Preventive chemotherapy coverage against Soil-transmitted helminthiases among school age children in vertical versus integrated treatment approaches: Implications from coverage validation survey in Ethiopia

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Soil-transmitted helminths (STH) are widely distributed in Ethiopia with 23 highest prevalence and burden. Since 2015 the country launched national deworming 24 programme to control STH associated morbidity using mass treatment with 25 Albendazole/Mebendazole. Data on routine coverage of Preventive chemotherapy (PC) are 26 available at different level of the health system, however in some circumstances these reports 27 are unreliable and evidence is lacking on validated treatment coverage against STH. 28 Methodology: A community-based cross-sectional study was conducted in ten districts of 29 Ethiopia; from January to April 2019. A total of 8154 SAC (4100 males and 4054 females) 30 were participated from randomly selected households. Data were analysed using SPSS 31 software (IBM, version 25); then di-aggregated by gender, age and school attendance and 32 presented in tables and graphs. 33 Principal findings: Albendazole/Mebendazole mass treatment coverage against STH among 34 school-age children was found to be 71%. In vertical (school-based) treatment approach, 35 4822(68.4%) were treated; whereas in integrated (community directed) approach, 963(86.9 36 %) were treated. The treatment coverage among males was 2948(71.9%), while among 37 females it was 2837(70%). Based on age the treatment coverage in the age group 10-14 years 38 was 77%; which is higher than the coverage in age group 5-9 years was 64.4%. In addition, 39 the treatment coverage in school attendant was 81%; which is higher than coverage non-40 enrolled children (28%). The main deworming site was school, 5223(91%). Moreover, the 41 main reported reasons for not swallowing drugs were not attending school, 422(19.75%) and 42 drugs were not given, 397(18.6%). 43 Concussions/significance: Albendazole/Mebendazole mass treatment coverage against soil-44 transmitted helminths among school-age children was below the WHO recommendation 45 (75%). Operational research is required to identify barriers for low coverage of ALB/MBD 46 . CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted March 23, 2020. ; https://doi.org/10.1101/2020.03.18.20038620doi: medRxiv preprint among children who are non-enrolled school-age children. Further, a call for action is 47 required from different stakeholders to improve treatment coverage of ALB/MBD. 48 Key words: PC; Coverage; STH; Albendazole/Mebendazole; SAC; NTDs 49 Author Summary 50 Neglected Tropical Diseases (NTDs) are a group of communicable diseases, which 51 inequitably affect the world’s poorest, marginalized, voiceless and powerless people. It is 52 prevalent in areas with unsafe water, poor sanitation and hygiene. STH (ascariasis, 53 hookworm, and trichuriasis), intestinal worms, are one of the common NTDs which are 54 transmitted through contact with soil contaminated with human feces. 55 Globally, more than 4 billion people are at risk for STH and with over 1 billion are already 56 infected. In Ethiopia, about 81 million people are at risk for STH infection. School age 57 children and pre-school age children are highly affected by the diseases, and it causes anemia, 58 vitamin A deficiency, stunting, malnutrition, impaired development, and intestinal 59 obstruction. 60 As one of NTDS, ending STH can contribute to Ethiopia be on track of attaining universal 61 health coverage (UHC). STH can be controlled, possibly eliminated by combined 62 interventions of preventive chemotherapy with improved water, sanitation and hygiene 63 (WASH). In Ethiopia, though remarkable attainments are made so far on controlling STH 64 morbidity through mapping and scaling-up mass drug administration, still more work is 65 required to increase coverage of PC and integration of PC with WASH to meet the national 66

of elimination or control of STH. 67 68 69 70 . CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted March 23, 2020. ; https://doi.org/10.1101/2020.03.18.20038620doi: medRxiv preprint

