Efficacy of a Single-Dose, Inactivated Oral Cholera Vaccine in Bangladesh.

BACKGROUND: A single-dose regimen of the current killed oral cholera vaccines that have been prequalified by the World Health Organization would make them more attractive for use against endemic and epidemic cholera. We conducted an efficacy trial of a single dose of the killed oral cholera vaccine Shanchol, which is currently given in a two-dose schedule, in an urban area in which cholera is highly endemic. METHODS: Nonpregnant residents of Dhaka, Bangladesh, who were 1 year of age or older were randomly assigned to receive a single dose of oral cholera vaccine or oral placebo. The primary outcome was vaccine protective efficacy against culture-confirmed cholera occurring 7 to 180 days after dosing. Prespecified secondary outcomes included protective efficacy against severely dehydrating culture-confirmed cholera during the same interval, against cholera and severe cholera occurring 7 to 90 versus 91 to 180 days after dosing, and against cholera and severe cholera according to age at baseline. RESULTS: A total of 101 episodes of cholera, 37 associated with severe dehydration, were detected among the 204,700 persons who received one dose of vaccine or placebo. The vaccine protective efficacy was 40% (95% confidence interval [CI], 11 to 60%; 0.37 cases per 1000 vaccine recipients vs. 0.62 cases per 1000 placebo recipients) against all cholera episodes, 63% (95% CI, 24 to 82%; 0.10 vs. 0.26 cases per 1000 recipients) against severely dehydrating cholera episodes, and 63% (95% CI, -39 to 90%), 56% (95% CI, 16 to 77%), and 16% (95% CI, -49% to 53%) against all cholera episodes among persons vaccinated at the age of 5 to 14 years, 15 or more years, and 1 to 4 years, respectively, although the differences according to age were not significant (P=0.25). Adverse events occurred at similar frequencies in the two groups. CONCLUSIONS: A single dose of the oral cholera vaccine was efficacious in older children (≥5 years of age) and in adults in a setting with a high level of cholera endemicity. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov number, NCT02027207.).

Safety of a bivalent, killed, whole-cell oral cholera vaccine in pregnant women in Bangladesh: evidence from a randomized placebo-controlled trial.

BACKGROUND: Cholera increases the risk of harmful effects on foetuses. We prospectively followed pregnant women unaware of their pregnancy status who received a study agent in a clinical trial evaluating the association between exposure to an oral cholera vaccine (OCV) and foetal survival. METHODS: Study participants were selected from a randomized placebo-controlled trial conducted in Dhaka, Bangladesh. The vaccination campaign was conducted between January 10 and February 4, 2014. We enrolled women who were exposed to an OCV or placebo during pregnancy (Cohort 1) and women who were pregnant after the vaccination was completed (Cohort 2). Our primary endpoint was pregnancy loss (spontaneous miscarriage or stillbirth), and the secondary endpoints were preterm delivery and low birth weight. We employed a log-binomial regression to calculate the relative risk of having adverse outcomes among OCV recipients compared to that among placebo recipients. RESULT: There were 231 OCV and 234 placebo recipients in Cohort 1 and 277 OCV and 299 placebo recipients in Cohort 2. In Cohort 1, the incidence of pregnancy loss was 113/1000 and 115/1000 among OCV and placebo recipients, respectively. The adjusted relative risk for pregnancy loss was 0.97 (95% CI: 0.58-1.61; p = 0.91) in Cohort 1. We did not observe any variation in the risk of pregnancy loss between the two cohorts. The risks for preterm delivery and low birth weight were not significantly different between the groups in both cohorts. CONCLUSIONS: Our study provides additional evidence that exposure to an OCV during pregnancy does not increase the risk of pregnancy loss, preterm delivery, or low birth weight, suggesting that pregnant women in cholera-affected regions should not be excluded in a mass vaccination campaign. TRIAL REGISTRATION: The study is registered at ( http://clinicaltrials.gov ). Identifier: NCT02027207 .

Feasibility and effectiveness of oral cholera vaccine in an urban endemic setting in Bangladesh: a cluster randomised open-label trial.

