Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000035022
Ethics application status
Approved
Date submitted
9/01/2010
Date registered
13/01/2010
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of training on use of Insecticide Treated Nets and integrated community network system for control of malaria in vulnerable groups
Scientific title
The effect of training on use of Insecticide Treated Nets and integrated community network system for control of malaria in vulnerable groups: randomized community trial
Secondary ID [1] 1257 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 256496 0
anemia 256497 0
Condition category
Condition code
Blood 256675 256675 0 0
Anaemia
Infection 256681 256681 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consisted of training of heads of the households in the intervention villages (11 villages) on propoer use of Insecticide Treated Nets(ITN) and continuous monitoring of use of ITN by village leaders. The training was given for two days using posters and demonstratoin in rural hourses
Intervention code [1] 255781 0
Prevention
Comparator / control treatment
11 comparative villages will serve as controls. In these villages, ITN will be provided but no trainng and follow up by village leaders.
Control group
Active

Outcomes
Primary outcome [1] 257559 0
The primary outcome will be prevalence of malaria and anemia in under-five children and pregnant women. Mass blood investigation for all under-five children and pregnant women is being done in the selected Gots three times a year. For malaria parasite identification, thick and thin films will be prepared in the field and stained with Giemsa in Jimma Specialized Hospital. Haemoglobin concentration for assessment of anemia will be determined using Hemo Cue analyzer in the field (HemoCue Hb 301, Sweden)
Timepoint [1] 257559 0
At month 2, 6, 10 after randomization
Secondary outcome [1] 262805 0
proper use of ITN will be the secondary outcome. Proper use of ITN will be determined using observation and interview
Timepoint [1] 262805 0
Every month after randomization for 24 monhts

Eligibility
Key inclusion criteria
There are two study population: underfive children and pregnant women. Underfive children who are above one month and live in the study villages will be included. Pregnant women who live in the study area will also be included. The study villages should be within 15 K.m radius of the dam.
Minimum age
1 Months
Maximum age
49 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under-five children and pregnant women who live outside the study villages

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Villages (Gots) in Gilgel Gibe field research centre were stratified into North and South in relation to the reservoir of Gilgel Gibe hydroelecteric dam. Gots in the north direction of the reservoir were selected randomly as intervention whereas villages in the South direction of the dam were selected to be control groups and both groups are within the same distance (15 Km) from the reservoir. For this trail, 22 Gots (11 interventions and 11 controls) were included. All households, under-five chilren and pregnant women in the selected
Gots were involved in the study. Since, the study is community triat, it was the Gots/villages which were allocated into treatment and control villages centrally using computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a ramdom table generated by computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment outside Australia
Country [1] 2390 0
Ethiopia
State/province [1] 2390 0

Funding & Sponsors
Funding source category [1] 256266 0
Charities/Societies/Foundations
Name [1] 256266 0
The United Nations Children's Fund(UNICEF)/ United Nations Development Program(UNDP)/ World Bank/ World Health Organization(WHO) Sprecial Program for Research and Training in Tropical Diseases(TDR)
Country [1] 256266 0
Switzerland
Primary sponsor type
Charities/Societies/Foundations
Name
The United Nations Children's Fund(UNICEF)/ United Nations Development Program(UNDP)/ World Bank/ World Health Organization(WHO) Sprecial Program for Research and Training in Tropical Diseases(TDR)
Address
Research Manager, Empowerment (Attn: Mrs Pearl Harlley)
Special Programme for Research and Training in Tropical Diseases (TDR)
World Health Organization
1211 Geneva 27
Switzerland
Country
Switzerland
Secondary sponsor category [1] 251593 0
University
Name [1] 251593 0
Jimma University
Address [1] 251593 0
Jimma University
P.O.BOX 378
Jimma, Ethiopia
Country [1] 251593 0
Ethiopia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258355 0
WHO Ethical Review Committee
Ethics committee address [1] 258355 0
Ethics committee country [1] 258355 0
Switzerland
Date submitted for ethics approval [1] 258355 0
10/05/2008
Approval date [1] 258355 0
05/08/2008
Ethics approval number [1] 258355 0
A80086
Ethics committee name [2] 258356 0
Jimm University Ethical review board
Ethics committee address [2] 258356 0
Jimma University,
P.O.BOX 378, Jimma, Ethiopia
Ethics committee country [2] 258356 0
Ethiopia
Date submitted for ethics approval [2] 258356 0
01/01/2008
Approval date [2] 258356 0
05/03/2008
Ethics approval number [2] 258356 0
RPO/101/2000

