Evaluation of Strategies for Improved Uptake of Preventive Treatment for Intestinal Schistosomiasis

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Brief Title

Evaluation of Strategies for Improved Uptake of Preventive Treatment for Intestinal Schistosomiasis

Official Title

Evaluation of Strategies for Improved Uptake of Preventive Treatment for Intestinal Schistosomiasis Among School Children in Jinja District, Uganda: a Stratified Cluster Randomized Controlled Trial

Brief Summary

      Previous research undertaken among adults in high endemic districts of Busia, Adjumani, Moyo
      and Nebbi reported unwillingness to take preventive treatment. A particular study conducted
      in primary schools of Jinja district showed that only 30% of school children took
      praziquantel during the 2011 Mass Drug Administration (MDA). Fear of side effects of
      praziquantel, lack of knowledge about schistosomiasis transmission and prevention and lack of
      teacher support were some of the major factors associated with the low uptake. Similar
      reasons for non-uptake have been reported elsewhere. Thus, measures are needed to increase
      uptake of Mass Drug Administration (MDA) in Uganda. There is no doubt that health education
      facilitates a better understanding of the obvious risks to health, including the knowledge of
      preventing parasitic infections among primary school children. Better compliance to treatment
      for schistosomiasis among school children can be achieved through implementing carefully
      designed programs involving face to face education methods. Increasing knowledge about
      schistosomiasis transmission and prevention and implementing measures to mitigate the side
      effects attributable to praziquantel, such as providing a snack prior to drug administration
      may improve uptake of the drug among school children.

      Hypothesis- Provision of a pre-treatment snack is effective in improving uptake of preventive
      treatment for intestinal schistosomiasis among primary school children.
    

Detailed Description

      Schistosomiasis is one of the most important parasitic infections in children particularly in
      Sub-Saharan Africa and the age related patterns of water contact explain the high prevalence
      and intensity of S. mansoni infection in children. If left untreated, schistosomiasis results
      in retarded growth and impairment of cognitive function especially among school children.
      Repeated treatment in the early stages of life has a long-lasting effect on morbidity at a
      later age. Focusing on the delivery of regular chemotherapy to the younger age groups
      produces maximum benefits and prevents chronic sequelae in adulthood.

      In 2001, the World Health Organization (WHO) recommended treatment programs for
      schistosomiasis to target school-age children who could be reached through the primary school
      system, in collaboration with the education sector. This method was considered affordable and
      cost-effective and the goal was to provide regular treatment to at least 75% of school-age
      children at risk of morbidity by the year 2010.

      The Ugandan national program for the control of schistosomiasis adopted the WHO
      recommendations in 2003 and has since supported Mass Drug Administration (MDA) with
      praziquantel, a single dose drug known for its efficacy and safety, in high burden
      communities including primary schools. The current national Health Sector Strategic and
      Investment Plan (HSSIP) underscores schistosomiasis as one of the diseases targeted for
      elimination by the year 2015. In Jinja, implementation of the control program for
      schistosomiasis started in August 2003 and has been scaled up to most of the endemic areas in
      the district. Annual mass treatment using praziquantel and albendazole for schistosomiasis
      and soil transmitted helminths (STH), respectively, targets all school-age children and
      adults at risk of infection. Preventive measures focusing on raising awareness on
      schistosomiasis include distribution of information, education and communication materials
      and health education especially in the primary schools but also in the wider communities.
      These are provided prior to MDA. In the primary schools, the teachers are trained to
      distribute the drugs to the children and to fill the treatment registers. These activities
      are supported through a parallel structure within the Ministry of Health with external
      funding from the United States Agency for International Development (USAID) channeled through
      Research Triangle Institute (RTI) International

      Previous research undertaken among adults in high endemic districts of Busia, Adjumani, Moyo
      and Nebbi reported unwillingness to take preventive treatment. A particular study conducted
      in primary schools of Jinja district showed that only 30% of school children took
      praziquantel during the 2011 MDA. Fear of side effects of praziquantel, lack of knowledge
      about schistosomiasis transmission and prevention and lack of teacher support were some of
      the major factors associated with the low uptake. Similar reasons for non-uptake have been
      reported elsewhere.

      Thus, measures are needed to increase uptake of MDA in Uganda. There is no doubt that health
      education facilitates a better understanding of the obvious risks to health, including the
      knowledge of preventing parasitic infections among primary school children. Better compliance
      to treatment for schistosomiasis among school children can be achieved through implementing
      carefully designed programs involving face to face education methods. Increasing knowledge
      about schistosomiasis transmission and prevention and implementing measures to mitigate the
      side effects attributable to praziquantel, such as providing a snack prior to drug
      administration may improve uptake of the drug among school children.

      Study objective:The objective of this study is to determine the efficacy of specific messages
      for schistosomiasis control and prevention alone or in combination with provision of a
      pre-treatment snack in improving uptake of preventive treatment for intestinal
      schistosomiasis among primary school children.

      Methods - Study design

      This will be a stratified cluster randomized controlled trial. The reasons for adopting a
      stratified cluster randomization in this study include the following:

        1. The study involves evaluation of interventions (specific messages for schistosomiasis
           transmission and control) which by nature, have to be implemented at a community or
           school level.

        2. Logistical convenience or to avoid the resentment or contamination that might occur if
           unblinded interventions were provided for some individuals but not others in each
           community

        3. In this study, it is desired to capture the mass effect of applying an intervention to a
           large proportion of primary school children e.g. reduction in the prevalence and
           intensity of the infection.

        4. The efficacy of some of the interventions has been established at individual levels but
           it is desired to measure the effectiveness when the interventions are applied on a
           community-wide basis.

