Stefano M. Bertozzi

Closed (1) Azithromycine pour la Vie des Enfants au Niger: Implémentation et Recherche (AVENIR): Azithromycin Distribution to Reduce Child Mortality in Niger [this position to support the cost-effectiveness/cost-benefit sub-study]

Applications for fall 2021 are now closed for this project.

Background: The MORDOR trial demonstrated that biannual distribution of azithromycin to children 1-59 months old reduces child mortality. Targeting treatment to children 1-11 months old could reduce selection for resistance by limiting antibiotic distributions while maximizing the mortality benefit among children at the highest mortality risk.

Objective: To determine the optimal age group to treat with biannual oral azithromycin distribution to reduce child mortality.

Trial Design: Large simple double-masked cluster-randomized trial with response-adaptive allocation (a platform, perpetual trial).

Trial Setting: Accessible rural and peri-urban communities in Niger.

Summary of Methods: Eligible communities in Niger will be randomized to one of three azithromycin distribution strategies: biannual oral azithromycin to children 1-11 months old with biannual oral placebo to children 12-59 months old, biannual oral azithromycin to children 1-59 months old, or biannual oral placebo to children 1-59 months old.

Mortality will be monitored through biannual census data collection, which will be used to adaptively allocate treatment assignments, with the allocation updated at each treatment period. Antimicrobial resistance will be monitored using cluster sampling of different groups of children and adults in the Dosso region. Additional data will be collected on implementation outcomes, including costs, reach and coverage, acceptability/adoption, and maintenance/sustainability.

Implementation will be phased in by region. Dosso will be enrolled in the first year, Maradi and Zinder in the second year, and secure areas of Tillabéri and Tahoua and in the third year.

Primary Outcomes
• Mortality rate (deaths per 1,000 person-years at risk) among children 1-11 months of age at 2.5 years from the first region enrollment, comparing the azithro 1-11 and placebo arms
• Mortality rate (deaths per 1,000 person-years at risk) among children 1-59 months of age at 2.5 years from the first region enrollment, comparing the azithro 1-59 and azithro placebo arms
• Mortality rate (deaths per 1,000 person-years at risk) among children 12-59 months of age at 2.5 years from the first region enrollment, comparing the azithro 1-11 and azithro 1-59 arms
• Prevalence of genetic determinants of resistance to macrolides from nasopharyngeal swabs in children 1-59 months old at 24 months from baseline
• Load of genetic determinants of resistance to macrolides from rectal swabs in children 1-59 months old at 24 months from baseline


Secondary Outcomes
• Prevalence of genetic determinants of resistance to macrolides from nasopharyngeal swabs and rectal swabs in:
o children 7-12 years old at 24 months from baseline
o mothers of treated children at 24 months from baseline
o children 1-59 months old who present to local health facilities with symptoms of respiratory and/or diarrheal illness at 12 months from baseline
o children 1-59 months presenting to hospitals with dysentery at 12 months from baseline
• Prevalence of genetic determinants of resistance to other antibiotic classes from nasopharyngeal swabs and rectal swabs in the all samples
• Proportion of pneumococcal isolates that are resistant to macrolides on phenotypic testing
• Costs and cost-effectiveness
• Feasibility and acceptability of implementation (RE-AIM)

Sample Size: For mortality outcomes, approximately 17,000 communities will be enrolled over 2.5 years. For population-based resistance assessments, 50 communities per arm in Dosso will be randomly sampled. Within each community, 30 children 1-59, 30 children 7-12, and 30 mothers will be sampled. For clinic resistance assessments, the first 30 children with respiratory illness and the first 30 children with diarrheal illness presenting to 20 randomly selected health care centers in Dosso will be sampled. For hospital-based resistance assessments, the first 300 children presenting to one of the four hospitals in Dosso with dysentery will be sampled.

Data Management: All data will be collected electronically using a custom-designed mobile census application and uploaded regularly to secure, cloud-based servers. Data management teams in Niger and at UCSF will monitor data collection in real time daily, with progress and quality control reports prepared and distributed to investigators weekly.

Sample Management: During collection, samples will be stored on ice at 4°C. At the end of each collection period, samples will be transported to a location near the sampled community with facilities to store samples at -20°C. At the end of the collection period, all samples will be transferred to a central storage location in Niamey stored at -20°C.

The project is looking for a Bilingual student (French-English) who can support the cost-effectiveness/cost-benefit sub-study of the larger project. The project provides a good opportunity for the student to get first-hand experience in an international research project. Tasks will include:
1. Support the modification/implementation of the costing instruments
2. Support the Monitoring of data quality
3. Assistance with basic statistical analysis
4. Assistance with cost effectiveness calculation
5. Assistance with general research support (formatting instruments,
literature search, drafting field procedures, organizing meetings,
taking notes, ensuring follow-up, etc.)



