MalariaNCT06805110
MaCRA Part B in Nigeria
A study testing Monthly RDT validation during DHIS2 data review meetings in people with Malaria, run by PATH.
Trial summary
This study aims to evaluate the effectiveness of monthly malaria rapid diagnostic test (RDT) validation meetings at district level on reducing the proportion of RDT results recorded as positive in health facility registers in Nigeria. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Monthly RDT validation during DHIS2 data review meetings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthcare workers responsible for testing or interpreting malaria RDTs in the selected study facilities
- LGA health teams involved in the monthly RDT validation meetings from LGAs selected for the study.
Who cannot join
None listed.
About this study
Official title: Improving the Accuracy of Malaria RDT Reporting in Public Primary Healthcare Facilities in Nigeria
This study aims to evaluate the effectiveness of monthly malaria rapid diagnostic test (RDT) validation meetings at district level on reducing the proportion of RDT results recorded as positive in health facility registers in Nigeria.
Read the detailed description
PMI Insights supported a multi-country evaluation of the accuracy of the recording and reporting of rapid diagnostic test (RDT) results at health facilities in Benin, Côte d'Ivoire, Nigeria, and Uganda (MaCRA Part A). The evaluation found a high degree of agreement between RDT results recorded in health facilities and an objective panel reading of the same RDTs. However, the changes in test positivity rate (TPR) after the start of the study suggest that some of this agreement may have been a result of the Hawthorne effect: in all countries except Benin, TPR declined after the start of the evaluation in facilities where evaluation staff were present, compared with control facilities. This suggests that the presence of evaluation staff caused health care workers to change their behavior with respect to reporting positive RDT results. The study evaluated the durability of RDT results and found that 95% of RDT cassettes retained their original reading over a one-month period. This provides evidence that stored RDT cassettes may be compared to health facility registers at monthly validation meetings, as long as a certain margin of error is used to account for the proportion of tests that may change.
The results from the first phase of the study were used to identify potential interventions to improve RDT reporting and recording accuracy in health facilities. The second phase of the study aims to evaluate the effectiveness of monthly district-level RDT result validation meetings on reducing the proportion of RDT results recorded as positive in health facility registers and reported to the national health management information system.
This is a two-arm cluster-randomized controlled effectiveness evaluation. Districts will serve as the clusters and will be assigned using restricted randomization to the intervention or control arm. In the intervention arm, the Ministry of Health will lead monthly district-level RDT validation meetings facilitated by a digital phone-based app which uses AI to record RDT results (HealthPulse, Audere, Johannesburg, South Africa). There will be no study activities in the control facilities.
Monthly RDT validation meetings will take place over a four-month period (April to July 2025), after which a cross-sectional survey and in- depth interviews will be conducted.
- Conditions
- Malaria
- Being tested
- Monthly RDT validation during DHIS2 data review meetings
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monthly RDT validation during DHIS2 data review meetingsBehavioural
The Nigeria national malaria program will lead monthly RDT validation at selected legal government areas (LGAs). Health facilities will be asked to retain all RDT cassettes performed for the prior month and bring them to a monthly validation meeting. During these meetings, RDT cassettes will be scanned using the HealthPulse application, which will automatically tally the number of RDTs by brand and result. The application will also allow for the entry of aggregated testing data, including the total number of tests conducted and the RDT results recorded in the health facility register. Discrepancies between the HealthPulse data and facility records will be calculated, with a focus on identifying and addressing discrepancies exceeding a designated threshold (e.g., 10%) that takes into account the proportion of cassettes that may have changed results over the past month. Facilities with significant discrepancies may undergo a detailed audit to align RDT cassettes with patient records.
