CompletedNot Applicable

Radical Cure (RC) With Tafenoquine or Primaquine After Semi-quantitative G6PD Testing: A Feasibility Study in Peru

Peru187 participantsStarted 2023-08-28

Plain-language summary

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

Who can participate

Age range

6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess health care provider (HCP) compliance to a revised case management algorithm for vivax malaria that involves providing radical cure (RC) after G6PD testing and a follow-up visit on day 3 days [+ 2 days])

Timeframe: Time from Malaria Vivax diagnosis until FU visit 3 days [+ 2 days]

Trial details

NCT IDNCT05361486

SponsorMedicines for Malaria Venture

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Malaria, Vivax trials