Condition category
Infections and Infestations
Date applied
04/11/2019
Date assigned
04/11/2019
Last edited
13/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The World Health Organization (WHO) has said that anybody who is suspected to have malaria should be tested before treated and followed up. This is to ensure that malaria medicines are given to only people who truly have malaria. In Africa, many people with symptoms that look like malaria visit drug shops, and are not tested but given malaria medicines. This means that people with other diseases that look like malaria are given malaria medicines when they do not need them. This study aims at improving the way drug sellers take care of people who visit their shops with signs and symptoms that look like malaria. The study findings will help the National Malaria Control Programme (NMCP) and other partners adopt measures that will ensure that only people with confirmed malaria receive malaria medicines in drug shops

Who can participate?
There are three types of participants: 1) selected Over The Counter Medicine Sellers (OTCMS) 2) children below ten years old 3) persons above 6 months (excluding pregnant women) visiting the selected drug shops with signs and symptoms that look like malaria

What does the study involve?
During the study, we will train selected drug sellers on how to test their patients for malaria using RDT kits, help the patients to pay for the test at a reduced cost, assist the drug sellers to overcome challenges during regular visits to their shops, and collect data on how they attend to their malaria patients

What are the possible benefits and risks of participating?
There will be no direct benefits to those taking part in this study. Participants will, however, help determine how to improve on the work of drug sellers when it comes to taking care of malaria patients, and also determine the accuracy of the malaria tests they do. The main risk in participating in this study is a little pain at the site of the finger prick during the malaria test

Where is the study run from?
The study is being run by the Noguchi Memorial Institute for Medical Research and takes place in four selected communities in the Fanteakwa North district in the Eastern region of Ghana

When is the study starting and how long is it expected to run for?
September 2019 to November 2020

Who is funding the study?
The World Health Organization / Special Programme for Research and Training in Tropical Diseases (WHO/TDR), Switzerland

Who is the main contact?
1. Dr. Soniran Olajoju Temidayo
temidayoolajoju@yahoo.com
2. Prof. Collins Ahorlu
cahorlu@noguchi.ug.edu.gh
3. Dr. Benjamin Abuaku
babuaku@noguhci.ug.edu.gh

Trial website

Contact information

Type

Scientific

Primary contact

Dr Benjamin Abuaku

ORCID ID

http://orcid.org/0000-0002-1840-6979

Contact details

Noguchi Memorial Institute for Medical Research
College of Health Sciences
University of Ghana
P.O.Box LG 581
Legon
Accra
LG581
Ghana
+233 244 573235
babuaku@noguchi.ug.edu.gh

Type

Scientific

Additional contact

Dr Olajoju Soniran

ORCID ID

http://orcid.org/0000-0002-7103-2961

Contact details

Noguchi Memorial Institute for Medical Research
College of Health Sciences
University of Ghana
P.O.Box LG 581
Legon
Accra
LG 581
Ghana
+233 269801672
temidayoolajoju@yahoo.com

Type

Scientific

Additional contact

Prof Collins Ahorlu

ORCID ID

http://orcid.org/0000-0001-8116-3984

Contact details

Noguchi Memorial Institute for Medical Research
College of Health Sciences
University of Ghana
P.O.Box LG 581
Legon
Accra
LG 581
Ghana
+233 208195705
cahorlu@noguchi.ug.edu.gh

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

STC Paper 6(6)2018-19 version 2

Study information

Scientific title

Evaluating interventions to improve test, treat and track (T3) malaria strategy among over the counter medicine sellers (OTCMS) in some rural communities of Fanteakwa North district, Ghana: study protocol for a cluster randomized controlled trial

Acronym

ETTTOMS

Study hypothesis

Provision of artemisinin-based combination therapies (ACTs) and other antimalarials without confirmed malaria frequently results in overtreatment of malaria and reduces the availability of ACTs for true malaria cases. Hence, this study is aimed at improving the implementation of the T3 strategy in the informal healthcare sector using a number of intervention tools that could be scaled-up easily at the national level. This will help to achieve universal access to prompt parasite-based diagnosis, reduce overprescribing of antimalarial to malaria-negative clients, and promote the tracking of malaria cases

Ethics approval

Approved 13/08/2019, Institutional Review Board (IRB) of Noguchi Memorial Institute for Medical Research (University of Ghana, P.O.Box LG581, Legon, Accra, Ghana; +233 302 916438; nirb@noguchi.ug.edu.gh), ref: NMIMR-IRB CPN 086/18-19

Study design

Single-centre interventional cluster randomized trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Malaria

Intervention

Intervention clusters have been randomly selected from one district while non-intervention clusters have been randomly selected from an adjacent district. An urban sub-district in the intervention district will act as a buffer between the two arms.

