparing the frequency of SARS-CoV-2 variants of concern among vaccinated and unvaccinated COVID-19
Jacek Skarbinski | Other | Completed

CISA COVID-19 Pediatric Study Kaiser
Nicole Klein | Other | Completed

Closing gaps in the HIV Preexposure Prophylaxis Continuum of Care
Jonathan Volk | CH | Completed

Duration of Protection against Mumps After the Second Dose of Measles, Mumps and Rubella Vaccine (MMR)
Ousseny Zerbo | CH | Completed

Effectiveness and safety of interferon-free treatment for hepatitis C virus (HCV) infection
David Witt, Michael Allerton, Michael Silverberg | DSGP | Completed | View Summary

Epidemiology of and Risk Factors for Nontyphoidal Salmonella Bacteremia in Children
Tara Greenhow | CH | Completed

Improving Latent Tuberculosis Infection (LTB) Screening and Treatment to Reduce Incidence of Active Tuberculosis (TB) in Kaiser Permanente Northern California
Jacek Skarbinski | CH | Completed

KPNC Women’s Anal Cancer Study: Secular trends and risk factors in a large integrated healthcare system
Gregory Barnell | CH | Completed

Leveraging EHR Data to Increase Uptake of HIV Preexposure Prophylaxis HIV Preexposure prophylaxis (PrEP)
Michael Silverberg, Jonathan Volk | DSGP | Completed

Monitoring Shared Variation in Genomes of SARS-CoV-2 Among Persons With COVID-19 With and Without Vaccination in Northern California
Jacek Skarbinski | Other | Completed

Neurocognitive Impairment and Dementia in Patients with and without HIV
Jennifer Lam | CH | Completed

Occult Hepatitis B Virus Infection and Risk of Hepatocellular Cancer and Cirrhosis
Jamila Champsi, Jacek Skarbinski | CH | Completed

Optimal Route and Duration of Antibacterial Therapy for Streptococcal Bacteremia
Dana Clutter | CH | Completed

Outcomes of Immediate versus Standard HIV Antiretroviral Therapy Initiation in a Large, Integrated Health System
Mitchell Luu | CH | Completed

Performance Characteristics of a New Algorithm for the Evaluation and Management of Febrile Young Infants
Beverly Young, Tara Greenhow | CH | Completed

Phase 1/2/3, Placebo-controlled, Randomized, Observer-blind, Dose-finding Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of SARS-CoV-2 RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
Nicole Klein | Other | Completed

Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of COVID-19 in an Outpatient Setting GS-US-540-9012
Jacek Skarbinski | Industry | Completed

Protective effect of prior flu vaccinations against Covid-19 infection
Stephanie Lowe | CH | Completed

Relative Risk of Active Tuberculosis Among Patients with Latent Tuberculosis Infection and Immunosuppressive Conditions
Jacek Skarbinski | CH | Completed

Targeting HIV-Prevention Efforts in a Large Integrated Healthcare System
Jonathan Volk | CH | Completed

Utilizing real world data to describe clinical and safety outcomes among hospitalized COVID-19 patients, and to create a comparator arm for a randomized controlled trial evaluating the efficacy and safety of actemra for COVID-19 patients
Jacek Skarbinski, Sara Tartof | Industry | Completed

A retrospective review of pediatric patients with E. coli O157:H7 or Shiga 1 or 2 toxin diarrhea with subsequent development of hemolytic uremic syndrome
Greenhow | Other |

HIV Drug Resistance Mutation as Predictors of Clinical Outcome; Collaboration with Stanford
Shafer / Hare | Other |

Outcomes of Children with Bacteriuria without Inflammation/Pyuria (Collaboration with Stanford)
Kane | Other |

Study the management and outcomes of children with urinary tract infections caused by third-generation cephalosporin-resistant Enterobacteriaceae (Collaboration with Stanford)
Greenhow | Other |

Test and Be Treated: Faster and Easier Entry to HIV Care; California HIV/AIDS Research Program; Collaboration with UCSF
Christopoulos / Hare | Other |