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Background: Exclusive breastfeeding (EBF) of infants during the first 6 months of their life is strongly recommended. Video‐based communication is an innovative method that could promote EBF. The present study is aimed at assessing the effectiveness of video‐based intervention in promoting breastfeeding practices from birth to 6 months postpartum. This was evaluated through maternal reports, as well as EBF of infants at 3 and 5 months of age, using the deuterium oxide dose‐to‐mother (DTM) technique. Methods: In a cluster randomized community trial, 16 communities were assigned to receive a video‐based behavior change communication (Video‐Health) or standard health care messages (Control). Pregnant women in their first trimester (12 ± 2 weeks) were enrolled and followed up, together with their infants, until 6 months postpartum. Data on breastfeeding practices were collected by questionnaire, monthly, in all the participants (n = 508). Human milk intake (HMI) and nonmilk oral intake (NMOI) were measured in a subsample of 60 mother–infant pairs at 3 and 5 months postpartum using DTM. Mixed models and logistic regression were used to examine the difference in continuous and discrete breastmilk practices between the intervention and the control arms, respectively. Results: The majority of mothers initiated breastfeeding early (92.1%), 82.4% reported colostrum feeding, and 17.5% provided prelacteal feeding. No significant differences were found between Video‐Health and Control arms (p > 0.05). The intervention significantly improved reported EBF rates at 4 and 5 months postpartum (p < 0.05). DTM results showed that the proportion of women practicing EBF was 50%–67% less than reported at 3 months for both arms and at 5 months in the intervention arm. The intervention did not significantly affect measured EBF at 3 and 5 months postpartum but did improve HMI at 3 months. Non significant differences in NMOI were observed at 3 months, but at 5 months, there was a significant difference between the study arms. Conclusions: Video‐based behavior change communication did not result in significant improvements in reported breastfeeding practices, except for a higher reported adherence to EBF beyond 3 months. Additionally, the intervention had no effect on EBF as measured by the DTM. Early introduction of non‐breastmilk foods and liquids persisted, despite self‐reported EBF extending up to 6 months postpartum. Trial Registration: ClinicalTrials.gov identifier: NCT04414527 [ABSTRACT FROM AUTHOR]

Maternal malnutrition is pervasive throughout the world, notably in sub-Saharan Africa (SSA), including Ethiopia. This study aimed to assess the effect of nutrition education on the nutritional status of pregnant women in urban settings in Southeast Ethiopia. A community-based two-arm parallel cluster randomized controlled trial was conducted among 447 randomly selected pregnant women attending antenatal care (224 intervention and 223 control). We used a multistage cluster sampling technique followed by systematic sampling to select the pregnant women. Pregnant women who participated in the intervention arm received six nutrition education sessions. Women in the control group received standard care. A nonstretchable mid-upper arm circumference (MUAC) tape was used to measure the MUAC. A linear mixed effects model (LMM) was used to evaluate the effect of the intervention on MUAC, accounting for the clustering. The net mean ± standard error of MUAC between the intervention and control groups was 0.59 ± 0.05 (P < 0.0001). The multivariable LMM indicated that having received nutrition education interventions (β = 0.85, 95% CI 0.60, 1.12, P < 0.0001) improved the MUAC measurement of pregnant women. Thus, nutrition education during pregnancy will combat undernutrition among pregnant women. Trial Registration: Clinicaltrials.gov (PACTR202201731802989), retrospectively registered on 24/01/2022. [ABSTRACT FROM AUTHOR]

Background: Over the last 20 years, global healthcare has placed a major focus on improving the survival rates of mothers and children, recognizing the potential to prevent a significant number of deaths resulting from pregnancy and childbirth. Nevertheless, there remains an ongoing obstacle to the insufficient utilization of critical obstetric services to achieve optimal health outcomes for pregnant women. This study aimed to assess the magnitude and determinants of maternal healthcare use in the Jimma Zone, Ethiopia. Methods: Data were obtained from a household survey as part of the baseline assessment of a cluster randomized controlled trial. The study participants comprised 588 women in early pregnancy, specifically those with a gestational age of less than 20 weeks. Logistic regression analysis was employed to identify factors associated with the use of maternal health services. Adjusted odds ratios (AORs) were used to assess the strength of the associations, with significance level set at a p-value ≤ 0.05. Results: The overall prevalence of maternal health service utilization was 87.9% (CI: 85.1, 90.4) for antenatal care, 74.7% (CI: 73.2, 79.9) for health facility delivery, and 60.4% (CI: 56.4, 64.3) for postnatal care. Multivariable logistic analysis revealed that maternal health service use was significantly influenced by access to health facilities (AOR: 6.6; 95% CI: 2.39, 18.16), financial hardship (AOR: 3; 95% CI: 1.97, 4.61), perceived respectful care (AOR: 2.3; 95% CI: 1.07, 5.11), perceived privacy of service provisions (AOR: 2.4; 95% CI: 1.47, 4.06), and attitudes toward maternal service use (AOR: 2.2; 95% CI: 1.48, 3.24). Conclusions: The study revealed slightly higher rates of antenatal care, facility delivery, and postpartum care utilization. However, there was a low proportion of early antenatal care initiation, and high rates of antenatal care dropout. Mobile phone-based messaging intervention may enhance maternal health service use by addressing factors such as lack of access, economic challenges, disrespectful care, no privacy of procedures, and unfavorable attitudes. [ABSTRACT FROM AUTHOR]

Cervical cancer is a major public health problem worldwide. Women die of the disease due to low early screening practices and its detection at advanced stages particularly in developing countries. Therefore, this study aimed to determine the effectiveness of couple education and counseling on the uptake of cervical screening among women. The study employed random allocation of 16 clusters into two study arms. A total of 288 women participated in the study. Structured home-based education and counseling were provided to the intervention group, while the control group received standard of care. Surveys were completed at baseline and end line. This study demonstrated that the proportion of women who had been aware of cervical cancer and screening grew from 22.9 to 100%, participants' mean knowledge scores showed improvement from 3.18 to 11.99, and cervical screening uptake increased from 2.1% to 72.5% in the intervention group (p < 0.001). Also, the difference in differences of screening uptake between the study groups was statistically significant (p = 0.021).The study shows the effectiveness of the intervention package in improving the uptake of cervical screening in the study setting. Therefore, we recommend that creating awareness, increasing knowledge, and improving women's perceptions through structured home-based couple education and counseling is important to improve cervical screening uptake among the target women. [ABSTRACT FROM AUTHOR]

Background: A significant proportion of women in Ethiopia suffer from violence by their intimate partner during pregnancy, which has adverse maternal and newborn outcomes. Couple-focused interventions are effective in reducing and/or controlling violence between women and their intimate partners. However, interventions addressing intimate partners of the victims are not well studied, particularly in the Ethiopian setting. This study aims to assess the effect of couple-based violence prevention education on intimate partner violence during pregnancy. Methods: We will use a cluster randomized controlled trial to evaluate the effectiveness of couple-based violence prevention education compared to routine care in reducing intimate partner violence during pregnancy. Sixteen kebeles will be randomly assigned to 8 interventions and 8 control groups. In the trial, 432 couples whose wife is pregnant will participate. Health extension workers (HEWs) will provide health education. Data will be collected at baseline and endline. All the collected data will be analyzed using Stata version 16.0 or SPSS version 25.0. We will use the McNemar test to assess the differences in outcomes of interest in both intervention and control groups before and after the intervention for categorical data. A paired t-test will be used to compare continuous outcome of interest in the intervention and the control groups after and before the intervention. The GEE (Generalized Estimating Equation), will be used to test the independent effect of the intervention on the outcome of the interest. Data analysis will be performed with an intention-to-treat analysis approach. During the analysis, the effect size, confidence interval, and p-value will be calculated. All tests will be two-sided, and statistical significance will be declared at p < 0.05. Discussion: We expect that the study will generate findings that can illuminate violence prevention strategies and practices in Ethiopia. Trial registration: It has been registered on ClinicalTrials.gov as NCT 05856214 on May 4, 2023. [ABSTRACT FROM AUTHOR]

Background: Despite the many supply- and demand-side interventions aimed at increasing uptake of maternal health service utilizations, the maternal and new-born health service utilizations remains low. Religious leaders have the power to inhibit or facilitate effective adoption of maternal health service utilizations to promote maternal health. However, evidence on the roles of religious leaders in promoting maternal health in developing world is not fully known. Therefore this cluster-randomized trial is designed to evaluate the effects of trained religious leaders' engagement in maternal health education in improving maternal health service utilization and knowledge of obstetric danger signs. Methods: A community based cluster randomized control trial in which the study kebeles are randomly assigned into intervention and control groups will be conducted. The sample size is calculated using stata software. Three hundred six pregnant mothers will be enrolled in each group. A baseline study will be conducted before the intervention and post-intervention evaluation will be conducted after four months of intervention. Religious leaders will be selected and trained to lead participatory sessions on maternal health. Data on maternal health service utilizations, knowledge about obstetric danger signs, attitude towards skilled delivery service utilization and perception of pregnancy risk will be collected from a repeated cross sectional household survey. Effect of intervention will be assessed using multivariable logistic regression with generalized estimating equation model. Data will be analyzed using STATA software. For qualitative study, coded transcripts will be further analyzed and summarized in narratives for each theme and sub-themes. Discussion: This is one of the first trials to evaluate the effectiveness of trained religious leaders' engagement in maternal health education and will provide much needed evidence to policy makers about aspects of functionality and the religious leaders engagement required as they scale-up this programme in Ethiopia. [ABSTRACT FROM AUTHOR]

