NCT04816318

Brief Summary

Latin America is one of the worst-hit areas from the COVID-19 pandemic worldwide. Policy responses to COVID-19 in Latin America have sought to reduce viral spread, increase the capacity of the health system response, mitigate negative consequences, and strengthen governance. Few studies have examined the effectiveness of COVID-19 policies in Latin America or explored subnational variation in their effectiveness. In this observational study, the investigators will use a two-stage interrupted time series to estimate the effectiveness of nonpharmaceutical interventions in third-tier subnational units on SARS-COV2 transmission and COVID-19 mortality in Latin America. The investigators will estimate the effects in each local government, and then run a random-effects meta-analysis to obtain pooled effects for each intervention (and combinations of) and heterogeneity estimates. Finally, the investigators will explore potential explanations for the heterogeneity at the local level.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 28, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

1 month

First QC Date

March 23, 2021

Last Update Submit

April 27, 2021

Conditions

Keywords

EffectivenessHealth policyHeterogeneityLatin America

Outcome Measures

Primary Outcomes (3)

  • 7-day moving average of daily confirmed cases of COVID-19/SARS-CoV-2

    Intervention period of up to 30 days (intervention periods lower than 7 days will be considered as a combined set of interventions)

  • Time-varying reproductive number of confirmed cases of COVID-19/SARS-CoV-2

    Intervention period of up to 30 days (intervention periods lower than 7 days will be considered as a combined set of interventions)

  • 7-day moving average of daily confirmed deaths of COVID-19/SARS-CoV-2

    Intervention period of up to 30 days (intervention periods lower than 7 days will be considered as a combined set of interventions)

Study Arms (2)

Social and public health measures against COVID-19

Public Health and Social measures against COVID-19. This group refers to the population exposed to public health and social measures against COVID-19

Other: Social and public health measures against COVID-19

Control

The comparator is the pre-intervention period

Other: Control

Interventions

1. Viral spread (for both outcomes) 1.1. Total lockdown 1.2 Partial lockdown (geographical, step-wise/graduated response) 1.3 Curfew 1.4 School closure 1.5 Closure of shopping malls, gyms, churches, parks 1.6 Remote work 1.7 Restrictions to national/subnational mobility 1.8 Prohibition of mass gatherings 2. Health systems response (for COVID-19 deaths outcome) 2.1 Interventions to increase testing capacity 2.2 Interventions to increase the number of ICU/critical beds 3. Mitigation strategies (for both outcomes) 3.1 Direct social assistance (in-kind/cash) 3.2 Cash transfer 3.3 Withdrawal of pension funds

Also known as: Non-pharmaceutical interventions against COVID-19
Social and public health measures against COVID-19
ControlOTHER

The comparator is a counterfactual outcome defined as the projection of the pre-intervention trend to simulate what would have happened if the policy had not occurred (see Statistical Analysis Plan for definitions)

Control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study covers the population of included countries in Latin America. Preliminarily this represents nine countries, covering 80.9% of the total population in Latin America

You may qualify if:

  • Country will be eligible if they are (1) Spanish or Portuguese speaking countries in Latin America, (2) availability of open data at the subnational level for any of the outcomes

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escuela de Salud Pública

Santiago, Santiago Metropolitan, 8380453, Chile

Location

Related Publications (20)

  • United Nations Department of Economic and Social Affairs. World Social Report 2020: Inequality in a rapidly changing world. New York, United States: United Nations; 2020

    BACKGROUND
  • Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020 May;20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1. Epub 2020 Feb 19. No abstract available.

    PMID: 32087114BACKGROUND
  • The Lancet. COVID-19 in Brazil: "So what?". Lancet. 2020 May 9;395(10235):1461. doi: 10.1016/S0140-6736(20)31095-3. No abstract available.

    PMID: 32386576BACKGROUND
  • Martinez-Gutierrez S., Cuadrado C., Peña S. Chile's response to the coronavirus pandemic. 2020. Available at: https://www.cambridge.org/core/blog/2020/04/11/chiles-response-to-the-coronavirus-pandemic/ (accessed April 12, 2020)

    BACKGROUND
  • Ali ST, Wang L, Lau EHY, Xu XK, Du Z, Wu Y, Leung GM, Cowling BJ. Serial interval of SARS-CoV-2 was shortened over time by nonpharmaceutical interventions. Science. 2020 Aug 28;369(6507):1106-1109. doi: 10.1126/science.abc9004. Epub 2020 Jul 21.