             -  Study setting The study will be conducted in Walukuba Division, Jinja District,
                South Eastern Uganda. Schistosoma mansoni is highly endemic in the Division with a
                prevalence of 35% among school children [24]. Lake Victoria which borders the
                Division to the south is the main source of S. mansoni infection. The Division has
                a total population of 40,882. The main socio-economic activities in the area
                include agriculture (subsistence farming), fishing, and petty trade between the
                main land and the islands. There are 12 primary schools in the Division, majority
                (8/12) of which are within a 5 km distance from the Lake.

             -  Implementation of MDA in the primary schools MDA in the primary schools in the
                Division is implemented on an annual basis as a standalone intervention. School
                teachers in-charge of health and sanitation are the focal persons for MDA. Prior to
                MDA with praziquantel and albendazole, the grade teachers sensitize their
                respective children about schistosomiasis prevention, including taking preventive
                treatment, mobilize and prepare them to receive treatment. This is done on a group
                (grade) basis. During MDA, a classroom in each school is organized for drug
                administration and all children are invited indiscriminately, according to their
                grade, to receive treatment. One grade is invited at a time. Praziquantel is
                distributed according to height of the child using a standard dose pole. In
                addition, each child receives a single tablet of albendazole. Both drugs are
                distributed by the teachers and the children swallow the tablets using water under
                observation of the teachers who also record the treatment in the registers.

             -  Randomization The 12 primary schools in Walukuba Division will be randomized into
                two arms to; i) receive specific messages for schistosomiasis transmission and
                control (hereafter referred to as the education arm) and ii) receive specific
                messages for schistosomiasis transmission and control plus a pre-treatment snack
                (hereafter referred to as the snack arm). The 12 schools will be stratified
                according to uptake of praziquantel into 2 strata; low uptake stratum (<50% uptake)
                and high uptake stratum (≥50% uptake). This is to ensure a good balance of school
                characteristics in each arm. Randomization to the education and snack arm will be
                performed within each stratum using a computer generated program in STATA 10.0
                (TX,USA)

      Sample size A total sample size of 1,277 children will be examined in 12 primary schools. At
      95% power and a 95% confidence interval (CI), and assuming that the uptake of praziquantel
      will increase from 49% (from a previous study) to 75% (WHO target), the sample size required
      to detect this increase is 96 in the education arm and 96 in the snack arm (STATA 10.0, TX,
      USA). This sample size will be adjusted by 5% non-response to 101. A design effect of 6.3
      from a previous study will be applied to obtain a minimum sample size of 636 in the education
      arm and 636 in the snack arm

      -Sampling and data collection Children in grade (year) 4-6 in the 12 primary schools will be
      randomly selected to participate in the study. This is because children in grade 4-6 are
      about 10-14 years of age which is the peak age for schistosomiasis infection in Uganda. A
      proportionate number of children will be selected from each school and grade using
      probability proportional to size of the school and grade population. Systematic sampling,
      using the grade registers as the sampling frame, where the names of the children are arranged
      in alphabetical order, will be employed. The sampling interval will be obtained by dividing
      the total population of the grade with the number of children to be studied in the grade
      (N/n). After obtaining a random start from a table of random numbers, the interval will be
      followed until the required number of children in each grade is obtained. Face to face
      interviews with each selected child will be conducted by trained research assistants using
      structured questionnaires with multiple choice questions. After the interview, stool
      specimens will be collected from each child, processed and examined for S. mansoni infection.
      Children who will fail to provide stool specimens for examination will be replaced by
      randomly selecting an equal number of children in grade 4-6.
    


Study Type

Interventional


Primary Outcome

Uptake of preventive treatment

Secondary Outcome

 Prevalence of schistosomiasis infection

Condition

Schistosomiasis

Intervention

Pre-treatment snack

Study Arms / Comparison Groups

 Education arm
Description:  In the education arm, children will receive specific messages for schistosomiasis transmission and control 1 month prior to Mass Drug Administration. A synopsis of the messages will include the following:What schistosomiasis is and its public health significance among school age children, Schistosomiasis transmission methods, signs and symptoms and its complications, Control methods including the importance of taking preventive treatment annually, Side effects of preventive treatment, why some people suffer serious side-effects and others do not and what to do in order to mitigate the side effects.From each school, the head teacher and the school teacher in-charge of health and sanitation will be trained in the above ,basic principles of health education and in communication skills through a 2 days training workshop. The trained head teachers and heath teachers will in turn, deliver the messages to the children through face to face interactions during school assemblies, twice a week.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

1277

Start Date

October 2012

Completion Date

June 2013

Primary Completion Date

June 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Children in forms 4-6 in the 12 primary schools will be eligible for the study.
             Children in forms 4-6 are about 10-14 years of age, which is the peak age for
             schistosomiasis infection in Uganda. Children in form 7 will not be selected to
             participate in the study because they will not be available to participate in the
             subsequent evaluation phase of the study. School heads, and class teachers who have
             been in the schools for more than 6 months will be interviewed. Staffs of the district
             vector control office, members of the District Health Team (DHT) and parents that have
             stayed in the Division for more than 6 months will also be interviewed.

        Exclusion Criteria:

          -  Children and residents who have stayed in the Division or have held their respective
             offices in the Division for less than 6 months will not be eligible for the study.
      

Gender

All

Ages

10 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Simon Muhumuza, MBChB, MPH, , 

Location Countries

Uganda

Location Countries

Uganda

Administrative Informations


NCT ID

NCT01869465

Organization ID

ESIUPT2013


Responsible Party

Principal Investigator

Study Sponsor

Makerere University

Collaborators

 University of Copenhagen

Study Sponsor

Simon Muhumuza, MBChB, MPH, Principal Investigator, Makerere University


Verification Date

June 2013