71 Neglected tropical diseases (NTDs) are a group of diseases mainly affect poorest and 72 marginalized people living in rural and urban areas, primarily in tropical and subtropical 73 areas [1, 2]. Soil-transmitted helminthiasis (STH), one of the major Neglected Tropical 74 Diseases (NTDs), are a group of intestinal parasites consisting of Ascaris lumbricoides 75 (roundworms), Trichuris trichiura (whipworms), and Hook worm, are transmitted by faecal 76 contamination of soil, and prevalent in areas with lack of improved water, sanitation and 77 hygiene [3-4]. 78 Globally, about two billion people are being estimated in developing countries that are 79 infected with one or more species of helminths [5]. In 2017, 1.9 million disability-adjusted 80 life years (DALYs) associated with STH infection worldwide are estimated [6, 7]. Ethiopia 81 has wide distribution, highest prevalence and burden of STH, which causes 873,500 82 disability-adjusted life-years (DALYs), annually which represent 1.9% of the total DALYs 83 lost due to all causes. In the country, about 81 million people are living in STH endemic 84 areas, of which 25.3 million are school-aged children [8, 9]. STH infections with moderate 85 and heavy intensity are associated with anemia, malnutrition, educational loss, and cognitive 86 deficits [10-12]. 87 The World Health Organization (WHO) recommends preventive chemotherapy (PC) with 88 Albendazole (ALB) or Mebendazole (MBD) to control STH-related morbidity in 89 combination with other recommended interventions such as health education and 90 improvement of interventions such as hygiene, water and sanitation [5, 13]. WHO sets a 91 target of regular provision of anthelminthic treatment to cover at least 75% of school age 92 children in endemic area [14]. In 2017, more than 500 million SAC (69% of total SAC in 93 need) received PC for STH globally, with 73% of implementation units reaching 75% 94 . CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted March 23, 2020. ; https://doi.org/10.1101/2020.03.18.20038620doi: medRxiv preprint effective coverage [15]. More than 596 million SAC in 101 countries were estimated in need 95 of PC for STH in 2017; 61 countries submitted reports on treatment [4]. 96 Ending NTDs by 2030 is targeted in the Sustainable Development Goal 3 (target 3.3); with a 97 focus of equity and Universal Health Coverage (UHC) [16]. Thus, addressing NTDs 98 contributes for achievement of the vision of universal health coverage, which means that all 99 individuals and communities who are in need of the health services will be addressed without 100 suffering financial hardship [17]. 101 Starting from the time when the first World health organization (WHO ) road map for the 102 prevention and control of NTDs was issued in 2012, significant progress has been made in 103 terms of controlling STH [2]. In line with the WHO goal, Ethiopia sets a target to achieve a 104 minimum 75% coverage of Albendazole or Mebendazole in school and pre-school age 105 children that should be achieved by the country program by 2020 [9]. 106 In fact, routine coverage data are available at different level of Ethiopian health system. 107 However, evidence is lacking on validated treatment coverage Albendazole or Mebendazole 108 against STH among school age children. These data are required for the following 109 programmatic purposes: First, determine treatment coverage of Albendazole or Mebendazole 110 in school and pre-school age children in vertical and integrated treatment approaches to 111 improve program planning of PC. Second, generate treatment coverage data, dis-aggregated 112 by gender, sex and school attendance. Third, identify the reasons for why some individuals 113 do not receive drugs. Additionally, it can also be used to identify main deworming sites of 114 drug distribution. 115 116 117 . CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted March 23, 2020. ; https://doi.org/10.1101/2020.03.18.20038620doi: medRxiv preprint

