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

March 18, 2026 updated by: Medicines for Malaria Venture

Health Care Provider Use of Plasmodium Vivax Radical Cure (RC) With Tafenoquine or Primaquine After Semi-quantitative G6PD Testing: A Feasibility Study in Peru

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to evaluate the operational feasibility of providing Tafenoquine and Primaquine after semi-quantitative G6PD testing at different levels of the health services, in order to inform potential policy change, malaria strategy, and introduction planning.

This implementation research study will be carried out in Peru .The study will be conducted in Loreto Region (Loreto, Maynas and Ramon Castilla provinces), an area which is endemic for P. vivax.

A total of 30 health facilities will be included: 6 in the first phase and 12 will be added in the second phase. An additional 12 health facilities have been selected as backup in case the malaria case load is low, and this is needed in order to meet the sample size.

All 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 Radical Cure and choosing the appropriate treatment as per their role accordingly.

HCP knowledge and skills regarding semi-quantitative G6PD testing and RC treatment will be assessed through standardized competency assessment (including self-assessments).

Adherence to the revised algorithm will be evaluated as follows. At each HF included in the study, the ideal patient case management cascade will be defined a priori. Individual HCP adherence to each step of the case management will be assessed against this cascade. By indexing each step in the patient care cascade to a specific HCP, the study will be able to consider feasibility at multiple levels, analysing adherence to specific steps of the case management algorithm.

A specific process will be put in place for patient counselling and standard tools such as a counselling checklist will be developed to assist HCPs. In addition, patient materials will be developed which will give explanations on the new Radical Cure tools, emphasize the need to come for a follow-up visit and outline the potential side effects that can be elicited by 8-AQ. Patients will be instructed to come back or call the facilities in case they experience those events.

The study will be carried out in following phases:

  1. A formative research and baseline phase ( approx. 3 months) : this phase is meant to collect baseline information from the selected study facilities prior to introduction of the implementation package. This phase will also be important to field-test and validate study tools, such as the training material and documents and data collection tools (e.g. qualitative research questionnaires and interview guides). Finally, during this formative research phase, the supervision processes and tools will be revised.

  2. A higher-level facilities phase ( approx. 8 months) : in this phase the implementation package will only be rolled out in selected higher-level facilities.

    An interim analysis will be conducted prior to rolling out the implementation package to lower-level facilities. The data cut-off point for this interim analysis will be once 50 patients have been treated with the revised algorithm. During this interim analysis, enrolment in Higher-level HF will continue.

  3. An All-level facilities phase ( approx.14 months) : in this phase the implementation package will be rolled out to the lower-level facilities.

Final analysis will be performed at study end and results will be shared with the Peru National Malaria Control Program (NMCP) to make informed decisions on revisions to national malaria treatment policies.

The study aims to achieve the following specific objectives:

  1. Assess HCP adherence to a revised case management algorithm for vivax malaria that involves providing RC treatment after semi-quantitative G6PD testing and a follow-up visit. This will be assessed at the provider, patient, and health facility (HF) level.
  2. Determine the ability of HCP to safely implement RC treatment after semi-quantitative G6PD testing
  3. Evaluate the quality and effectiveness of training and supervision strategies to support the implementation of semi-quantitative G6PD testing before RC treatment
  4. Explore barriers and facilitators at the patient, provider, and facility level that mediate effective use of RC treatment with semi-quantitative G6PD testing. 5. Determine the costs associated with introducing semi-quantitative G6PD testing before RC treatment as part of routine care

Study Type

Observational

Enrollment (Actual)

187

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
    • Loreto
      • Nauta, Loreto, Peru, 16310
        • Nauta Nucleo- Base

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  • All Health Care Providers (HCPs) working in the selected facilities who are involved in the management of vivax patients
  • All patients aged 6 months onward, who have a confirmed P. vivax infection and who are treated in a Health Facility participating in the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients with confirmation of vivax, attending one of the study facilities All patients aged 6 months onward, who have a confirmed P. vivax infection and who are in a study HF were approached to participate in the study.
Drug: Tafenoquine (TQ)
G6PD test after Malaria Vivax diagnosis
Other Names:
  • SD Biosensor Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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])
Time Frame: Time from Malaria Vivax diagnosis until FU visit 3 days [+ 2 days]
Percentage of patients that were correctly treated with RC [chloroquine (CQ) plus either primaquine (PQ) or tafenoquine (TQ)] based on the revised algorithm
Time from Malaria Vivax diagnosis until FU visit 3 days [+ 2 days]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicines for Malaria Venture

Collaborators

UNITAID
Universidad Peruana Cayetano Heredia
ICON plc

Investigators

  • Principal Investigator: Elmer Alejandro Llanos Cuentas, MD, PhD, Universidad Peruana Cayetano Heredia (UPCH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

April 29, 2022

First Submitted That Met QC Criteria

April 29, 2022

First Posted (Actual)

May 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMV_TQ_21_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Considering to share study related information such as protocol, ICFs and final CSR after final publication has been published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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