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Food Borne DiseasesSFFF CambodiaNCT04594122

Good Hygiene Practice Interventions for Safer Pork at Traditional Markets in Cambodia

A study testing Improve hygiene practice of pork sellers in people with Food Borne Diseases and Food Safety, run by The International Livestock Research Institute (ILRI) at 1 site in Cambodia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Safe Food Fair Food for Cambodia (SFFF) is a Feed the Future Innovation Lab project funded by USAID. This 3-year project aims to improve food safety of animal source food (ASF) in Cambodia. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Food Borne Diseases, Food Safety
What is being tested?
Improve hygiene practice of pork sellers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
1 siteCambodia
Study dates
30 Jun 2020to 15 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Under selected markets
  • Selling pork only
  • Daily selling
  • Voluntary

Who cannot join

  • Out of the age range 18-65

Trial locations and contacts

1 site in 1 country.

Cambodia1 site
  • National Animal Health and Production Research Institute

    Phnom Penh

Other trials in Cambodia

About this study

Official title: Safe Food, Fair Food For Cambodia

Safe Food Fair Food for Cambodia (SFFF) is a Feed the Future Innovation Lab project funded by USAID. This 3-year project aims to improve food safety of animal source food (ASF) in Cambodia. SFFF was awarded to the International Livestock Research Institute (ILRI), National Animal Health and Production Research Institute (NAHPRI) and Livestock Development for Community Livelihood Organization (LDC) and in collaboration with Cambodian Ministry of Health CDC and NIPH. Based on the findings and consultations with food safety stakeholders in Cambodia, we have developed a set of interventions to improve hygienic practice and pork safety at the traditional markets in Cambodia. Those interventions will be introduced and tested at retail in six selected provinces using Randomized Controlled Trials (RCT). To ensure compliance of targeted actors (e.g. retailers), participatory methods (e.g. FGD) were used to validate intervention packages. There are two steps of intervention which contain of part 1) Retailer formative research for SFFF Cambodia and 2) Interventions for Good Hygiene Practices for Safer Pork at Traditional Markets.

Part 1. Retailer formative research for SFFF Cambodia: We will implement an intervention package to this trial group and collect biological sampling to determine the hygienic status before and after the intervention. The intervention packages will be developed for SFFF Cambodia in consultation with partners and based on findings of SFFF Cambodia project.

Part 2. Intervention for Good Hygiene Practices for Safer Pork at Traditional Markets: A randomized controlled trial (RCT) intervention will be conducted in 12 markets in 6 provinces. Those provinces were selected based on the prevalence of Salmonella in a market survey study, namely Kampot, Kampong Cham, Kampong Speu, Takeo, Siem Reap, and Phnom Penh. Another 12 markets, in the same provinces, will be used as a control group. In total 24 traditional wet markets will be included in the sampling, by selecting the 4 largest traditional markets in the six provinces with at least 15 pork shops. At each market, 15 pork shops were selected for sampling. The intervention package includes 5 keys actions (Handbook) and provision of equipment incentive (e.g. inox tray, easy-clean surface material), and training on good hygiene practices.

