Setting
The study was carried out in Mbale district, Eastern Uganda. The district has 46 government-run health centres and one regional referral hospital. Mbale district has an estimated population of 568,192 people in 912 villages and a network of 2454 trained Village Health Workers as recorded from the district health office.
The alcohol-based hand rub (ABHR)
The formulations of ABHR were manufactured for the study by Saraya East Africa Co. Ltd. based in Jinja, Uganda. At the beginning of each week, participants were given a 100 ml bottle of hand rub formulation with a label containing usage and safety instructions and the blinded formulation code (either A, B, or C). The codes were added to enable the research team to confirm the nature of the ABHR at the end of each follow-up period. The bottle contents were stated as being an ABHR, but it was not stated which additives were used. The following formulations were compared: “A” was plain ABHR containing ethanol 80% (Alsoft V, Saraya East Africa Ltd); “B” was Alsoft V with added bittering agent, and “C” was Alsoft V with an added floral perfume.
Recruitment
All women with children aged utmost 3 months attending infant immunisation clinics in three lower health facilities in Mbale district, eastern Uganda during the week commencing 2nd June 2015 were screened for eligibility. All women were included except those who were currently using antiseptic hand wash at home and wished to continue its use.
Design
This was a 3-way blinded non-randomised cross-over study design. Each participant received the ABHRs in the order “A” (plain), “B” (bitterant), “C” (perfumed of floral scent). All three formulations were provided in identical 100 ml bottles and colour with instructions to use for 5 consecutive days, followed by a 2-day ‘washout’ period in which any or no hand rub could be used. Participants were asked to return to the health centre with their current ABHR bottle at the end of each week; the research assistant then completed the study evaluation from the participant’s perspective (participant’s reported practice) and provided observer evaluation of the participant in line with the WHO protocol [12]. Hand rub bottles from the previous week were retrieved and participants received the next ABHR formulation at each evaluation visit. The frequency of ABHR use was assessed, the amount of the formulation remaining in the bottle measured and any remaining hand rub was given back to women only after the third formulation-follow up had been completed. The volume of ABHR consumed was physically calculated by subtracting the remaining volume of ABHR in the bottle at the time of evaluation from the total volume in the bottle at the start (100mls). Those who failed to attend for follow-up were contacted by mobile phone or through the village health worker and the visit was rescheduled to another appropriate time and place, including the option of a home visit if preferred.
Participants were instructed by the researchers at the time of recruitment on how to use the hand rubs based on the adopted ‘3 moments of hand hygiene for community neonatal care’ (Fig. 1) derived from the WHO ‘5 moments for hand hygiene’ in non-hospital settings [10]. The three moments included; 1- before touching the baby (eg before breastfeeding), 2- before a clean/aseptic procedure (eg cleaning of the umbilical cord end until it falls off), 3- after body fluid exposure (eg after using the toilet, after cleaning baby’s bottom, after changing the baby’s diapers/nappy). The moments’ poster was translated into the local language (Lumasaba). Pictorial instructions on how to hand rub were provided to each participant.
Data collection
Data were collected using the WHO validated tool designed to evaluate the acceptability and tolerability of different ABHRs [12]. The primary outcome measure was the participant’s overall evaluation of the three ABHRs on a 7-point Likert scale, demonstrated to participants using water filling levels in a glass model for each point scale, as shown in Fig. 2. At each evaluation visit, a participant was asked to provide an overall evaluation following the ABHR use according to the WHO protocol [12]. Data were also collected on some participant demographics, the frequency of ABHR use, ABHR volume consumed, the opinion of the hand rubs (colour, smell, texture, ease of use, drying), skin condition after use, and factors the participants both liked and disliked about the ABHR. The frequency of ABHR Use was assessed by asking women the number of times the hand rub was used at the last 10 times that they did particular activities related to the baby, like breastfeeding, changing diapers, after using toilets etc.
The data were collected on paper case report forms and then transferred onto a secure, password-protected database for statistical analysis.
Sample size
A sample size of 40 mothers or carers with children utmost 3 months old and attending the immunisation clinics was used. WHO protocol recommends approximately 40 volunteer participants using at least 30 ml of product per day to participate in acceptability and tolerability studies for ABHR use [12] and previous studies have adopted similar sample size [13].
Statistical analysis
Participant characteristics and product performance measures were summarised using means and standard deviations (± range) for continuous variables and frequency counts (with percentages) for categorical measures. User comparisons of the performances of the three hand rub formulations were summarised using mean differences with their 95% confidence intervals. Observer evaluations of the impact of the formulations on participants’ skin condition were summarised using frequency counts and percentages; as only one participant reported a (very minor) problem, no formal statistical comparisons were performed for these variables. Time spent away from home compound by participants was measured using an ordered categorical scale and summarised using frequency counts with their percentages. Differences between the formulations on this measure were evaluated using the Wilcoxon matched-pairs rank sum test but mean scores were also computed to help inform the interpretation of these differences. Preferences for the two bottle sizes (1-Litre large and 100 ml small) used were summarised using frequency counts with their percentages; differences between these preferences were evaluated using the McNemar test. All analyses were conducted using the SPSS 22.0 (IBM Corp, Chicago, USA). Statistical significance was set at the conventional 5% level.