Day-to-day supervisor for this project: Stefano Bertozzi, Staff Researcher

Qualifications: At least one course in statistics, biostatistics, or econometrics. Data 8 is acceptable, but at least one additional quantitative methods course is desirable. Familiarity with cost-effectiveness analysis is a plus. We do not expect the student will have native-level French and speakers of French as a second or learning language are encourage to apply. Ideally, the student can understand the main ideas of a complex text on both concrete and abstract topics, including technical discussions in their field of specialization and can interact with a degree of fluency and spontaneity that makes regular interaction with native speakers possible without strain for either party).

Weekly Hours: to be negotiated

Off-Campus Research Site: Off-campus (Remote) with occasional in-person meetings if desired.

Related website: http://cghdde.berkeley.edu/
Related website: http://proctor.ucsf.edu/

Closed (2) Modeling COVID Transmission in a Carceral Setting

Applications for fall 2021 are now closed for this project.

The COVID–19 pandemic in the United States has emerged as an ongoing crisis that disproportionately harms people of color. Disparities in Latinx populations may be associated with high risk employment, large household sizes, and concentration of foreign-born non-citizens, while in Black populations medical comorbidities and structural inequalities such as imprisonment rates may be important drivers.
A crucial driver of heterogeneity in transmission dynamics is concentration in high density settings including prisons, food processing facilities, nursing homes, and schools, which accounts for over 40 percent of deaths collectively, and disproportionately affects people of color. COVID–19 transmission in prisons has been stunningly intense: in the recent San Quentin outbreak, over 60% of inmates were infected. Prisons, and even more so jails, which have much more turnover than prisons, may contribute significantly to community spread of the disease. Black and Latinx populations are highly overrepresented in prisons and jails, and outbreaks there likely contribute to racial disparities in community spread. Transmission in these settings can be very different from general transmission, and can yield important information.

The project has the following aims:
1. Within-facility transmission. We will estimate routes of transmission
in California prison outbreaks
2. Modeling of COVID-19 transmission into and out of facilities
3. Assessing the effects of long-term COVID (long-lasting complications)
among incarcerated persons.


The student will be expected to support researchers conduct the following tasks. The specifics will depend on which sub-project the student works on. For example, for the work on long-term COVID, familiarity with medical sciences and clinical charts is useful and the student might assist in chart review and be less involved in data analysis:
1. Review and prepare datasets.
2 Support researchers in creating a file with descriptive statistics, which can include formatting, validating information or extracting the information or any other request as appropriate
3. Support researchers in developing epidemiological models of COVID-19 transmission.
4. Other general research support tasks including: preparing presentations, formatting tables, conducting literature reviews, extracting information, data management, and generating summary statistics.

Day-to-day supervisor for this project: Stefano Bertozzi, Staff Researcher

Qualifications: 1. Interest and enthusiasm for research related to the spread of COVID-19 in vulnerable populations in prisons. A student could either have background in biology/medical sciences and work on the 3rd sub-project -- or could support the data analysis efforts more broadly, in which case: 2. Knowledge of Python, Stata or R. 3. Experience manipulating datasets 4. Knowledge of cost-effectiveness methods is an advantage. 5. Courses in statistics, data management, econometrics are an advantage.

Weekly Hours: 6-8 hrs

Off-Campus Research Site: Off-campus (remote).

Related website: https://amend.us/calprotect/

Closed (3) Literature review and data extraction in support of decision analysis models for psychedelic assisted therapies.

Applications for fall 2021 are now closed for this project.

Psychiatric disorders including depression, anxiety disorders including PTSD; and alcohol use disorder and other addictions are responsible for a large portion of both the global burden and US burden of disease. Current therapies help a significant portion of people suffering from these disorders. Nevertheless, many patients do not respond adequately or cannot tolerate the side-effects accompanying ongoing medical therapies such as SSRIs.
Novel therapies incorporating psychedelics show substantial early promise for these major mental health conditions. In brief, a new generation of psychedelic-assisted therapies may be effective not only in managing these serious conditions, but often resolving them. This huge clinical promise raises many questions of economics. What are the costs, per person and for society? What are the savings from averted illness? What are the net costs and cost-effectiveness? A new UCB / UCSF initiative, the Global Initiative for Psychedelic Science Economics (GIPSE) is working to address these questions. To do so, a wide variety of data must be identified, extracted and organized to be used in the various economic models being developed by GIPSE and its collaborators.

