Mass drug administration campaigns: Comparing two approaches for schistosomiasis and soil-transmitted helminths prevention and control in selected southern Malawi districts

Preventive chemotherapy using mass drug administration (MDA) is one of the key interventions recommended by WHO, to control neglected tropical diseases. In Malawi, health workers distribute anti-helminthic drugs annually with most support from donors. The mean community coverage of MDA from 2018 to 2020 were high at 87% for praziquantel and 82% for albendazole, however posing a sustainability challenge once donor support diminishes. This study was conducted to compare use of the community-directed intervention (CDI) approach with the use of health workers in delivery of MDA. It was carried out in three districts, where cross-sectional, mixed-methods approach to data collection during baseline and follow-up assessments was used. Knowledge levels were high for what schistosomiasis is (65% - 88%) and what STH are (32% - 83%); and low for what causes schistosomiasis (32% - 58%), causes of STH (7% - 37%), intermediate organisms for schistosomiasis (13% - 33%) and types of schistosomiasis (2% - 26%). At follow-up, increases in praziquantel coverage were registered in control (86% to 89%) and intervention communities (83% to 89%); decreases were recorded for control (86% to 53%) and intervention schools (79% to 59%). Assessment of the costs for implementation of the study indicated that most resources were used at community (51%), health centre (29%) and district levels (19%). The intervention arm used more resources at health centre (27%) and community levels (44%) than the control arm at 2% and 4% respectively. Health workers and community members perceived the use of the CDI approach as a good initiative and more favorable over the standard practice of delivering MDA. The use of the CDI in delivery of MDA campaigns against schistosomiasis and STH is feasible, increases coverage and is acceptable in intervention communities. This could be a way forward addressing the sustainability concern when donor support wanes.

127 The study districts were selected purposively based on their level of co-endemicity with 128 schistosomiasis and STH, and the comparative socio-economic, demographic and health 129 indicators of the three districts [7]. In each district, four health centres and 16 villages within the 130 catchment areas of the health centres were randomly selected to participate in the study. Each 131 study arm was randomly allocated two health centres with eight villages in total (Table 1).
. CC-BY 4.0 International license It 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, 2022. ; https://doi.org/10.1101/2022.03.21.22272679 doi: medRxiv preprint 147 participate in a face-to-face questionnaire-based knowledge, attitudes and practices survey. Any 148 household member above 14 years available during the time of the visit was invited to participate 149 in the survey while ensuring gender balance. Data were collected in three districts comprising 150 totals of 12 health centres and 48 villages. Table 2 summarizes the methods, purposes, levels, 151 sample sizes and quantities of data collected in the study.
152 Table 2: Methods, purposes, levels, sample sizes and amount of data collected in the study 179 At every stage at health centre and village levels, both the district and health centre teams 180 participated in the training as observers to ensure quality delivery and adherence to the study 181 protocol. In the control arm of the study, no briefing and training were offered to health staff 182 from the corresponding health centres and villages.
. CC-BY 4.0 International license It 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) 184 During the implementation of the CDI process at community level, the health services, 185 implementation partners and the community had the following roles and responsibilities (Table   186 3).
187 Table 3: Roles and responsibilities of the key players in CDI process

Category of players Roles and responsibilities played in CDI process
1) District-level officers  Introduced to the community the concept of CDI and technical aspects of the interventions.  Provided and facilitated capacity building, supplies and technical support as required by the interventions.  Provided and supported supervision to health centres based on procedures and criteria of the interventions.
2) Implementation partners  Provided and facilitated capacity-building and technical support as required by the interventions.  Provided and supported supervision on the basis of procedures and criteria of the interventions that were agreed upon with the community.  Ensured adequate provision of the necessary supplies, i.e. drugs, and other intervention materials.
3) Health centre staff and responsible HSAs  Identified community leadership structures and socio-cultural organizations and took these into account in all interactions with the community.  Introduced to the communities the concept of CDI and technical aspects of the interventions.  Provided and supported supervision to Village Health Committees, CDDs and communities based on procedures and criteria of the interventions.

