Last Updated: 07/03/2016
Evaluating the feasibility and effectiveness of Reactive Targeted Parasite Elimination vs. Reactive Case Detection as a community level intervention in response to a passively identified index case: a cluster randomised controlled trial in Namibia
Objectives
This is a cluster randomised controlled trial with factorial study design comparing the impact of reactive community-based malaria interventions:
- presumptive treatment (or TPE, targeted parasite elimination, mass drug administration) versus reactive case detection (RACD), and
- reactive IRS (indoor residual spraying) versus control on the incidence of malaria in Namibia.
Arm 1: RACD as per program + RDT screening and treatment
Arm 2: RACD + IRS with Actellic CS to EA after first reported cases
Arm 3: Focal MDA (household and immediate neighbours) in response to a case
Arm 4: Focal MDA + IRS with Actellic CS
Primary aim: To compare the impact of focal MDA versus RACD, and reactive IRS versus no reactive IRS, on the incidence of confirmed, passively identified malaria cases.
Secondary aims:
Effectiveness:
- To compare the impact of each intervention package (focal MDA+/- reactive IRS, RACD +/-reactive IRS) on:
- Prevalence of infection, among all ages, as detected by quantitative polymerase chain reaction (qPCR)
- Seroprevalence, among all ages, measured by ELISA
Feasibility:
- To compare operational coverage, and determine the feasibility of reaching 80% coverage, for each intervention package;
- To compare the safety of the intervention packages;
- To compare the acceptability of the interventions, individually and as packages;
- To compare the costs and cost-effectiveness of the interventions, individually and as packages;
- To measure medication adherence in both focal MDA and RACD arms.
University of California San Francisco (UCSF), United States
In recent years, many countries, including Namibia, have experienced reductions in malaria transmission in association with the scale-up of effective interventions and are now moving towards malaria elimination. In malaria control, the goal is to reduce the clinical burden of malaria. In malaria elimination, the aim is to interrupt transmission, and it becomes necessary to address not only symptomatic malaria, but also asymptomatic infections that contribute to transmission. Since malaria transmission is highly geographically heterogeneous, elimination activities should target hot spots, or areas where the risk of future infection is highest. Hence, in the transition from control to elimination, enhanced surveillance and response is necessary to target hot spots with interventions to interrupt transmission.
ClinicalTrials.gov Identifier: NCT02610400
| Study Type : | Interventional (Clinical Trial) |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
Study protocol for a cluster randomised controlled factorial design trial to assess the effectiveness and feasibility of reactive focal mass drug administration and vector control to reduce malaria transmission in the low endemic setting of NamibiaEffectiveness of reactive focal mass drug administration and reactive focal vector control to reduce malaria transmission in the low malaria-endemic setting of NamibiaCommunity acceptance of reactive focal mass drug administration and reactive focal vector control, a mixed-methods study in NamibiaCost and cost effectiveness of reactive case detection (RACD), reactive focal mass drug administration (rfMDA) and reactive focal vector control (RAVC) to reduce malaria in the low endemic setting of Namibia: an analysis alongside a 2×2 factorial design cSerological evaluation of the effectiveness of reactive focal mass drug administration and reactive vector control to reduce malaria transmission in Zambezi Region, Namibia: Results from a secondary analysis of a cluster randomised trial
Evaluation of Targeted Parasite Elimination (TPE) in Namibia
Sep 2015 — Dec 2017
