Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06313619
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-11-25
Brief Title:
Decreasing Irrational Antimicrobial Use in Bangladesh A Digital Intervention Program
Sponsor:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Organization:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Study Overview
Official Title:
Decreasing Irrational Antimicrobial Use in Bangladesh A Digital Intervention Program
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The misuse irrational or overuse of antibiotics antibioticantimicrobial resistance AMR is a global threat to human health Even though the awareness of the potential threat from AMR is widespread studies and monitoring programs describing the present situation are lacking The presence of a pluralistic health system and a large informal sector involving unqualified drug dispenserproviderspractitioners in Bangladesh is a matter of grave concern for the rising antimicrobial resistance situation in the country An estimated 63 of antibiotic prescriptions are from unqualified providers Besides misconception about antibiotics is very common in Bangladesh Meanwhile the use of antibiotics in animal food production with insufficient veterinary supervision for therapeutic purposes which poses the risk of antimicrobial resistance transmission in the food chain Without adherence to national regulations unnecessary and inappropriate prescriptions become common practice particularly in rural areas Domestic drug industries contribute to easily accessible and affordable drugs To tackle this problem prescriptions and sales of antibiotics need to be regulated and integrated in a national HMIS Awareness programs for antibiotic providers that promote understanding of antibiotics and antibiotic resistance through tailored interventions may be helpful in changing current antibiotic sales practices Therefore this study will attempt to identify the underlying causes of irrational anti-microbial usage in Bangladesh which were grouped into four interlinked areas - lack of awareness among patients consumers demand side perverse incentives and lack of knowledge among providers supply side poorly regulated pharmaceutical marketing and retail sales regulatory side and lack of data and research evidence to support awareness raising and policymaking enabler
A before-after designed quasi experimental study will be conducted in urban areas Data will be collected in both qualitative and quantitative methods Multi-cluster sampling method will be used to select study locations Pharmacists or drug sellers and patients aged more than 18 years and located within selected intervention areas will be our target population A baseline survey will be conducted among the pharmacy volunteers to evaluate their knowledge perception and practice of rational use of anti-microbials prior to any intervention Additionally a household survey will be conducted among community members applying systematic random sampling where one adult from every selected household will be approached maintaining gender equality After collecting the baseline data intervention will be given to the community people through awareness building campaign and distributing leaflets and posters on rational use of anti-microbials After three months a follow-up survey will be conducted among the same participants with the same questionnaire For quantitative portion of the study all the medicine shops in the selected study areas will be included in the study sample alongside a total of anticipated 6240 community dwellers For qualitative part the sample will be selected purposively until data saturation and a total of 20 experts will be interviewed Two sets of questionnaires for pharmacy volunteers and the community dwellers will be prepared based on literature review that will include health literacy questions regarding anti-microbial use The questionnaire for the follow-up data collection will include some additional questions regarding acceptability adoption feasibility and cost of the intervention
The study is expected to bring light upon a comprehensive understanding of the current level of knowledge perception and practice of irrational use of anti-microbials among target population Furthermore a digital intervention design will be produced to reduce irrational use of anti-microbials after considering its effectiveness The wide range of the study findings will aid in assessing the acceptability adoption feasibility and cost of the intervention to make recommendations on sustainability and scaling up of the intervention programs
A before-after designed quasi experimental study will be conducted in urban areas Data will be collected in both qualitative and quantitative methods Multi-cluster sampling method will be used to select study locations Pharmacists or drug sellers and patients aged more than 18 years and located within selected intervention areas will be our target population A baseline survey will be conducted among the pharmacy volunteers to evaluate their knowledge perception and practice of rational use of anti-microbials prior to any intervention Additionally a household survey will be conducted among community members applying systematic random sampling where one adult from every selected household will be approached maintaining gender equality After collecting the baseline data intervention will be given to the community people through awareness building campaign and distributing leaflets and posters on rational use of anti-microbials After three months a follow-up survey will be conducted among the same participants with the same questionnaire For quantitative portion of the study all the medicine shops in the selected study areas will be included in the study sample alongside a total of anticipated 6240 community dwellers For qualitative part the sample will be selected purposively until data saturation and a total of 20 experts will be interviewed Two sets of questionnaires for pharmacy volunteers and the community dwellers will be prepared based on literature review that will include health literacy questions regarding anti-microbial use The questionnaire for the follow-up data collection will include some additional questions regarding acceptability adoption feasibility and cost of the intervention
The study is expected to bring light upon a comprehensive understanding of the current level of knowledge perception and practice of irrational use of anti-microbials among target population Furthermore a digital intervention design will be produced to reduce irrational use of anti-microbials after considering its effectiveness The wide range of the study findings will aid in assessing the acceptability adoption feasibility and cost of the intervention to make recommendations on sustainability and scaling up of the intervention programs
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None