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Integrated Control of Malaria and PolyparasitismZimwormsNCT01283165

Worm Infestation and Child Health in Zimbabwe

An observational study of Integrated Control of Malaria and Polyparasitism, run by University of Zimbabwe at 1 site in Zimbabwe.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective of the project was to determine the effect of integrated school based deworming and health education on prevalence and morbidity due to co-infection infection with schistosomiasis, STHs and malaria among primary school age children living in rural and farming areas in Zimbabwe There is need for… Read more about this study

Who is it for?
Ages 5 to 17 yearsHealthy volunteers can take part
What is being tested?
Health education intervention
How many people
1,303 participants
Where
1 siteZimbabwe
Study dates
Apr 2003to Dec 2006
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Primary school going children living in rural and commercial farming areas

Who may be able to join

  • all school children at the primary schools

Who cannot join

  • Very sick with known TB or HIV infection

Trial locations and contacts

1 site in 1 country.

Zimbabwe1 site
  • Biochemistry Department University of Zimbabwe

    Harare

Other trials in Zimbabwe

About this study

Official title: Analysis on the Burden of Helminths-plasmodium Polyparasitism, Impact on Anaemia and Effects of Integrated School Based Parasite Control and Health Education in Zimbabwe

The main objective of the project was to determine the effect of integrated school based deworming and health education on prevalence and morbidity due to co-infection infection with schistosomiasis, STHs and malaria among primary school age children living in rural and farming areas in Zimbabwe

There is need for regular school based de-worming and health education programs for the helminths-Plasmodium co-infections in primary schoolchildren living in rural and commercial farming areas in Zimbabwe

Read the detailed description

Schistosomiasis is one of the major communicable diseases of public health and socio-economic importance in the developing world. More than 600 million people are at risk of infection with schistosomiasis, 207 million are infected and 120 million are suffering from severe morbidity due to schistosomiasis. Soil transmitted helminths (hookworms, Trichuris trichura and Ascaris lumbricoides) infect more than 2 billion people with children being the most at risk age group. Common clinical outcomes of soil transmitted helminths (STHs) include anaemia, impaired physical development, cognition and malnutrition area especially in primary school children. Global estimates indicate 243 million cases of malaria worldwide of which (85%) were reported in African region only. It accounted for an estimated 863 000 deaths in 2008, of which 89% occurred in the Africa alone.

The high prevalence of schistosomiasis, STHs and malaria and the striking similarity of the conditions that favour their survival, reproduction and transmission that include poverty, lack of preventive measures, health care, safe water and sanitary facilities, and the similarity in temperatures conditions, make polyparasitism from these parasites a "norm that an exception" in tropical and sub-tropical areas. Separate studies have shown endemicity of schistosomiasis, STHs and malaria in Zimbabwe and all these studies have demonstrated high prevalence of schistosomiasis, STHs and malaria among primary schoolchildren. Though only single parasite were investigated in separate studies, results from previous studies indicate geographic overlap of helminths and Plasmodium and thus polyparasitism especially in primary schoolchildren. However data is scarce on extend of polyparasitism with schistosomiasis, STHs and Plasmodium malaria in Zimbabwe and else where. Delineation of areas co-endemic for helminthiasis and malaria and the knowledge of the proportion of the population with co-infections is a first step in allocating limited public health resources for integrated control programmes. Using parasitological methods this study sought to determine the distribution of polyparasitism in primary schoolchildren living in rural and commercial farming areas in Zimbabwe.

Prevalence of anaemia among children under 5 years of age in Zimbabwe is 58% (range 55.4%-63.1%) and it is 38% (range 30.7%-47.5%) for women. However the prevalence of anaemia in primary school age children (5-15 years) is not reported. Neither is there a report on the etiology of anaemia in this age group. Data is also lacking on the contribution of STHs, schistosomiasis and Plasmodium falciparum on the reported anaemia prevalence in Zimbabwe although they are major contributors to this disease. There is also a paucity of evidence on the impact of polyparasitism with helminths and Plasmodium on anaemia especially among the most susceptible primary schoolchildren in the developing world including Zimbabwe. These gaps derail policy decisions on appropriate integrated control strategies that should be based on scientific evidence from field studies. The impact of polyparasitism on anaemia among primary schoolchildren living in the commercial farming area was determined in this study.

The growing interest for the global control of polyparasitism by combining different interventions is economically considered cost effective and the global attention is focused on this strategy. However a number of operational research questions including the choice of different integrated control strategies, timing of treatment cycles, feasibility of implementation and impact on prevalence of polyparasitism, and anaemia requires evaluation before rolling out large scale control programmes. A longitudinal study was conducted to investigate the impact of combined regular school based treatment and delayed treatment of parasitic diseases on polyparasitism and anaemia.

