MalariaNCT06804902
MaCRA Part B in Côte d'Ivoire
A study testing Monthly RDT Validation Meeting in people with Malaria, run by PATH at 1 site in Côte d’Ivoire.
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 Cote d'Ivoire. 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 Meeting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCôte d’Ivoire
- 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
- District and regional health teams involved in the monthly RDT validation meetings from districts selected for the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Côte d’Ivoire1 site
Health facilities in selected districts
Cities in Selected Districts
About this study
Official title: Improving the Accuracy of Malaria RDT Reporting in Public Primary Healthcare Facilities in Côte d'Ivoire
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 Cote d'Ivoire.
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 Meeting
- 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 MeetingBehavioural
Health facilities in intervention districts will bring all RDT cassettes performed in their facility and all outpatient registers to a monthly data validation meeting led by the surveillance, monitoring and evaluation officers (CSE). During these meetings, Audere's HealthPulse application will be used to take photos of each facility's RDT cassettes, tallying the total number of RDTs and total by result. The test positivity rates (TPRs) from the registers will be manually entered into the application and compared with the TPR from the RDT photos. Healthcare facilities with a discrepancy above a certain threshold between TPR derived from register data and the TPR derived from the RDT images may be asked to carry out a more detailed audit to better understand the source of discrepant results. If discrepancies are identified, the CSE will determine what corrections are required before entry into the DHIS2.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Health facilities in intervention districts will bring all RDT cassettes performed in their facility and all outpatient registers to a monthly data validation meeting led by the surveillance, monitoring and evaluation officers (CSE). During these meetings, Audere's HealthPulse application will be used to take photos of each facility's RDT cassettes, tallying the total number of RDTs and total by result. The test positivity rates (TPRs) from the registers will be manually entered into the application and compared with the TPR from the RDT photos. Healthcare facilities with a discrepancy above a certain threshold between TPR derived from register data and the TPR derived from the RDT images may be asked to carry out a more detailed audit to better understand the source of discrepant results. If discrepancies are identified, the CSE will determine what corrections are required before entry into the DHIS2. Receives: Behavioral: Monthly RDT Validation Meeting |
| Control | No intervention | There will be no activities in the control arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of RDTs recorded as positive in healthcare facility registers.
Data will be collected from the DHIS2 after the end of the study for both control and intervention arms.
Measured: Four months
Secondary outcomes (6)
Ratio of TPR between healthcare facility registers and RDT cassettes in intervention facilities over time.
The TPR for RDT cassettes will be collected from each healthcare facility by the HealthPulse application during monthly RDT validation meetings. The ratio will be calculated with these data, and the TPRs calculated from DHIS2.
Measured: Four months
Proportion of suspected patients tested by RDT who receive an antimalarial prescription.
For both the intervention and control arms, data on ACT prescription will be downloaded from the DHIS2 after the end of the study.
Measured: Four months
The total number of antimalarials.
For both arms, ACT prescription data will be downloaded from the DHIS2, and ACT consumption data from the integrated electronic logistics management system (e-SIGL) after the end of the study.
Measured: Four months
The cost required to implement the monthly RDT validation meetings.
This estimate will be made by recording the cost of training, the cost of smartphones and communication time, the number and categories of staff needed to plan and implement the monthly data validation meetings, as well as their travel expenses and per diems for attending the meeting. The costs of any follow-up activities will be noted. The time spent by different categories of staff will be tracked to provide an estimate of the level of effort required to implement the monthly validation meetings.
Measured: Four months
Proportion of healthcare workers reporting compliance with negative RDT results when patients present with fever (i.e. recording the RDT result as negative, not recording the case as malaria and not prescribing antimalarial medication).
Subjective norms, attitudes and practices towards RDTs will be measured in a cross-sectional survey of healthcare workers in selected facilities at the end of the study.