Intervention activities for this study will be:
1. Facilitating acquisition of subsidized mRDT kits
2. Training OTCMS operators on malaria diagnosis, treatment, and tracking of cases
3. Quarterly supportive visits to OTCMSs after training
4. Community sensitization on malaria focusing on the T3 strategy
5. Introduction of malaria surveillance tool for use by OTCMS operators

he methods for measuring the primary outcome will include mystery client surveys (monthly from March 2020 to November), assessment of OTCMS surveillance register (January 2020, April 2020, July 2020, and October 2020), mRDT quality survey (May - October 2020), and end-line household survey (November 2020)

Intervention type

Other

Phase

Drug names

Primary outcome measure

Proportion of patients attended to by OTCMS operators with report of fever or suspected malaria that receive a diagnostic test (using RDT). The methods for measuring the primary outcome will include mystery client surveys (monthly from March 2020 to November), assessment of OTCMS surveillance register (January 2020, April 2020, July 2020, and October 2020), mRDT quality survey (May - October 2020), and end-line household survey (November 2020)

Secondary outcome measures

1. Proportion of children under 10 years who received an antimalarial drug from an OTCMS operator without testing (method of assessment will be baseline household survey in October 2019 and end-line household survey in November 2020)
2. Adherence to treatment guidelines:
2.1. Percentage of clients/patients testing negative or not tested receiving ACT or other antimalarial drug (method of assessment will be an assessment of surveillance registers in January 2020, April 2020, July 2020, and October 2020)
2.2. Percentage of clients/patients referred to the public health facility by the OTCMS operator for further care (method of assessment will be an assessment of register in January 2020, April 2020, July 2020, and October 2020)
2.3. Percentage of OTCMS operators who could accurately perform an RDT, interpret results and dispose of waste (method of assessment will be monthly mystery client surveys from March 2020 to November 2020)
3. Adherence to RDT retail price: percentage of OTCMS operators who adhered to the recommended RDT retail price (method of assessment will be monthly mystery client surveys from March 2020 to November 2020)
4. The sensitivity, specificity, and predictive values of mRDTs used in the study (method of assessment will be mRDT quality survey from May 2020 to October 2020)

Overall trial start date

17/09/2019

Overall trial end date

30/11/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. In-depth interviews: OTCMS operators within the selected clusters/communities
2. Household surveys: Children less than 10 years old
3. mRDT quality survey: Suspected uncomplicated malaria cases 6 months and above

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

OTCMS operators: 12 from 8 clusters; Children less than 10 years old: 776 from 8 clusters; Suspected malaria cases in intervention arm only: 591 from 4 clusters

Participant exclusion criteria

mRDT quality survey: pregnant women; signs and symptoms of severe malaria

Recruitment start date

17/09/2019

Recruitment end date

30/11/2020

Locations

Countries of recruitment

Ghana

Trial participating centre

Fanteakwa North District
c/o District Health Directorate
Begoro
GH
Ghana

Sponsor information

Organisation

WHO/TDR

Sponsor details

Avenue Appia 20
Geneva
1211
Switzerland
+41 227912666
tdr@who.int

Sponsor type

Other

Website

https://www.who.int/tdr/en/

Funders

Funder type

Research organisation

Funder name

WHO Special Programme for Research and Training in Tropical Diseases (TDR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Baseline data (perception on malaria, testing rate and barriers to implementation of test before treatment) will be published in PLOS ONE journal in June, 2020.
Intervention phase data will be published in BMJ in April, 2021.
Results of the study will be disseminated to WHO/TDR through biannual progress reports.
At the end of the study, study outcome will be disseminated to Ghana Health Service through the National Malaria Control Programme, and also presented at the institutional seminar of Noguchi Memorial Institute of Medical Research and two international conferences.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

31/03/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/11/2019: Internal review. 05/11/2019: Trial’s existence confirmed by Institutional Review Board (IRB) of Noguchi Memorial Institute for Medical Research