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CompletedNCT02878200RHOSTUpdated Sep 7, 2020

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

An interventional study of dihydroartemisinin-piperaquine in Malaria, sponsored by London School of Hygiene and Tropical Medicine. Completed at 1 site in Gambia. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-07.

Sponsored by London School of Hygiene and Tropical Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
2,236
Allocation
Randomized
Ages
6 Months and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Malaria

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03

In context

Malaria

1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.

This study's enrollment of 2,236 is above the median of 252 across 937 interventional studies indexed under Malaria.

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Lead sponsor

London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Resident in the study area for at least two weeks
  • to participate in the trial
  • willing to receive DHAP (intervention villages)
  • Age ≥6 months and weight ≥5kg*

Exclusion criteria

Exclusion Criteria:

  • Pregnancy (first trimester only)†
  • Known allergies to DHAP
  • Known chronic cardiac disease
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,236 participants (actual)

Study arms

  • 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

  • No intervention
    standard care

    In control villages, no household treatment will be done

Interventions

  • Biologicaldihydroartemisinin-piperaquine

    Drug pages: Artenimol · Piperaquine

    A treatment course of DHAP consists of three doses taken daily. Treatment doses for household members will be prepared based on measured weight

    Also known as: DHAP

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What researchers measure

Primary outcomes

  1. prevalence of malaria infection

    the prevalence of malaria infection (determined by molecular methods) in all age groups at the end of the second intervention year

    Time frame: 24 months

Secondary outcomes

  1. prevalence of clinical (laboratory confirmed) malaria cases

    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

    Time frame: 3-4 months

  2. the prevalence of antimalarial drug resistance molecular markers

    the prevalence of antimalarial drug resistance molecular markers as determined among malaria infected individuals detected at cross-sectional surveys;

    Time frame: 4 months and 16 months

  3. treatment coverage

    treatment coverage as determined by percentage of household members having received and taken at least 80% of the prescribed dose.

    Time frame: 4 months and 16 months

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Study locations

1 site
  • Health Centres in North Bank Region
    North Bank Region, Gambia
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References and documents

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. PubMed 34098984 ↗
  • 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. PubMed 29463288 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02878200
Collaborators
Institute of Tropical Medicine, Belgium, University of Sheffield
Responsible party
Sponsor
First posted
Aug 25, 2016
Start date
Nov 4, 2016
Primary completion
Dec 18, 2018
Completion
Jul 16, 2020
Last update
Sep 7, 2020

Study contacts

Umberto D'Alessandro, MD
principal investigator · Medical Research Council Unit, The Gambia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Artenimol · Piperaquine

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