The overall aim of this project is to generate a set of policy-relevant decision analytic
models for publication in the peer-reviewed medical literature of the cost-effectiveness
mass and other economic aspects of the emerging psychedelic-assisted therapies.


1. Review the peer-reviewed and ‘gray’ medical and public health literature to identify articles pertinent to a wide range of estimates needed to parameterize cost and cost-effectiveness models for psychedelic-assisted therapies. These include, but are not limited to: disease state transition probabilities for depression, addiction and other related conditions; medical costs associated with these conditions by disease stage, and the relevant health state utilities.
2. Extract the relevant quantitative estimates, both base case and ranges into a standardized template.
3. Work with research staff to interpret the results of this search and extraction process.


Day-to-day supervisor for this project: Elliot Marseille, DrPH, Staff Researcher, Staff Researcher

Qualifications: 1. Interest and enthusiasm for research related to the potential of the emerging psychedelic assisted therapies. 2. Experience in conducting literature reviews is an advantage. 3. Knowledge of cost-effectiveness methods is an advantage. 4. Courses in epidemiology, statistics, research design data management, econometrics are an advantage.

Weekly Hours: 6-8 hrs

Off-Campus Research Site: Off-campus (remote).

Related website: https://cghdde.berkeley.edu/projects/global-initiative-psychedelic-science-economics-gipse

Closed (4) Construct cost-effectiveness model for psilocybin to treat tobacco addiction

Applications for fall 2021 are now closed for this project.

Despite steady reductions in smoking rates since 1965, a large portion of current smokers have tried unsuccessfully to quit at least once. Interventions to support tobacco cessation have limited effectiveness. Against this backdrop of major persisting disease burden and the limited efficacy of current interventions, promising, even if novel, approaches to smoking cessation should be explored. One such approach is the administration of the psychedelic drug psilocybin in a supportive and safe setting following cognitive behavioral therapy (CBT). Results from a recent trial in which subjects were randomized to either CBT followed by nicotine replacement therapy (NRT) or by one session of psilocybin-assisted smoking therapy (PAST), demonstrated substantial superiority of the PAST arm. The overall aim of this project is to estimate and report on the incremental cost and cost-effectiveness of PAST compared with NRT from both a health care payers’ and a societal perspective.
We will develop a Markov decision-analytic model to portray clinical benefits, PAST costs, and net medical costs in a hypothetical cohort of 1,000 patients reflecting the age, sex and smoking-related characteristics of patients treated in an ongoing phase 2 clinical trial conducted at Johns Hopkins University’s Center for Psychedelic and Consciousness Research. Based on empirical carbon monoxide breath samples and urinary cotinine (a metabolite of nicotine) results, trial participants were classified as either having achieved cessation or as continuing smokers. PAST efficacy is portrayed as a change in the distribution by smoking category (past or continuing) at the trial’s primary endpoints compared with baseline. Mortality, health state utilities, and medical costs will be estimated from published literature and vary by smoking category. The Markov cycle-length is annual until death, with costs and QALYs discounted to the present at 3% annually, and with results presented for several time horizons

The project has the following aims: 
1. Estimate the incremental cost and cost effectiveness of PAST compared with standard of care from both a health care payers’ and a societal perspective.
2. Estimate base-case findings according to a wide range of assumptions concerning relapse rates and analytic time horizons.
3. Subject findings from aim 1 above to extensive sensitivity and scenario analyses.

1. Construct a Markov Model using TreeAge software. Previous familiarity with TreeAge is desirable but it is not a requirement. The basic structure of the model will be designed in conjunction with the staff researcher; however, the student will be expected to include placeholder values for: transition probabilities, utilities, intervention costs, and health care costs. Consideration will be given to implementing this as a microsimulation model.
2. Using TreeAge or Excel, generate tables and diagrams displaying model structure and “dummy” results as may be requested by the staff researcher.
3. Other general research support tasks including: preparing presentations, formatting tables, conducting literature reviews, extracting information, data management, and generating summary statistics. 

Day-to-day supervisor for this project: Elliot Marseille, DrPH, Staff Researcher, Staff Researcher

Qualifications: 1. Interest and enthusiasm for research related to the potential of the emerging psychedelic assisted therapies and/or an interest in the public health issues of tobacco addiction and tobacco cessation. 2. Familiarity with TreeAge is an advantage, but by no means required, though in that case a strong interest in becoming adept with this powerful decision-analysis software would be required. 3. Knowledge of cost-effectiveness methods is an advantage. 4. Courses in statistics, data science, and/or econometrics are an advantage.

Weekly Hours: 6-8 hrs

Related website: https://cghdde.berkeley.edu/projects/global-initiative-psychedelic-science-economics-gipse
Related website: https://hopkinspsychedelic.org/