Field Assessment of a Novel Household-Based Water Filtration Device: A Randomised, Placebo-Controlled Trial in the Democratic Republic of Congo

BACKGROUND: Household water treatment can improve the microbiological quality of drinking water and may prevent diarrheal diseases. However, current methods of treating water at home have certain shortcomings, and there is evidence of bias in the reported health impact of the intervention in open trial designs. METHODS AND FINDINGS: We undertook a randomised, double-blinded, placebo-controlled trial among 240 households (1,144 persons) in rural Democratic Republic of Congo to assess the field performance, use and effectiveness of a novel filtration device in preventing diarrhea. Households were followed up monthly for 12 months. Filters and placebos were monitored for longevity and for microbiological performance by comparing thermotolerant coliform (TTC) levels in influent and effluent water samples. Mean longitudinal prevalence of diarrhea was estimated among participants of all ages. Compliance was assessed through self-reported use and presence of water in the top vessel of the device at the time of visit. Over the 12-month follow-up period, data were collected for 11,236 person-weeks of observation (81.8% total possible). After adjusting for clustering within the household, the longitudinal prevalence ratio of diarrhoea was 0.85 (95% confidence interval: 0.61-1.20). The filters achieved a 2.98 log reduction in TTC levels while, for reasons that are unclear, the placebos achieved a 1.05 log reduction (p<0.0001). After 8 months, 68% of intervention households met the study's definition of current users, though most (73% of adults and 95% of children) also reported drinking untreated water the previous day. The filter maintained a constant flow rate over time, though 12.4% of filters were damaged during the course of the study. CONCLUSIONS: While the filter was effective in improving water quality, our results provide little evidence that it was protective against diarrhea. The moderate reduction observed nevertheless supports the need for larger studies that measure impact against a neutral placebo. TRIAL REGISTRATION: Current Controlled Trials ISRCTN03844341

Promoting latrine construction and use in rural villages practicing open defecation: process evaluation in connection with a randomised controlled trial in Orissa, India.

BACKGROUND: Our group conducted a cluster-randomised trial in 100 villages of Orissa, India to measure the impact of a rural sanitation intervention implemented under the government of India's Total Sanitation Campaign, on diarrhoea and soil-transmitted helminth infections. This paper reports on a process evaluation conducted in the context of the trial. METHODS: Process evaluation data were collected through review of key documentation, quantitative surveys, direct observations, and semi-structured interviews with staff from implementing NGOs and community members. Between March 2011 and March 2012, trained enumerators recorded observations on latrine construction status every 6-8 weeks in the 50 intervention villages and noted activities reported to have taken place based on NGO staff interviews and review of NGO records. A survey among 10% of households in intervention and control villages was conducted to compare levels of awareness of key intervention components. In addition, 10% of village water and sanitation committee (VWSC) members were interviewed to measure their level of involvement in the intervention delivery. RESULTS: The percentage of households with a latrine (completed or under construction) increased from 8% at baseline to 66% one year after the start of the intervention in March 2012. Almost none of the intervention households recall any form of participatory community-level activities at the start of the programme, although intervention households were generally more aware of the Total Sanitation Campaign (91% versus 49%, p < 0.001), VWSCs (51% versus 9%, p < 0.001), adolescent girls groups (23% versus 8%, p < 0.01), wall paintings (44% versus 7%, p < 0.001) and were more likely to report a household visit on sanitation during the past three months (65% versus 3%, p < 0.001). We found no strong evidence of an association between levels of awareness of or participation in mobilisation activities and levels of latrine coverage in intervention villages. CONCLUSIONS: The levels of coverage achieved and the levels of awareness of the mobilisation process in our intervention villages were lower than planned, but similar to those reported elsewhere in India under the TSC. Our process evaluation highlights important gaps between the TSC guidelines and their implementation on the ground. TRIAL REGISTRATION: Number on clinicaltrial.gov: NCT01214785