4) Community members
With the facilitation by the health centre staff and responsible HSAs, community members had the following roles and responsibilities:  Collectively discussed the health problems and possible interventions from their own perspective while considering relevant community knowledge and information provided to them by the health professionals.  Collectively decided whether they will take responsibility for implementation of interventions at community level.
. CC-BY 4.0 International license It 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)    CC-BY 4.0 International license It 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, 2022. ; https://doi.org/10.1101/2022.03.21.22272679 doi: medRxiv preprint . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.    Table 4 summarizes distribution of the demographic and socio-economic 250 characteristics of the respondents during baseline and follow-up for the three study districts.
. CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

Knowledge of schistosomiasis in Chiradzulu
What is schistosomiasis? What causes schistosomiasis?
Intermediate organism Types of schistosomiasis . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. 277 causes of STH (15% to 26%) for intervention and control arms. In the districts, Zomba (range: 278 21% -83%) was highest in terms of knowledge levels, followed by Chiradzulu (range: 7% -279 76%) and Mangochi (range: 9% -50%). Chiradzulu registered decreases in knowledge of what 280 STH are (59% to 40%) in intervention arm, causes of STH (28% to 7%) in intervention and 281 control arms. Figure 3 shows how the respondents answered to selected knowledge-based 282 questions about STH during the surveys according to study arms and districts.

Knowledge of schistosomiasis in Zomba
What is schistosomiasis? What causes schistosomiasis?
Intermediate organism Types of schistosomiasis . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.  . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.  . CC-BY 4.0 International license It 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, 2022. ; https://doi.org/10.1101/2022.03.21.22272679 doi: medRxiv preprint 309 due to a logistical supply chain problem. Figure 5 illustrates albendazole coverage trends for the 310 study districts during the three years. . CC-BY 4.0 International license It 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, 2022. ; https://doi.org/10.1101/2022.03.21.22272679 doi: medRxiv preprint 324 intervention and control arms for both community and school MDA in the district.
325 In Mangochi district, follow-up MDA coverage rates were higher than those obtained in baseline 326 for both community and school praziquantel MDA. Increases in coverage rates were observed in 327 intervention (from 62% to 96%) and control (from 75% to 99%) communities; and in 328 intervention (from 61% to 94%) and control (from 83% to 85%) schools. There were no 329 observed differences between follow-up coverage rates in intervention and control arms and for 330 communities and schools.
331 Praziquantel coverage rates in Zomba were low during follow-up than during baseline in both 332 communities and schools. The coverage rates decreased in intervention communities (from 87% 333 to 81%) and schools (from 87% -83%); and control communities and schools (from 84% to 75% 334 for both). However, there were no observed differences between coverage scores between 335 intervention and control arms for both communities and schools meaning that there was no effect 336 on the follow-up MDA attributable to the implementation of the study in the district. Figure 6 337 illustrates how the three districts generally and individually fared on praziquantel coverage for 338 communities and schools, and according to the study arms.

Praziquantel coverage in Chiradzulu
Community School . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

Praziquantel coverage in Zomba
Community School . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

Delta values for praziquantel and albendazole coverages (%)
. CC-BY 4.0 International license It 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, 2022. ; https://doi.org/10.1101/2022.03.21.22272679 doi: medRxiv preprint 369 levels, most resources were used for personnel related costs (85%) followed by other logistics 370 (9%) and transportation (5%). For both arms of the study (intervention and control), most 371 resources were used at community level (51%) followed by health centre level (29%) and district 372 level (19%). At both health centre and community levels, the intervention arm used more 373 resources at 27 percent and 44 percent than the control arm at 2 percent and 4 percent 374 respectively (Table 5).

