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

NCT02878200 | Completed DMC

• 1 other identifier: SCC1488
• Study Type: interventional
• Target: 2,236
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Outcome Measures

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

  24 months

Secondary Outcomes (3)

• prevalence of clinical (laboratory confirmed) malaria cases

  3-4 months

• the prevalence of antimalarial drug resistance molecular markers

  4 months and 16 months

• treatment coverage

  4 months and 16 months

Study Arms (2)

reactive treatment

EXPERIMENTAL

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

standard care

NO INTERVENTION

In control villages, no household treatment will be done

Interventions

dihydroartemisinin-piperaquine BIOLOGICAL

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

reactive treatment

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\*

You may not qualify if:

• Pregnancy (first trimester only)†
• Known allergies to DHAP
• Known chronic cardiac disease

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Institute of Tropical Medicine, Belgium: collaborator
• University of Sheffield: collaborator

Study Sites (1)

Health Centres in North Bank Region

North Bank Region, The Gambia

Location

Related Publications (2)

• 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.

  PMID: 34098984 DERIVED

• 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.

  PMID: 29463288 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Umberto D'Alessandro, MD

  Medical Research Council Unit, The Gambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 25, 2016
• Study Start: November 4, 2016
• Primary Completion: December 18, 2018
• Study Completion: July 16, 2020
• Last Updated: September 7, 2020

Record last verified: 2020-09

Locations

TH (1)