Effect of a low-cost, behaviour-change intervention on latrine use and safe disposal of child faeces in rural Odisha, India: a cluster-randomised controlled trial.

BACKGROUND: Uptake of Government-promoted sanitation remains a challenge in India. We aimed to investigate a low-cost, theory-driven, behavioural intervention designed to increase latrine use and safe disposal of child faeces in India. METHODS: We did a cluster-randomised controlled trial between Jan 30, 2018, and Feb 18, 2019, in 66 rural villages in Puri, Odisha, India. Villages were eligible if not adjacent to another included village and not designated by the Government to be open-defecation free. All latrine-owning households in selected villages were eligible. We assigned 33 villages to the intervention via stratified randomisation. The intervention was required to meet a limit of US$20 per household and included a folk performance, transect walk, community meeting, recognition banners, community wall painting, mothers' meetings, household visits, and latrine repairs. Control villages received no intervention. Neither participants nor field assessors were masked to study group assignment. We estimated intervention effects on reported latrine use and safe disposal of child faeces 4 months after completion of the intervention delivery using a difference-in-differences analysis and stratified results by sex. This study is registered at ClinicalTrials.gov, NCT03274245. FINDINGS: We enrolled 3723 households (1807 [48·5%] in the intervention group and 1916 [51·5%] in the control group). Analysis included 14 181 individuals (6921 [48·8%] in the intervention group and 7260 [51·2%] in the control group). We found an increase of 6·4 percentage points (95% CI 2·0-10·7) in latrine use and an increase of 15·2 percentage points (7·9-22·5) in safe disposal of child faeces. No adverse events were reported. INTERPRETATION: A low-cost behavioural intervention achieved modest increases in latrine use and marked increases in safe disposal of child faeces in the short term but was unlikely to reduce exposure to faecal pathogens to a level necessary to achieve health gains. FUNDING: The Bill & Melinda Gates Foundation and International Initiative for Impact Evaluation

Imaging Long-Term Fate of Intramyocardially Implanted Mesenchymal Stem Cells in a Porcine Myocardial Infarction Model

The long-term fate of stem cells after intramyocardial delivery is unknown. We used noninvasive, repetitive PET/CT imaging with [18F]FEAU to monitor the long-term (up to 5 months) spatial-temporal dynamics of MSCs retrovirally transduced with the sr39HSV1-tk gene (sr39HSV1-tk-MSC) and implanted intramyocardially in pigs with induced acute myocardial infarction. Repetitive [18F]FEAU PET/CT revealed a biphasic pattern of sr39HSV1-tk-MSC dynamics; cell proliferation peaked at 33–35 days after injection, in periinfarct regions and the major cardiac lymphatic vessels and lymph nodes. The sr39HSV1-tk-MSC–associated [18F]FEAU signals gradually decreased thereafter. Cardiac lymphography studies using PG-Gd-NIRF813 contrast for MRI and near-infrared fluorescence imaging showed rapid clearance of the contrast from the site of intramyocardial injection through the subepicardial lymphatic network into the lymphatic vessels and periaortic lymph nodes. Immunohistochemical analysis of cardiac tissue obtained at 35 and 150 days demonstrated several types of sr39HSV1-tk expressing cells, including fibro-myoblasts, lymphovascular cells, and microvascular and arterial endothelium. In summary, this study demonstrated the feasibility and sensitivity of [18F]FEAU PET/CT imaging for long-term, in-vivo monitoring (up to 5 months) of the fate of intramyocardially injected sr39HSV1-tk-MSC cells. Intramyocardially transplanted MSCs appear to integrate into the lymphatic endothelium and may help improve myocardial lymphatic system function after MI