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Effectiveness and Chemoprevention Efficacy of Implementing Seasonal Malaria Chemoprevention in Karamoja Region, Uganda

NCT05323721 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6805

Last updated 2023-11-01

No results posted yet for this study

Summary

To-date, seasonal malaria chemoprevention (SMC) has only been scaled up across the Sahel region of west and central Africa, primarily because of concerns over widespread resistance to sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) in east and southern Africa. There are increasing calls for this successful intervention to be used more widely and aggressively, including in areas of east and southern Africa where malaria transmission is seasonal. To test the feasibility, acceptability and impact of SMC with SPAQ in new geographies outside of the Sahel, Malaria Consortium, together with the malaria programmes in Mozambique and Uganda, is conducting implementation studies in both countries. The studies comprise two phases, with the first phase focusing on acceptability and feasibility, followed by more rigorous assessments of the effectiveness of the intervention and chemoprevention efficacy of the medicines used in SMC.

Phase 1 of the studies has been successfully completed. The studies showed that SMC with SPAQ was safe, acceptable and feasible, with very high coverage achieved among the target population.Phase 2 of the SMC implementation study in Uganda will include study components exploring the effectiveness of SMC with SPAQ and dihydroartemisinin-piperaquine (DP), as well as the chemoprevention efficacy of DP when used in SMC. The study will be conducted in five districts of Karamoja region. It will involve SMC delivery to around 142,000 children. The majority of the target population will receive SPAQ, but around 15,000 children will receive DP. Five monthly SMC cycles will be implemented between May and September 2022. As the protective period of SPAQ and DP are comparable, monthly administration cycles will be implemented irrespective of the drug regimen used.

Conditions

Interventions

DRUG

Sulfadoxine pyrimethamine and amodiaquine

This is where children 3-59 months will receive SPAQ for SMC

DRUG

dihydroartemisinin-piperaquine

This is where children 3-59 months will receive DP for SMC

Sponsors & Collaborators

  • Malaria Consortium

    lead OTHER

Principal Investigators

  • Jimmy Opigo, MD · National Malaria Control Division, Ministry of Health, Uganda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2022-11-01
Completion
2023-12-01

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05323721 on ClinicalTrials.gov