    PMID: 32694200BACKGROUND
  • Pan A, Liu L, Wang C, Guo H, Hao X, Wang Q, Huang J, He N, Yu H, Lin X, Wei S, Wu T. Association of Public Health Interventions With the Epidemiology of the COVID-19 Outbreak in Wuhan, China. JAMA. 2020 May 19;323(19):1915-1923. doi: 10.1001/jama.2020.6130.

    PMID: 32275295BACKGROUND
  • Salvatore M, Basu D, Ray D, Kleinsasser M, Purkayastha S, Bhattacharyya R, Mukherjee B. Comprehensive public health evaluation of lockdown as a non-pharmaceutical intervention on COVID-19 spread in India: national trends masking state-level variations. BMJ Open. 2020 Dec 10;10(12):e041778. doi: 10.1136/bmjopen-2020-041778.

    PMID: 33303462BACKGROUND
  • Flaxman S, Mishra S, Gandy A, Unwin HJT, Mellan TA, Coupland H, Whittaker C, Zhu H, Berah T, Eaton JW, Monod M; Imperial College COVID-19 Response Team; Ghani AC, Donnelly CA, Riley S, Vollmer MAC, Ferguson NM, Okell LC, Bhatt S. Estimating the effects of non-pharmaceutical interventions on COVID-19 in Europe. Nature. 2020 Aug;584(7820):257-261. doi: 10.1038/s41586-020-2405-7. Epub 2020 Jun 8.

    PMID: 32512579BACKGROUND
  • Hyafil A, Morina D. Analysis of the impact of lockdown on the reproduction number of the SARS-Cov-2 in Spain. Gac Sanit. 2021 Sep-Oct;35(5):453-458. doi: 10.1016/j.gaceta.2020.05.003. Epub 2020 May 23.

    PMID: 32571528BACKGROUND
  • Siedner MJ, Harling G, Reynolds Z, Gilbert RF, Haneuse S, Venkataramani AS, Tsai AC. Correction: Social distancing to slow the US COVID-19 epidemic: Longitudinal pretest-posttest comparison group study. PLoS Med. 2020 Oct 6;17(10):e1003376. doi: 10.1371/journal.pmed.1003376. eCollection 2020 Oct.

    PMID: 33022016BACKGROUND
  • Islam N, Sharp SJ, Chowell G, Shabnam S, Kawachi I, Lacey B, Massaro JM, D'Agostino RB Sr, White M. Physical distancing interventions and incidence of coronavirus disease 2019: natural experiment in 149 countries. BMJ. 2020 Jul 15;370:m2743. doi: 10.1136/bmj.m2743.

    PMID: 32669358BACKGROUND
  • Candido DS, Claro IM, de Jesus JG, Souza WM, Moreira FRR, Dellicour S, Mellan TA, du Plessis L, Pereira RHM, Sales FCS, Manuli ER, Theze J, Almeida L, Menezes MT, Voloch CM, Fumagalli MJ, Coletti TM, da Silva CAM, Ramundo MS, Amorim MR, Hoeltgebaum HH, Mishra S, Gill MS, Carvalho LM, Buss LF, Prete CA Jr, Ashworth J, Nakaya HI, Peixoto PS, Brady OJ, Nicholls SM, Tanuri A, Rossi AD, Braga CKV, Gerber AL, de C Guimaraes AP, Gaburo N Jr, Alencar CS, Ferreira ACS, Lima CX, Levi JE, Granato C, Ferreira GM, Francisco RS Jr, Granja F, Garcia MT, Moretti ML, Perroud MW Jr, Castineiras TMPP, Lazari CS, Hill SC, de Souza Santos AA, Simeoni CL, Forato J, Sposito AC, Schreiber AZ, Santos MNN, de Sa CZ, Souza RP, Resende-Moreira LC, Teixeira MM, Hubner J, Leme PAF, Moreira RG, Nogueira ML; Brazil-UK Centre for Arbovirus Discovery, Diagnosis, Genomics and Epidemiology (CADDE) Genomic Network; Ferguson NM, Costa SF, Proenca-Modena JL, Vasconcelos ATR, Bhatt S, Lemey P, Wu CH, Rambaut A, Loman NJ, Aguiar RS, Pybus OG, Sabino EC, Faria NR. Evolution and epidemic spread of SARS-CoV-2 in Brazil. Science. 2020 Sep 4;369(6508):1255-1260. doi: 10.1126/science.abd2161. Epub 2020 Jul 23.