Summary
Brief summary
Efforts devoted to understanding the biology of the malaria parasite and mosquito vector in the past 2 decades have resulted in new and improved tools against malaria. However, there is paucity of researches on human behavior regarding the proper use of Insecticide Treated Nets to prevent malaria in vulnerable groups (under-five children and pregnant mothers). This study assesses the effect of training of heads of the households and subsequent follow up for use of Insecticide Treated Nets and integrated community network system on the burden of malaria. The study will employ randomized community trial to be conducted in Gilgel Gibe Field Research Center, Southwest Ethiopia. To avoid the effect of contamination, villages in the field research center were stratified into North and South in relation to the reservoir of the dam. One of the directions will be selected as intervention site by simple random sampling technique. A total of 22 Gotes (11 in the intervention and 11 in the control) were included in the study. Control and intervention villages will have similar distance(15 K.m) from the reservoir of the dam.
Baseline survey on socio-economic status; knowledge, perception and use of Insecticide Treated Nets and prevalence of malaria in under-five children and pregnant women will be undertaken in both the intervention and control group. The study will be conducted for 3 years (Feb 2009 - Dec 2011). The intervention consists of training of the heads of the households about the proper use of Insecticide Treated Nets for vulnerable groups and establishing community network system that makes the training sustainable. Tailored training and demonstration about use of Insecticide Treated Nets will be given to the heads of the households by community leaders using local language. Information Education communication materials e.g. training manuals, pamphlets and posters will be prepared by local language. After training, there will be monitoring of use of Insecticide Treated Nets in each household in the intervention village. The community leaders and community health agents will use checklist to assess the proper use of Insecticide Treated Nets in each house. At the end of the intervention, proper use of Insecticide Treated Nets and burden of malaria in under-five children and pregnant women will be assessed in both the intervention and control villages. Data will be entered into computer, edited, cleaned, and analyzed using SPSS-12 statistical soft ware. Descriptive statistics will be done to measure the burden of malaria and the use of Insecticide Treated Nets . Multivariate logistic regression technique supported by qualitative findings will be done to assess the effect of the intervention while controlling confounding variables. There is a possibility of hampering the training activities during sowing and harvesting season where training will be planned in consultation with the community. Proper and sustainable use of Insecticide Treated Nets and reduced incidence of malaria is the expected outcomes of the study
Trial website
Trial related presentations / publications
Effect of training on use of long lasting treated bed nets on the burden of malaria among vulnerable groups in Gilgel Gibe Field Research Center, Ethiopia: baseline results of a cluster randomized trial (submitted, December, 2009)
Authors: Amare Deribew, Fessehaye Alemseged, Zewudie Birhanu, Lelisa Sena, Ayalew Tegegn, Ahmed Zeynudin, Tariku Dejene, Morankar Sudhakar, Nasir Abdo, Fasil Tessema
Public notes

Contacts
Principal investigator
Name 30677 0
Address 30677 0
Country 30677 0
Phone 30677 0
Fax 30677 0
Email 30677 0
Contact person for public queries
Name 13924 0
Amare Deribew
Address 13924 0
Jimma University
P.O.BOx 205, Jimma, Ethiopia
Country 13924 0
Ethiopia
Phone 13924 0
251917 803581
Fax 13924 0
251471 119521
Email 13924 0
[email protected]
Contact person for scientific queries
Name 4852 0
Amare Deribew
Address 4852 0
Jimma University
P.O.BOx 205, Jimma, Ethiopia
Country 4852 0
Ethiopia
Phone 4852 0
251917 803581
Fax 4852 0
251471 119521
Email 4852 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe effect of household heads training about the use of treated bed nets on the burden of malaria and anaemia in under-five children: a cluster randomized trial in Ethiopia2012https://doi.org/10.1186/1475-2875-11-8
N.B. These documents automatically identified may not have been verified by the study sponsor.