Background: Poor behavior change communication on maternal nutrition and health throughout pregnancy is thought to be to blame for Ethiopia's high rate of low birthweight babies, and this has implications for neonatal morbidity and mortality. The effect of behavior change communication on birth weight in the study district was not examined. This study was to determine whether improving neonatal birthweight using nutrition and health behavior change communication (NHBCC) interventions was successful. Methods: A cluster randomized controlled trial was conducted in the Ambo district of Ethiopia from May 5, 2018–January 30, 2019. At the beginning of the study, 385 women in the 24 intervention groups and 385 women in the 24 control groups were recruited. In the intervention group, health development armies delivered the NHBCC core message every two weeks for four months by grouping pregnant women in specific clusters. Pregnant women in the control group received the routine treatment offered by the healthcare system during their ANC visits. Within 24 h of birth, the birthweights of 302 and 292 neonates in the intervention and control groups, respectively, were measured at the end point of the study. A binary generalized linear model analysis was employed. Result: The control group had a larger absolute risk of neonates with low birthweight (0.188 vs. 0.079, p < 0.001) than the intervention group. Pregnant women in the intervention group had an absolute risk difference of 10.9% for low birthweight. Pregnant women who received the intervention were 62% less likely to have low-risk birthweight compared to pregnant women who were in the control group (ARR = 0.381, 95% CI: 0.271–0.737). Conclusion: Nutrition and health behavior change Communication by health development armies improves birthweight. The findings demonstrated that to improve birthweight, NHBCC must be administered to pregnant women in groups via health development armies in their communities. Trial registration number: PACTR201805003366358. [ABSTRACT FROM AUTHOR]

When pregnancy occurs in adolescence, the growth and development of the mother and fetus may be impaired due to strong competition for nutrients between the still-growing adolescent and the fetus. Pregnant adolescents constitute an underserved population; they lack adequate nutritional knowledge. Therefore, this study investigated the effect of nutritional behavior change communication (NBCC) through alliance for development (AFD) on the nutritional status and gestational weight gain (GWG) of pregnant adolescents. A two-arm parallel cluster randomized controlled community trial was conducted in the West Arsi Zone, central Ethiopia, from August 2022 to July 2023. The nutritional status of the pregnant adolescent was assessed using mid-upper arm circumference. Weight was measured at baseline and at the end of the intervention. A total of 207 and 219 pregnant adolescents participated in the intervention and control clusters, respectively. The intervention started before 16 weeks of gestation, and the intervention group attended four NBCC sessions. The NBCC was based on the health belief model (HBM) and was given at the participants' homes with their husbands. The NBCC intervention was delivered by AFDs and community-level health actors. Pregnant adolescents in the control group received routine nutrition education from the health care system. A linear mixed-effects model and difference in difference (DID) were used to measure the intervention effect after adjusting for potential confounders. After the implementation of the trial, the mean mid-upper arm circumference (MUAC) in the intervention arm significantly increased from baseline (p ≤ 0.001), 23.19 ± 2.1 to 25.06 ± 2.9 among intervention group and 23.49 ± 2.1 to 23.56 ± 2.0 among control group and the mean difference in the MUAC (DID) was 1.89 ± 2 cm (p ≤ 0.001); the mean GWG in the intervention arm significantly increased from baseline; 51.54 ± 4.7 to 60.98 ± 4.6 among intervention group and 52.86 ± 5.27 to 58 ± 5.3 among control group; the mean GWG in the intervention group was 9.4 kg, and that in the control group was 5.14 kg, and the difference in difference was 4.23 kg and this was statically significant p ≤ 0.001). This study demonstrated that the use of the HBM for NBCC delivered through the AFD was effective at improving the nutritional status and GWG of pregnant adolescents. These results imply the need for the design of model-based nutritional counseling guidelines. Clinical trial registration: PACTR202203696996305, Pan African Clinical Trials Registry, date of first registration: 16/03/2022. [ABSTRACT FROM AUTHOR]

Background: Maternal anemia, miscarriage, low birth weight (LBW), preterm birth (PTB), intrauterine growth restriction (IUGR), prenatal and infant mortality, morbidity, and the risk of chronic disease later in life are all increased by a lack of dietary diversity during pregnancy. However, evidence for the effect of nutrition education on the dietary diversity score (DDS) among pregnant women was sparse in Ethiopia, particularly in the study areas. This study aimed to assess the effect of nutrition education on dietary diversity among pregnant women in urban settings in Southeast Ethiopia. Methods: A community-based two-arm parallel cluster randomized controlled trial was conducted among 447 randomly selected pregnant women attending antenatal care (224 intervention group and 223 control group) at health facilities from February to December 2021. A multistage cluster sampling technique, followed by systematic sampling, was used to select the pregnant women. Pregnant women who participated in the interventions were given nutrition education starting at 16 weeks of gestation and continuing for 6 months. We used a pre-tested, interviewer-administered, structured questionnaire to collect the data. A 24-hour qualitative dietary recall was used to calculate the dietary diversity score (DDS). A multivariable generalized estimating equation (GEE) model was conducted to evaluate the intervention effect. Results: After the intervention, the proportion of adequate dietary diversity was 14.15% higher in the intervention arm compared to the control group (45.09% versus 30.94%, P = 0.002). The overall difference in adequate dietary diversity between the two groups was 8.5%. After adjusting for background characteristics, the multivariable GEE binary logistic model revealed that having received intervention [(AOR = 1.89, 95% CI: 1.27, 2.79)], being literate [(AOR = 3.41, 95% CI: 1.13, 10.23)], and having high wealth [(AOR = 1.60, 95% CI: 1.09, 2.35)] significantly improved adequate dietary diversity. Conclusion: The findings indicated that having received the intervention, being literate, and having a high level of wealth significantly improved maternal dietary diversity. Efforts should be made to increase nutrition education using the health belief model (HBM) and the theory of planned behavior (TPB). Moreover, there is a need to improve literacy and economic empowerment through income-generating activities to enhance adequate dietary diversification during pregnancy. Trial registration: Clinicaltrials.gov (PACTR202201731802989, Retrospectively registered on 24 January 2022). [ABSTRACT FROM AUTHOR]

Background: Non-optimal infant and young child feeding practices (IYCFP) are linked to malnutrition and infant mortality in poor countries, notably in Ethiopia. The majority of growth stalls occur within the first two years of life; hence, there is a need to discover interventions that enhance appropriate IYCFP for improving nutritional outcomes during this critical period. Using the experience of mothers who have come up with solutions to their IYCFP problems to educate others, is a potential pathway to initiate and sustain behavioral changes in resource-limited areas. However, such interventions are not widely implemented in Ethiopia. Objective: This study aims to assess the effectiveness of a positive deviance approach (PDA) to improve appropriate feeding and nutritional status in South West region, Ethiopia. Methods: A cluster randomized controlled trial will be conducted to compare the effect of positive deviant intervention versus routine health education. The intervention will be provided by positive deviant mothers based on uncommon practices that potentially benefit IYCFP will be identified. Training of the trainers manual on counselling and supporting non-positive deviant mothers based on the uncommon practices identified and WHO IYCFP guidelines will be provided for facilitating change. Culturally appropriate and scientifically acceptable operational packages of information will be developed. A total of 516 mothers will be recruited from 36 zones. The intervention arm will receive 12 demonstration sessions in groups and every 15th day home visit by positive deviant mothers. Data will be entered into epi data version 3.1 and analyzed using STATA version 16.0. All analyses will be done as intention-to-treat. We will fit the mixed effects linear regression model for continuous outcomes and mixed effects linear probability model for the binary outcomes in the study zone as a random intercept to estimate study arm difference (intervention vs. routine health education) adjusted for the baseline values of the outcome and additional relevant covariates. Discussion: We expect that the trial will generate findings informing IYCFP and nutritional policies and practices in Ethiopia. Trial registration: This trial was registered at ClinicalTrials.gov as PACTR202108880303760, 30/8/2021. [ABSTRACT FROM AUTHOR]

The growing aging population raises nutrition and health concerns, with malnutrition in the elderly linked to negative health outcomes. Our objective was to implement theory‐based nutritional education interventions to improve the nutritional status of the elderly through diversified dietary practices. A cluster randomized controlled trial was conducted from December 1, 2021, to May 30, 2021, among 782 older persons randomly selected from two urban and 12 semi‐urban areas in southwest Ethiopia. We used Social cognitive theory (SCT) in guiding the nutritional education intervention. Data were collected using an interviewer‐administered questionnaire. The Mini Nutritional Assessment (MNA) tool was used to assess nutritional status, and a qualitative 24‐h eating recall was used to evaluate dietary diversity. Difference‐in‐difference and generalized estimating equation models were used to assess the intervention effect. In total, 720 participants (361 in the intervention group and 359 in the control group) were included for analysis. The mean dietary diversity score differed significantly between the intervention group and the control group (p <.001). According to the multivariable generalized estimating equations model, the intervention group was 7.7 times (AOR = 7.746, 95% CI: 5.012, 11.973) more likely to consume a diverse diet than the control group. The nutrition status of the elderly in the intervention group improved significantly at the end of the intervention (p <.001). SCT‐based nutritional education interventions can effectively improve healthy eating and nutritional status. For older adults, with its convenient approach and low cost, SCT should be considered an effective and efficient nutritional education approach for behavior change. [ABSTRACT FROM AUTHOR]

