Decreasing Irrational Antimicrobial Use in Bangladesh: A Digital Intervention Program

The misuse, irrational, or overuse of antibiotics, antibiotic/antimicrobial 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 dispenser/providers/practitioners 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.

Study Overview

• Status: Recruiting
• Conditions: Increased Drug Resistance; Resistance Bacterial; Drug Resistance, Microbial
• Intervention / Treatment: Combination product: SmartAMR

• Study Type: Interventional
• Enrollment (Estimated): 39
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: M Atiqul Haque, PhD; Phone Number: +8801711428141; Email: atiqulm26@bsmmu.edu.bd
• Study Contact Backup: Name: Marium Salwa, MPH; Phone Number: +8801722386959; Email: mariumsalwa@bsmmu.edu.bd

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1212
    • Recruiting
    • Medicine Shop
    • Contact: Abid Hasan Khan, MPH; Phone Number: +8801308634347; Email: ahkriaz.ju@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged 18 years and above
• Registered drug seller/pharmacist
• Permanent residents of the study areas
• Willing to participate

Exclusion Criteria:

• Disoriented or critically ill

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital Pharmacy Intervention; A total of 39 pharmacy will be included in the intervention. The digital intervention named "SmartAMR" will be introduced among them. The participants will install the mobile app and use it to keep record of the antimicrobial sales in a central database.	Combination product: SmartAMR; "SmartAMR" is a digital system including a mobile app that helps keeping record of medicine sales, sending auto-generated messages to the consumers to remind them about medicine taking time and completing doses. It also poses a symptom checker driven by artificial intelligence and a telemedicine service.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Irrational usage of anti-microbials	Irrational usage of anti-microbials will be demonstrated by number and pattern of purchasing of anti-microbials	24 weeks
Acceptance rate	Number of pharmacy agreed and accepted the intervention and install the mobile app.	24 weeks
Completion rate	The number of pharmacy who use the mobile app for the total duration of intervention.	24 weeks

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: November 25, 2023
• First Submitted That Met QC Criteria: March 10, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Digital intervention; Anti-microbial resistance; Irrational use
• Other Study ID Numbers: BSMMU/20236831

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD will be shared after completion of the study through the Mendeley data repository.
• IPD Sharing Time Frame: march 2024 to March 2025
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No