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Study protocol of a cluster randomized controlled trial of strategies to increase antenatal iron and folic acid supplementation and malaria prophylaxis in rural south-central Cote d'Ivoire.

ABSTRACT: BACKGROUND:Coverage of antenatal iron and folic acid supplementation (IFAS) and intermittent preventive treatment of malaria in pregnancy (IPTp) remains low in many countries. Evidence on the most effective ways to increase both IFASIPTp is mixed overall, with only few studies directly identifying cost-effective ways to increase coverage of both interventions. The proposed study aims to assess the cost, impact and relative cost-effectiveness of two complementary strategies of increasing IFAS and malaria chemoprophylaxis coverage among pregnant women relative to the current default system in a rural low-income setting of sub-Saharan Africa. METHODS/DESIGN:This study will be carried out in the Taabo health and demographic surveillance system (HDSS) in south-central Côte d'Ivoire. This is a cluster-randomized trial targeting 720 consenting pregnant women aged ?15?years. The 118 clusters constituting the Taabo HDSS monitoring area will be randomly allocated to one of the following three groups with equal probability: a control group, an information only group, and an information plus home delivery group. To assess the relative effectiveness of each strategy, we will conduct an endline survey within the first 2 weeks after delivery. The primary outcomes of the trial will be maternal post-partum anaemia and malaria infection. Anaemia will be assessed using HEMOCUE devices; malaria infections will be assessed using standard rapid diagnostic tests named CareStart™ Malaria Pf (HRP2) Ag RDT (Multi Kit with capped lancet and inverted cup specimen transfer device). Other outcomes will include self-reported adherence to supplementation and malaria chemoprophylaxis, as well as miscarriages, stillbirths and low birth weight deliveries. DISCUSSION:This study will assess the cost-effectiveness of two alternative strategies to increase antenatal IFAS and malaria chemoprophylaxis coverage among pregnant women in rural Côte d'Ivoire and similar settings. TRIAL REGISTRATION:ClinicalTrials.gov NCT04250428 ; Registered 31 January 2020.

SUBMITTER: Kone S

PROVIDER: S-EPMC7590727 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Study protocol of a cluster randomized controlled trial of strategies to increase antenatal iron and folic acid supplementation and malaria prophylaxis in rural south-central Côte d'Ivoire.

Koné Siaka S Utzinger Jürg J Probst-Hensch Nicole N Dao Daouda D Fink Günther G

BMC public health 20201027 1

<h4>Background</h4>Coverage of antenatal iron and folic acid supplementation (IFAS) and intermittent preventive treatment of malaria in pregnancy (IPTp) remains low in many countries. Evidence on the most effective ways to increase both IFASIPTp is mixed overall, with only few studies directly identifying cost-effective ways to increase coverage of both interventions. The proposed study aims to assess the cost, impact and relative cost-effectiveness of two complementary strategies of increasing ...[more]

