Malaria, VivaxNCT05361486
Radical Cure (RC) With Tafenoquine or Primaquine After Semi-quantitative G6PD Testing: A Feasibility Study in Peru
An observational study of Malaria, Vivax, run by Medicines for Malaria Venture at 1 site in Peru.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Malaria, Vivax
- What is being tested?
- Tafenoquine (TQ)
- How many people
- 187 participants
- Where
- 1 sitePeru
- Study dates
- 28 Aug 2023to 31 Dec 2024
- Phase
- Observational
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- All 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 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
Who cannot join
- Patients with signs of severe infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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:
- 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.
- 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.
- 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:
- 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.
- Determine the ability of HCP to safely implement RC treatment after semi-quantitative G6PD testing
- Evaluate the quality and effectiveness of training and supervision strategies to support the implementation of semi-quantitative G6PD testing before RC treatment
- 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
- Conditions
- Malaria, Vivax
- Being tested
- Tafenoquine (TQ)
- Keywords
- Feasibility study, Tafenoquine, G6PD Testing
- Medical subject headings
- Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tafenoquine (TQ)Drug
Also called SD Biosensor Test
G6PD test after Malaria Vivax diagnosis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tafenoquine (TQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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])
Percentage of patients that were correctly treated with RC [chloroquine (CQ) plus either primaquine (PQ) or tafenoquine (TQ)] based on the revised algorithm
Measured: Time from Malaria Vivax diagnosis until FU visit 3 days [+ 2 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start28 Aug 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Malaria, VivaxStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines for Malaria Venture
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Peruana Cayetano Heredia, UNITAID, ICON plc
- Responsible party
- Sponsor
- Investigators
- Elmer Alejandro Llanos Cuentas, MD, PhD, Principal investigator, Universidad Peruana Cayetano Heredia (UPCH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361486
- Sponsor's protocol ID
- MMV_TQ_21_01
- Status last verified
- Mar 2026
- First submitted
- 29 Apr 2022
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Considering to share study related information such as protocol, ICFs and final CSR after final publication has been published.
Publications
Llanos-Cuentas A, Lacerda MV, Rueangweerayut R, Krudsood S, Gupta SK, Kochar SK, Arthur P, Chuenchom N, Mohrle JJ, Duparc S, Ugwuegbulam C, Kleim JP, Carter N, Green JA, Kellam L. Tafenoquine plus chloroquine for the treatment and relapse prevention of Plasmodium vivax malaria (DETECTIVE): a multicentre, double-blind, randomised, phase 2b dose-selection study. Lancet. 2014 Mar 22;383(9922):1049-58. doi: 10.1016/S0140-6736(13)62568-4. Epub 2013 Dec 19.
PubMed 24360369Anderle A, Bancone G, Domingo GJ, Gerth-Guyette E, Pal S, Satyagraha AW. Point-of-Care Testing for G6PD Deficiency: Opportunities for Screening. Int J Neonatal Screen. 2018;4(4):34. doi: 10.3390/ijns4040034. Epub 2018 Nov 19.
PubMed 31709308Chu CS, Bancone G, Kelley M, Advani N, Domingo GJ, Cutiongo-de la Paz EM, van der Merwe N, Cohen J, Gerth-Guyette E. Optimizing G6PD testing for Plasmodium vivax case management and beyond: why sex, counseling, and community engagement matter. Wellcome Open Res. 2020 Aug 25;5:21. doi: 10.12688/wellcomeopenres.15700.2. eCollection 2020.
PubMed 32766454Commons RJ, Simpson JA, Watson J, White NJ, Price RN. Estimating the Proportion of Plasmodium vivax Recurrences Caused by Relapse: A Systematic Review and Meta-Analysis. Am J Trop Med Hyg. 2020 Sep;103(3):1094-1099. doi: 10.4269/ajtmh.20-0186.
PubMed 32524950Domingo GJ, Advani N, Satyagraha AW, Sibley CH, Rowley E, Kalnoky M, Cohen J, Parker M, Kelley M. Addressing the gender-knowledge gap in glucose-6-phosphate dehydrogenase deficiency: challenges and opportunities. Int Health. 2019 Jan 1;11(1):7-14. doi: 10.1093/inthealth/ihy060.
PubMed 30184203Douglas NM, Poespoprodjo JR, Patriani D, Malloy MJ, Kenangalem E, Sugiarto P, Simpson JA, Soenarto Y, Anstey NM, Price RN. Unsupervised primaquine for the treatment of Plasmodium vivax malaria relapses in southern Papua: A hospital-based cohort study. PLoS Med. 2017 Aug 29;14(8):e1002379. doi: 10.1371/journal.pmed.1002379. eCollection 2017 Aug.
