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. 2023 Jan 30;2023(1):CD006207. doi: 10.1002/14651858.CD006207.pub6

Abaluck 2022.

Study characteristics
Methods Cluster‐RCT
Randomisation unit: villages (N = 600)
Intervention duration: 8 weeks “Our intervention was designed to last 8 weeks in each village”
Participants Inclusion criteria: community level participants
Intervention = 178,322 individuals, control = 163,861 individuals (Total N = 342,183 adults) 
Interventions 2 types of mask used: surgical and cloth masks PLUS a brief video of notable public figures discussing why, how, and when to wear a mask, PLUS a brochure based on WHO materials depicting proper mask‐wearing.
Control villages: the control group did not receive any interventions
See Table 4 for details.
Outcomes Effectiveness: primary outcome: symptomatic seroprevalence (symptomatic and seropositive)
Laboratory: seropositivity was defined by having detectable IgG antibodies against SARS‐CoV‐2
Symptoms defined as per WHO‐defined COVID‐19 symptoms: (a) fever and cough; (b) 3 or more of the following symptoms (fever, cough, general weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnoea, anorexia/nausea/vomiting, diarrhoea, altered mental status); or (c) loss of taste or smell.
Secondary outcomes: prevalence of proper mask‐wearing as wearing either a project mask or an alternative face‐covering over the mouth and nose and improper mask‐wearing as wearing a mask in any way that did not fully cover the mouth and nose; prevalence of physical distancing per WHO guideline that defines physical distancing as one meter of separation; prevalence of symptoms consistent with COVID‐19: definition (see above)
Safety not assessed. However, study mentioned that there was no adverse events reported during the study period
Notes The authors conclude that: a randomised trial of community‐level mask promotion in rural Bangladesh during the COVID‐19 pandemic shows that the intervention increased mask usage and reduced symptomatic SARS‐CoV‐2 infections, demonstrating that promoting community mask‐wearing can improve public health (a scalable and effective method to promote mask adoption and reduce symptomatic SARS‐CoV‐2 infections.)
Funding: this trial was financially supported by a grant from GiveWell.org to Innovations for Poverty Action.
The trial authors declare no competing interests.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number generator used
Allocation concealment (selection bias) High risk Significant differences in the numbers of households included in each treatment group suggestive of a lack of allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants, mask promoters, and mask surveillance staff were not blinded as intervention materials were clearly visible
Blinding of outcome assessment (detection bias)
All outcomes High risk Although the pre‐specified analyses and sample exclusions were made by analysts blinded to the treatment assignment, investigators dropped individuals who were missing symptom data or who did not consent to blood spot collection from the primary outcome. One of the outcomes is COVID‐19 symptoms reported by participants. Mask promoters, and mask surveillance staff were not blinded
Incomplete outcome data (attrition bias)
All outcomes High risk Laboratory testing results were only available for around 40% of the symptomatic participants
Selective reporting (reporting bias) High risk Primary outcome of seroconversion was not reported