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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Ghana
Pokrom sub district
RECRUITING
Accra
Contact Information
Primary
Ndong Ignatius Cheng, PhD
Ncheng@noguchi.ug.edu.gh
+233561817573
Backup
Collins S Ahorlu, PhD
CAhorlu@noguchi.ug.edu.gh
+233240878106
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 9000
Treatments
Active_comparator: Arm 1: MDA with dihydroartemisinin-piperaquine (DHAP) alone
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.
Active_comparator: Arm 2: DHAP + Primaquine (PQ)
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.
No_intervention: Arm 3: Control
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.
Related Therapeutic Areas
Sponsors
Collaborators: Medical Research Center Unit The Gambia (MRCG)
Leads: Noguchi Memorial Institute for Medical Research

This content was sourced from clinicaltrials.gov