Clinical trial
Health Care Provider Use of Plasmodium Vivax Radical Cure (RC) With Tafenoquine or Primaquine After Semi-quantitative G6PD Testing: A Feasibility Study in Peru
Name
MMV_TQ_21_01
Description
The goal of this study is to evaluate the operational feasibility of using a new treatment algorithm for Malaria Vivax in Peru.
The implementation package includes the following interventions:
* A revised vivax treatment algorithm that incorporates new Radical Cure tools (G6PD test + Tafenoquine or Primaquine)
* The training of Health Care Providers ( HCPs) in the revised algorithm and the use of the new RC tools
* Patient counselling
* A follow-up visit at Day 3 \[+2 days\] for patients after treatment start
* Accompanying supporting measures: job aids, strengthening of supervision and PV processes
Trial arms
Trial start
2023-08-28
Estimated PCD
2024-10-31
Trial end
2024-10-31
Status
Recruiting
Treatment
Training on revised algorithm
relevant HCP working in study facilities will be trained on the relevant aspects of performing the G6PD testing, interpreting its result, evaluating patient's eligibility for RC and choosing the appropriate treatment as per their role accordingly
Arms:
Health Care Provider managing vivax patients in study facilities
Enhancing Pharmacovigilance
Refresher training on PV reporting in the selected facilities. National PV forms will be reviewed and if required, modified in consultation with the national PV system.
Arms:
Health Care Provider managing vivax patients in study facilities
Supervision of malaria services in selected facilities.
Supervisors in target regions will be trained as for the HCPs.
Arms:
Health Care Provider managing vivax patients in study facilities
G6PD testing
G6PD test after Malaria Vivax diagnosis
Arms:
Patients with confirmation of vivax, attending one of the study facilities
Tafenoquine
300 mg (2x150mg tablets) tafenoquine
Arms:
Patients with confirmation of vivax, attending one of the study facilities
Other names:
Kozenis
Primaquine
0.5mg/kg/7 days
Arms:
Patients with confirmation of vivax, attending one of the study facilities
Follow Up Visit at Day 3 [+2 days] after treatment start
It will be checked if all patients have a Follow Up Visit at Day 3 \[+2 days\] after treatment start
Arms:
Patients with confirmation of vivax, attending one of the study facilities
Size
40
Primary endpoint
Proportion of HCP who adhere to the revised RC treatment algorithm as relevant to their role in patient case management.
Time from Malaria Vivax diagnosis until FU visit ( Day 3 [-1 day; +2 days]
Eligibility criteria
Inclusion Criteria Health Care Providers:
• All HCPs working in the selected facilities who are involved in the management of vivax patients.
Inclusion criteria patients:
* All patients aged 6 months onward, who have a confirmed P. vivax infection and who are treated in a study Health Facilities
* Pregnant and lactating women, who have a contra-indication to both Primaquine and Tafenoquine, but for whom correct case management will be evaluated as part of the primary endpoints.
* Patients providing informed consent and/or informed assent
Exclusion criteria patients:
• Patients with signs of severe infection
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'ECOLOGIC_OR_COMMUNITY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-12-05
1 organization
Organization
Medicines for Malaria Venture