PMID: 33109138

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Project description:IntroductionCoverage of antenatal iron and folic acid (IFA) supplementation and malaria chemoprophylaxis remains low in many low-income and middle-income settings. We assessed the effectiveness of personal information (INFO) sessions and personal information session plus home deliveries (INFO+DELIV) to increase coverage of IFA supplementation and intermittent preventive treatment in pregnancy (IPTp), and their effectiveness on postpartum anaemia and malaria infection.MethodsWe included 118 clusters randomised to a control (39), INFO (39) and INFO+DELIV (40) arm, in a trial conducted between 2020 and 2021 with pregnant women (age ≥15 years) in their first or second trimester of pregnancy in Taabo, Côte d'Ivoire. We used generalised linear regression models to assess intervention impact in postpartum anaemia and malaria parasitaemia, and displayed resulting estimates as prevalence ratios.ResultsOverall, 767 pregnant women were enrolled and 716 (93.3%) were followed up after delivery. Neither intervention had an impact on postpartum anaemia, with estimated adjusted prevalence ratios (aPRs) of 0.97 (95% CI 0.79 to 1.19, p=0.770) for INFO and 0.87 (95% CI 0.70 to 1.09, p=0.235) for INFO+DELIV. While INFO had no effect on malaria parasitaemia (aPR=0.95, 95% CI 0.39 to 2.31, p=0.915), INFO+DELIV reduced malaria parasitaemia by 83% (aPR=0.17, 95% CI 0.04 to 0.75, p=0.019). No improvements in antenatal care (ANC) coverage (aPR=1.05, 95% CI 0.81 to 1.36, p=0.692), IFA (aPR=2.00, 95% CI 0.89 to 4.46, p=0.093) and IPTp (aPR=1.03, 95% CI 0.87 to 1.21, p=0.728) compliance were found for INFO. INFO+DELIV increased ANC attendance (aPR=1.35, 95% CI 1.02 to 1.78, p=0.037) and compliance with IPTp (aPR=1.60, 95% CI 1.41 to 1.80, p<0.001) and IFA recommendations (aPR=7.06, 95% CI 3.68 to 13.51, p<0.001).ConclusionsINFO+DELIV can substantially increase compliance with IFA supplementation and improve malaria prevention. However, the increases in IFA supplementation are likely insufficient to address the prevalence of often severe anaemia in this population.Trial registration numberNCT04250428.

Project description:BackgroundDaily antenatal multiple micronutrient (MM) compared with iron folic acid (IFA) supplementation from early pregnancy improved birth outcomes and maternal micronutrient status in rural Bangladesh, but effects on newborn status are unknown.ObjectiveWe examined cord blood micronutrient biomarkers in relation to antenatal MM and IFA supplementation and maternal gestational micronutrient status in rural Bangladeshi newborns.DesignIn a double-blinded, cluster-randomized trial of antenatal IFA or MM (with the same IFA content), we analyzed cord blood plasma from 333 singleton births, and corresponding maternal plasma at 32.5 ± 2.6 wk of gestation, for ferritin (iron stores), folate, cobalamin (vitamin B-12), retinol (vitamin A), 25-hydroxyvitamin D [25(OH)D, vitamin D status], α-tocopherol (vitamin E), zinc, thyroglobulin, and free thyroxine (iodine status). Intervention effects and associations were determined using linear regression, exploring maternal status as a mediator of intervention effects on cord biomarkers.ResultsThe MM intervention increased cord ferritin (mean: +12.4%; 95% CI: 1.3, 24.6%), 25(OH)D (mean: +14.7%; 95% CI: 4.8, 25.6%), and zinc (mean: +5.8%; 95% CI: 1.0, 10.8%). Cord folate (mean: +26.8%; 95% CI: 19.6, 34.5%), cobalamin (mean: +31.3%; 95% CI: 24.6, 38.3%), 25(OH)D (mean: +26.7%; 95% CI: 23.2, 30.3%), α-tocopherol (mean: +8.7%; 95% CI: 3.6, 13.7%), zinc (mean: +2.3%; 95% CI: 0.5, 4.2%), thyroglobulin (mean: +20.1%; 95% CI: 9.0, 32.2%) and thyroxine (mean: +1.5%; 95% CI: 0.0, 3.0%) increased per 1-SD increment in maternal status (all P < 0.05); ferritin and retinol changed by +2.0%; 95% CI: -8.9, 14.3%; P = 0.72; and +3.5%; 95% CI: -0.4, 7.3%; P = 0.07, respectively. Ferritin, folate, cobalamin, zinc, and thyroglobulin averaged 1.57-6.75 times higher and retinol, α-tocopherol, and 25(OH)D 0.30-0.84 times lower in cord than maternal plasma, suggesting preferential maternal-fetal transfer of iron, folate, cobalamin, and zinc; limited transfer of fat-soluble vitamins; and high fetal iodine demand.ConclusionsAntenatal MM supplementation increased newborn ferritin, 25(OH)D, and zinc, while maternal and newborn folate, vitamins B-12, D, and E, zinc, and iodine biomarkers were positively related. Despite limited effects of MM, better maternal micronutrient status was associated with improved micronutrient status of Bangladeshi newborns. This trial was registered at clinicaltrials.gov as NCT00860470.

