Improving the test, treat and track (T3) malaria strategy in the informal sector
| ISRCTN | ISRCTN77836926 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77836926 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | STC Paper 6(6)2018-19 version 2 |
| Sponsor | World Health Organization (WHO) Special Programme for Research and Training in Tropical Diseases (TDR) |
| Funder | World Health Organization |
- Submission date
- 04/11/2019
- Registration date
- 04/11/2019
- Last edited
- 07/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
Noguchi Memorial Institute for Medical Research
College of Health Sciences
University of Ghana
P.O.Box LG 581
Legon
Accra
LG581
Ghana
 ORCID ID |
0000-0002-1840-6979 |
|---|---|
| Phone | +233 244 573235 |
| babuaku@noguchi.ug.edu.gh |
Scientific
Noguchi Memorial Institute for Medical Research
College of Health Sciences
University of Ghana
P.O.Box LG 581
Legon
Accra
LG 581
Ghana
| ORCID ID |
0000-0002-7103-2961 |
|---|---|
| Phone | +233 269801672 |
| temidayoolajoju@yahoo.com |
Scientific
Noguchi Memorial Institute for Medical Research
College of Health Sciences
University of Ghana
P.O.Box LG 581
Legon
Accra
LG 581
Ghana
| ORCID ID |
0000-0001-8116-3984 |
|---|---|
| Phone | +233 208195705 |
| cahorlu@noguchi.ug.edu.gh |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional cluster randomized trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | ETTTOMS |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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) |
| Key secondary outcome measure(s) |
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) |
| Completion date | 30/11/2020 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 1379 |
| Key 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 |
| Key exclusion criteria | mRDT quality survey: pregnant women; signs and symptoms of severe malaria |
| Date of first enrolment | 17/09/2019 |
| Date of final enrolment | 30/11/2020 |
Locations
Countries of recruitment
- Ghana
Study participating centre
Begoro
GH
Ghana
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 05/11/2022 | 07/11/2022 | Yes | No | |
| Protocol article | protocol | 08/07/2020 | 10/07/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/11/2022: Publication reference added.
08/09/2021: The intention to publish date has been changed from 31/03/2021 to 30/04/2022.
10/07/2020: Publication reference added.
17/01/2020: Internal review.
13/11/2019: Internal review.
05/11/2019: Trial’s existence confirmed by Institutional Review Board (IRB) of Noguchi Memorial Institute for Medical Research