Zimbabwe is among WHO member states that have placed control of schistosomiasis, malaria and STHs high on the agenda. Wide spread use of Praziquantel will be inevitable. However whilst global use of Praziquantel is scaling up, there is also a growing concern in the use of this single drug for treatment of a disease affecting more than 200 million people especially in the wake of low cure rates reported in Senegal and Egypt. Consequently recommendations for continued monitoring for Praziquantel resistance under the pressure of wide spread use of the drug have been made. Current data is lacking on the efficacy of Praziquantel in treatment of schistosomiasis in Zimbabwean population. Praziquantel drug efficacy was determined in this study in order to advice health managers on the implications of mass drug administration that is pending as Zimbabwe prepares from mass treatment using the school based approach.

The World Health Organization recommends that any large scale control programme should be preceded by a baseline survey in order to monitor and evaluate control strategies during and after implementation. For the control of helminthiasis, conducting the baseline survey in grade three children (8-10years) is recommended since they harbour the highest prevalence and intensity of infection in the community and can be followed up to at least two years to monitor and evaluate effectiveness of any control strategy implemented. Thus the prevalence of helminths in this age group can be used as an index for assessing community prevalence. However data on Knowledge attitudes and practice (KAP) of grade three children in relation to schistosomiasis, STHs and malaria is lacking. The impact of school health education on behaviour modification of the school children towards prevention of helminthiasis and malaria in Zimbabwe is also scarce. A follow up KAP study was conducted in grade three children before and after school based health education integrated with treatment.

Being tested
Health education intervention
Keywords
health education, Polyparasitism, school based deworming program, integrated control of parasites
Medical subject headings
Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health education interventionBehavioural

    Also called Knowledge Attitude and Practice intervention

    Health education was conducted in two ways. (1) Teachers were taught how to use the flip chart that contained health education material about parasites. The lessons were done during free periods as this intervention had not been formally fitted into the school syllabus. (2) The research team provided health education to school children. Focus group discussions were conducted by the research team with school children all assembled outside their classes. Health education leaflets were distributed to all school children at the school. Children were asked to share the health information with their friends and families.

Study groups in NCT01283165
Study groupRoleWhat they receive
health educationThis was an intervention follow up Knowledge Attitude and Practice study that investigated the distribution of polyparasitism with schistosomiasis, STHs and P. falciparum among primary schoolchildren.
Receives: Behavioral: Health education intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. This study was conducted to determine the prevalence of polyparasitism among primary school children living in rural and commercial farming areas in Zimbabwe.

    This study was conducted to determine the prevalence of polyparasitism, the impact of polyparasitism on anaemia, the effect of combined school based treatment for STHs, schistosomiasis, health education and prompt malaria treatment on anaemia and prevalence of polyparasitism in primary school children.

    Measured: 3 years

Secondary outcomes (1)
  1. Impact of school based parasite treatment and health education intervention.

    To determine the impact of combined school based deworming and prompt malaria treatment on prevalence of helminths-Plasmodium co-infections, anaemia and severity of anaemia among primary schoolchildren in rural and commercial farming areas in Zimbabwe. Combined school based parasite treatment were performed at baseline and at each follow up survey. Sustained prompt malaria treatment was performed throughout the study period.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2011 (estimated)
  2. Study startApr 2003
  3. Primary completionJun 2006
  4. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01283165
Sponsor's protocol ID
ZimWorm
Acronym
Zimworms
Status last verified
Jan 2003
First submitted
24 Jan 2011
Last updated
10 Nov 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Midzi N, Mtapuri-Zinyowera S, Mapingure MP, Sangweme D, Chirehwa MT, Brouwer KC, Mudzori J, Hlerema G, Mutapi F, Kumar N, Mduluza T. Consequences of polyparasitism on anaemia among primary school children in Zimbabwe. Acta Trop. 2010 Jul-Aug;115(1-2):103-11. doi: 10.1016/j.actatropica.2010.02.010. Epub 2010 Feb 20.

    PubMed 20175980
  • Midzi N, Sangweme D, Zinyowera S, Mapingure MP, Brouwer KC, Munatsi A, Mutapi F, Mudzori J, Kumar N, Woelk G, Mduluza T. The burden of polyparasitism among primary schoolchildren in rural and farming areas in Zimbabwe. Trans R Soc Trop Med Hyg. 2008 Oct;102(10):1039-45. doi: 10.1016/j.trstmh.2008.05.024. Epub 2008 Jul 24.

    PubMed 18656215
  • Midzi N, Sangweme D, Zinyowera S, Mapingure MP, Brouwer KC, Kumar N, Mutapi F, Woelk G, Mduluza T. Efficacy and side effects of praziquantel treatment against Schistosoma haematobium infection among primary school children in Zimbabwe. Trans R Soc Trop Med Hyg. 2008 Aug;102(8):759-66. doi: 10.1016/j.trstmh.2008.03.010. Epub 2008 May 16.

    PubMed 18486169

Questions about this trial

What is this clinical trial studying?

An observational study of Integrated Control of Malaria and Polyparasitism, run by University of Zimbabwe at 1 site in Zimbabwe.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

This study was conducted to determine the prevalence of polyparasitism among primary school children living in rural and commercial farming areas in Zimbabwe. (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01283165, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2011.

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