Background: Protein undernutrition is a prevalent health problem in Ethiopia severely affecting the reproductive outcome of women. This is mainly because of inadequate consumption of protein due to the high cost of animal-origin food and the lack of knowledge about the benefits and the methods of preparation of pulses-based foods. Therefore, this trial was conducted to evaluate the effectiveness of nutrition education in improving the consumption of pulses-based foods among female adolescents. Methods: A two-arm pragmatic cluster randomized controlled trial was conducted among female adolescents in Northwest Ethiopia. Clusters were schools assigned into intervention and control groups by cluster randomization. The trial participants were female adolescents. The intervention was pulses-based nutrition education, and the comparator was the usual dietary practice of adolescent girls. The education was delivered over four weeks on a 45–60 min session per week basis. The primary outcome of the intervention was pulses-based food consumption, and the secondary outcomes were knowledge and attitude about pulses food. Data on the outcome and the confounding variables were collected at baseline and end-line of the intervention. The analysis was based on intention-to-treat analysis, and a log-binomial logistic regression model was fitted to the data to calculate relative risk with the corresponding p value adjusted for baseline characteristics. The intervention was considered effective when the p value was < 0.05. Results: A total of 269 intervention and 278 control participants from the four clusters completed the trial making response rates of 92.1% and 95.2%, respectively. The pulses-based nutrition education enabled participants in the intervention group to maintain their pulses-based food consumption state, while participants in the control group significantly reduced their consumption by about threefold [ARR; 95% CI 2.99 (1.87, 4.79)] from harvesting to non-harvesting season. The consumption of pulses-based food was higher by 16% among the intervention participants as compared to the control participants [ARD; 95% CI 0.16 (0.10, 0.21)]. Conclusion: Pulses-based nutrition education is effective in improving the consumption of pulses-based food among female adolescents. Therefore, policies and strategies are required to integrate this intervention in the school nutrition program. Trial registration: The trial was registered in the Pan African Clinical Trials Registry (PACTR202111813445259) on 02 November 2021. [ABSTRACT FROM AUTHOR]

Background: A birth companion is a simple and low-cost intervention that can improve both maternal and newborn health outcomes. The evidence that birth companionship improves labor outcomes and experiences of care has been available for many years. Global and national policies exist in support of birth companions. Many countries including Ethiopia, Kenya, and Nigeria have not yet incorporated birth companions into routine practice in health facilities. This paper presents the protocol for a trial that aims to assess if a package of interventions that addresses known barriers can increase the coverage of birth companions. Methods: This two parallel arm cluster randomized controlled trial will evaluate the impact of a targeted intervention package on scale-up of birth companionship at public sector health facilities in Ethiopia (five study sites encompassing 12 facilities), Kenya (two sites encompassing 12 facilities in Murang'a and 12 facilities in Machakos counties), and Nigeria (two sites encompassing 12 facilities in Kano and 12 facilities in Nasarawa states). Baseline and endline assessments at each site will include 744 women who have recently given birth in the quantitative component. We will interview a maximum of 16 birth companions, 48 health care providers, and eight unit managers quarterly for the qualitative component in each country. Discussion: Ample evidence supports the contribution of birth companions to positive health outcomes for mothers and newborns. However, limited data are available on effective strategies to improve birth companion coverage and inform scale-up efforts. This trial tests a birth companion intervention package in diverse clinical settings and cultures to identify possible barriers and considerations to increasing uptake of birth companions. Findings from this study may provide valuable evidence for scaling up birth companionship in similar settings. Trial registration: Trial is registered with ClinicalTrials.gov with identifier: NCT05565196, first posted 04/10/ 2022. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to assess the effect of intensive nutrition education and counseling on hemoglobin level during pregnancy. Methods and materials: The study was a one year two-arm parallel design cluster randomized controlled trial in East Shoa zone, Ethiopia. End-line data were collected from 163 intervention and 163 control group pregnant women. The intervention was a three consecutive trimester based counseling sessions using health belief model, weekly regular SMS sent on mobile phone containing core message and providing leaflet with food menu of Iron rich diet. The women in the control group received routine nutrition education from facilities. After adjusting for potential confounders, a linear mixed-effects model was used to assess the intervention effect. Results: There was a significant change in both hemoglobin level and proportion of anemia in the intervention group. The mean hemoglobin level within intervention group before and after intervention was (12.08± 1.15, 12.53± 1.18) with p value of 0.01. The prevalence of anemia among intervention group declined from 14.7 % at the baseline to 9.2% after intervention. At the end of the trial, women in the intervention group had significantly better hemoglobin level than women in the control group (β = 0.50, p < 0.01). Conclusion: The intervention was effective in improving the hemoglobin level and consumption of iron rich diet among pregnant women. Therefore, employing trimester based counseling by using HBM constructs and regular reminding messages have to be provided to pregnant women as part of the regular antenatal care service. [ABSTRACT FROM AUTHOR]

Background: The Enhancing Nutrition and Antenatal Infection Treatment (ENAT) intervention was implemented in Ethiopia to improve newborn birth weight (BW) by strengthening the contents and quality of antenatal care (ANC), especially point-of-care testing for maternal infections. This study examined the effect of the ENAT intervention on birth weight. Methods: We conducted a cluster randomized controlled trial of 22 clusters (health centers), randomized equally between 11 intervention and 11 control clusters. This study enrolled and followed pregnant women from ANC booking to the end of pregnancy or loss to follow-up. The primary outcome was mean BW, and the incidence of low birth weight (LBW) was the secondary outcome. We presented univariate comparisons of outcomes between the intervention and control arms for mean BW and LBW. Multilevel analyses using random effects models were performed to adjust for clustering and individual-level covariates. Results: We enrolled and followed up 4,868 and 4,821 pregnant women in the intervention and control arms, respectively, from March 2021-July 2022. During follow-up, 3445 pregnant women in the intervention and 3192 in the control delivered in the health centers, and BW measurements of their babies were recorded within 48 h. The mean BW was 3,152 g (standard deviation (SD) = 339.8 g) in the intervention and 3,044 g (SD = 353.8 g) in the control arms (mean difference, 108 g; 95% confidence interval (CI): 91.3-124.6; P = 0.000). Adjusting for clustering and several covariates, the mean BW remained significantly higher in the intervention arm than in the control arm (adjusted ß coef., 114.3; p = 0.011). The incidence of LBW was 4.7% and 7.3% in the intervention and control arms, respectively. The adjusted risk of LBW was significantly lower by 36% in the intervention arm than in the control arm (adjusted relative risk, 0.645; p = 0.027). Conclusion: This study provided sufficient evidence of the effectiveness of the ENAT intervention in improving birth weight in the study population. The intervention demonstrated that an increase in birth weight can be attained by availing point-of-care testing, strengthening infection prevention, and maternal nutrition within the ANC platform of public health facilities in a low-income setting. Trial Registration: Registered at Pan African Clinical Trial Registry (PACTR) database dated 09/05/2023, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25493. The unique identification number for the registry is PACTR202305694761480. [ABSTRACT FROM AUTHOR]

Background: Each year, 1 million children develop TB resulting in over 200,000 child deaths. TB preventive treatment (TPT) is highly effective in preventing TB but remains poorly implemented for household child contacts. Home-based child contact management and TPT services may improve access to care. In this study, we aim to evaluate the effectiveness and cost-effectiveness of home-based contact management with TPT initiation in two TB high-burden African countries, Ethiopia and South Africa. Methods: This pragmatic cluster randomized trial compares home-based versus facility-based care delivery models for contact management. Thirty-six clinics with decentralized TB services (18 in Ethiopia and 18 in South Africa) were randomized in a 1:1 ratio to conduct either home-based or facility-based contact management. The study will attempt to enroll all eligible close child contacts of infectious drug-sensitive TB index patients diagnosed and treated for TB by one of the study clinics. Child TB contact management, including contact tracing, child evaluation, and TPT initiation and follow-up, will take place in the child's home for the intervention arm and at the clinic for the control arm. The primary outcome is the cluster-level ratio of the number of household child contacts less than 15 years of age in Ethiopia and less than 5 years of age in South Africa initiated on TPT per index patient, comparing the intervention to the control arm. Secondary outcomes include child contact identification and the TB prevention continuum of care. Other implementation outcomes include acceptability, feasibility, fidelity, cost, and cost-effectiveness of the intervention. Discussion: This implementation research trial will determine whether home-based contact management identifies and initiates more household child contacts on TPT than facility-based contact management. Trial registration: NCT04369326. Registered on April 30, 2020. [ABSTRACT FROM AUTHOR]