PubMed 28850568Edwards SJ, Braunholtz DA, Lilford RJ, Stevens AJ. Ethical issues in the design and conduct of cluster randomised controlled trials. BMJ. 1999 May 22;318(7195):1407-9. doi: 10.1136/bmj.318.7195.1407. No abstract available.
PubMed 10334756
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Care Provider Use of Plasmodium Vivax Radical Cure (RC) With Tafenoquine or Primaquine After Semi-quantitative G6PD Testing: A Feasibility Study in Peru
- ClinicalTrials.gov ID
- NCT05361486
- Acronym / sponsor ID
- MMV_TQ_21_01
- Conditions
- Malaria, Vivax
- Keywords
- Feasibility study, Tafenoquine, G6PD Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Collaborators
- Universidad Peruana Cayetano Heredia, UNITAID, ICON plc
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 May 2022 (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.
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
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:
- 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.
- 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.
- 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:
- 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.
- Determine the ability of HCP to safely implement RC treatment after semi-quantitative G6PD testing
- Evaluate the quality and effectiveness of training and supervision strategies to support the implementation of semi-quantitative G6PD testing before RC treatment
- 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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Drug: Tafenoquine (TQ)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. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- All 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 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
Key exclusion criteria (1 listed)
- Patients with signs of severe infection
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 |
|---|---|---|
| Tafenoquine (TQ)Also: SD Biosensor TestG6PD test after Malaria Vivax diagnosis | Drug | Patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Background: PubMed 24360369Llanos-Cuentas A, Lacerda MV, Rueangweerayut R, Krudsood S, Gupta SK, Kochar SK, Arthur P, Chuenchom N, Mohrle JJ, Duparc S, Ugwuegbulam C, Kleim JP, Carter N, Green JA, Kellam L. Tafenoquine plus chloroquine for the treatment and relapse prevention of Plasmodium vivax malaria (DETECTIVE): a multicentre, double-blind, randomised, phase 2b dose-selection study. Lancet. 2014 Mar 22;383(9922):1049-58. doi: 10.1016/S0140-6736(13)62568-4. Epub 2013 Dec 19.
- Background: PubMed 31709308Anderle A, Bancone G, Domingo GJ, Gerth-Guyette E, Pal S, Satyagraha AW. Point-of-Care Testing for G6PD Deficiency: Opportunities for Screening. Int J Neonatal Screen. 2018;4(4):34. doi: 10.3390/ijns4040034. Epub 2018 Nov 19.
- Background: PubMed 32766454Chu CS, Bancone G, Kelley M, Advani N, Domingo GJ, Cutiongo-de la Paz EM, van der Merwe N, Cohen J, Gerth-Guyette E. Optimizing G6PD testing for Plasmodium vivax case management and beyond: why sex, counseling, and community engagement matter. Wellcome Open Res. 2020 Aug 25;5:21. doi: 10.12688/wellcomeopenres.15700.2. eCollection 2020.
- Background: PubMed 32524950Commons RJ, Simpson JA, Watson J, White NJ, Price RN. Estimating the Proportion of Plasmodium vivax Recurrences Caused by Relapse: A Systematic Review and Meta-Analysis. Am J Trop Med Hyg. 2020 Sep;103(3):1094-1099. doi: 10.4269/ajtmh.20-0186.
- Background: PubMed 30184203Domingo GJ, Advani N, Satyagraha AW, Sibley CH, Rowley E, Kalnoky M, Cohen J, Parker M, Kelley M. Addressing the gender-knowledge gap in glucose-6-phosphate dehydrogenase deficiency: challenges and opportunities. Int Health. 2019 Jan 1;11(1):7-14. doi: 10.1093/inthealth/ihy060.
- Background: PubMed 28850568Douglas NM, Poespoprodjo JR, Patriani D, Malloy MJ, Kenangalem E, Sugiarto P, Simpson JA, Soenarto Y, Anstey NM, Price RN. Unsupervised primaquine for the treatment of Plasmodium vivax malaria relapses in southern Papua: A hospital-based cohort study. PLoS Med. 2017 Aug 29;14(8):e1002379. doi: 10.1371/journal.pmed.1002379. eCollection 2017 Aug.
- Background: PubMed 10334756Edwards SJ, Braunholtz DA, Lilford RJ, Stevens AJ. Ethical issues in the design and conduct of cluster randomised controlled trials. BMJ. 1999 May 22;318(7195):1407-9. doi: 10.1136/bmj.318.7195.1407. No abstract available.
- Individual participant dataSharing planned: Undecided. Considering to share study related information such as protocol, ICFs and final CSR after final publication has been published.
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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.
Elmer Alejandro Llanos Cuentas, MD, PhD principal investigator
Universidad Peruana Cayetano Heredia (UPCH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, Vivax, run by Medicines for Malaria Venture at 1 site in Peru.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 20 Mar 2026. 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 Peru. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05361486, which also lists 7 linked publications.
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 20 Mar 2026.