BACKGROUND: Cholera is endemic in Bangladesh with epidemics occurring each year. The decision to use a cheap oral killed whole-cell cholera vaccine to control the disease depends on the feasibility and effectiveness of vaccination when delivered in a public health setting. We therefore assessed the feasibility and protective effect of delivering such a vaccine through routine government services in urban Bangladesh and evaluated the benefit of adding behavioural interventions to encourage safe drinking water and hand washing to vaccination in this setting. METHODS: We did this cluster-randomised open-label trial in Dhaka, Bangladesh. We randomly assigned 90 clusters (1:1:1) to vaccination only, vaccination and behavioural change, or no intervention. The primary outcome was overall protective effectiveness, assessed as the risk of severely dehydrating cholera during 2 years after vaccination for all individuals present at time of the second dose. This study is registered with ClinicalTrials.gov, number NCT01339845. FINDINGS: Of 268,896 people present at baseline, we analysed 267,270: 94,675 assigned to vaccination only, 92,539 assigned to vaccination and behavioural change, and 80,056 assigned to non-intervention. Vaccine coverage was 65% in the vaccination only group and 66% in the vaccination and behavioural change group. Overall protective effectiveness was 37% (95% CI lower bound 18%; p=0·002) in the vaccination group and 45% (95% CI lower bound 24%; p=0·001) in the vaccination and behavioural change group. We recorded no vaccine-related serious adverse events. INTERPRETATION: Our findings provide the first indication of the effect of delivering an oral killed whole-cell cholera vaccine to poor urban populations with endemic cholera using routine government services and will help policy makers to formulate vaccination strategies to reduce the burden of severely dehydrating cholera in such populations. FUNDING: Bill & Melinda Gates Foundation.

Female unmarried adolescents' knowledge on selected reproductive health issues in two low performing areas of Bangladesh: an evaluation study.

BACKGROUND: In Bangladesh, 24 % of the total populations are adolescents. Twelve months intervention was implemented under Demand-Based Reproductive Health Commodity Project (DBRHCP) in two low performing areas: rural Sub-district Nabiganj (population 323,357) and an urban slum in Dhaka city (population 141,912). We evaluated the changes in knowledge of female unmarried adolescents on selected reproductive health issues over the project period in two low performing areas of Bangladesh. METHODS: A pre-post study design was adopted. Under DBRHCP, interventions were focused on training of government service providers, disseminating behaviour change materials within the targeted communities, and employing community-based health promoters (Community Support Group and Peer Promoters) to foster linkages between the community and providers. All households were enumerated. A baseline survey was conducted during November 2006 to March 2007 and an end-line survey was conducted during November 2008 to March 2009. Eight hundred female unmarried adolescents (12-19 years) were selected independently for each survey from each study area through systematic random sampling, capturing changes over the 12 months intervention period. Data was analyzed using SPSS. A chi-square test was used to assess the changes in knowledge between baseline and end-line among the female unmarried adolescents. RESULTS: Female unmarried adolescents had significantly increased knowledge at the end-line about measures to be taken during menstruation like: using clean and dry cloths. Overall, two-third of female unmarried adolescents knew about Family Planning (FP) methods in both study areas but had significantly increased knowledge on injectables and condoms at the end-line. Overall knowledge on Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDs) was markedly different in the urban and rural areas, but a significantly higher proportion of female unmarried adolescents knew about HIV/AIDs from relatives and school curricula, and had increased knowledge about mode of transmission of HIV/AIDs, like: receiving blood from an HIV infected person and using a HIV infected needle or syringe, at the end-line. A significantly higher proportion of female unmarried adolescents reported sexually transmitted infection (STI) related symptoms at the end-line compared to baseline. Overall variation in knowledge about Government healthcare facilities, Non-Government Organization (NGO) healthcare facilities and private healthcare facilities was found in both study areas, but awareness was increased about the type of healthcare facilities at the end-line. CONCLUSION: The improvement of the female unmarried adolescents' knowledge on selected Reproductive Health (RH) issues suggest that the interventions affected RH related knowledge reported in the study. These interventions can be adapted in the health service delivery system to enhance people's knowledge on RH issues to achieve RH for adolescents.

Changes in the selected reproductive health indicators among married women of reproductive age in low performing areas of Bangladesh: findings from an evaluation study.