Read the detailed description
  1. Selection of provinces, markets and retailers Six provinces were selected including Phnom Penh, Siem Reap, Takeo, Kampong Cham, Kampot, Kampong Speu with the following selection criteria: i) The number of markets in provinces, ii) Salmonella prevalence (above 50%), iii) Population density and risk, urban - rural, iv) Distance from laboratory, v) Compliance of market board and traders, local animal health workers. Phnom Penh had a reported Salmonella prevalence of less than 50% in the recent market study but was included as an urban center with expected high output of pork sells. In each province, four markets which have at least 15 pork shops will be selected. Among those markets, two markets will be assigned for control and trial groups. Group of retailers will be chosen from selected markets for the intervention based on their "similarity" (e.g., environment, shop facilities, sells volume) and their compliance to participate. Intervention package includes providing incentive equipment and training on good hygiene practice. Equipment provision comprise: (i) equip the shops with inox trays and advise them to separate raw pork/processed pork and intestines; (ii) In case the surface of the shop is not made from granite or inox, we will provide them with feasible surface cover material; (iii) Apron to retailers with the project logo/brand; (iv)Shop's banner with our logo; (v) Hand washing soap (antibacterial) and dish detergent; (vi) Disinfectant spray (Anolyte). Guide retailers to rearrange their shops to suit their own facility and space. Introduce plastic cutting boards for light cut, check currently used wooden cutting boards at shop to advice to use properly. Introduce frequent washing and disinfection of sale place and shop equipment. Washing with dish detergent and disinfection using spray disinfectant (Electrochemically activated water, pH=7). This shall include:
  • Cutting boards. Washing with dish detergent (soap) and water with scrub, then disinfection using spraying bleach. Leave for five minutes then rinse with water (can also be a spray) and let it air dry. At least prior to open or after closing the shop and once in between.
  • Knives. At least prior to open or after closing the shop and once in between.
  • Cloth. Guide how to use cloth. Each shop should have 2-3 cloth to wipe separate surfaces/tools.
  • Table surface. Require retailers to wash and disinfect throughout at the end of selling day; and apply disinfectant spray at the beginning of the selling day. Only retailers with an easy to clean surface (inox, granite or plastic etc.) shall be selected.
  • Training. Introduce frequent washing of hands, at least once within each selling hour, with clean water and liquid soap, and dry by tissue paper. Proper disposal of tissue paper in closed top bin For control group: No intervention or training activities for this group but collection of biological samples and observation checklist to determine hygienic status at their shops over three consecutive days.
  1. Intervention description
  2. Procedure to introduce the intervention:
  • Introduce and discuss trial with market authorities and vets (as appropriate)
  • Identify potential retailers, discuss and make plan with them
  • Pre- evaluate current knowledge and practice of selected retailers.
  • Procure suitable (shop size) equipment for "trial" retailers
  • Provide training, instructions and guidelines for selected retailers and introduce equipment
  • Monitoring of hygienic practice, sampling and checking practice of retailer
  • Timelines: "Training and equipment" in the 1st week, follow up, and supervise in week 2-4, sampling will be conducted in the fourth week.
  • Summary report, sharing and discussion with trial retailers to re-evaluate their knowledge.
  1. Procedure for sampling and analysis:
  • At each market, 15 of pork vendors will be selected for sampling.
  • From each vendor, one specimen will be purchased approximately 300 to 400 grams each.
  • All pork samples (n=360) from trial and control groups will be tested for total bacteria count (TBC).
  • In addition, a sub-set of 60 cut pork samples of trial group will be also analyzed for Salmonella Yes/No (qualitative), 30 out of 60 of these samples will be quantified for Salmonella concentration using MPN method.
Being tested
Improve hygiene practice of pork sellers
Keywords
Hygiene Practice, Bacterial Contamination, Traditional Market, Pork Shop, Cambodia
Medical subject headings
Foodborne Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Improve hygiene practice of pork sellersBehavioural

    includes 5 keys actions (Handbook) and provision of equipment incentive and training on good hygiene practices, branding, and certification

Study groups in NCT04594122
Study groupRoleWhat they receive
ControlNo interventionNo intervention in this group
InterventionExperimentalHygiene package, training, branding, and certification
Receives: Behavioral: Improve hygiene practice of pork sellers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of samples fulfill Cambodian microbiological standards for pork

    Total bacterial count in pork samples will be measured from both trial and control groups to assess level of compliance with national standards

    Measured: 16 weeks

Secondary outcomes (2)
  1. Change in knowledge of pork retailers

    There are 8 questions on the knowledge part. Each correct answer is given 1 score. The minimum and maximum scores of each participant are 0 and 8, respectively. The means of knowledge score will be compared to see the difference between the 2 groups.

    Measured: 16 weeks

  2. Change in practice of pork retailers

    The practice will be observed using a checklist during the selling time of the sampling day. There are 20 items on the checklist. Each appropriate practice is given 1 score per item. Practice score will be ranged from 0 to 20. The difference between the 2 groups will be compared using means of practice score.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2020
  2. Study start30 Jun 2020
  3. Primary completion28 Feb 2021
  4. Study completion15 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two groups of pork retailers will be recruited: control group and intervention group
Masking
None (open label)
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04594122
Sponsor's protocol ID
SFFF-RCT2020
Acronym
SFFF Cambodia
Status last verified
Oct 2020
First submitted
4 Sep 2020
Last updated
2 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: RCT data can be shared for other researchers but not the IPD.

Publications

  • Dang-Xuan S, Nguyen-Viet H, Unger F, Pham-Duc P, Grace D, Tran-Thi N, Barot M, Pham-Thi N, Makita K. Quantitative risk assessment of human salmonellosis in the smallholder pig value chains in urban of Vietnam. Int J Public Health. 2017 Feb;62(Suppl 1):93-102. doi: 10.1007/s00038-016-0921-x. Epub 2016 Nov 11.

    PubMed 27837223
  • Darapheak C, Takano T, Kizuki M, Nakamura K, Seino K. Consumption of animal source foods and dietary diversity reduce stunting in children in Cambodia. Int Arch Med. 2013 Jul 17;6:29. doi: 10.1186/1755-7682-6-29. eCollection 2013.

    PubMed 23866682
  • Devleesschauwer B, Haagsma JA, Angulo FJ, Bellinger DC, Cole D, Dopfer D, Fazil A, Fevre EM, Gibb HJ, Hald T, Kirk MD, Lake RJ, Maertens de Noordhout C, Mathers CD, McDonald SA, Pires SM, Speybroeck N, Thomas MK, Torgerson PR, Wu F, Havelaar AH, Praet N. Methodological Framework for World Health Organization Estimates of the Global Burden of Foodborne Disease. PLoS One. 2015 Dec 3;10(12):e0142498. doi: 10.1371/journal.pone.0142498. eCollection 2015.