Background: School-aged children (SAC) have an increased risk to contract malaria and play a major role in its transmission dynamics. However, their malaria prevention experience is poor. Thus, the effect of malaria prevention education (MPE) on bed net utilization, treatment seeking from a health facility and cumulative incidence of malaria was evaluated in Southern Ethiopia. Methods: A two arm cluster randomized controlled trial was conducted by recruiting 2038 SAC from 32 schools. Structured questionnaire was used to collect data on socio-demographic, economic, bed net ownership, bed net utilization, whether the participated child suffered from malaria and has got treatment from a health facility. Generalized mixed effect logistic regression using school as random variable was used to assess the effect of the intervention on the outcome variables. Results: The ownership of bed net in households of the control and intervention schools was similar respectively with 84.6 and 88.6% (Crude Odds Ratio (COR): 1.5; 95%CI: 0.5–4.8). The percentage of SAC slept under the bed net the night before the survey was also similar (55.1% versus 54.0%); COR:1.04; 95%CI: 0.5–2.4). Bed net utilization was affected by household size to the bed net ratio ≤ 2 (Adjusted Odds Ratio (AOR) = 1.6; 95%CI:1.3–2.1), bed net utilization at baseline of the study (AOR = 2.3; 95%CI:1.5–3.6), and history of malaria attack in the last twelve months (AOR = 1.3; 95%CI:1.01–1.8). Reported cumulative incidence of malaria and treatment seeking from a health facility by SAC was similar between intervention and control arms: -2.1% (COR = 0.8; 95%CI: 0.5–1.5) and 9.6% (COR = 1.4; 95%CI: 0.4–4.3) respectively. The reported incidence of malaria was affected by altitude (AOR = 0.5; 95%CI: 0.3–0.8), low and medium wealth index (AOR = 0.7; 95%CI: 0.5–0.96 and AOR = 0.7; 95%CI: 0.5–0.98), adequate bed net number for household members (AOR = 0.7; 95%CI:0.5–0.9) and bed net utilization (AOR = 1.3; 95%CI:1.1–1.8). Conclusions: MPE had no significant effect on the use of malaria prevention measures considered, treatment seeking from a health facility and reported cumulative incidence of malaria though bed net use was associated with malaria incidence. Before organizing any health education program, sustainable implementation efforts have to be warranted especially in SAC, a neglected but relevant vulnerable and reservoirs. Trial registration: Pan African Clinical Trials Registry PACTR202001837195738, registered 21/01/2020. [ABSTRACT FROM AUTHOR]

Objective: Empathy has deteriorated throughout clinical training and medical practice, and little is known about the effect of empathy training on the empathy level of healthcare providers. To address this gap, we assessed the effect of empathy training on the empathy level of healthcare providers in Ethiopia. Design: A cluster randomized controlled trial study design was conducted from 20 December 2021 to 20 March 2022. The empathy training intervention was conducted for three consecutive days. Setting: The study was conducted in five fistula treatment centers in Ethiopia. Participants: The participants were all randomly selected healthcare providers. Main outcome measures: Total mean score, percentage changes, and Cohen’s effect size were computed. A linear mixed effects model and independent t-test were used for data analysis. Results: A majority of the study participants were nurses in the profession, married, and first-degree holders. There was no statistically significant difference in the baseline empathy score of the intervention arm across their socio-demographic features. At the baseline, the mean empathy scores of the control and intervention arms were 102.10 ± 15.38 and 101.13 ± 17.67, respectively. The effect of empathy training on the total mean score changes of empathy of the intervention arm compared to the control arm at each follow-up time had a statistically significant difference. After a week, a month, and three months of post-intervention, the total mean empathy scores between the intervention and control arms were as follows: (intervention 112.65 ± 18.99, control 102.85 ± 15.65, d = 0.55, p = 0.03); (intervention 109.01 ± 17.79, control 100.52 ± 12.57, d = 0.53, p = 0.034); and (intervention 106.28 ± 16.24, control 96.58 ± 14.69, d = 0.60, p = 0.016) with the overall percentage changes of 11, 8, and 5% from the baseline scores, respectively. Conclusion: In this trial, the empathy training intervention was found to have more than a medium effect size. However, over the follow-up intervals, there was a decreasing trend in the total mean empathy scores of healthcare providers; suggesting that there should be continued empathy training and integration of it into educational and training curriculums to enhance and sustain the empathy of healthcare providers. [ABSTRACT FROM AUTHOR]

Despite the beneficial effect of bubble continuous positive airway pressure (BCPAP) oxygen therapy for children with severe pneumonia under the supervision of physicians that has been shown in different studies, effectiveness trials in developing country settings where low-flow oxygen therapy is the standard of care are still needed. Thus, the aim of this study is to assess the effectiveness of bubble CPAP oxygen therapy compared to the WHO standard low-flow oxygen therapy among children hospitalized with severe pneumonia and hypoxemia in Ethiopia. This is a cluster randomized controlled trial where six district hospitals are randomized to BCPAP and six to standard WHO low-flow oxygen therapy. The total sample size is 620 per arm. Currently, recruitment of the patients is still ongoing where the management and follow-up of the enrolled patients are performed by general physicians and nurses under the supervision of pediatricians. The primary outcome is treatment failure and main secondary outcome is death. We anticipate to complete enrollment by September 2022 and data analysis followed by manuscript writing by December 2022. Findings will also be disseminated in December 2022. Our study will provide data on the effectiveness of BCPAP in treating childhood severe pneumonia and hypoxemia in a real-world setting. [ABSTRACT FROM AUTHOR]

Background: Cervical cancer occurred nearly in 570 000 women and 311 000 women died from the disease worldwide in 2018. Of the new cases diagnosed globally in 2012, approximately 85% of the burden took place in low- and middle-income countries. Human Papilloma virus is the necessary cause for the development of cervical cancer and the majority of these infections resolves naturally but progress to precancerous lesions whenever there is persistence and delay in treatment. Majority of the cervical cancer cases, over 80% in sub-Saharan Africa including Ethiopia, have been detected at a late stage mainly due to poor early preventive measures. Therefore, utilization of early preventive measures could increase timely detection and treatment of precancerous changes and significantly reduce morbidity & mortality due to advanced disease. Methods: In this interventional study we will randomly assign 16 clusters (kebeles) in to the intervention and the control arm using block randomization. The study will employ a cluster randomized controlled trial. Women are eligible to participate in this study when they satisfy certain eligibility criteria; being in the age range of 30–49 years, no history of hysterectomy, did not receive cervical cancer or pre-cancer treatment and non-pregnant. Home based couple education and counseling will be provided to the eligible participants within the intervention group, while the control group receives standard of care. Base line and end line surveys will be completed by interviewing 288 eligible women to evaluate the effect of couple education and counseling on the knowledge, attitude and cervical cancer screening uptake. Generally the intervention lasts for six months. The results of baseline & end line surveys will be compared between the groups to determine the effectiveness of the intervention. Blinding is not possible due to the clustering of the trial arms. Discussion: Findings of the study will inform the regional or national scale up of the intervention modality to achieve the screening targets set by the Ethiopian government and world health organization. Trial registration: PACTR, PACTR202108529472385. Registered on 05 August 2021, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=16037 [ABSTRACT FROM AUTHOR]

Background: Reactive and proactive case detection measures are widely implemented by national malaria elimination programs globally. Ethiopia decided to include Reactive Case Detection (RCD) and targeted Mass Drug Administration (tMDA) approaches as part of their elimination strategy along with rigorous evaluation. The purpose of this study is to compare the impact of RCD and tMDA on malaria elimination over the 2-year study period, by looking at the annual parasite incidence before and after the intervention.Methods: The study will be conducted in the East Hararghe zone of Ethiopia. Malaria transmission in the area is low to moderate. This study will deploy a community-based, three-arm, cluster-randomized control trial implemented over 2 years. Forty-eight clusters (16 clusters per arm) will be selected based on the annual number of confirmed malaria cases seen in the cluster. All clusters will receive the current standard of care in terms of malaria elimination interventions provided by the national malaria control program. In addition, following the identification of malaria parasite infection, individuals who reside within a 100-m radius of the index case will receive a diagnosis for malaria and treatment if positive in the RCD arm or presumptive treatment in the tMDA arm. The primary effectiveness endpoint will be measured at baseline and endline for each intervention arm and compared to the control arm using a difference in difference approach.Discussion: This randomized controlled trial will provide evidence of the impact of the proposed intervention approaches for malaria elimination.Trial Registration: ClinicalTrials.gov NCT04241705 . Registration date: January 27, 2020. [ABSTRACT FROM AUTHOR]

Background: In Ethiopia, the proportion of mothers who attend the fourth antenatal care visit is lower than the proportion who attend the first visit. Although the reasons for these dropouts were investigated, few studies introduced interventions to promote the fourth antenatal care visit. Hence, the aim of this study was to assess the effectiveness of checklist-based box system intervention on improving fourth antenatal care visit.Method: This study employed a double-blind, parallel-group, two-arm cluster randomized controlled trial to compare the effectiveness of checklist-based box system intervention with the usual standard of care as a control arm. Study clusters are assigned to intervention and control arm in 1:1 allocation ratio using simple randomization technique. Pregnant mothers below 16 weeks of gestation were enrolled. Open data kit was used to collect data from the baseline and end-line surveys, and STATA version 15.0 was used to analyse the data. A difference-in-difference estimator was used to compare fourth antenatal care visit between the intervention and control groups across time. Mixed effect multi-level logistic regression was used to examine the relationship between the dependent and independent variables.Result: Data were collected from 2224 mothers who belong to 15 intervention and 15 control clusters. The difference in difference estimation resulted in a significant difference (26.1, 95%CI: 18-34%, p < 0.0001) between the intervention and control groups. Similarly, as compared to controls, the fourth antenatal care visit was found significantly higher in the intervention clusters (432 (85.2%) Vs. 297 (53.7%), p < 0.0001)/(AOR:5.69, 95% CI:4.14-7.82). Mothers who were knowledgeable about the services given during antenatal care visits (AOR: 2.31, 95% CI:1.65-3.24) and mothers who had a high level of social support (AOR:1.47, 95% CI: 1.06-2.04) were more likely to attend the fourth antenatal care visit.Conclusion: Implementation of checklist-based box system intervention resulted in a statistically significant effect in attendance of fourth antenatal care visit. Community-level variables were found to be more important in explaining variability in the fourth antenatal care visit. It is recommended that the intervention be implemented on a larger scale.Trial Registration: ClinicalTrials.gov , Retrospectively registered on 26/03/2019, with trial registration number-NCT03891030. [ABSTRACT FROM AUTHOR]

Background: Better understanding of the distribution of Plasmodium vivax and its risk factors could be used to prevent and control malaria infection. Therefore, the aim of this study was to characterize the distribution and risk factors of P. vivax, and to compare them with Plasmodium falciparum occurrence in south-central Ethiopia. Methods: A cohort of 34,548 individuals were followed for 121 weeks between 2014 and 2016 as part of larger cluster randomized controlled trial to evaluate the effect of long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS) on malaria prevention in Ethiopia. Weekly home visit (active search) and patient self- report to health post (passive search) between the weekly home visits were used to register malaria cases. A blood sample was collected by finger prick and malaria was diagnosed using rapid diagnostic test (RDT). Generalized estimating equation (GEE) Poisson model that accounts for repeated measure of malaria episodes was applied to assess the risk factors of P. vivax episode. Results: The overall incidence rate of P. vivax was 7.4 episodes per 1000 person-years of observation. The study showed households closer to the lake Zeway and Bulbula river (potential mosquito breeding sites) were more at risk of P. vivax infection (incidence rate ratio (IRR): 1.33; 95% CI = 1.23–1.45). Furthermore, the age group under 5 years (IRR: 1.40, 95% CI = 1.10–1.79), the age group 5–14 years (IRR: 1.27, 95% CI = 1.03–1.57), households with less educated household head (IRR: 1.63, 95% CI = 1.10–2.44) and house roof made of thatch/leaf (IRR: 1.35, 95% CI = 1.11–1.65) were at higher risk for P. vivax. Similar explanatory variables such as distance from the breeding sites, age group (under 5 years but not 5–14 years old), educational status and type of housing were also found to be the predictors of P. falciparum incidence. Conclusion: Households living closer to a mosquito breeding site, age group under 15 years, less educated household heads and thatch/leaf roof housing were the risk factor for P. vivax. The result of this study can be used for tailored interventions for malaria control and prevention by prioritizing those living close to potential mosquito breeding site, enhancing bed net use of children less than 15 years of age, and improving housing. [ABSTRACT FROM AUTHOR]

Background: Ethiopia has high rates of maternal and neonatal mortality. In 2019 and 2020, the maternal and newborn mortality rates were estimated at 412 per 1,000,000 births and 30 per 10,000 births, respectively. While mobile health interventions to improve maternal and neonatal health management have shown promising results, there are still insufficient scientific studies to assess the effectiveness of mobile phone messaging-based message framing for maternal and newborn health., Objective: This research aims to examine the effectiveness of mobile phone messaging-based message framing for improving the use of maternal and newborn health services in the Jimma Zone, Ethiopia., Methods: A 3-arm cluster-randomized trial design was used to evaluate the effects of mobile phone-based intervention on maternal and newborn health service usage. The trial arms were (1) gain-framed messages (2) loss-framed messages, and (3) usual care. A total of 21 health posts were randomized, and 588 pregnant women who had a gestational age of 16-20 weeks, irrespective of their antenatal care status, were randomly assigned to the trial arms. The intervention consisted of a series of messages dispatched from the date of enrolment until 6-8 months. The control group received existing care without messages. The primary outcomes were maternal health service usage and newborn care practice, while knowledge, attitude, self-efficacy, iron supplementation, and neonatal and maternal morbidity were secondary outcomes. The outcomes will be analyzed using a generalized linear mixed model and the findings will be reported according to the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth) statement for randomized controlled trials., Results: Recruitment of participants was conducted and the baseline survey was administered in March 2023. The intervention was rolled out from May 2023 till December 2023. The end-line assessment was conducted in February 2024., Conclusions: This trial was carried out to understand how mobile phone-based messaging can improve maternal and newborn health service usage. It provides evidence for policy guidelines around mobile health strategies to improve maternal and newborn health., Trial Registration: Pan African Clinical Trials Registry PACTR202201753436676; https://tinyurl.com/ykhnpc49., International Registered Report Identifier (irrid): DERR1-10.2196/52395., (©Gebeyehu Bulcha, Hordofa Gutema Abdissa, Josef Noll, Demisew Amenu Sori, Zewdie Birhanu Koricha. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 23.07.2024.)

Background: Despite the growing evidence that malaria and anaemia are two interlinked health problems of school-aged children (SAC) in developing countries, there is scarce information about malaria among SAC in Ethiopia. Moreover, anaemia-related studies were more concentrated in easily accessible areas. This study aimed to assess the prevalence of malaria and anaemia and corresponding risk factors among SAC in Dara Mallo and Uba Debretshay districts, in hard to reach areas, so as to inform appropriate integrated interventions for both diseases. Methods: This study was part of baseline data collected for a cluster-randomized trial registered in Pan African Clinical Trials Registry (PACTR202001837195738). Data were collected from 2167 SAC and their households through face-to-face interview; malaria was diagnosed by using rapid diagnostic test (RDT); haemoglobin concentration was determined using hemoCue hb 301 and adjusted for altitude to determine anaemic status; helminth infections were determined by using kato-katz, and anthropometric measurements were made to determine nutritional status of children. Generalized mixed effects logistic regression model was used to assess the association between predictor variables and malaria and anaemia using school as a random variable. Results: The overall prevalence of malaria was 1.62% (95% CI 1.15–2.27%) (35/2167). Of the 35 children positive for malaria, 20 (57.14%), 3 (8.57%) and 12 (34.29%) were due to Plasmodium falciparum, Plasmodium vivax and mixed infections of P. falciparum and P. vivax, respectively. Malaria was significantly lower among children from literate household head (Adjusted OR = 0.38; 95% CI 0.15–0.95) and residence house located at an altitude range above 1100 masl (AOR = 0.40; 95% CI 0.17–0.94). The prevalence of anaemia was 22.00% (95% CI 20.3–23.8%) (477/2167) and was significantly reduced by eating legumes, nuts or seed group of food in their 24-h dietary diversity recall (AOR = 0.64; 95% CI 0.41–0.99). Conclusions: The prevalence of malaria was low and unevenly distributed per school while the overall prevalence of anaemia was moderate. It is important to implement integrated interventions targeting both malaria and anaemia, with special emphasis given to children from illiterate households and living at an altitude below 1100 masl. The micronutrient content of locally grown legumes should be further investigated to recommend specific interventions to overcome anaemia. [ABSTRACT FROM AUTHOR]

Introduction: in poorly developed countries, no single intervention is adequate to interrupt diarrhea occurrence in rural households. However, the effect sizes of multiple interventions and participants combined adherence to the interventions are understudied. This study aimed at comparing combined intervention of water sanitation and hygiene (WASH) with each individual intervention in reducing diarrhea among under-five children in rural Dire Dawa. Methods: a cluster randomized controlled factorial trial was conducted between October 2018 and January 2019. Householders in the first, second and third arms received waterguard, soap and both, respectively. However, householders in the control arm were followed with their customary practices. Generalized estimation equations (GEE) with log link Poisson distribution was used to compute adjusted incidence rate ratio and the corresponding 95% CIs. Results: overall, 36% (aIRR = 0.64, 95% CI: 0.57 - 0.73), 41% (aIRR = 0.588, 95% CI: 0.53 - 0.65), and 41% (aIRR = 0.585, 95% CI: 0.53 - 0.65) reduction in incidence of diarrhea was observed in the water treatment, handwashing and combined arms, respectively. This study showed no additional benefit of combining the two interventions than the individual intervention. Conclusion: we recommend implementing either household water disinfection using sodium hypochlorite or household handwashing with hand hygiene promotion independently at large scale to vulnerable population to reduce diarrheal morbidity. [ABSTRACT FROM AUTHOR]

Background: Afar region is one of the pastoralist dominated regions in Ethiopia. The region is characterized by a low contraceptive prevalence rate (CPR) of 5.4%. Lack of awareness of contraceptive use, husband objection and religious barriers are attributed to low CPR in the region. This study assessed the effect of community-based interventions for promoting family planning (FP) use among pastoralist communities in Ethiopia.Methods: The study design was a three-arm, parallel, clustered randomized controlled trial (CRT). The three study arms were: (1) male involvement in family planning (FP) education; (2) women's education on FP; and (3) control. A total of 33 clusters were randomized and allocated with a one-to-one ratio. Intervention components included (1) health education on FP to married women and men by faema leaders (a traditional community-based structure that serves as a social support group); (2) video-assisted message on FP; and (3) assisting the faema leader using health workers and health extension workers (HEWs). The intervention was given for a total of nine months. FP use and intentions were measured as outcome variables. In addition, a cluster-level summary considering a cluster effect analysis was performed. The result was presented with t.test, adjusted risks and its 95% confidence interval (CI).Results: The proportion of FP use among the arms was 34% in the male involvement in FP education, 17.5% in women's education on FP and 4.3% in the control. There was a positive change in the proportion of FP use in the male involvement in FP education and women's education on FP arms with absolute risk (AR) of 0.29 (95% CI, 0.23,0.34) and 0.13 (95% CI,0.08,0.17), respectively, as compared to the control arm. Similarly, married women in the male involvement in FP education and women's education on FP arms had 3.4 (2.48, 4.91) and 2.1 (1.50, 2.95) higher intention to use FP, respectively, as compared with the control arm.Conclusion: The present study suggests that in such male-dominated pastoralist communities with more considerable religious barriers, the community-based health education mainly targeting males appears to be a promising strategy for improving FP use and intention to use FP.Trial Registration: ClinicalTrials.gov, NCT03450564, March, 2018. [ABSTRACT FROM AUTHOR]

Background: Suboptimal breastfeeding (BF) contributes to a significant number of infant deaths. A positive deviance approach (PDA) was not studied in Ethiopia, whether it improve exclusive breastfeeding (EBF) practice. Therefore, we determined the effectiveness of positive deviant approached intervention in increasing the proportion of EBF practice. Methods: A cluster-randomized controlled trial was employed in Jimma town from February 01 to September 30, 2018. Six randomly selected clusters (kebeles) were randomized into two arms. Then, 260 mothers who met the eligibility criteria were enrolled in either the intervention or control arm depending on where they lived. Women in the intervention group received counseling and social support in addition to the usual service to promote EBF, from women identified and trained as positive deviants in their community, while those in the control groups received the usual community-based services from urban health extension professionals. Data on primary and secondary outcome variables were collected at three points, and statistical difference was estimated using Chi-X2 or Fisher exact test. The net effect of the intervention was calculated. The magnitude of the intervention effect was estimated using the relative risk. For all statistical tests, 95% CI with a P-value of < 0.05 was used. Results: The overall response rate at the endline was 98.8%. Exclusive BF was significantly different between the groups at mid and end points, while no difference at baseline. A higher proportion of mothers in the intervention group reported EBF compared to the control group at mid and end-line. The rate of EBF increased by 18.5% (P=0.01) in the intervention group while 0.2% in the counterparts, with a net effect of +18.2%. The probability of practicing EBF was significantly higher for the intervention group compared to the control group. At baseline, the relative risk of avoiding EBF (RR:1.112) was similar among the two groups. However, at follow-up, mothers in the intervention group were 2 times more likely to practice EBF (RR: 2.294) compared to those in the control group. Conclusion and Recommendation: The PD approach is an effective intervention to promote EBF and also positively affected frequency and duration of BF. Therefore, we recommend the promotion and use of positive deviance approach as a strategy to improve EBF practice in urban settings. Trial Registration Number: Clinical trial PACTR201805003379263, 23 May 2018. [ABSTRACT FROM AUTHOR]

Background: Persisting within-country disparities in maternal health service access are significant barriers to attaining the Sustainable Development Goals aimed at reducing inequalities and ensuring good health for all. Sub-national decision-makers mandated to deliver health services play a central role in advancing equity but require appropriate evidence to craft effective responses. We use spatial analyses to identify locally-relevant barriers to access using sub-national data from rural areas in Jimma Zone, Ethiopia.Methods: Cross-sectional data from 3727 households, in three districts, collected at baseline in a cluster randomized controlled trial were analysed using geographically-weighted regressions. These models help to quantify associations within women's proximal contexts by generating local parameter estimates. Data subsets, representing an empirically-identified scale for neighbourhood, were used. Local associations between outcomes (antenatal, delivery, and postnatal care use) and potential explanatory factors at individual-level (ex: health information source), interpersonal-level (ex: companion support availability) and health service-levels (ex: nearby health facility type) were modelled. Statistically significant local odds ratios were mapped to demonstrate how relevance and magnitude of associations between various explanatory factors and service outcomes change depending on locality.Results: Significant spatial variability in relationships between all services and their explanatory factors (p < 0.001) was detected, apart from the association between delivery care and women's decision-making involvement (p = 0.124). Local models helped to pinpoint factors, such as danger sign awareness, that were relevant for some localities but not others. Among factors with more widespread influence, such as that of prior service use, variation in estimate magnitudes between localities was uncovered. Prominence of factors also differed between services; companion support, for example, had wider influence for delivery than postnatal care. No significant local associations with postnatal care use were detected for some factors, including wealth and decision involvement, at the selected neighbourhood scale.Conclusions: Spatial variability in service use associations means that the relative importance of explanatory factors changes with locality. These differences have important implications for the design of equity-oriented and responsive health systems. Reductions in within-country disparities are also unlikely if uniform solutions are applied to heterogeneous contexts. Multi-scale models, accommodating factor-specific neighbourhood scaling, may help to improve estimated local associations. [ABSTRACT FROM AUTHOR]

Background: Handwashing with soap reduces diarrheal diseases burden considerably. However, the importance of handwashing in homes has received little attention in rural eastern Ethiopia. The effectiveness of handwashing may be reduced by lack of information on when and in what event hands must be washed, the frequency of handwashing, the individual who should wash his/her hands, and the procedure of handwashing. In these areas, indicators of adherence to handwashing are yet to be established. This study aimed at assessing the efficiency of handwashing on reducing diarrheal disease in children under 5 years old in rural kebeles of Dire Dawa, east Ethiopia. Methods: Community-based cluster randomized controlled trial was conducted in rural kebeles of Dire Dawa for 4 months starting from October 2018 to January 2019. Selected clusters were randomized in intervention and control arms using draw method and data collectors conducted the baseline survey. Households assigned to the intervention group were given two bars of plain soap on a bi-monthly basis together with information promoting hand hygiene. Control households were allowed to continue their habitual handwashing practices. We compared the diarrheal incidences of the intervention and non-intervention households. Generalized estimation equations using Poisson family and log choice of the link was employed to calculate adjusted incidence rate ratio with its 95% confidence interval. Results: We recorded a significant lesser diarrheal incidence in the handwashing arm than in the non-intervention arm (6.9 versus 13.8 episodes per 100 person weeks of observation). In all, there was a 41% reduction in diarrheal incidence in the intervention arm in relation to the non-intervention arm. Conclusion: Handwashing with soap complemented with hand hygiene promotion significantly decreased diarrheal episodes in children under 5 years old in rural kebeles of Dire Dawa. We recommend the promotion and adaptation of washing hands using soap at recommended times to be an effective means of reducing childhood diarrhea morbidity in rural populations of Ethiopia towards achieving the Sustainable Development Goal 6. Trial registration: PACTR, PACTR201807815961394. Registered 16 July 2018, [ABSTRACT FROM AUTHOR]

Background: Maternity waiting homes (MWHs), residential spaces for pregnant women close to obstetric care facilities, are being used to tackle physical barriers to access. However, their effectiveness has not been rigorously assessed. The objective of this cluster randomized trial was to evaluate the effectiveness of functional MWHs combined with community mobilization by trained local leaders in improving institutional births in Jimma Zone, Ethiopia.Methods: A pragmatic, parallel arm cluster-randomized trial was conducted in three districts. Twenty-four primary health care units (PHCUs) were randomly assigned to either (i) upgraded MWHs combined with local leader training on safe motherhood strategies, (ii) local leader training only, or (iii) usual care. Data were collected using repeat cross-sectional surveys at baseline and 21 months after intervention to assess the effect of intervention on the primary outcome, defined as institutional births, at the individual level. Women who had a pregnancy outcome (livebirth, stillbirth or abortion) 12 months prior to being surveyed were eligible for interview. Random effects logistic regression was used to evaluate the effect of the interventions.Results: Data from 24 PHCUs and 7593 women were analysed using intention-to-treat. The proportion of institutional births was comparable at baseline between the three arms. At endline, institutional births were slightly higher in the MWH + training (54% [n = 671/1239]) and training only arms (65% [n = 821/1263]) compared to usual care (51% [n = 646/1271]). MWH use at baseline was 6.7% (n = 256/3784) and 5.8% at endline (n = 219/3809). Both intervention groups exhibited a non-statistically significant higher odds of institutional births compared to usual care (MWH+ & leader training odds ratio [OR] = 1.09, 97.5% confidence interval [CI] 0.67 to 1.75; leader training OR = 1.37, 97.5% CI 0.85 to 2.22).Conclusions: Both the combined MWH+ & leader training and the leader training alone intervention led to a small but non-significant increase in institutional births when compared to usual care. Implementation challenges and short intervention duration may have hindered intervention effectiveness. Nevertheless, the observed increases suggest the interventions have potential to improve women's use of maternal healthcare services. Optimal distances at which MWHs are most beneficial to women need to be investigated.Trial Registration: The trial was retrospectively registered on the Clinical Trials website ( https://clinicaltrials.gov ) on 3rd October 2017. The trial identifier is NCT03299491 . [ABSTRACT FROM AUTHOR]

Background: Few studies have evaluated iron-rich plant-based foods, such as amaranth grain, to reduce anemia and iron deficiency anemia. Amaranth is rich in nutrients, but with high level of phytate. The objective of this trial was to evaluate the efficacy of home processed amaranth grain containing bread in the treatment of anemia, hemoglobin concentration and iron deficiency anemia among two-to-five year-old children in Southern Ethiopia. Method: Children with anemia (hemoglobin concentration <110.0g/L) (N = 100) were identified by random sampling and enrolled in a 1:1 cluster randomized controlled trial for six months in 2017. The amaranth group (N = 50), received 150g bread containing 70% amaranth and 30% chickpea, the amaranth grain was processed at home (soaking, germinating, and fermenting) to decrease the phytate level. The maize group (N = 50), received 150g bread, containing processed maize (roasted and fermented) to give a similar color and structure with amaranth bread. Hemoglobin, ferritin, and CRP were measured at baseline and at the end of intervention. Hemoglobin and ferritin values were adjusted for altitude and infection, respectively. Generalized estimating equation and generalized linear model were used to analyze the data. Result: In the last follow-up measure anemia prevalence was significantly lower in the amaranth group (32%) as compared with the maize group (56%) [adjusted risk ratios, aRR: 0.39 (95%CI: 0.16–0.77)]. Hemoglobin concentration estimate of beta coefficient was significantly higher in the amaranth group compared with the maize group [aβ 8.9g/L (95%CI: 3.5–14.3)], p-value <0.01. The risk of iron deficiency anemia is significantly lower in the amaranth group [aRR: 0.44 (95%CI: 0.23–0.83)] in the intention to treat analysis but not significant in the complete case analysis. There was no significant difference between groups in iron deficiency [aRR: 0.81 (95%CI: 0.55–1.19)]. Conclusion: Processed amaranth bread had favorable effects on hemoglobin concentration and has the potential to minimize anemia prevalence. Clinical trial registration: Trial registry number: PACTR201705002283263 https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2283 [ABSTRACT FROM AUTHOR]

Background: Trachoma prevalence surveys, including impact surveys (TIS) and surveillance surveys (TSS), provide information to program managers on the impact of the SAFE (surgery, antibiotics, facial cleanliness, and environmental improvement) strategy and current burden of disease, and they provide a crucial component of the evidence base necessary for the validation of the elimination of trachoma as a public health problem. The prevalence surveys included in this analysis are multi-level cluster random surveys that provide population-based estimates for program planning. This study conducted an analysis of the cost of 8 rounds of TIS/TSS executed in Amhara, Ethiopia, 2012–2016, comprising 232,357 people examined over 1,828 clusters in 187 districts. Methodology and findings: Cost data were collected retrospectively from accounting and procurement records from the implementing partner, The Carter Center, and coded by survey activity (i.e. training and field work) and input category (i.e. personnel, transportation, supplies, venue rental, and other). Estimates of staff time were obtained from The Carter Center Ethiopia. Data were analyzed by activity and input category. The mean total cost per cluster surveyed was $752 (standard deviation $101). Primary cost drivers were personnel (39.6%) and transportation (49.2%), with costs increasing in the last 3 rounds of TIS/TSS. Conclusion: Despite the considerable cost of conducting TIS and TSS, these surveys provide necessary information for program managers. Limited options are available to reduce the costs of TIS/TSS and gain economies of scale, as the surveys must be designed to achieve their designated sample size. However, surveys must also be designed in a way that is possible to be executed given the financial resources, personnel, and time required. Program managers can use these findings to improve estimates of the total cost of a survey and its components to ensure that sufficient resources are budgeted accordingly. Author summary: Population-based trachoma surveys are necessary to determine the impact of interventions and to build the case for the validation of elimination of trachoma as a public health problem. Many trachoma-endemic areas are currently receiving mass drug administration, which will require trachoma impact surveys (TIS) and trachoma surveillance surveys (TSS). We analyzed the costs accrued by the implementing non-governmental organization during 8 rounds of trachoma surveys in Amhara, Ethiopia, that included 187 districts surveyed over four years. The costs were sorted by activity (i.e. training and field work) and input category (i.e. transportation, personnel, venue rental, supplies, and other). Field work was the most expensive activity for trachoma surveys, with transportation and personnel as the most significant drivers of cost. As the global trachoma program matures, these surveys must be executed given the financial resources, personnel, and time available. Program managers can use these findings to improve total cost estimates of trachoma surveys and survey components to ensure that sufficient resources are being budgeted accordingly. Additionally, managers in hyperendemic settings can use these findings to better understand the drivers in cost of repeated surveys in a single geography. [ABSTRACT FROM AUTHOR]

Background: Analysis of disaggregated national data suggest uneven access to essential maternal healthcare services within countries. This is of concern as it hinders equitable progress in health outcomes. Mounting an effective response requires identification of subnational areas that may be lagging behind. This paper aims to explore spatial variation in maternal healthcare service use at health centre catchment, village and household levels. Spatial correlations of service use with household wealth and women's education levels were also assessed.Methods: Using survey data from 3758 households enrolled in a cluster randomized trial geographical variation in the use of maternity waiting homes (MWH), antenatal care (ANC), delivery care and postnatal care (PNC) was investigated in three districts in Jimma Zone. Correlations of service use with education and wealth levels were also explored among 24 health centre catchment areas using choropleth maps. Global spatial autocorrelation was assessed using Moran's I. Cluster analyses were performed at village and household levels using Getis Ord Gi* and Kulldorf spatial scan statistics to identify cluster locations.Results: Significant global spatial autocorrelation was present in ANC use (Moran's I = 0.15, p value = 0.025), delivery care (Moran's I = 0.17, p value = 0.01) and PNC use (Moran's I = 0.31, p value < 0.01), but not MWH use (Moran's I = -0.005, p value = 0.94) suggesting clustering of villages with similarly high (hot spots) and/or low (cold spots) service use. Hot spots were detected in health centre catchments in Gomma district while Kersa district had cold spots. High poverty or low education catchments generally had low levels of service use, but there were exceptions. At village level, hot and cold spots were detected for ANC, delivery care and PNC use. Household-level analyses revealed a primary cluster of elevated MWH-use not detected previously. Further investigation of spatial heterogeneity is warranted.Conclusions: Sub-national variation in maternal healthcare services exists in Jimma Zone. There was relatively higher poverty and lower education in areas where service use cold spots were identified. Re-directing resources to vulnerable sub-groups and locations lagging behind will be necessary to ensure equitable progress in maternal health. [ABSTRACT FROM AUTHOR]

Background: Diarrheal disease is a leading cause of child mortality and morbidity worldwide. Household water treatment with chlorine significantly reduces morbidity due to waterborne diseases. However, the effect of point-of-use (POU) water treatment in improving the quality of water in areas where POU is not provided free of charge and the effectiveness of home visits in inspiring household members to use POU regularly have not been studied. The objective of this study was to evaluate the effectiveness of drinking water disinfection by chlorination on diarrheal disease reduction among children under the age of 5 years in rural eastern Ethiopia. Methods: A cluster randomized controlled trial was carried out in rural Dire Dawa from October 2018 through January 2019. The 405 households were randomized to intervention and control arms and intervention materials were distributed after conducting a baseline survey. This trial evaluated the effectiveness of household drinking water disinfection by chlorination in reducing incidence of diarrhea among children under the age of 5 years. Intervention households received 1.2% sodium hypochlorite with demonstration of its proper use. Participants in the control households continued with their usual habits of water collection and water storage. Generalized estimation equation (GEE) with log link Poisson distribution family and exchangeable correlation matrix was used to compute crude incidence rate ratio (IRR), adjusted IRR and the corresponding 95% confidence intervals. Results: In the intervention households, in total, 281 cases of diarrhea were documented (8.7 cases per 100 person-weeks observation); in the control households, in total 446 cases of diarrhea were documented (13.8 cases per 100 person-weeks observation). A 36.0% (adjusted IRR = 0.64, 95% CI: 0.57–0.73) reduction in incidence of diarrhea was observed in the intervention arm when compared with the control arm. The highest and the lowest reductions were obtained in children of age ranges 1 to 2 years and 3 to 4 years, 42.7 and 30.4%, respectively. Adherence to the intervention was 81.3% as measured by free residual chlorine test. Conclusions: In rural areas where diarrhea is the second leading cause of morbidity, water chlorination at the household level using liquid bleach considerably reduced episodes of diarrhea among children under the age of 5 years. Therefore, chlorinating drinking water at the household level may be a valuable interim solution for reducing the incidence of diarrheal diseases until potable water is made accessible to the majority of the population in Dire Dawa Administration and other Ethiopian communities. Trial registration: PACTR, PACTR201807815961394. Registered 16 July 2018, www.pactr.org [ABSTRACT FROM AUTHOR]

Background: In Ethiopia, although nutrition education has been given during pregnancy, most women have inadequate nutrient intakes. As a result, the prevalence of malnutrition is high during pregnancy. In this study, we set out to evaluate the effect of guided counseling based on the health belief model and the theory of planned behavior on the dietary practices of pregnant women. Methods: A two-arm parallel cluster randomized controlled community trial was carried out among pregnant women in West, Gojjam Zone, Ethiopia from May 1, 2018, to April 30, 2019. A total of 346 and 348 pregnant women were recruited from the intervention and control clusters, respectively. Of which endline data were collected from 313 and 332 pregnant women in the intervention and control groups, respectively. Each woman in the intervention group attended four counseling sessions. Women in the control group attended the routine nutrition education given by the health care system. Data were collected using a structured questionnaire. McNemar test and Generalized Estimating Equations were used to evaluate the intervention effect. Results: The average difference of appropriate dietary practice between the two groups was 30.7%. After controlling for the possible confounders, women in the intervention group had 7.2 times [AOR = 7.187, 95% CI: (4.49, 11.49)] higher odds of having appropriate dietary practices compared with the control group. Dietary diversity and meal frequency of counseled women were 7 [AOR = 6.994, 95% CI: (4.59, 10.66)] and 8 [AOR = 8.146, 95% CI: (5.377, 12.341)] times higher than dietary diversity and meal frequency of women in the control group, respectively. Conclusion: Counseling based on the health belief model and the theory of planned behavior is an effective approach in increasing the proportion of women who had appropriate dietary practices. Thus, these findings suggest the need for employing trimester based counseling using the HBM and the TPB to improve the dietary practices of pregnant women. Trial registration: The trial was registered in Clinical Trials.gov (NCT03627156). [ABSTRACT FROM AUTHOR]

Background: Undernutrition during pregnancy affects birth outcomes adversely. In Ethiopia, despite nutrition counseling on the maternal diet being given by the health workers during pregnancy, maternal undernutrition is still high in the country. Hence, this study aimed to assess the effect of guided counseling using the health belief model and the theory of planned behavior on the nutritional status of pregnant women.Methods: A two-arm parallel cluster randomized controlled community trial was conducted in West Gojjam Zone, Ethiopia, from May 1, 2018, to April 30, 2019. The nutritional status of the women was assessed using mid-upper arm circumference. A total of 694 pregnant women were recruited from the intervention (n=346 ) and control (n=348) clusters. Of which endline data were collected from 313 and 332 pregnant women in the intervention and control clusters, respectively. The intervention was started before 16 weeks of gestation and pregnant women in the intervention group attended 4 counseling sessions. Counseling was given at the participants' homes using a counseling guide with the core contents of the intervention. Leaflets with appropriate pictures and the core messages were given for women in the intervention arm. Women in the control group got the routine nutrition education given by the health care system. Data were collected using interviewer administered structured questionnaires and mid-upper arm circumference was measured using an adult MUAC tape. Descriptive statistics  and linear mixed-effects model were used to assess the intervention effect after adjusting for potential confounders.Results: After the intervention, the prevalence of undernutrition was 16.7% lower in the intervention group compared with the control arm (30.6% Vs 47.3%, P = < 0.001). Women in the intervention group showed significant improvement in nutritional status at the end of the trial than the control group (β = 0.615, p = < 0.001).Conclusion: This study demonstrated that guided counseling using the health belief model and the theory of planned behavior was effective in improving the nutritional status of pregnant women. The results imply the need for the design of model and theory based nutrition counseling guidelines. The trial was registered in Clinical Trials.gov (NCT03627156). [ABSTRACT FROM AUTHOR]

Background: Maternal mortality is still high in Ethiopia. Antenatal care, the use of skilled delivery and postnatal care are key maternal health care services that can significantly reduce maternal mortality. However, in low- and middle-income countries, including Ethiopia, utilization of these key services is limited, and preventive, promotive and curative services are not provided as per the recommendations. The aim of this study is to examine the effectiveness of checklist-based box system interventions on improving maternal health service utilization.Methods: A community-level, cluster-randomized controlled trial will be conducted to compare the effectiveness of checklist-based box system interventions over the routine standard of care as a control arm. The intervention will use a health-extension program provided by health extension workers and midwives using a special type of health education scheduling box placed at health posts and a service utilization monitoring box placed at health centers. For this, 1200 pregnant mothers at below 16 weeks of gestation will be recruited from 30 clusters. Suspected pregnant mothers will be identified through a community survey and linked to the nearby health center. With effective communication between health centers and health posts, dropout-tracing mechanisms are implemented to help mothers resume service utilization. Data will be collected using an open data kit and analyzed using STATA version 13.0. Data will be analyzed by the intention-to-treat analysis. Risk ratios will be computed at the cluster level and the summary will be compared using t tests. Outcomes between intervention and control groups will be compared with random effects logistic regression models. Achieving four antenatal care visits, health facility delivery, and postnatal care visits at 6 weeks after delivery were treated as primary outcomes for this study.Discussion: We expect that the study will generate evidence on the effectiveness of checklist-based box system interventions on improving utilization of maternal health care service that will produce inputs for related policies in Ethiopia.Trial Registration: ClinicalTrials.gov, NCT03891030. Retrospectively registered on 26 March 2019. [ABSTRACT FROM AUTHOR]

Effectively implemented nutrition education can provide participants with the knowledge and skills to make healthy food choices in the context of their lifestyles and economic resources. In Ethiopia, the government equips health extension workers (HEWs) to provide nutrition education to communities by enabling HEWs to transfer knowledge to women's development team leaders (WDTLs) who in turn share the knowledge with the one-to-five network leaders (1-5NWL) and members. The objective of this study was to examine the effectiveness of WDTLs in delivering nutrition education to women as the intervention group (IG). This was compared to having trained HEWs educate women directly (the positive control group, PCG), and having women receive no specific education (negative control group, NCG). A cluster randomized trial design was used. Three kebeles (villages of 5000 people) were purposively selected from which the WDTLs were randomly selected and their respective 1-5NWL and members were participants. Nutrition education to teach pulse sprouting was provided every other week for 6 months to intervention and positive control groups. Focus group discussions and demonstrations were held to reinforce knowledge and skills. Knowledge, attitude and practice (KAP) of the women were evaluated pre and post-intervention. At baseline all three groups had similar low scores in KAP. After the education intervention, knowledge improved in IG compared to PCG (p=0.009), and both were greater than NCG (p=0.001). Attitude in IG improved more in PCG (p=0.008) and both increased compared to NCG (p=0.001). Practices improved, similarly, in IG and PCG (p=0.084) after intervention, and both were better than NCG (p=0.001). From this study, we conclude that nutrition education delivered through WDTLs, as is intended in communities in Ethiopia having HEWs, was more effective than delivery by HEWs alone. Nutrition education on pulse sprouting has the potential to bring positive changes on KAP of rural women who depend on this processing skill to provide nutritious foods for their families. [ABSTRACT FROM AUTHOR]

Background: Trachoma is the leading infectious cause of blindness worldwide. In communities where the district level prevalence of trachomatous inflammation-follicular among children ages 1–9 years is ≥5%, WHO recommends annual mass drug administration (MDA) of antibiotics with the aim of at least 80% coverage. Population-based post-MDA coverage surveys are essential to understand the effectiveness of MDA programs, yet published reports from trachoma programs are rare. Methods: In the Amhara region of Ethiopia, a population-based MDA coverage survey was conducted 3 weeks following the 2016 MDA to estimate the zonal prevalence of self-reported drug coverage in all 10 administrative zones. Survey households were selected using a multi-stage cluster random sampling design and all individuals in selected households were presented with a drug sample and asked about taking the drug during the campaign. Zonal estimates were weighted and confidence intervals were calculated using survey procedures. Self-reported drug coverage was then compared with regional reported administrative coverage. Results: Region-wide, 24,248 individuals were enumerated, of which, 20,942 (86.4%) individuals were present. The regional self-reported antibiotic coverage was 76.8% (95%Confidence Interval (CI):69.3–82.9%) in the population overall and 77.4% (95%CI = 65.7–85.9%) among children ages 1–9 years old. Zonal coverage ranged from 67.8% to 90.2%. Five out of 10 zones achieved a coverage >80%. In all zones, the reported administrative coverage was greater than 90% and was considerably higher than self-reported MDA coverage. Main reasons reported for MDA campaign non-attendance included being physically unable to get to MDA site (22.5%), traveling (20.6%), and not knowing about the campaign (21.0%). MDA refusal was low (2.8%) in this population. Conclusions: Although self-reported MDA coverage in Amhara was greater than 80% in some zones, programmatic improvements are warranted throughout Amhara to achieve higher coverage. These results will be used to enhance community mobilization and improve training for MDA distributors and supervisors to improve coverage in future MDAs. [ABSTRACT FROM AUTHOR]

The article presents a cluster randomized clinical trial in five rural districts of Ethiopia for assessing the efficacy of mobile-based application on the quality of medical care and perinatal mortality. It offers information on the impact of the availability, acceptability and affordability of mobile communication devices on health care. The relevance of the trial, its strengths and limitations have been discussed.

Background: Maximizing comprehension is a major challenge for informed consent processes in low-literacy and resource-limited settings. Application of rapid qualitative assessments to improve the informed consent process is increasingly considered useful. This study assessed the effects of Rapid Ethical Assessment (REA) on comprehension, retention and quality of the informed consent process.Methods: A cluster randomized trial was conducted among participants of HPV sero-prevalence study in two districts of Northern Ethiopia, in 2013. A total of 300 study participants, 150 in the intervention and 150 in the control group, were included in the study. For the intervention group, the informed consent process was designed with further revisions based on REA findings. Informed consent comprehension levels and quality of the consent process were measured using the Modular Informed Consent Comprehension Assessment (MICCA) and Quality of Informed Consent (QuIC) process assessment tools, respectively.Result: Study recruitment rates were 88.7 % and 80.7 % (p = 0.05), while study retention rates were 85.7 % and 70.3 % (p < 0.005) for the intervention and control groups respectively. Overall, the mean informed consent comprehension scores for the intervention and control groups were 73.1 % and 45.2 %, respectively, with a mean difference in comprehension score of 27.9 % (95 % CI 24.0 % - 33.4 %; p < 0.001,). Mean scores for quality of informed consent for the intervention and control groups were 89.1 % and 78.5 %, respectively, with a mean difference of 10.5 % (95 % CI 6.8 -14.2 %; p < 0.001).Conclusion: Levels of informed consent comprehension, quality of the consent process, study recruitment and retention rates were significantly improved in the intervention group. We recommend REA as a potential modality to improve informed consent comprehension and quality of informed consent process in low resource settings. [ABSTRACT FROM AUTHOR]