BACKGROUND: Three-year duration Demand-Based Reproductive Commodity Project (DBRHCP) was launched in three low performing areas: rural Nabiganj (population 323,357), Raipur (population 260,983) and urban slum in Dhaka (population 141,912). OBJECTIVES: Assessing changes in knowledge among married women of reproductive age on selected reproductive health issues and to explore their service utilization patterns over the project period in selected low performing areas of Bangladesh. METHODS: The study adopted a pre- posts design. In the project areas, the entire chain of service provision were modified through the interventions under the DBRHCP, including training of the providers, enhanced behavioral change communication activities, follow-up and counseling, record keeping, reporting and monitoring, as well as improvement in logistics and supplies. Peer promoters were established as linkages between clients and service providers. All households were enlisted. Baseline and end line surveys were done using representative simple random sampling method, capturing changes over one year intervention period. Descriptive analysis was done using SPSS package, version 10. Proportional tests using Stata, version 8 were done to assess changes from baseline to end line. RESULTS: The overall contraceptive prevalence was markedly different in the three study areas but significantly increased in both Dhaka urban slums and Nabiganj. In the rural areas, a higher proportion of the women in endline compared to baseline obtained contraceptive methods from the public sectors. Irrespective of study sites, significantly higher proportion of women received ANC (Antenatal Care) and PNC (Post natal care) in endline compared to baseline. In all study sites higher proportions of women were aware of maternal complications at endline. Services were obtained from qualified persons for reported symptoms of sexually transmitted infections by a higher proportion of women at endline compared to baseline. There were improvements in other RH indicators, such as use of skilled birth attendants and overall utilization of health care facilities by women. CONCLUSIONS: The improvements in several important RH indicators in the intervention areas suggest that the interventions affected selected outcomes reported in the study. The study findings also suggest that investment in the reproductive health sector, particularly in existing government programs, improves RH outcomes.

Treatment-seeking for selected reproductive health problems: behaviours of unmarried female adolescents in two low-performing areas of Bangladesh.

PURPOSE: The reproductive health needs of unmarried adolescents in Bangladesh are largely unmet. This study aimed to explore treatment-seeking behaviour of unmarried female adolescents for selected reproductive health (RH) concerns in two low-performing areas of Bangladesh. METHODS: As part of a large community based-project, a cross-sectional survey was conducted from November 2006 to March 2007. From each of two select study areas, 800 unmarried female adolescents aged 12-19 years were selected for participation by simple random sampling through household listing and were recruited into the study. Trained interviewers administered a structured questionnaire to participating female adolescents. Descriptive and bivariate analytic methods were used compare RH conditions and healthcare seeking behaviour of adolescents across urban and rural settings. RESULTS: Approximately 50% of the sample reported experiencing menstrual problems in the last year. The predominant problems reported by participants included: lower abdominal pain, back pain, irregular menstruation, and excessive bleeding during menstruation. Irrespective of study area, only 40% of the female adolescents with menstrual problems sought treatment from qualified physicians. Otherwise, utilization of healthcare facilities and care providers for reported problems varied significantly by rural and urban areas. Higher proportions of adolescents in the urban setting (15%) also reported recent symptoms of sexually transmitted infections (STIs), compared to those in the rural setting (9%; p<0.001). Across sites, however, self-treatment was the most commonly reported method of care for those who experienced any symptoms of STI. CONCLUSIONS: In general, treatment-seeking behaviours by unmarried female adolescents was low for menstrual problems. A vast majority of unmarried female adolescents practiced self-care for symptoms of STIs while only small proportions sought treatment from qualified physicians. These findings emphasize the need for offering relevant information on RH issues and introducing confidential adolescent-friendly reproductive healthcare facilities to enable unmarried female adolescents access to RH services when necessary.

Knowledge of, attitudes toward, and preventive practices relating to cholera and oral cholera vaccine among urban high-risk groups: findings of a cross-sectional study in Dhaka, Bangladesh.

