Condition category
Infections and Infestations
Date applied
14/04/2009
Date assigned
13/05/2009
Last edited
13/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Philip McCall

ORCID ID

Contact details

Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial of insecticide-treated bednets for control of domestic ticks and prevention of African tick-borne relapsing fever

Acronym

Study hypothesis

We investigated whether insecticide-treated bednets, using the insecticide formulation and standard practices currently promoted and used widely for malaria prevention in Africa, could control household infestations of soft ticks (Argasids) and prevent transmission of tick-borne relapsing fever (TBRF) to humans.

Ethics approval

1. The Medical Research Coordinating Committee (MRCC) of the National Institute for Medical Research (NIMRI) Tanzania gave approval on the 24th May 2001 (ref: NIMR/HQ/R.8a/Vol.IX /28)
2. The Research Ethics Committee of the Liverpool School of Tropical Medicine gave approval on the 4th July 2001 (ref: 01.30)

A research permit (03849) was issued by the Tanzanian Committee for Science and Technology (COSTECH), Dar es Salaam, Tanzania on 02/04/2001.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Tick-borne relapsing fever (TBRF)

Intervention

This is a randomised controlled trial performed over 29 months; households are selected by two-stage random sampling and randomised to either receive insecticide-treated nets (ITNs) or no nets (control). Households in both arms were unmatched.

Treated households were provided with insecticide-treated bednets: standard green medium-sized circular bednets (1.5 m x 1.8 m at base, 2.1 m high; total net area of 2.7 sq m), of 75-denier polyester fibre (Tanzania manufacturing Textile Limited factory), impregnated with the pyrethroid lambdacyhalothrin (ICONET; Syngenta Crop Protection AG, Basel, Switzerland), using NGAO sachets (dosage of 55.6 mg/m^2) locally marketed for malaria control. Nets were retreated by staff at time of distribution and at 6, 18 and 24 months later.

Control households received no treatment.

Intervention type

Drug

Phase

Not Applicable

Drug names

Insecticide-treated bednets (impregnated with pyrethroid lambdacyhalothrin)

Primary outcome measures

Percentages of households infested with O. moubata s.l. (domestic infestations with the soft tick vector of TBRF), numbers of O. moubata s.l. per house (tick-density) and incidence of Borrelia infections in under five year-old children. Surveys were carried out at baseline, with five follow-ups at 3, 7, 15, 18 and 25 months post-intervention.

Secondary outcome measures

Using a structured questionnaire, studies on knowledge, attitudes, perceptions and behaviours with regard to the efficacy of ITNs in reducing tick infestations and tick-biting and their perceived benefits were conducted in April 2004 (14 months after the trial began) and at the end of the trial (April 2005). In the latter study, behaviours in the control households and the practice of anti-tick activities were additionally investigated in response to perceived anomalies in the data collected in the previous 12 months.

Overall trial start date

01/01/2003

Overall trial end date

30/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

All members of families living in traditional style constructed ‘tembe’ houses (rectangular with a flat roof of sod or earth supported by poles and walls of mud plastered wicker or sun-dried bricks) were eligible for inclusion.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

1,472 households

Participant exclusion criteria

Families living in households in which floors and walls were plastered with cement and/or roofed with corrugated metal were excluded because it has long been known that they are rarely, if ever, infested with ticks

Recruitment start date

01/01/2003

Recruitment end date

30/04/2005

Locations

Countries of recruitment

Tanzania

Trial participating centre

Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom

Sponsor information

Organisation

Sir Halley Stewart Trust (UK)

Sponsor details

22 Earith Road
Cambridge
CB24 5LS
United Kingdom
+44 (0)1954 260707
email@sirhalleystewart.org.uk

Sponsor type

Charity

Website

http://www.sirhalleystewart.org.uk/

Funders

Funder type

Charity

Funder name

Sir Halley Stewart Trust (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/14575974

Publication citations

  1. Results

    Kisinza WN, McCall PJ, Mitani H, Talbert A, Fukunaga M, A newly identified tick-borne Borrelia species and relapsing fever in Tanzania., Lancet, 2003, 362, 9392, 1283-1284.

Additional files

Editorial Notes