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

NCT05323721 | Unknown Phase 4 DMC

• 1 other identifier: SMCUGPHASE2
• Study Type: interventional
• Target: 6,805
• Locations: 1 country
• Sites: 1

Brief 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

Malaria

Keywords

seasonal malaria chemoprevention

Outcome Measures

Primary Outcomes (3)

• Malaria incidence

  Malaria cases recorded through passive surveillance

  Four months

• Chemoprevention failure

  As defined by qPCR positive parasites on day 28 for SPAQ and DP) or malaria slide positive parasites at any time from day 7

  1 month

• Chemoprevention efficacy

  As defined by drug concentrations on Day 7 and Day 28

  1 month

Secondary Outcomes (2)

• Anemia

  Four months

• 28 day malaria incidence

  1 month

Study Arms (3)

Control - No SMC

NO INTERVENTION

This arm will not receive any SPAQ

Intervention SMC - SPAQ

ACTIVE COMPARATOR

This arm will receive SPAQ as seasonal malaria chemoprevention

Drug: Sulfadoxine pyrimethamine and amodiaquine

Intervention SMC - SP

ACTIVE COMPARATOR

This arm will receive SP as seasonal malaria chemoprevention

Drug: dihydroartemisinin-piperaquine

Interventions

Sulfadoxine pyrimethamine and amodiaquine DRUG

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

Also known as: SPAQ

Intervention SMC - SPAQ

dihydroartemisinin-piperaquine DRUG

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

Also known as: DP

Intervention SMC - SP

Eligibility Criteria

• Age: 3 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Malaria Consortium: lead

Study Sites (1)

Amudat

Amudat, Karamoja, Uganda

Location

Related Publications (2)

• Nuwa A, Baker K, Kajubi R, Nnaji CA, Theiss-Nyland K, Odongo M, Kyagulanyi T, Nabakooza J, Salandini D, Asua V, Nakirunda M, Rassi C, Rutazaana D, Achuma R, Sagaki P, Bwanika JB, Magumba G, Yeka A, Nsobya S, Kamya MR, Tibenderana J, Opigo J. Effectiveness of sulfadoxine-pyrimethamine plus amodiaquine and dihydroartemisinin-piperaquine for seasonal malaria chemoprevention in Uganda: a three-arm, open-label, non-inferiority and superiority, cluster-randomised, controlled trial. Lancet Infect Dis. 2025 Jul;25(7):726-736. doi: 10.1016/S1473-3099(24)00746-1. Epub 2025 Jan 15.

  PMID: 39826559 DERIVED

• Kajubi R, Ainsworth J, Baker K, Richardson S, Bonnington C, Rassi C, Achan J, Magumba G, Rubahika D, Nabakooza J, Tibenderana J, Nuwa A, Opigo J. A hybrid effectiveness-implementation study protocol to assess the effectiveness and chemoprevention efficacy of implementing seasonal malaria chemoprevention in five districts in Karamoja region, Uganda. Gates Open Res. 2023 Dec 18;7:14. doi: 10.12688/gatesopenres.14287.2. eCollection 2023.

  PMID: 38196920 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

fanasil, pyrimethamine drug combination; Amodiaquine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jimmy Opigo, MD

  National Malaria Control Division, Ministry of Health, Uganda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: April 12, 2022
• Study Start: June 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)