BACKGROUND: In endemic countries such as Bangladesh, consequences of cholera place an enormous financial and social burden on patients and their families. Cholera vaccines not only provide health benefits to susceptible populations but also have effects on the earning capabilities and financial stability of the family. Community-based research and evaluations are necessary to understand perceptions about and practices of the community relating to cholera and oral cholera vaccines. This may help identify the ways in which such vaccines may be successfully introduced, and other preventive measures can be implemented. The present study assessed the knowledge of, attitudes toward, and preventive practices relating to cholera and oral cholera vaccine among an urban population residing in a high cholera-prone setting in Dhaka, Bangladesh. METHODS: This cross-sectional study was conducted in an area of high cholera prevalence in 15 randomly-selected clusters in Mirpur, Dhaka city. A study team collected data through a survey and in-depth interviews during December 2010-February 2011. RESULTS: Of 2,830 families included in the final analysis, 23% could recognize cholera as acute watery diarrhea and 16% had ever heard of oral cholera vaccine. About 54% of the respondents had poor knowledge about cholera-related issues while 97% had a positive attitude toward cholera and oral cholera vaccine. One-third showed poor practice relating to the prevention of cholera.The findings showed a significant (p < 0.05) association between the respondents' knowledge and sex, education, occupation, monthly overall household expenditure, attitudes and practice. In the adjusted model, male sex, having a lower monthly overall household expenditure, and having a less positive attitude toward cholera were the significant predictors to having poor knowledge. CONCLUSIONS: The findings suggest the strengthening of health education activities to improve knowledge on cholera, its prevention and treatment and information on cholera vaccination among high-risk populations. The data also underscore the potential of mass cholera vaccination to prevent and control cholera.

Association of programmatic factors with low contraceptive prevalence rates in a rural area of Bangladesh.

OBJECTIVE: The study was conducted to identify selected programmatic factors relating to low contraceptive-use in a low-performing rural sub-district in Sylhet division of Bangladesh. METHODS: A cross-sectional survey was carried out among 6983 currently-married women of reproductive age (MWRA) (15-49 years). To estimate the association between current contraceptive-use and other selected factors, multivariate analyse were performed, estimating the crude and adjusted odds ratios (OR), including 95% confidence intervals (CI). RESULTS: The use of health facility by the MWRA in the last three months, distance from the residence to the nearest health facility, and contact with field workers in the last six months was significantly associated with contraceptive prevalence rate (CPR). There were potential differences regarding CPR, sources of contraceptive supply and Family Welfare Assistant (FWA) visit between hard to reach and non-hard to reach unions of Nabiganj sub-district. CONCLUSION: Strategies should be devised to increase the accessibility of MWRA to contraceptive methods by increased partnership with non-public sector and increased contacts with outreach workers through introducing community volunteers, and mobile phones help lines, by organizing frequent satellite clinics (SCs) and making community clinics (CCs) functional. Innovative strategies should be piloted for improving use of contraception in such hard to reach and low performing locality.

Strategies for providing healthcare services to street-dwellers in Dhaka city: evidence from an operations research.

BACKGROUND: In almost every major urban city, thousands of people live in overcrowded slums, streets, or other public places without any health services. Bangladesh has experienced one of the highest rates of urban population growth in the last three decades compared to the national population growth rate. The numbers of the urban poor and street-dwellers are likely to increase at least in proportion to the overall population growth of the country. The street-dwellers in Bangladesh are extremely vulnerable in terms of their health needs and healthcare-seeking behaviours. In Bangladesh, there is no health service-delivery mechanism targeting this marginalized group of people. This study, therefore, assessed the effectiveness of two models to provide primary healthcare (PHC) services to street-dwellers. METHODS: This study of experimental pre-post design tested two models, such as static clinic and satellite clinics, for providing PHC services to street-dwellers in the evening through paramedics in Dhaka city during May 2009-April 2010. Both quantitative and qualitative techniques were used for collecting data. Data were analyzed comparing before and after the implementation of the clinics for the assessment of selected health and family-planning indicators using the statistical t-test. Services received from the model l and model 2 clinics were also compared by calculating the absolute difference to determine the relative effectiveness of one model over another. RESULTS: The use of healthcare services by the street-dwellers increased at endline compared to baseline in both the model clinic areas, and the difference was highly significant (p < 0.001). Institutional delivery among the female street-dwellers increased at endline compared to baseline in both the clinic areas. The use of family-planning methods among females also significantly (p < 0.001) increased at endline compared to baseline in both the areas. CONCLUSIONS: As the findings of the study showed the promise of this approach, the strategies could be implemented in all other cities of Bangladesh and in other countries which encounter similar problems.

Electronic data capture for large scale typhoid surveillance, household contact tracing, and health utilisation survey: Strategic Typhoid Alliance across Africa and Asia.