118 Study setting 119 Ethiopia is the second largest country by population in sub-Saharan Africa, and is home to 120 over 85 million people in need of preventive treatment, has a much higher burden of these 121 diseases than in other countries of sub-Saharan Africa. Since the launch of the first national 122 master plan for NTDs in 2013, the Government of Ethiopia has been liaising with WHO and 123 other partners to achieve its objectives [9, 18]. Fig 1 shows the area where study was 124 conducted. 125 Fig 1. Map of study area for coverage of Albendazole/Mebendazole in Ethiopia, 2019. 126 Study design and population 127 We conducted a community-based cross-sectional study in ten districts of Ethiopia (selected 128 from sentinel site of Federal Ministry of Health); from January to April 2019. All selected 129 school age children who were available during the survey were included in the study. 130 Sample size and Sampling technique 131 A total of 30 segments were randomly selected from each district. The name of kebeles, 132 number of households and the number of segments to be involved were predetermined using 133 survey builder method before going to field for data collection. From each selected segment, 134 at least 16 randomly selected households were included in the survey. From each selected 135 household, all SAC were involved in the survey. Segment means group of 50 households. 136 The sampling is performed using the WHO Coverage Evaluation Guidelines for Preventive 137 Chemotherapy [16]. 138 Data collection and Statistical analysis 139 . CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted March 23, 2020. ; https://doi.org/10.1101/2020.03.18.20038620doi: medRxiv preprint The data were collected using Survey CTO software using smartphones. Data were cleaned 140 and analyzed using an Excel spread sheet and SPSS software (IBM, version 25). Then, data 141 were dis-aggregated by gender, age and school attendance; presented in tables and figures. 142 Measurements 143 Coverage rate is defined as: 144 /g1846/g1867/g1872/g1853/g1864 /g1866/g1873/g1865/g1854/g1857/g1870 /g1867/g1858 /g1861/g1866/g1872/g1857/g1870/g1874/g1861/g1857/g1875/g1857/g1856 /g1861/g1866/g1856/g1861/g1874/g1861/g1856/g1873/g1853/g1864/g1871 /g1872/g1860/g1853/g1872 /g1861/g1866/g1859/g1857/g1871/g1872/g1857/g1856 /g1872/g1860/g1857 /g1872/g1853/g1870/g1859/g1857/g1872 /g1856/g1870/g1873/g1859 /g1846/g1867/g1872/g1853/g1864 /g1866/g1873/g1865/g1854/g1857/g1870 /g1867/g1858 /g1861/g1866/g1872/g1857/g1870/g1874/g1861/g1857/g1875/g1857/g1856 /g1861/g1866/g1856/g1861/g1874/g1861/g1856/g1873/g1853/g1864/g1871 /g1499 100 % [16]. 145 Ethical considerations 146 Ethical permission was obtained from the Federal Ministry of Health. A letter of support 147 outlining the aims and objectives of the survey was submitted from the FMOH to the 148 Regional Health Bureaux and their respective local administrations. Before collecting the 149 data, informed consent was obtained from household heads (HH). In addition, purpose of the 150 survey was explained to HH, and interview was took place only if he or she agreed to sign on 151 the digital consent form on the data collection tablet. 152

153 Characteristics of study participants 154 A total of 8,446 SAC were eligible for the study. Out of these, 8154 participated in the study 155 giving a response rate of 96.5%. Out of the interviewed SAC, 1108 were from districts with 156 integrated approach; while 7046 were from districts with vertical approach. In addition, 7,840 157 (96.15%) and 314 (3.85%) were interviewed during the first and second visits, respectively. 158 Regarding socio-demographic characteristics of participants: 3939(48.31%) SAC were within 159 age group of 5-9 years; the gender proportions of SAC showed male and female were almost 160 equally involved in the survey; and almost all children (99.7%) were enrolled in primary or 161 secondary (Table 1). 162 . CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted March 23, 2020. ; https://doi.org/10.1101/2020.03.18.20038620doi: medRxiv preprint Table 1. Socio-demographic characteristics of SAC among selected districts of Ethiopia, 163 2019. 164 Variables Categories Frequency % Age (years) 5-9 3939 48.3 10-14 4215 51.7 Gender Female 4054 49.7 Male 4100 50.3 School Attendance No 1563 19.2 Yes 6591 80.8 Educational level Primary 6571 99.7 Secondary 20 0.3 School type Public 6441 97.7 Private 138 2.1 Religious 12 0.2 Albendazole/Mebendazole treatment coverage 165 The overall treatment coverage of Albendazole/Mebendazole against STH was found to be 166 71.0% (5785/8154) (Fig 2). Out of 7046 interviewed SAC in districts with non-integrated 167 approach, 4822(68.4%) reported that they swallowed ALB/MBD for STH. Among 1108 168 interviewed SAC in districts with integrated approach, 963(86.9%) reported that they 169 swallowed ALB/MBD against STH. Dis-aggregated data on treatment coverage of 170 Albendazole by districts showed Guagusa had the highest (91.6%) coverage whereas Gura-171 Ferda had the lowest coverage (21.6%) (Fig 2). 172 Fig 2. Albendazole/Mebendazole treatment coverage among SAC in Ethiopia, 2019. 173 Albendazole/Mebendazole treatment status disaggregated by gender, age and school 174 attendance 175 The proportion of STH treatment coverage among males was 2948(72%) while among 176 females was 2837(70%). Treatment coverage in the age group (10-14) years was significantly 177 higher than coverage in group (5-9) years old, (x2 = 170.57, P-value <0.001). In addition, the 178 treatment coverage in school attendant was higher than coverage non-enrolled children 179 (Table 2). 180 . CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted March 23, 2020. ; https://doi.org/10.1101/2020.03.18.20038620doi: medRxiv preprint Table 2. Albendazole/Mebendazole treatment coverage disaggregated by age, gender 181 and school attendance in Ethiopia 2019, (N= 8,154). 182 Variables Swallowed ALB/MBD Pearson_ chi square (p_ value) Yes No Unknown n (%) n (%) n(%) Gender Female 2837(70.00) 1095(27.00) 122(3.00) 3.81(0.15) Male 2948(71.90) 1042(25.4) 110(2.7) Age in years 170.57(0.001) 5-9 2534(64.4) 1246(31.6) 159(4.0) 10-14 3251(77.1) 891(21.2) 73(1.7) School attendance Yes 5343(81.1) 1178(17.9) 70 (1.0) No 442(28.3) 959(61.4) 162(10.3) Heard on MDA Yes 5227(86.7) 783(13) 19(0.3) No 557(26.2) 1353(63.8) 213(10.0) 183 Reasons for not swallowing ALB against STH 184 A total of 2137 (26.2%) children reported that they didn’t receive STH treatment. The main 185 reported reasons for not taking the medication were not attending school (n=422, (19.75%) 186 and drugs was not given 397(18.6%) (Table 3). 187 188 189 190 191 192 193 194 195 196 197 . CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted March 23, 2020. ; https://doi.org/10.1101/2020.03.18.20038620doi: medRxiv preprint Table 3. Reasons for not swallowing Albendazole in selected districts of Ethiopia, 2019. 198 Variables Frequency % Reasons for not swallowing ALB/MBD Fear of side effects 136 6.36 Too sick 25 1.20 Not eaten break fast 5 0.23 Drug not given 397 18.60 No MDA 227 10.60 Not attending school 422 19.75 Absent at the time of MDA 246 11.51 Not living in village 52 2.42 Drugs run out 75 3.51 No definite reason 313 14.65 Bad rumors 26 1.21 Un aware about MDA 213 9.90 199 200 201 202 203 204 . CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted March 23, 2020. ; https://doi.org/10.1101/2020.03.18.20038620doi: medRxiv preprint Treatment coverage of ALB/MBD in vertical versus integrated treatment approaches 205 The difference in treatment coverage of ALB/MBD was statistically different between the 206 vertical and integrated approaches (X2 = 158.72, P = <0.001) (Table 5). 207 Table 5. Treatment coverage of ALB/MBD in vertical Vs. integrated approaches, 208 Ethiopia, 2019. 209 Treatment approach Swallowed ALB/MBD X 2 P-value Yes (%) No (%) Unknown (%) Vertical 4822(68.4) 2008(28.5) 216(3.1) 158.72 < 0.001 Integrated 963 (86.9) 129(11.6) 16(1.5) Mass drug administration distribution sites for ALB/MBD 210 The main site where children received the treatment was in school compound as evidenced by 211 the high percentage value 5223(91%) shown in pie chart below (Fig 3). 212 Fig 3. Place of deworming using Albendazole/Mebendazole in Ethiopia, 2019. 213

214 This study in ten districts of Ethiopia shows Albendazole/Mebendazole mass treatment 215 against soil-transmitted helminthiases among school-age children in integrated versus vertical 216 treatment approaches result in overall treatment coverage of 71%. In vertical treatment 217 approach 68.4% (4822/7046) were treated; while in integrated approach 86.9 % (963/1108) 218 individuals were treated. The overall treatment coverage in our study is lower than the 219 WHO’s and Ethiopian target; which is to achieve at least 75% coverage of PC by 2020 either 220 through annual or biannual treatment of SAC [9, 19]. The overall coverage in our study is 221 slightly higher than the a global coverage of 68.8% in 2017; which is presented in the WHO 222 fact sheet [15]. In addition, a policy platform on treatment coverage with ALB/MBD of 223 different countries using 2016 WHO data showed 31 countries achieved <75% coverage 224 including Ethiopia, while 57 countries achieved 75% and above treatment coverage [19]. 225 . CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted March 23, 2020. ; https://doi.org/10.1101/2020.03.18.20038620doi: medRxiv preprint Moreover, WHO report in 2017 showed 36 countries reached 75% coverage for SAC [15]. In 226 our study, the treatment coverage in integrated approach is 87%; it is greater than the WHO 227 recommendation (75%). This result is consistent with a study conducted in Mali where 87% 228 coverage was reported [20]. The possible explanation for higher coverage of ALB/MBD in 229 integrated approach than the vertical approach could be due to its effectiveness to deliver the 230 drugs to those who are in need of drugs at community level. 231 In our study, gender dis-aggregated data showed the proportion of STH treatment coverage 232 among males was 2948(72%); while among females it was 2837(70%), which means the 233 coverage among males is slightly higher for males. However, this finding dis-agree with a 234 data obtained from 16 countries in which the coverage for females was slightly higher than 235 the coverage for males [21]. Moreover, the coverage of ALB/MBD in this survey is lower 236 than coverage survey of Ethiopia conducted in 2015 [22]. 237 The treatment coverage in school attendant was 81%; which is higher than coverage non-238 enrolled children (28%). This finding is differ from the coverage survey result of Ethiopia in 239 2015; which is 92.95% for school attendant while 52.2% for non-enrolled children [22]. The 240 possible explanation for the lower coverage of ALB/MBD among non-enrolled children in 241 this study could be exclusive school based deworming platform is inadequate to address those 242 children who are out of school. 243 Moreover, our study showed the treatment coverage in the age group 10-14 years was 244 significantly higher than coverage in group 5-9 years. Probably the higher coverage in this 245 age group is due to these children have better chance of attending school. In addition, the 246 main reported reasons for not taking treatment were not attending school and treatment was 247 not given. These reasons can be explained as attending school can increase in association 248 . CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted March 23, 2020. ; https://doi.org/10.1101/2020.03.18.20038620doi: medRxiv preprint with accessing drugs for those who are in needs. In this case evidence is lacking to discuss 249 over this finding. 250 The study has the following limitations: First, purposive selection and small of districts make 251 difficult to generalize the findings to national level. Second, identifying barriers associated 252 with low treatment coverage of ALB/MBD among non-enrolled school-age children could be 253 difficult with descriptive cross-sectional study. However, as strength we identified possible 254 reasons for not swallowing the drugs; and this study showed validated treatment coverage of 255 ALB/MBD at national level. 256

257 The study showed Albendazole/Mebendazole mass treatment coverage against soil-258 transmitted helminths among school-age children was found to be 71%, which is below the 259 WHO recommendation (75%). In addition, coverage survey should be performed in many 260 districts of Ethiopia to validate routine reports. Moreover, operational research is required to 261 identify factors with low coverage of school AlB/MBD among non-enrolled school-age 262 children. Further, a call for action is required from different stakeholders to improve 263 treatment coverage of ALB/MBD. 264 Funding: This study is made possible by the generous support of Federal Ministry of 265 Health. 266 Competing interests: Authors declared that there are no conflicts of interests. 267

268 Authors would like to thank NTD focal persons in each of the woredas involved in the study; 269 community guiders who were directing households in each segment of the kebeles; study 270 participants, and staff in College of Medicine and Health Sciences who participated in the 271 data collection process. 272 . CC-BY-NC-ND 4.0 International licenseIt is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted March 23, 2020. ; https://doi.org/10.1101/2020.03.18.20038620doi: medRxiv preprint Author’s contributions 273 MA drafted the original manuscript. MA, ZZ, CC, MY, YC and AT contributed in data 274 analysis. MA, ZZ, CC, FS, MY, YC, AT, BG and NN involved in the conception, design & 275 interpretation of the data. All authors read and approved the final manuscript. 276

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