    PubMed 26633883
  • Dror DK, Allen LH. The importance of milk and other animal-source foods for children in low-income countries. Food Nutr Bull. 2011 Sep;32(3):227-43. doi: 10.1177/156482651103200307.

    PubMed 22073797
  • Gilbert M, Conchedda G, Van Boeckel TP, Cinardi G, Linard C, Nicolas G, Thanapongtharm W, D'Aietti L, Wint W, Newman SH, Robinson TP. Income Disparities and the Global Distribution of Intensively Farmed Chicken and Pigs. PLoS One. 2015 Jul 31;10(7):e0133381. doi: 10.1371/journal.pone.0133381. eCollection 2015.

    PubMed 26230336
  • Grace D. Food Safety in Low and Middle Income Countries. Int J Environ Res Public Health. 2015 Aug 27;12(9):10490-507. doi: 10.3390/ijerph120910490.

    PubMed 26343693
  • Grace D, Omore A, Randolph T, Kang'ethe E, Nasinyama GW, Mohammed HO. Risk assessment for Escherichia coli O157:H7 in marketed unpasteurized milk in selected East African countries. J Food Prot. 2008 Feb;71(2):257-63. doi: 10.4315/0362-028x-71.2.257.

    PubMed 18326173
  • Grace D, Dipeolu M, Olawoye J, Ojo E, Odebode S, Agbaje M, Akindana G, Randolph T. Evaluating a group-based intervention to improve the safety of meat in Bodija market, Ibadan, Nigeria. Trop Anim Health Prod. 2012 Sep;44 Suppl 1:S61-6. doi: 10.1007/s11250-012-0208-z. Epub 2012 Aug 7.

    PubMed 22869336
  • Grace D, Olowoye J, Dipeolu M, Odebode S, Randolph T. The influence of gender and group membership on food safety: the case of meat sellers in Bodija market, Ibadan, Nigeria. Trop Anim Health Prod. 2012 Sep;44 Suppl 1:S53-9. doi: 10.1007/s11250-012-0207-0. Epub 2012 Aug 8.

    PubMed 22872520
  • Hoang VM, Tran TA, Ha AD, Nguyen VH. Cost of Hospitalization for Foodborne Diarrhea: A Case Study from Vietnam. J Korean Med Sci. 2015 Nov;30 Suppl 2(Suppl 2):S178-82. doi: 10.3346/jkms.2015.30.S2.S178. Epub 2015 Nov 6.

    PubMed 26617452
  • Kouame-Sina SM, Makita K, Costard S, Grace D, Dadie A, Dje M, Bonfoh B. Hazard identification and exposure assessment for bacterial risk assessment of informally marketed milk in Abidjan, Cote d'Ivoire. Food Nutr Bull. 2012 Dec;33(4):223-34. doi: 10.1177/156482651203300402.

    PubMed 23424888
  • Kruy SL, Soares JL, Ping S, Sainte-Marie FF. [Microbiological quality of " ice, ice cream. sorbet" sold on the streets of Phnom Penh; April 1996-April 1997]. Bull Soc Pathol Exot. 2001 Dec;94(5):411-4. French.

    PubMed 11889944
  • Lay KS, Vuthy Y, Song P, Phol K, Sarthou JL. Prevalence, numbers and antimicrobial susceptibilities of Salmonella serovars and Campylobacter spp. in retail poultry in Phnom Penh, Cambodia. J Vet Med Sci. 2011 Mar;73(3):325-9. doi: 10.1292/jvms.10-0373. Epub 2010 Nov 2.

    PubMed 21060246
  • Makita K, Fevre EM, Waiswa C, Eisler MC, Welburn SC. How human brucellosis incidence in urban Kampala can be reduced most efficiently? A stochastic risk assessment of informally-marketed milk. PLoS One. 2010 Dec 1;5(12):e14188. doi: 10.1371/journal.pone.0014188.

    PubMed 21152072
  • Meng CY, Smith BL, Bodhidatta L, Richard SA, Vansith K, Thy B, Srijan A, Serichantalergs O, Mason CJ. Etiology of diarrhea in young children and patterns of antibiotic resistance in Cambodia. Pediatr Infect Dis J. 2011 Apr;30(4):331-5. doi: 10.1097/INF.0b013e3181fb6f82.

    PubMed 21412204

Questions about this trial

What is this clinical trial studying?

A study testing Improve hygiene practice of pork sellers in people with Food Borne Diseases and Food Safety, run by The International Livestock Research Institute (ILRI) at 1 site in Cambodia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of samples fulfill Cambodian microbiological standards for pork (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04594122, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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