Electronic data capture systems (EDCs) have the potential to achieve efficiency and quality in collection of multisite data. We quantify the volume, time, accuracy and costs of an EDC using large-scale census data from the STRATAA consortium, a comprehensive programme assessing population dynamics and epidemiology of typhoid fever in Malawi, Nepal and Bangladesh to inform vaccine and public health interventions. A census form was developed through a structured iterative process and implemented using Open Data Kit Collect running on Android-based tablets. Data were uploaded to Open Data Kit Aggregate, then auto-synced to MySQL-defined database nightly. Data were backed-up daily from three sites centrally, and auto-reported weekly. Pre-census materials' costs were estimated. Demographics of 308,348 individuals from 80,851 households were recorded within an average of 14.7 weeks range (13-16) using 65 fieldworkers. Overall, 21.7 errors (95% confidence interval: 21.4, 22.0) per 10,000 data points were found: 13.0 (95% confidence interval: 12.6, 13.5) and 24.5 (95% confidence interval: 24.1, 24.9) errors on numeric and text fields respectively. These values meet standard quality threshold of 50 errors per 10,000 data points. The EDC's total variable cost was estimated at US$13,791.82 per site. In conclusion, the EDC is robust, allowing for timely and high-volume accurate data collection, and could be adopted in similar epidemiological settings.

Child immunization coverage in rural hard-to-reach Haor areas of Bangladesh: possible alternative strategies.

This article assessed the status of childhood vaccination coverage and the possibility of using selected alternative vaccination strategies in rural hard-to-reach haor (low lying) areas of Bangladesh. Data were collected through survey, in-depth interviews, group discussion, and observations of vaccination sessions. Complete immunization coverage among 12- to 23-month-old children was found to be significantly lower in study areas when compared with the national coverage levels. The study identified reasons for low complete immunization coverage in hard-to-reach areas, including irregular/cancelled extended program on immunization (EPI) sessions, less time spent in EPI spots by field staff, and absence of any alternative strategy for remote areas. The findings indicated that the existing service delivery strategy is not sufficient to improve immunization coverage in hard-to-reach areas. However, most of the strategies assessed are considered possible to implement by health care providers in hard-to-reach areas. The study suggested that before implementing alternative strategies in hard-to-reach areas, feasibility and effectiveness of the possible strategies need to be tested to identify evidence-based strategies.

Feasibility, coverage and cost of oral cholera vaccination conducted by icddr,b using the existing national immunization service delivery mechanism in rural setting Keraniganj, Bangladesh.

Background: Cholera is a considerable health burden in developing country settings including Bangladesh. The oral cholera vaccine (OCV) is a preventative tool to control the disease. The objective of this study was to describe whether the International Centre for Diarrheal Disease Research, Bangladesh (icddr,b), could provide the OCV to rural communities using existing government infrastructure. Methods: The study was conducted in rural sub-district Keraniganj, 20 km from the capital city Dhaka. All listed participants one year and above in age (excluding pregnant women) were offered two doses of OCV at a 14 day interval. Existing government facilities were used to deliver and also maintain the cold chain required for the vaccine. All events related to vaccination were recorded at the 17 vaccination sites to evaluate the coverage and feasibility of OCV program. Results: A total of 29,029 individuals received the 1st dose (90% of target) and 26,611 individuals received the 2nd dose (83% of target and 92% of 1st dose individuals) of OCV. The highest vaccination coverage was in younger children (1-9 years) and the lowest was amongst 18-29-year age group. Somewhat better coverage was seen amongst the female participants than males (92% vs. 88% for the 1st dose and 93% vs. 90% for the 2nd dose). The cost of vaccine cost was calculated as US$1.00 per dose plus freight, insurance, and transportation and the total vaccine delivery cost was US$70,957. Conclusion: This was a project undertaken using existing public health program resources to collect empirical evidence on the use of a mass OCV campaign in the rural setting. Mass vaccination with the OCV is feasible in the rural setting using existing governmental vaccine delivery systems in Bangladesh.

Organization and implementation of an oral cholera vaccination campaign in an endemic urban setting in Dhaka, Bangladesh.

Bangladesh has historically been cholera endemic, with seasonal cholera outbreaks occurring each year. In collaboration with the government of Bangladesh, the Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) initiated operational research to test strategies to reach the high-risk urban population with an affordable oral cholera vaccine (OCV) "ShancholTM" and examine its effectiveness in reducing diarrhea due to cholera. Here we report a sub-analysis focusing on the organization, implementation and effectiveness of different oral cholera vaccine delivery strategies in the endemic urban setting in Bangladesh. We described how the vaccination program was planned, prepared and implemented using different strategies to deliver oral cholera vaccine to a high-risk urban population in Dhaka, Bangladesh based on administrative data and observations made during the program. The objective of this study is to evaluate the organization, implementation and effectiveness of different oral cholera vaccine delivery strategies in the endemic urban setting in Bangladesh. OCV administration by trained local volunteers through outreach sites and mop-up activities yielded high coverage of 82% and 72% of 172,754 targeted individuals for the first and second dose respectively, using national Expanded Program on Immunization (EPI) campaign mechanisms without disrupting routine immunization activities. The cost of delivery was low. Safety and cold chain requirements were adequately managed. The adopted strategies were technically and programmatically feasible. Current evidence on implementation strategies in different settings together with available OCV stockpiles should encourage at-risk countries to use OCV along with other preventive and control measures.

Vibriocidal Titer and Protection From Cholera in Children.

BACKGROUND: Vibrio cholerae, the causative agent of cholera, is a major cause of diarrhea worldwide. Children under the age of 5 have the highest disease burden of cholera. Vibriocidal antibody responses following natural infection and oral cholera vaccination (OCV) are associated with protective immunity, but whether this holds uniformly true in young children is not known. METHODS: Household contacts of cholera patients are at high risk of V cholerae infection. We measured the association between baseline vibriocidal titer and the subsequent risk of infection in 50 household contacts <5 years old, 228 contacts 5-15 years old, and 548 contacts 16-70 years old in Bangladesh to determine whether vibriocidal antibody responses predict protection from V cholerae infection equally in all age groups. RESULTS: We found that the vibriocidal titer predicted protection similarly in young children and other age strata. There was no interaction between age and vibriocidal titer. Mean baseline serum vibriocidal titers were higher in individuals in all age groups who remained uninfected compared with those who developed V cholerae infection during the follow-up period. CONCLUSIONS: After OCV, children have comparable vibriocidal responses to adults but a shorter duration and magnitude of protection compared with adults. In persons exposed to natural infection, we found that the vibriocidal titer predicts protection uniformly in all age groups. The vibriocidal titer may not be the optimal marker to demonstrate protection after OCV, and improved markers for estimating OCV efficacy in children are needed.

Efficacy of a single-dose regimen of inactivated whole-cell oral cholera vaccine: results from 2 years of follow-up of a randomised trial.

BACKGROUND: A single-dose regimen of inactivated whole-cell oral cholera vaccine (OCV) is attractive because it reduces logistical challenges for vaccination and could enable more people to be vaccinated. Previously, we reported the efficacy of a single dose of an OCV vaccine during the 6 months following dosing. Herein, we report the results of 2 years of follow-up. METHODS: In this placebo-controlled, double-blind trial done in Dhaka, Bangladesh, individuals aged 1 year or older with no history of receipt of OCV were randomly assigned to receive a single dose of inactivated OCV or oral placebo. The primary endpoint was a confirmed episode of non-bloody diarrhoea for which the onset was at least 7 days after dosing and a faecal culture was positive for Vibrio cholerae O1 or O139. Passive surveillance for diarrhoea was done in 13 hospitals or major clinics located in or near the study area for 2 years after the last administered dose. We assessed the protective efficacy of the OCV against culture-confirmed cholera occurring 7-730 days after dosing with both crude and multivariable per-protocol analyses. This trial is registered at ClinicalTrials.gov, number NCT02027207. FINDINGS: Between Jan 10, 2014, and Feb 4, 2014, 205 513 people were randomly assigned to receive either vaccine or placebo, of whom 204 700 (102 552 vaccine recipients and 102 148 placebo recipients) were included in the per-protocol analysis. 287 first episodes of cholera (109 among vaccine recipients and 178 among placebo recipients) were detected during the 2-year follow-up; 138 of these episodes (46 in vaccine recipients and 92 in placebo recipients) were associated with severe dehydration. The overall incidence rates of initial cholera episodes were 0·22 (95% CI 0·18 to 0·27) per 100 000 person-days in vaccine recipients versus 0·36 (0·31 to 0·42) per 100 000 person-days in placebo recipients (adjusted protective efficacy 39%, 95% CI 23 to 52). The overall incidence of severe cholera was 0·09 (0·07 to 0·12) per 100 000 person-days versus 0·19 (0·15 to 0·23; adjusted protective efficacy 50%, 29 to 65). Vaccine protective efficacy was 52% (8 to 75) against all cholera episodes and 71% (27 to 88) against severe cholera episodes in participants aged 5 years to younger than 15 years. For participants aged 15 years or older, vaccine protective efficacy was 59% (42 to 71) against all cholera episodes and 59% (35 to 74) against severe cholera. The protection in the older age groups was sustained throughout the 2-year follow-up. In participants younger than 5 years, the vaccine did not show protection against either all cholera episodes (protective efficacy -13%, -68 to 25) or severe cholera episodes (-44%, -220 to 35). INTERPRETATION: A single dose of the inactivated whole-cell OCV offered protection to older children and adults that was sustained for at least 2 years. The absence of protection of young children might reflect a lesser degree of pre-existing natural immunity in this age group. FUNDING: Bill & Melinda Gates Foundation to the International Vaccine Institute.

Impact of an in-built monitoring system on family planning performance in rural Bangladesh.

BACKGROUND: During 1982-1992, the Maternal and Child Health Family Planning (MCH-FP) Extension Project (Rural) of International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B), in partnership with the Ministry of Health and Family Welfare (MoHFW) of the Government of Bangladesh (GoB), implemented a series of interventions in Sirajganj Sadar sub-district of Sirajganj district. These interventions were aimed at improving the planning mechanisms and for reviewing the problem-solving processes to build an effective monitoring system of the interventions at the local level of the overall system of the MOHFW, GoB. METHODS: The interventions included development and testing of innovative solutions in service-delivery, provision of door-step injectables, and strengthening of the management information system (MIS). The impact of an in-built monitoring system on the overall performance was assessed during the period from June 1995 to December 1996, after the withdrawal of the interventions in 1992. RESULTS: The results of the assessment showed that Family Welfare Assistants (FWAs) increased household-visits within the last two months, and there was a higher use of service-delivery points even after the withdrawal of the interventions. The results of the cluster surveys, conducted in 1996, showed that the selected indicators of health and family-planning services were higher than those reported by the Bangladesh Demographic and Health Survey (BDHS) 1996-1997. During June 1995-December, 1996, the contraceptive prevalence rate (CPR) increased by 13 percentage points (i.e. from 40% to 53%). Compared to the national CPR (49%), this increase was statistically significant (p < 0.05). CONCLUSION: The in-built monitoring systems, including effective MIS, accompanied by rapid assessments and review of performance by the programme managers, have potentials to improve family planning performance in low-performing areas.

Safety of the oral cholera vaccine in pregnancy: Retrospective findings from a subgroup following mass vaccination campaign in Dhaka, Bangladesh.

BACKGROUND: Pregnant women are vulnerable to complications of cholera. Killed oral cholera vaccines (OCV) are not recommended for pregnant women though there is no evidence of harmful effects during pregnancy. We evaluated the effect of a killed OCV, Shanchol™, on pregnancy outcomes during an effectiveness trial of the vaccine in urban Bangladesh. METHODOLOGY: Individuals ⩾1year were invited to participate in the trial, conducted in 2011 in Dhaka, Bangladesh. Pregnancy by history was an exclusion criterion and all women of reproductive age (15-49years) were verbally questioned about pregnancy at enrollment and prior to vaccination. Out of 48,414 women of reproductive age 286 women received the OCV unknowingly while pregnant. Out of these, we could recruit 69 women defined as exposed to OCV. Accordingly, we selected 69 pregnant women randomly from those who did not take the OCV (non-exposed to OCV). We evaluated adverse pregnancy outcome (spontaneous miscarriages, still births, or congenital malformations) between those who were exposed to OCV and those who were not exposed to OCV. RESULTS: About 16% of pregnant women exposed to OCV had pregnancy loss, as compared to 12% of unvaccinated pregnant women (P=0.38). One congenital anomaly was observed and occurred in women non-exposed to OCV group. Models that adjusted for baseline characteristics that were unbalanced between the exposed and non-exposed groups, revealed a no elevation of risk of adverse pregnancy outcomes in vaccinees versus non-vaccinees (Adj. OR (95% CI): 0.45 (0.11-1.88). CONCLUSIONS: No excess of adverse fetal outcomes associated with receipt of OCV was observed in this study. TRIAL REGISTRATION: Clinical Trials.gov number NCT01339845.