Measured: immediately after the intervention period
Qualitative description of the acceptability and feasibility of conducting monthly RDT validations and using a digital tool (HealthPulse, Audere, Johannesburg, South Africa).
The acceptability and feasibility of the monthly RDT validation exercise, as well as perceptions of the digital tools used for RDT validation, will be measured through in-depth interviews with health facility staff, district epidemiological surveillance and monitoring and evaluation (CSE) officers and malaria focal points.
Measured: immediately after the intervention period
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, Institut National de Sante Publique, US President's Malaria Initiative
- Responsible party
- Sponsor
- Investigators
- William Yavo, Principal investigator, INSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804902
- Sponsor's protocol ID
- RES-00849
- Status last verified
- Mar 2025
- First submitted
- 22 Jan 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Côte d'Ivoire
- ClinicalTrials.gov ID
- NCT06804902
- Acronym / sponsor ID
- RES-00849
- 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, Institut National de Sante Publique, 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 Cote d'Ivoire.
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 |
|---|---|---|
| Intervention | Experimental | Behavioral: Monthly RDT Validation MeetingHealth facilities in intervention districts will bring all RDT cassettes performed in their facility and all outpatient registers to a monthly data validation meeting led by the surveillance, monitoring and evaluation officers (CSE). During these meetings, Audere's HealthPulse application will be used to take photos of each facility's RDT cassettes, tallying the total number of RDTs and total by result. The test positivity rates (TPRs) from the registers will be manually entered into the application and compared with the TPR from the RDT photos. Healthcare facilities with a discrepancy above a certain threshold between TPR derived from register data and the TPR derived from the RDT images may be asked to carry out a more detailed audit to better understand the source of discrepant results. If discrepancies are identified, the CSE will determine what corrections are required before entry into the DHIS2. |
| Control | No intervention | –There will be no activities in the control arm. |
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
- District and regional health teams involved in the monthly RDT validation meetings from districts 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 MeetingHealth facilities in intervention districts will bring all RDT cassettes performed in their facility and all outpatient registers to a monthly data validation meeting led by the surveillance, monitoring and evaluation officers (CSE). During these meetings, Audere's HealthPulse application will be used to take photos of each facility's RDT cassettes, tallying the total number of RDTs and total by result. The test positivity rates (TPRs) from the registers will be manually entered into the application and compared with the TPR from the RDT photos. Healthcare facilities with a discrepancy above a certain threshold between TPR derived from register data and the TPR derived from the RDT images may be asked to carry out a more detailed audit to better understand the source of discrepant results. If discrepancies are identified, the CSE will determine what corrections are required before entry into the DHIS2. | Behavioural | Intervention |
Primary outcome
The proportion of RDTs recorded as positive in healthcare facility registers.
Time frame: Four months
Data will be collected from the DHIS2 after the end of the study for both control and intervention arms.
6 secondary outcomes
Ratio of TPR between healthcare facility registers and RDT cassettes in intervention facilities over time.
Time frame: Four months
Proportion of suspected patients tested by RDT who receive an antimalarial prescription.
Time frame: Four months
The total number of antimalarials.
Time frame: Four months
The cost required to implement the monthly RDT validation meetings.
Time frame: Four months
Proportion of healthcare workers reporting compliance with negative RDT results when patients present with fever (i.e. recording the RDT result as negative, not recording the case as malaria and not prescribing antimalarial medication).
Time frame: immediately after the intervention period
Qualitative description of the acceptability and feasibility of conducting monthly RDT validations and using a digital tool (HealthPulse, Audere, Johannesburg, South Africa).
Time frame: immediately after the intervention period
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.
William Yavo principal investigator
INSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monthly RDT Validation Meeting in people with Malaria, run by PATH at 1 site in Côte d’Ivoire.
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.
Where is the study taking place?
The record lists 1 site in Côte d’Ivoire. Whether a site is taking part right now should be confirmed with that site. See every site.
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 RDTs recorded as positive in healthcare facility registers. (time frame: Four months). 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.