Project description:BackgroundCoverage of iron-folic acid (IFA) supplementation is a key indicator for tracking programmatic progress within and across countries. However, the validity of maternal report of this information during household surveys has yet to be determined.ObjectivesThis study aimed to examine the validity of maternal recall of receipt of IFA supplementation during antenatal care (ANC) and factors associated with accuracy of maternal recall.MethodsA longitudinal cohort design was employed. The direct observation of the IFA received during all ANC visits at the 5 study health posts served as the "gold standard" to the maternal report of IFA received during the postpartum interview. Individual-level validity was assessed by calculating indicator sensitivity, specificity, and AUC. The inflation factor (IF) measured population-level bias. A multivariable log-binomial model was used to assess factors associated with accurate recall.ResultsThe majority (95.8%) of women were observed receiving IFA during pregnancy. Women overreported the number of IFA tablets received compared with what was observed during ANC visits (mean difference: 45 tablets). Maternal report of any IFA receipt was moderate (AUC = 0.60; 95% CI: 0.50, 0.71), and population bias was low (IF = 1.01). However, the individual-level validity was poor across the 7 IFA tablet count categories; the AUC for categories ranged from misleading to moderate. Driven by the trend of maternal overreport, the IF indicated that maternal report drastically underestimated the coverage of lower tablet categories and overestimated the coverage of higher tablet counts. Accuracy of maternal report was not associated with months since last ANC observation nor any maternal characteristics.ConclusionsMaternal report of the amount of IFA supplementation received during pregnancy produced extremely biased population coverage and performed poorly to moderately for individual-level validity. It is imperative to improve this indicator because it is used in global frameworks and national program planning.

Project description:BackgroundInsecticides play a key role in rural farming; however, their over- or misuse has been linked with a negative impact on malaria vector control policies. This study was conducted amongst agricultural communities in Southern Côte d'Ivoire to identify which insecticides are used by local farmers and how it relates to the perception of farmers on malaria. Understanding the use of insecticides may help in designing awareness programme on mosquito control and pesticides management.MethodsA questionnaire was administered to 1399 farming households across ten villages. Farmers were interviewed on their education, farming practices (e.g. crops cultivated, insecticides use), perception of malaria, and the different domestic strategies of mosquito control they use. Based on some pre-defined household assets, the socioeconomic status (SES) of each household was estimated. Statistical associations were calculated between different variables, showing significant risk factors.ResultsThe educational level of farmers was significantly associated with their SES (p < 0.0001). Most of the householders (88.82%) identified mosquitoes as the principal cause of malaria, with good knowledge of malaria resulting as positively related to high educational level (OR = 2.04; 95%CI: 1.35, 3.10). The use of indoor chemical compounds was strongly associated to the SES of the households, their education level, their use of ITNs and insecticide in agricultural (p < 0.0001). Indoor application of pyrethroid insecticides was found to be widespread among farmers as well as the use of such insecticide for crops protection.ConclusionOur study shows that the education level remains the key factor influencing the use of insecticides by farmers and their awareness of malaria control. We suggest that better communication tailored to education level and including SES, controlled availability and access to chemical products, should be considered when designing campaigns on use of pesticides and vector borne disease control for local communities.