Diarrheal Illness and Healthcare Seeking Behavior among a Population at High Risk for Diarrhea in Dhaka, Bangladesh.

Diarrhea remains one of the major causes of death in Bangladesh. We studied diarrheal disease risk and healthcare seeking behavior among populations at high risk for diarrhea in Dhaka, Bangladesh. Data were obtained from a cross-sectional survey conducted during April and September 2010. The prevalence of diarrhea was calculated by age-group and sex. A generalized estimating equation with logit link function was used to predict diarrheal disease risk and seeking care from a professional healthcare provider. Of 316,766 individuals, 10% were young children (<5 years). The prevalence of diarrhea was 16 per 1000 persons among all ages; young children accounted for 44 per 1000 persons. Prevalence of diarrhea was significantly higher (p=.003) among younger males (<15 years) compared to that among younger females. In contrast, prevalence of diarrhea was significantly higher (p<.0001) among older females (≥15 years) compared to that among older males. An increased risk for diarrhea was observed in young children, males, and those staying in rented houses, lower family members in the house, using non-sanitary toilets, living in the area for short times, living in a community with less educated persons, living in a community with less use of safe water source for drinking, or living close to the hospital. About 80% of those with diarrhea sought care initially from a non-professional healthcare provider. Choice of the professional healthcare provider was driven by age of the patient, educational status of the household head, and hygienic practices by the household. The study reaffirms that young children are at greater risk for diarrhea. Like other developing countries most people in this impoverished setting of Dhaka are less likely to seek care from a professional healthcare provider than from a non-professional healthcare provider, which could be attributed to a higher number of diarrheal deaths among young children in Bangladesh. Dissemination of information on health education, increasing the supply of skilled healthcare providers, and low-cost and quality healthcare services may encourage more people to seek care from professional healthcare providers, thus may help reduce child mortality in the country. Further studies are warranted to validate the results.

Feasibility, acceptability, and programme effectiveness of misoprostol for prevention of postpartum haemorrhage in rural bangladesh: a quasiexperimental study.

We explored the feasibility of distributing misoprostol tablets using two strategies in prevention of postpartum haemorrhage (PPH) among women residing in the Abhoynagar subdistrict of Bangladesh. We conducted a quasiexperimental study with a posttest design and nonequivalent comparison and intervention groups. Paramedics distributed three misoprostol tablets, one delivery mat (Quaiyum's delivery mat), a packet of five standardized sanitary pads, and one lidded plastic container with detailed counseling on their use. All materials except misoprostol were also provided with counseling sessions to the control group participants. Postpartum blood loss was measured by paramedics using standardized method. This study has demonstrated community acceptability to misoprostol tablets for the prevention of PPH that reduced overall volume of blood loss after childbirth. Likewise, the delivery mat and pad were found to be useful to mothers as tools for assessing the amount of blood loss after delivery and informing care-seeking decisions. Further studies should be undertaken to explore whether government outreach health workers can be trained to effectively distribute misoprostol tablets among rural women of Bangladesh. Such a study should explore and identify the programmatic requirements to integrate this within the existing reproductive health program of the Government of Bangladesh.

Coverage and acceptability of cholera vaccine among high-risk population of urban Dhaka, Bangladesh.

The oral cholera vaccine (Shanchol), along with other interventions, is a potential new measure to prevent or control cholera. A mass cholera-vaccination programme was launched in urban Dhaka, Bangladesh, during February-April 2011 targeting about 173,041 people who are at high risk of cholera. This cross-sectional, descriptive study assessed the coverage and acceptability of the vaccine. The study used a quantitative household survey and qualitative data-collection techniques comprising focus-group discussions, in-depth interviews, and observations for assessment. The findings revealed that 88% of the target population received the first dose of the vaccine, and 79% received the second dose. Absence of persons at home was a prominent cause of not administering the first (71%) and the second dose (67%). Thirty-three percent of the respondents (n=9308) did not like the taste of the vaccine. Only 1.3% and 3% recipients of the first dose and the second dose of the vaccine respectively reported adverse effects within 28 days of vaccination, and the adverse effects included vomiting or vomiting tendency and diarrhoea. To improve the coverage of the cholera vaccine, exploration of effective solutions to reach the unvaccinated population is required. The vaccine may be more acceptable to the community through changing its taste.