- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02878200
RHOST-cRCT, Reactive Household-based Self-administered Treatment Against Residual Malaria Transmission (RHOST)
Reactive Household-based Self-administered Treatment Against Residual Malaria Transmission: a Cluster Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Achieving malaria elimination presents a challenge because of important gaps in the knowledge about the strategies and tools needed achieve this. While malaria control measures aim to reduce morbidity and mortality in vulnerable populations, interventions to reduce transmission are designed to interrupt transmission of malaria parasites from humans, especially asymptomatic parasite carriers [1], to mosquitoes.
The importance of asymptomatic infections in transmission has grown with the awareness that the majority of the human reservoir of infection are asymptomatic carriers [2] and these are quite difficult to target [3]. Previous malaria elimination campaigns have applied a strategy of mass drug administration: extensive treatment of entire populations, irrespective of their infection status, in one or multiple rounds [4]. Although transmission was interrupted in some cases, albeit temporarily [5], there is a reluctance to apply this method because the evidence of its impact has been mixed. A Cochrane systematic review of MDAs showed that long term reductions were not possible within the current concept and highlighted the need for studies in low- and moderate-transmission settings and studies that could address potential barriers for community uptake, and contribution to the development of drug resistance [6].
More conservative approaches involving screening for infection with a rapid malaria diagnostic test (RDT) and treating only positive individuals; mass screening and treatment, did not have a significant impact on the malaria incidence [7], largely due to low test's sensitivity that would miss a large proportion of infected individuals with low parasite densities. Implementing reactive screening on a programmatic scale puts significant pressure on the health system [8] and available field-based screening tests lack the required sensitivity for low-density parasitaemia seen with asymptomatic infections [9]. More importantly, understanding the local context and adapting intervention strategies may help improve coverage and participation by recipient communities [10].
This study investigates a novel approach to reducing residual malaria transmission that combines the elements of reactive treatment of household contacts of a clinical case reporting at a health facility with the active involvement of both patients and their households. The approach to implementation will be developed through formative research that identifies the optimum means of community engagement that will result in the best possible compliance and adherence to the treatment in the household.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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North Bank Region, Gambia
- Health Centres in North Bank Region
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Resident in the study area for at least two weeks
- Informed consent to participate in the trial
- willing to receive DHAP (intervention villages)
- Age ≥6 months and weight ≥5kg*
Exclusion Criteria:
- Pregnancy (first trimester only)†
- Known allergies to DHAP
- Known chronic cardiac disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: reactive treatment
Household members; defined as those sharing the same sleeping area, in the intervention villages, will be treated with a full course of dihydroartemisinin-piperaquine (DHAP)
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A treatment course of DHAP consists of three doses taken daily.
Treatment doses for household members will be prepared based on measured weight
Other Names:
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No Intervention: standard care
In control villages, no household treatment will be done
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevalence of malaria infection
Time Frame: 24 months
|
the prevalence of malaria infection (determined by molecular methods) in all age groups at the end of the second intervention year
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevalence of clinical (laboratory confirmed) malaria cases
Time Frame: 3-4 months
|
the incidence of clinical (laboratory confirmed) malaria cases as detected through the health system; health facilities and village health worker, in both intervention and control clusters
|
3-4 months
|
the prevalence of antimalarial drug resistance molecular markers
Time Frame: 4 months and 16 months
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the prevalence of antimalarial drug resistance molecular markers as determined among malaria infected individuals detected at cross-sectional surveys;
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4 months and 16 months
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treatment coverage
Time Frame: 4 months and 16 months
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treatment coverage as determined by percentage of household members having received and taken at least 80% of the prescribed dose.
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4 months and 16 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Umberto D'Alessandro, MD, Medical Research Council Unit, The Gambia
Publications and helpful links
General Publications
- Okebe J, Dabira E, Jaiteh F, Mohammed N, Bradley J, Drammeh NF, Bah A, Masunaga Y, Achan J, Muela Ribera J, Yeung S, Balen J, Peeters Grietens K, D'Alessandro U. Reactive, self-administered malaria treatment against asymptomatic malaria infection: results of a cluster randomized controlled trial in The Gambia. Malar J. 2021 Jun 7;20(1):253. doi: 10.1186/s12936-021-03761-8.
- Okebe J, Ribera JM, Balen J, Jaiteh F, Masunaga Y, Nwakanma D, Bradley J, Yeung S, Peeters Grietens K, D'Alessandro U. Reactive community-based self-administered treatment against residual malaria transmission: study protocol for a randomized controlled trial. Trials. 2018 Feb 20;19(1):126. doi: 10.1186/s13063-018-2506-x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCC1488
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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