| Study group | Role | What they receive |
|---|---|---|
| Monthly RDT validation during DHIS2 data review meetings | Experimental | The Nigeria national malaria program will lead monthly RDT validation at selected legal government areas (LGAs). Health facilities will be asked to retain all RDT cassettes performed for the prior month and bring them to a monthly validation meeting. During these meetings, RDT cassettes will be scanned using the HealthPulse application, which will automatically tally the number of RDTs by brand and result. The application will also allow for the entry of aggregated testing data, including the total number of tests conducted and the RDT results recorded in the health facility register. Discrepancies between the HealthPulse data and facility records will be calculated, with a focus on identifying and addressing discrepancies exceeding a designated threshold (e.g., 10%) that takes into account the proportion of cassettes that may have changed results over the past month. Facilities with significant discrepancies may undergo a detailed audit to align RDT cassettes with patient records. Receives: Behavioral: Monthly RDT validation during DHIS2 data review meetings |
| Control | No intervention | There will be no new activities in the control facilities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of RDT results reported as positive from study facilities on the DHIS2
Data for the intervention and control facilities will be downloaded from the DHIS2 at the end of August 2025
Measured: 4 months (April - July 2025)
Secondary outcomes (5)
Ratio of TPR between health facility registers and RDT cassettes in intervention facilities over time.
The change in ratio will be measured by using the TPR from the facility registers and the TPR from the cassettes entered into the HealthPulse app
Measured: 4 months (April - July 2025)
Total costs associated with monthly RDT validation exercises
Collection and analysis of cost data, including personnel costs, travel expenses, and other project-related expenses will be used to estimate the total costs associated with the validation meetings
Measured: 4 months (April - July 2025)
HCWs subjective norms, attitudes, perceptions and practices regarding RDT usage
A questionnaire will be administered to HCWs in the intervention and control group to compare differences in their subjective norms, attitudes, perceptions and practices regarding RDT
Measured: Immediately after intervention period (August 2025)
Acceptability and feasibility of implementing monthly RDT validation exercises
In-depth interviews will be conducted with HCWs, local government areas (LGAs) and state officials to understand their perceptions of the acceptability of the monthly validation processes
Measured: Immediately after intervention period (August 2025)
Acceptability and feasibility of using a digital smartphone application for monthly RDT validation exercises
In-depth interviews will be conducted with HCWs, LGA and state officials to understand their perceptions of the acceptability and feasibility of using the digital application during monthly validation
Measured: Immediately after intervention period (August 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study startApr 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Why it stopped: USAID termination of project funding and activities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Sydani Group, US President's Malaria Initiative
- Responsible party
- Sponsor
- Investigators
- Sunday Atobatele, Principal investigator, Sydani Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805110
- Sponsor's protocol ID
- RES-00850
- Status last verified
- Mar 2025
- First submitted
- 22 Jan 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Accuracy of Malaria RDT Reporting in Public Primary Healthcare Facilities in Nigeria
- ClinicalTrials.gov ID
- NCT06805110
- Acronym / sponsor ID
- RES-00850
- Conditions
- Malaria
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: USAID termination of project funding and activities
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Sydani Group, US President's Malaria Initiative
- Study start
- Apr 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness of monthly malaria rapid diagnostic test (RDT) validation meetings at district level on reducing the proportion of RDT results recorded as positive in health facility registers in Nigeria.
Detailed description
PMI Insights supported a multi-country evaluation of the accuracy of the recording and reporting of rapid diagnostic test (RDT) results at health facilities in Benin, Côte d'Ivoire, Nigeria, and Uganda (MaCRA Part A). The evaluation found a high degree of agreement between RDT results recorded in health facilities and an objective panel reading of the same RDTs. However, the changes in test positivity rate (TPR) after the start of the study suggest that some of this agreement may have been a result of the Hawthorne effect: in all countries except Benin, TPR declined after the start of the evaluation in facilities where evaluation staff were present, compared with control facilities. This suggests that the presence of evaluation staff caused health care workers to change their behavior with respect to reporting positive RDT results. The study evaluated the durability of RDT results and found that 95% of RDT cassettes retained their original reading over a one-month period. This provides evidence that stored RDT cassettes may be compared to health facility registers at monthly validation meetings, as long as a certain margin of error is used to account for the proportion of tests that may change.
