Assessing the Feasibility of Combining Dihydroartemisinin Piperaquine and Primaquine for Malaria Mass Drug Administration in High Endemic Communities in the Eastern Region of Ghana

NCT07389057 | Recruiting

• 1 other identifier: NoguchiMIMR 3
• Study Type: interventional
• Target: 9,000
• Locations: 1 country
• Sites: 1

Brief Summary

Previous malaria control studies in Ghana have shown that community-wide approaches can substantially reduce malaria infections. In a mass testing, treatment and tracking (MTTT) study, more than 75% of people in target communities were reached, leading to a 24% reduction in asymptomatic malaria after one year. However, rapid diagnostic tests (RDTs) can miss very low-level infections, meaning some infected individuals are not treated and can continue to spread malaria. A pilot malaria mass drug administration (MDA) study using artemether-lumefantrine (AL) in the Eastern Region of Ghana showed a very large reduction (over 95%) in parasite carriage after repeated rounds of treatment. Despite this success, malaria infections later fluctuated, possibly because some parasites remained in mosquitoes and because mature gametocytes-the parasite stage responsible for transmission-are not fully eliminated by standard malaria medicines. To better interrupt malaria transmission, this study will use MDA with dihydroartemisinin-piperaquine (DHAP) combined with a single low dose of primaquine (PQ), which targets these transmission stages. The intervention will be given to the whole community every two months (six times per year) and compared with the current standard malaria control measures. The study will examine whether this approach reduces malaria parasite carriage, whether malaria returns after treatment stops, and whether repeated MDA affects malaria drug resistance markers in the population. This two-year implementation research will generate practical evidence to guide national malaria policy in Ghana and inform the potential use of MDA in other malaria-endemic African countries.

Conditions

Malaria Asymptomatic Parasitaemia; Malaria Falciparum; Malaria Infection; Malaria Transmission

Keywords

Malaria; Mass drug administration; Ghana; Feasibility; Implementation Research

Outcome Measures

Primary Outcomes (1)

• Effect of DHAP and DHAP+PQ on the prevalence of malaria infection following MDA

  Outcomes of primary objective: asymptomatic parasitaemia will be compared over time and between intervention arms using chi-square tests (or fisher exact tests) and logistic regression (or conditional logistic regression). Adjustments for potential confounders including participant's age and use of ITN and baseline temperature will be considered. In addition, these outcomes will also be compared over time using Cochrane Armitage test of trends.

  Time Frame: From enrolment of participants to end of treatment every two months over 24 months

Secondary Outcomes (4)

• Prevalence of symptomatic malaria among febrile participants attending health facilities in intervention arm compared to the control communities.

  From enrolment of participants to end of treatment every two months over 24 months

• Changes prevalence of anaemia in children <15 years over time across arms

  From enrolment of participants to end of treatment every two months over 24 months

• Effect of MDA on the prevalence of resistance markers.

  From enrolment of participants to end of treatment every two months over 24 months

• Perception of the impact MDA implementation

  From enrolment of participants to end of treatment every two months over 24 months

Study Arms (3)

Arm 1: MDA with dihydroartemisinin-piperaquine (DHAP) alone

ACTIVE COMPARATOR

Participants in this arm only receive DHAP. Each participants recieves one dose per day. All three doses (1 dose/day x 3days) of DHAP will be administered following NMEP guidelines. A full 3-day course of oral DHAP (40/320 mg) will be based on weight and/or age. Treatment doses will be as follow: participants weighing: (i) 5 to 10 kg (under 1 year) will received ½ tablet per day; (ii) 11 to 24 kg (1-6 years), 1 tablet per day; (iii) 24 to 50 kg (7-13 years) 1½ tablets per day and (iv) 51-70 kg (14-18 years), 2 tablets per day and ≥70 Kg (≥18 years) 3 tablets per day. All participants will be observed for 30 minutes to ensure that they retain the drug. Any participant vomiting after receiving the replacement dose will not be retreated but referred to the nearest clinic for care where necessary. All treated participants will be followed up on day 1, 2, 3 and 7 post-treatments to ensure to ensure adherence to treatment.

Drug: DHAP

Arm 2: DHAP + Primaquine (PQ)

ACTIVE COMPARATOR

In addition the DHAP as described in arm 1, we will add PQ. Single low dose Primaquine (0.25mg/Kg) will only be administered on day-3 to participants 10-19Kg ¼ table, 20-44kg ½ tablet, and ≥45kg 1 tablet. Under 1 years (\<9Kg) children will be excluded from primaquine.

Drug: DHAP; Drug: Single low dose PQ

Arm 3: Control

NO INTERVENTION

There will be no intervention in the control arm beyond the standard of care provided by health facilities in the study communities. However, at baseline and during evaluation, 100 participants will be randomly selected per community and screened for malaria parasites to determine prevalence, which will be compared with the intervention arms.

Interventions

DHAP DRUG

A full 3-day course of oral DHAP will be based on weight and/or age taken once daily.

Arm 1: MDA with dihydroartemisinin-piperaquine (DHAP) alone; Arm 2: DHAP + Primaquine (PQ)

Single low dose PQ DRUG

One dose of PQ on day 3

Arm 2: DHAP + Primaquine (PQ)

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• must be aged 3 months and above and
• be resident in the communities for the period of the study,
• completed and signed a consent form from the parent or guardian of children below 18 years
• Completed and signed assent for 12-17 years old children.
• Completed and signed consent for those from age 18 years and above.

You may not qualify if:

• Pregnant women
• individual with a life-threatening illness (excluding malaria)
• less than 10Kg body weight (or less than 1 year old)
• individuals who had experienced adverse effects related to primaquine or
• known to be G6PD deficient .

Sponsors & Collaborators

• Noguchi Memorial Institute for Medical Research: lead
• Medical Research Center Unit The Gambia (MRCG): collaborator

Study Sites (1)

Pokrom sub district

Accra, Eastern Region, 233, Ghana

RECRUITING

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Interventions

Single Person

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Ndong Ignatius Cheng, PhD

  Noguchi Memorial institute for Medical Research, College of Health Sciences, University of Ghana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ndong Ignatius Cheng, PhD

CONTACT

+233561817573; Ncheng@noguchi.ug.edu.gh

Collins S Ahorlu, PhD

CONTACT

+233240878106; CAhorlu@noguchi.ug.edu.gh

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a community-randomized clinical study with a parallel design involving three arms: two intervention arms and one control arm. Eighteen communities will participate, with six communities allocated to each arm. Arm 1 will receive mass drug administration (MDA) with dihydroartemisinin-piperaquine (DHAP) alone, while Arm 2 will receive DHAP combined with a single low dose of primaquine (DHAP+PQ) to clear stage V gametocytes. Arm 3 will serve as the control with no intervention. Six rounds of MDA will be delivered bi-monthly over two years. The first round will occur 28 days after baseline, followed by 60-day intervals between subsequent rounds. If malaria prevalence falls below 5%, the second year will shift to intensive serological surveillance with targeted MDA; otherwise, MDA will continue. Treatments will be directly observed by community health workers. To assess impact, 100 participants will be randomly selected per community at baseline and follow-up.

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: February 5, 2026
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)