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.
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
- Conditions the study is for
- Integrated Control of Malaria and Polyparasitism
- What is being tested?
- Health education intervention
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| health education | This 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.
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)
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.
- First posted25 Jan 2011 (estimated)
- Study startApr 2003
- Primary completionJun 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Integrated Control of Malaria and PolyparasitismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Zimbabwe
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health Research, Zimbabwe
- Investigators
- Takafira Mduluza, PhD, Principal investigator, University of Zimbabwe
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 20175980Midzi 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 18656215Midzi 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01283165
- Acronym / sponsor ID
- Zimworms / ZimWorm
- Keywords
- health education, Polyparasitism, school based deworming program, integrated control of parasites
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,303 participants (actual)
- Lead sponsor
- University of ZimbabweUniversity, hospital or other
- Collaborators
- National Institute of Health Research, Zimbabwe
- Study start
- Apr 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 25 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| health education | – | Behavioral: Health education interventionThis 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Primary school going children living in rural and commercial farming areas
Key inclusion criteria (1 listed)
- all school children at the primary schools
Key exclusion criteria (1 listed)
- Very sick with known TB or HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health education interventionAlso: Knowledge Attitude and Practice interventionHealth 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. | Behavioural | health education |
Primary outcome
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
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.
1 secondary outcome
Impact of school based parasite treatment and health education intervention.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2011.
- Results publication: PubMed 20175980Midzi 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.
- Results publication: PubMed 18656215Midzi 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.
- Results publication: PubMed 18486169Midzi 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.
- Medical Research Council of ZimbabweLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takafira Mduluza, PhD principal investigator
University of Zimbabwe
1 site in 1 country: see every site and its status.
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.