The results from the first phase of the study were used to identify potential interventions to improve RDT reporting and recording accuracy in health facilities. The second phase of the study aims to evaluate the effectiveness of monthly district-level RDT result validation meetings on reducing the proportion of RDT results recorded as positive in health facility registers and reported to the national health management information system.
This is a two-arm cluster-randomized controlled effectiveness evaluation. Districts will serve as the clusters and will be assigned using restricted randomization to the intervention or control arm. In the intervention arm, the Ministry of Health will lead monthly district-level RDT validation meetings facilitated by a digital phone-based app which uses AI to record RDT results (HealthPulse, Audere, Johannesburg, South Africa). There will be no study activities in the control facilities.
Monthly RDT validation meetings will take place over a four-month period (April to July 2025), after which a cross-sectional survey and in- depth interviews will be conducted.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monthly RDT validation during DHIS2 data review meetings | Experimental | Behavioral: Monthly RDT validation during DHIS2 data review meetingsThe Nigeria national malaria program will lead monthly RDT validation at selected legal government areas (LGAs). Health facilities will be asked to retain all RDT cassettes performed for the prior month and bring them to a monthly validation meeting. During these meetings, RDT cassettes will be scanned using the HealthPulse application, which will automatically tally the number of RDTs by brand and result. The application will also allow for the entry of aggregated testing data, including the total number of tests conducted and the RDT results recorded in the health facility register. Discrepancies between the HealthPulse data and facility records will be calculated, with a focus on identifying and addressing discrepancies exceeding a designated threshold (e.g., 10%) that takes into account the proportion of cassettes that may have changed results over the past month. Facilities with significant discrepancies may undergo a detailed audit to align RDT cassettes with patient records. |
| Control | No intervention | –There will be no new activities in the control facilities. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Healthcare workers responsible for testing or interpreting malaria RDTs in the selected study facilities
- LGA health teams involved in the monthly RDT validation meetings from LGAs selected for the study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monthly RDT validation during DHIS2 data review meetingsThe Nigeria national malaria program will lead monthly RDT validation at selected legal government areas (LGAs). Health facilities will be asked to retain all RDT cassettes performed for the prior month and bring them to a monthly validation meeting. During these meetings, RDT cassettes will be scanned using the HealthPulse application, which will automatically tally the number of RDTs by brand and result. The application will also allow for the entry of aggregated testing data, including the total number of tests conducted and the RDT results recorded in the health facility register. Discrepancies between the HealthPulse data and facility records will be calculated, with a focus on identifying and addressing discrepancies exceeding a designated threshold (e.g., 10%) that takes into account the proportion of cassettes that may have changed results over the past month. Facilities with significant discrepancies may undergo a detailed audit to align RDT cassettes with patient records. | Behavioural | Monthly RDT validation during DHIS2 data review meetings |
Primary outcome
The proportion of RDT results reported as positive from study facilities on the DHIS2
Time frame: 4 months (April - July 2025)
Data for the intervention and control facilities will be downloaded from the DHIS2 at the end of August 2025
5 secondary outcomes
Ratio of TPR between health facility registers and RDT cassettes in intervention facilities over time.
Time frame: 4 months (April - July 2025)
Total costs associated with monthly RDT validation exercises
Time frame: 4 months (April - July 2025)
HCWs subjective norms, attitudes, perceptions and practices regarding RDT usage
Time frame: Immediately after intervention period (August 2025)
Acceptability and feasibility of implementing monthly RDT validation exercises
Time frame: Immediately after intervention period (August 2025)
Acceptability and feasibility of using a digital smartphone application for monthly RDT validation exercises
Time frame: Immediately after intervention period (August 2025)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunday Atobatele principal investigator
Sydani Group
Questions about this trial
What is this clinical trial studying?
A study testing Monthly RDT validation during DHIS2 data review meetings in people with Malaria, run by PATH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of RDT results reported as positive from study facilities on the DHIS2 (time frame: 4 months (April - July 2025)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.