The Clean Study

Every year, thousands of mothers and babies suffer from infections acquired during a hospital stay, sometimes from poor hygiene and sometimes with fatal consequences. This study will investigate whether training 'cleaning champions' to educate hospital cleaners in best practice methods improves environmental hygiene in maternity and newborn units in three Tanzanian hospitals. It will also measure whether doing this leads to changes in the knowledge, beliefs, skills and behaviour of champions and cleaners. The lessons learnt from this study will help inform a bigger trial to investigate whether our intervention actually reduces infections in mothers and babies. Our previous research in two regions of Tanzania found most maternity beds to be contaminated, and that most cleaners had not received training in the last year.
In this study we will start by identifying staff (for example, nurse/midwives, ward managers, or experienced cleaners) in each hospital who can become 'cleaning champions'. Next, the champions will receive training on how to educate cleaners on the maternity and newborn units. We will adapt and use an existing training package which includes a set of lessons on best cleaning techniques (e.g. start in a clean area, and end in a dirty area; wear personal protective equipment); and also on how cleaning breaks the 'chain of transmission' of infection. Practical demonstrations are included (e.g. using talcum powder to show how invisible germs are spread) which encourage active participation - an approach which is better for adult learners, especially those with lower literacy, than traditional teaching methods. The training of the cleaning champions will be undertaken by an experienced local organisation (e.g. School of Nursing at Muhimbili University of Health and Allied Sciences).
However, training alone will not necessarily improve environmental hygiene, rather other improvements need to occur too (e.g. ensuring mops and disinfectant are always provided when they run out). We will use 'Quality Improvement' (QI) methods to identify these needs and to monitor performance of cleaning staff after they have been trained by their local cleaning champion. These champions will be supported in their role by regular supervisory meetings over a four-month period from the organization who trained them.
To determine if there have been any positive changes we will do assessments both before and after the training of the champions and the cleaners. This includes measuring their knowledge and beliefs using questionnaires. We will also secretly stick fluorescent tags on relevant places, like beds, which can only be removed by thorough cleaning, and monitoring these tags will help us to know if the environment has become cleaner. This will enable us to decide upon the methods to be used in the bigger follow-on trial, which will also include measuring hygiene levels using microbiology, and measuring infections in newborns using the same clinical methods a doctor would employ, such as recording temperature and blood pressure.
We will share the findings of this preliminary research both in Tanzania and internationally, through published papers, local workshops, conference presentations and relevant websites.

Infection Prevention & Control (IPC) is critical to minimizing Healthcare-associated Infections (HAI), currently affecting around 15% of hospital patients in Tanzania & similar to other low-income settings. Cleanliness of surfaces prevents direct & indirect (via hands air or equipment) contamination of patients & also contributes to a respectful & welcoming maternity environment. Poor cleanliness of the maternity & paediatric wards has been reported in Tanzania & in other parts of sub-Saharan African. The "Clean Study" will be conducted in three Tanzanian hospitals over 18 months from March 2018, & represents the development phase for a cluster-randomized trial to reduce HAIs in mothers & newborns by improving environmental hygiene in maternity & newborn units.
The main aim of the development phase is to adapt the intervention & to assess its potential for improving environmental hygiene in maternity & newborn units (including the antenatal, labour & postnatal wards; obstetric operating theatre; & newborn intensive care units). The composite intervention comprises the training & mentorship of local "cleaning champions" (e.g. IPC leaders, or cleaning managers), who in turn educate & supervise existing cleaners of maternity & newborn units employing standard Quality Improvement tools. We will also test & refine a) environmental microbiology procedures to measure cleanliness, & b) assessment methods to capture clinical HAI. This information collected during the development phase will inform key design features of the main trial, in particular, sample size & primary outcome measurement.
With an increasing number of women delivering in Tanzanian facilities, no formal in-country cleaners' training, & a recent governmental commitment to improve hygiene, our intervention could provide the Ministry of Health with the means to improve women's & newborn health, & potentially patient outcomes in other wards too, with wide significance across LMICs.

The potential beneficiaries of this research are the following:
1. Women and hospital-delivered newborns
2. Health facility cleaners and 'cleaning champions'
3. Infection Prevention & Control leaders and managers at hospital and district level
4. National and international policy-makers and policy-influencers of Infection Prevention & Control
5. Staff and patients in control hospitals

In Tanzania, as in many LAMICs, the burden of maternal and newborn infection-related mortality and morbidity is still considerable. Zaidi et al's (2005) review of incidence of neonatal sepsis or infection in hospital-born babies found rates in sub-Saharan Africa of around 20 per 1000 live births. A contributor to this problem is poor environmental hygiene in hospitals, determinants of which include lack of training for facility cleaners. Our development phase (and main trial) intervention seeks to address this. Beneficiaries are expected to benefit thus:
1. Women and newborns using maternity units in the development phase intervention hospitals may benefit from improved environmental hygiene standards. This will not only make their stay in hospital more acceptable, but is also likely to reduce their likelihood of contracting a HAI. In turn, these improvements will make women more likely to use the facility in future, as they will trust that it is a safe and acceptable place to give birth. This will in turn influence their friends and relatives, amplifying the effect into the wider community.
2. Facility cleaners will value the employment-related education and the heightened attention brought to their key role in IPC and as members of the healthcare workforce. This may lead to wider esteem for their work, traditionally seen as low-status. Those experienced cleaners (and other staff) identified as cleaning champions will benefit from learning how to train other cleaners as they will not only themselves learn more about best practice cleaning, but also have the opportunity to increase their skillset in the form of participatory training methods, so building capacity in these cadres.
3. Those in charge of IPC at hospital and district level in the development phase study sites will benefit from the identification and training of the cleaning champions, the training of the cleaners, and in the ongoing mentoring of the champions. Such activities will promote IPC and develop workforce capacity by empowering staff to develop up-to-date cleaning practices and structures supporting them. Ward managers (plus any other IPC supervisors or nurse/midwives) identified as cleaning champions will also learn best-practice cleaning science, participatory training methods, and Quality Improvement tools to support and supervise cleaners.
4. National and international policy-makers and influencers on IPC will benefit from the dissemination of best practice in the intervention hospitals. Improvements to hospital hygiene are also likely to increase uptake of facility delivery in-country, in line with global and national strategies, potentially reducing maternal and perinatal morbidity and mortality. A successful main trial would also trigger the intervention's implementation elsewhere, and this would in turn affect HAI rates, potentially reducing the need for curative and prophylactic antibiotics and other treatments.
5. If the main trial is successful, staff and patients at the control hospitals as well as non-participating hospitals and in wards beyond maternity and newborn units will benefit from the scale-up of the intervention and its adoption into routine services.

REFERENCES:
Zaidi, Anita KM, et al. "Hospital-acquired neonatal infections in developing countries." The Lancet 365.9465 (2005): 1175-1188.