Improving the test, treat and track (T3) malaria strategy in the informal sector

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN77836926

Enrollment

1379

Registered

2019-11-04

Start date

2019-09-17

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria Infections and Infestations Malaria

Interventions

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 dis

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Ghana

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026