drugset / Trial / NCT02009215
School-Based Treatment With ACT to Reduce Transmission
Phase 4
Completed
10746 enrolled
London School of Hygiene and Tropical Medicine
Infectious Diseases Research Collaboration, Uganda · collabUniversity of California, San Francisco · collabUniversity of Durham · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
We propose to evaluate the community-level impact of intermittent preventive treatment (IPT) for malaria in schoolchildren on clinical outcomes and malaria transmission, using a cluster-randomised design in Jinja, Uganda. Dihydroartemisinin-piperaquine (DP) will be administered to schoolchildren monthly for up to six rounds of treatment during one school year. Outcomes will be measured using surveys of communities, schoolchildren, and mosquito vectors. Our proposal also includes health service research to evaluate the potential feasibility of taking the programme to scale, which will guide future research and implementation of the intervention, and help shape policies in Uganda and elsewhere in Africa.
Timeline
- Start
- 2014-02
- Primary completion
- 2015-04
- Completion
- 2015-04
Publications
- Background Nankabirwa J, Cundill B, Clarke S, Kabatereine N, Rosenthal PJ, Dorsey G, Brooker S, Staedke SG. Efficacy, safety, and tolerability of three regimens for prevention of malaria: a randomized, placebo-controlled trial in Ugandan schoolchildren. PLoS One. 2010 Oct 19;5(10):e13438. doi: 10.1371/journal.pone.0013438.
- Background Nankabirwa JI, Wandera B, Amuge P, Kiwanuka N, Dorsey G, Rosenthal PJ, Brooker SJ, Staedke SG, Kamya MR. Impact of intermittent preventive treatment with dihydroartemisinin-piperaquine on malaria in Ugandan schoolchildren: a randomized, placebo-controlled trial. Clin Infect Dis. 2014 May;58(10):1404-12. doi: 10.1093/cid/ciu150. Epub 2014 Mar 12.
- Rehman AM, Maiteki-Sebuguzi C, Gonahasa S, Okiring J, Kigozi SP, Chandler CIR, Drakeley C, Dorsey G, Kamya MR, Staedke SG. Intermittent preventive treatment of malaria delivered to primary schoolchildren provided effective individual protection in Jinja, Uganda: secondary outcomes of a cluster-randomized trial (START-IPT). Malar J. 2019 Sep 18;18(1):318. doi: 10.1186/s12936-019-2954-0.
- Staedke SG, Maiteki-Sebuguzi C, Rehman AM, Kigozi SP, Gonahasa S, Okiring J, Lindsay SW, Kamya MR, Chandler CIR, Dorsey G, Drakeley C. Assessment of community-level effects of intermittent preventive treatment for malaria in schoolchildren in Jinja, Uganda (START-IPT trial): a cluster-randomised trial. Lancet Glob Health. 2018 Jun;6(6):e668-e679. doi: 10.1016/S2214-109X(18)30126-8. Epub 2018 Apr 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dihydroartemisinin-piperaquine | Unknown | 40 mg | Oral |
| Subject | Dihydroartemisinin-piperaquine | Unknown | 320 mg | Oral |