    PMID: 32703910BACKGROUND
  • Bennett M. All things equal? Heterogeneity in policy effectiveness against COVID-19 spread in chile. World Dev. 2021 Jan;137:105208. doi: 10.1016/j.worlddev.2020.105208. Epub 2020 Sep 24.

    PMID: 32994662BACKGROUND
  • Silva L, Figueiredo Filho D, Fernandes A. The effect of lockdown on the COVID-19 epidemic in Brazil: evidence from an interrupted time series design. Cad Saude Publica. 2020 Oct 19;36(10):e00213920. doi: 10.1590/0102-311X00213920. eCollection 2020.

    PMID: 33084836BACKGROUND
  • Peña S., Cuadrado C., Rivera-Aguirre A., Hasdell R., Nazif-Munoz J., Yusuf M. et al. PoliMap: A taxonomy proposal for mapping and understanding the global policy response to COVID-19. OSF Preprint. 2020. Available at: https://osf.io/h6mvs (accessed March 22, 2021)

    BACKGROUND
  • Li Y, Campbell H, Kulkarni D, Harpur A, Nundy M, Wang X, Nair H; Usher Network for COVID-19 Evidence Reviews (UNCOVER) group. The temporal association of introducing and lifting non-pharmaceutical interventions with the time-varying reproduction number (R) of SARS-CoV-2: a modelling study across 131 countries. Lancet Infect Dis. 2021 Feb;21(2):193-202. doi: 10.1016/S1473-3099(20)30785-4. Epub 2020 Oct 22.

    PMID: 33729915BACKGROUND
  • Gebski V, Ellingson K, Edwards J, Jernigan J, Kleinbaum D. Modelling interrupted time series to evaluate prevention and control of infection in healthcare. Epidemiol Infect. 2012 Dec;140(12):2131-41. doi: 10.1017/S0950268812000179. Epub 2012 Feb 16.

    PMID: 22335933BACKGROUND
  • Kontopantelis E, Doran T, Springate DA, Buchan I, Reeves D. Regression based quasi-experimental approach when randomisation is not an option: interrupted time series analysis. BMJ. 2015 Jun 9;350:h2750. doi: 10.1136/bmj.h2750.

    PMID: 26058820BACKGROUND
  • Taljaard M, McKenzie JE, Ramsay CR, Grimshaw JM. The use of segmented regression in analysing interrupted time series studies: an example in pre-hospital ambulance care. Implement Sci. 2014 Jun 19;9:77. doi: 10.1186/1748-5908-9-77.

    PMID: 24943919BACKGROUND
  • Bernal JL, Cummins S, Gasparrini A. Interrupted time series regression for the evaluation of public health interventions: a tutorial. Int J Epidemiol. 2017 Feb 1;46(1):348-355. doi: 10.1093/ije/dyw098.

    PMID: 27283160BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19Communicable DiseasesDeathSevere Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sebastián Peña, MD, PhD

    Escuela de Salud Pública

    PRINCIPAL INVESTIGATOR
  • Cristóbal Cuadrado, MD, PhD

    Escuela de Salud Pública

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastián Peña, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-investigator

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 25, 2021

Study Start

April 28, 2021

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

The study uses open access data available at the municipal/district/canton level. The investigators will include the data and statistical code as a Supplementary Appendix in the published papers.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
The Study Protocol and SAP will be available in the project OSF repository upon publication of the registration in ClinicalTrials.gov. The Statistical code will be published as a Supplementary Appendix with the publish paper or preprint.
Access Criteria
Any interested party can access the data and documents
More information

Locations