The need for a holistic approach toward pandemic control: lessons from a cross-sectional study on COVID-19 in Meghalaya, India.

We conducted a community-based cross-sectional survey of 416 participants from Meghalaya, India to assess knowledge, perceptions, and practices toward recommended COVID-19 preventive measures, and to explore health-seeking behavior and stigma during early phase of the pandemic. Most participants had knowledge of the signs and symptoms of COVID-19 (94%) and its spread (96%), and reported positive behavior change such as handwashing ≥ 6 times/day (41% pre-COVID-19 vs. 81% during COVID-19, P < 0.001), sneezing or coughing into sleeves (65% pre-COVID-19 vs. 89% during COVID-19, P < 0.001) and staying home if having flu-like symptoms (44% pre-COVID-19 vs. 94% during COVID-19, P < 0.001). We found delayed healthcare seeking for non-COVID-19 illnesses (16%). Fear of losing life was reported by 26% participants, as was discrimination toward migrant returnees, with 35% blaming returnees for the spread of COVID-19. We highlight the need for a holistic approach toward pandemic control, including social and mental health interventions, in public health strategies.

The effect of probiotics and zinc supplementation on the immune response to oral rotavirus vaccine: A randomized, factorial design, placebo-controlled study among Indian infants.

BACKGROUND: Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation could improve RV immunogenicity by altering the intestinal microbiota and immune function. METHODS: Infants 5weeks old living in urban Vellore, India were enrolled in a randomized, double-blind, placebo-controlled trial with a 4-arm factorial design to assess the effects of daily zinc (5mg), probiotic (1010Lactobacillus rhamnosus GG) or placebo on the immunogenicity of two doses of RV (Rotarix®, GlaxoSmithKline Biologicals) given at 6 and 10weeks of age. Infants were eligible for participation if healthy, available for the study duration and without prior receipt of RV or oral poliovirus vaccine other than the birth dose. The primary outcome was seroconversion to rotavirus at 14weeks of age based on detection of VP6-specific IgA at ≥20U/ml in previously seronegative infants or a fourfold rise in concentration. RESULTS: The study took place during July 2012 to February 2013. 620 infants were randomized equally between study arms and 551 (88.9%) completed per protocol. Seroconversion was recorded in 54/137 (39.4%), 42/136 (30.9%), 40/143 (28.0%), and 37/135 (27.4%) infants receiving (1) probiotic and zinc, (2) probiotic and placebo, (3) placebo and zinc, (4) two placebos. Seroconversion showed a modest improvement among infants receiving probiotic (difference between groups 1, 2 and 3, 4 was 7.5% (97.5% Confidence Interval (CI): -1.4%, 16.2%), p=0.066) but not zinc (difference between groups 1, 3 and 2, 4 was 4.4% (97.5% CI: -4.4%, 13.2%), p=0.272). 16 serious adverse events were recorded, none related to study interventions. CONCLUSIONS: Zinc or probiotic supplementation did not significantly improve the low immunogenicity of rotavirus vaccine given to infants in a poor urban community in India. A modest effect of combined supplementation deserves further investigation. TRIAL REGISTRATION: The trial was registered in India (CTRI/2012/05/002677).

Locally made ready to use therapeutic food for treatment of malnutrition a randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness of a locally made ready-to-use therapeutic food (RUTF) in decreasing mild to moderate malnutrition. DESIGN: A randomized open label, controlled trial. SETTING: Pre-schools run by the Department of Community Health in Kaniyambadi administrative block, Vellore, India; duration of follow-up 3 months from the date of recruitment. PARTICIPANTS: Pupils aged 18 -60 months with Weight-for-Age 2 SD. INTERVENTIONS: A locally produced energy-dense supplement (RUTF), and the current standard of care [teaching caregivers how to make a fortified cereal-milk supplement called High Calorie Cereal Milk (HCCM)]. MAIN OUTCOME MEASURES: Increase in weight-for-age status; increase in levels of plasma zinc, vitamin B12, serum albumin and haemoglobin. RESULTS: The Mean (SD) weight gain at 3 months was higher in the RUTF group: RUTF (n=51): 0.54 kg; (SE = 0.05; 95% CI = 0.44 - 0.65) vs HCCM (n=45): 0.38 kg;(SE = 0.06; 95% CI = 0.25 - 0.51), P = 0.047. The weight gain per kilogram of body weight was directly proportional to the severity of malnutrition. CONCLUSIONS: Community-based treatment showed weight gain in both groups, the gain being higher with RUTF.

Comparison of group counseling with individual counseling in the comprehension of informed consent: a randomized controlled trial.

BACKGROUND: Studies on different methods to supplement the traditional informed consent process have generated conflicting results. This study was designed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling, based on the hypothesis that group counseling would foster discussion among potential participants and enhance their understanding of the informed consent. METHODS: Parents of children participating in a trial of nutritional supplementation were randomized to receive either group counseling or individual counseling prior to administration of the informed consent. To assess the participant's comprehension, a structured questionnaire was administered approximately 48-72 hours afterwards by interviewers who were blinded to the allocation group of the respondents. RESULTS: A total of 128 parents were recruited and follow up was established with 118 (90.2%) for the study. All respondents were aware of their child's participation in a research study and the details of sample collection. However, their understanding of study purpose, randomization and withdrawal was poor. There was no difference in comprehension of key elements of the informed consent between the intervention and control arm. CONCLUSIONS: The results suggest that the group counseling might not influence the overall comprehension of the informed consent process. Further research is required to devise better ways of improving participants' understanding of randomization in clinical trials.