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

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Malaria Consortium
• Treatments: Amodiaquine; Artenimol; Fanasil, pyrimethamine drug combination; Piperaquine; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• Children between 3-59 months

• Being resident in the project area

• Afebrile with no other malaria associated symptoms in the past 48 hours or at time of recruitment

• Consent to participate in the study obtained

• Can comply with 3 days DOT of standard SPAQ or DP regimen (day 0-2)

• Willingness and ability of the child's guardians to comply with the study protocol for the duration of the study including all dry blood spot and slide collections

Exclusion Criteria:

• Symptoms of malaria (tympanic fever ≥ 37.5 °C or history of fever in past 48 hours)

• Known allergy to medicine provided

• Receiving a sulfa-based medication for treatment or prophylaxis, including co-trimoxazole (trimethoprim-sulfamethoxazole).

• Individuals receiving azithromycin due to the antimalarial activity of azithromycin.

• Severe malnutrition according to WHO guidelines

• Treatment of uncomplicated malaria with DP in the past 28 days

• HIV positive or ARV use (SPAQ MUST NEVER be used with children taking the antiretroviral efavirenz)

• Chronic illness of any kind

• Recruited in cRCT or any other studies

• Treatment with an ACT in previous 2 weeks.