Project description:Since the 1970s, the northern part of Côte d'Ivoire has experienced considerable fluctuation in its meteorology including a general decrease of rainfall and increase of temperature from 1970 to 2000, a slight increase of rainfall since 2000, a severe drought in 2004-2005 and flooding in 2006-2007. Such changing climate patterns might affect the transmission of malaria. The purpose of this study was to analyze climate and environmental parameters associated with malaria transmission in Korhogo, a city in northern Côte d'Ivoire. All data were collected over a 10-year period (2004-2013). Rainfall, temperature and Normalized Difference Vegetation Index (NDVI) were the climate and environmental variables considered. Association between these variables and clinical malaria data was determined, using negative binomial regression models. From 2004 to 2013, there was an increase in the annual average precipitation (1100.3-1376.5 mm) and the average temperature (27.2°C-27.5°C). The NDVI decreased from 0.42 to 0.40. We observed a strong seasonality in these climatic variables, which resembled the seasonality in clinical malaria. An incremental increase of 10 mm of monthly precipitation was, on average, associated with a 1% (95% Confidence interval (CI): 0.7 to 1.2%) and a 1.2% (95% CI: 0.9 to 1.5%) increase in the number of clinical malaria episodes one and two months later respectively. A 1°C increase in average monthly temperature was, on average, associated with a decline of a 3.5% (95% CI: 0.1 to 6.7%) in clinical malaria episodes. A 0.1 unit increase in monthly NDVI was associated with a 7.3% (95% CI: 0.8 to 14.1%) increase in the monthly malaria count. There was a similar increase for the preceding-month lag (6.7% (95% CI: 2.3% to 11.2%)). The study results can be used to establish a malaria early warning system in Korhogo to prepare for outbreaks of malaria, which would increase community resilience no matter the magnitude and pattern of climate change.

Project description:BackgroundEvidence from armed conflict settings points to high levels of intimate partner violence (IPV) against women. Current knowledge on how to prevent IPV is limited-especially within war-affected settings. To inform prevention programming on gender-based violence in settings affected by conflict, we evaluated the impact of adding a targeted men's intervention to a community-based prevention programme in Côte d'Ivoire.MethodsWe conducted a two-armed, non-blinded cluster randomized trial in Côte d'Ivoire among 12 pair-matched communities spanning government-controlled, UN buffer, and rebel-controlled zones. The intervention communities received a 16-week IPV prevention intervention using a men's discussion group format. All communities received community-based prevention programmes. Baseline data were collected from couples in September 2010 (pre-intervention) and follow-up in March 2012 (one year post-intervention). The primary trial outcome was women's reported experiences of physical and/or sexual IPV in the last 12 months. We also assessed men's reported intention to use physical IPV, attitudes towards sexual IPV, use of hostility and conflict management skills, and participation in gendered household tasks. An adjusted cluster-level intention to treat analysis was used to compare outcomes between intervention and control communities at follow-up.ResultsAt follow-up, reported levels of physical and/or sexual IPV in the intervention arm had decreased compared to the control arm (ARR 0.52, 95% CI 0.18-1.51, not significant). Men participating in the intervention reported decreased intentions to use physical IPV (ARR 0.83, 95% CI 0.66-1.06) and improved attitudes toward sexual IPV (ARR 1.21, 95% CI 0.77-1.91). Significant differences were found between men in the intervention and control arms' reported ability to control their hostility and manage conflict (ARR 1.3, 95% CI 1.06-1.58), and participation in gendered household tasks (ARR 2.47, 95% CI 1.24-4.90).ConclusionsThis trial points to the value of adding interventions working with men alongside community activities to reduce levels of IPV in conflict-affected settings. The intervention significantly influenced men's reported behaviours related to hostility and conflict management and gender equitable behaviours. The decreased mean level of IPV and the differences between intervention and control arms, while not statistically significant, suggest that IPV in conflict-affected areas can be reduced through concerted efforts to include men directly in violence prevention programming. A larger-scale trial is needed to replicate these findings and further understand the mechanisms of change.Trial registrationclinicaltrials.gov NCT01803932.

Dataset Information

Study protocol of a cluster randomized controlled trial of strategies to increase antenatal iron and folic acid supplementation and malaria prophylaxis in rural south-central Cote d'Ivoire.

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Study protocol of a cluster randomized controlled trial of strategies to increase antenatal iron and folic acid supplementation and malaria prophylaxis in rural south-central Côte d'Ivoire.

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