Perceptions of health workers and community members on the use of the CDI approach in
379 MDA delivery 380 The study sought to get the perceptions of the health workers as providers and community 381 members as beneficiaries in the intervention arm on the use CDDs in delivery of MDA. The . CC-BY 4.0 International license It 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, 2022. ; https://doi.org/10.1101/2022.03.21.22272679 doi: medRxiv preprint 383 MDA as a welcomed and a good initiative.

384
"I think drugs should be administered by the communities themselves, because these 385 people reside in the same area and they know their fellow community members very 386 well as compared to health workers." -A male health worker, Chiradzulu.
387 On the other hand, community leaders and members viewed the CDI approach convenient 388 because people were easily accessing drugs right in their homes. . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. 442 as compared to control communities. These findings demonstrate that there was no effect 443 attributable to the implementation of the study apart from demonstrating the feasibility of using 444 the CDI approach to deliver MDA campaigns in the study districts. We believe that since this 445 was first time the CDI approach was used in Malawi for delivery of MDA for praziquantel and 446 albendazole, there is a likelihood that the coverage rates may increase with subsequent 447 implementation because CDDs will now be familiar with the process. A major contributing 448 factor for variations in coverage rates that were obtained in this study was due to emergence of . CC-BY 4.0 International license It 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)  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, 2022. ; https://doi.org/10.1101/2022.03.21.22272679 doi: medRxiv preprint 473 gained through resultant improved health services or due to the development of community 474 capacity to handle its own health challenges. This is truer when the intervention is juxtaposed 475 with the standard practice where it is mostly dependent on donor support which cannot always be 476 guaranteed. With the study mostly registering no observable differences in scores between the 477 intervention and control arms, it would be reasonable to postulate that the CDI approach is 478 equally capable of producing the same results as the standard approach. The CDI approach is 479 implementable at a lower cost in the long term than the standard approach if the once off cost of 488 The main challenge related to implementation of the study were disruptive delays due to the 489 COVID-19 pandemic, which challenged the original intended timing of the study as well as the 490 budget. This included the experienced need for appropriate timing and communication with 491 District Health authorities, who had to focus more on urgent COVID-19 matters than on 492 schistosomiasis and STH control. There was also a delay experienced by the National 493 Schistosomiasis and STH Control Programme in delivery of drugs for the 2020 MDA campaign 494 in all the districts. It is encouraging though that in this study both the health workers as providers . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. 509 In conclusion, the study has demonstrated the feasibility of using the CDI approach for delivery 510 of MDA for prevention and control of schistosomiasis and STH in Malawi. This study has also 511 shown that there were no observed major differences in MDA coverage rates between 512 intervention and control arms despite some challenges encountered during implementation. The 513 findings have revealed existence of gaps in health education messages regarding control of 514 schistosomiasis and STH. Although it was more costly to implement the interventions in the 515 short term, the long term benefits of using the CDI approach in delivery of MDA outweigh the 516 investments, and both the health providers and beneficiaries perceived the interventions as good . CC-BY 4.0 International license It 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, 2022. ; https://doi.org/10.1101/2022.03.21.22272679 doi: medRxiv preprint 517 and welcome. This could be a way forward addressing the sustainability concern for 518 schistosomiasis and STH control when donor support wanes. 530 Similarly for the study participants who were children (under 16 years of age), consent to 531 participate was collected from their parents or guardians on their behalf. All the research 532 instruments that were used at community level were also translated to local languages.

Consent for publication
534 Not applicable. The manuscript does not contain any individual person's data in any form.
. CC-BY 4.0 International license It 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, 2022. ; https://doi.org/10.1101/2022.03.21.22272679 doi: medRxiv preprint 536 The datasets generated and/or analyzed during the current study are not publicly available 537 because participants did not grant permission for public sharing of the data in our informed 538 consent process, approved by Malawi National Health Sciences Research Committee but 539 available from the corresponding author on reasonable request.  . CC-BY 4.0 International license It 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, 2022. ; https://doi.org/10.1101/2022.03.21.22272679 doi: medRxiv preprint