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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Malaria

anemia

Condition category

Condition code

Blood

Anaemia

Infection

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]

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]

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]

At month 2, 6, 10 after randomization

Secondary outcome [1]

proper use of ITN will be the secondary outcome. Proper use of ITN will be determined using observation and interview

Timepoint [1]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Ethiopia

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

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 [1]

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 [1]

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]

University

Name [1]

Jimma University

Address [1]

Jimma University
P.O.BOX 378
Jimma, Ethiopia

Country [1]

Ethiopia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

WHO Ethical Review Committee

Ethics committee address [1]

Ethics committee country [1]

Switzerland

Date submitted for ethics approval [1]

10/05/2008

Approval date [1]

05/08/2008

Ethics approval number [1]

A80086

Ethics committee name [2]

Jimm University Ethical review board

Ethics committee address [2]

Jimma University,
P.O.BOX 378, Jimma, Ethiopia

Ethics committee country [2]

Ethiopia

Date submitted for ethics approval [2]

01/01/2008

Approval date [2]

05/03/2008

Ethics approval number [2]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Amare Deribew

Address

Jimma University
P.O.BOx 205, Jimma, Ethiopia

Country

Ethiopia

Phone

251917 803581

Fax

251471 119521

amare.deribew@ju.edu.et

Contact person for scientific queries

Name

Amare Deribew

Address

Jimma University
P.O.BOx 205, Jimma, Ethiopia

Country

Ethiopia

Phone

251917 803581

Fax

251471 119521

amare.deribew@ju.edu.et

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

Source	Title	Year of Publication	DOI
Dimensions AI	The 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 Ethiopia	2012	https://doi.org/10.1186/1475-2875-11-8

N.B. These documents automatically identified may not have been verified by the study sponsor.

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