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RHOST-cRCT, Reactive Household-based Self-administered Treatment Against Residual Malaria Transmission (RHOST)

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ClinicalTrials.gov Identifier: NCT02878200
Recruitment Status : Active, not recruiting
First Posted : August 25, 2016
Last Update Posted : May 24, 2019
Sponsor:
Collaborators:
Institute of Tropical Medicine, Belgium
University of Sheffield
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:
Reactive treatment of household contacts of a confirmed malaria case has been shown to reduce infection prevalence since the former as they are at an increased risk of infection. However, implementing this on a programmatic scale poses significant pressure on the health system and may not be sustainable without the active involvement of the recipient community. This study investigates a novel approach to reducing residual malaria transmission that combines the elements of active community involvement in reactive treatment of household contacts of a clinical case reporting at a health facility. The investigators hypothesize that in areas of low transmission (prevalence of infection ≤10%), most asymptomatic carriers are clustered around clinical malaria cases in the same households. Also, targeting individuals sharing a sleeping area with diagnosed malaria case will reduce parasite carriage in the community. This is a cluster-randomized trial where villages in Central and Upper Baddibu, North Bank East Region of The Gambia, are randomized to receive either reactive treatment of household contacts following a confirmed case of malaria or standard care, i.e. treatment of index case only. Formative research into community perception and reaction to self-administered treatment will be used to generate, adapt and evaluate messages that encourage adherence and compliance to treatment. This will be tested in the first year of the implementation, and findings used to develop a final model of messages to be implemented in the second year of the study. The primary outcome is the prevalence of malaria infection, determined by molecular methods, in all age groups at the end of the second intervention year and the incidence of clinical malaria during the transmission season.

Condition or disease Intervention/treatment Phase
Malaria Biological: dihydroartemisinin-piperaquine Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reactive Household-based Self-administered Treatment Against Residual Malaria Transmission: a Cluster Randomized Trial
Actual Study Start Date : November 4, 2016
Actual Primary Completion Date : December 18, 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

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)
Biological: dihydroartemisinin-piperaquine
A treatment course of DHAP consists of three doses taken daily. Treatment doses for household members will be prepared based on measured weight
Other Name: DHAP

No Intervention: standard care
In control villages, no household treatment will be done



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. the prevalence of antimalarial drug resistance molecular markers [ Time Frame: 4 months and 16 months ]
    the prevalence of antimalarial drug resistance molecular markers as determined among malaria infected individuals detected at cross-sectional surveys;

  3. treatment coverage [ Time Frame: 4 months and 16 months ]
    treatment coverage as determined by percentage of household members having received and taken at least 80% of the prescribed dose.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02878200


Locations
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Gambia
Health Centres in NBR
Farafenni, North Bank Region, Gambia
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Institute of Tropical Medicine, Belgium
University of Sheffield
Investigators
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Principal Investigator: Umberto D'Alessandro, MD Medical Research Council Unit, The Gambia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02878200     History of Changes
Other Study ID Numbers: SCC1488
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Piperaquine
Dihydroartemisinin
Artemisinins
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents