Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04093765 |
| Other study ID # |
MAL17011 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2018 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
October 2021 |
| Source |
University of Oxford |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this project, the investigators aim at an operational research deployment of
Ultrasensitive Rapid Diagnostic Test (URDT) -based Mass Screening and Treatment (MSAT) in the
Malaria Elimination Task Force (METF) elimination program. This intervention will be tested
in two types of setting. In group 1, MSAT will be used in a programmatic setting in order to
decrease the reservoir of asymptomatic carriers in high incidence villages (following the
same principles and objective as previously deployed MDA interventions). In group 2, the
investigators take advantage of the lighter framework of MSAT to use it as a reactive
intervention in order to respond to malaria outbreaks in low to intermediate incidence
villages. The MSAT intervention will be preceded with community-level consent and community
engagement (CE) activities. MSAT will be conducted over a period of approximately 1 week in
each hamlet, village or group of villages, and will consist in administering a P. falciparum
URDT to all individuals agreeing to participate. A limited subgroup (expected 5-25%) will be
found positive and receive supervised treatment over 3 days for the standard regimen (DP to
cure asexual stage infection + single low-dose primaquine to destroy gametocytes). After this
intervention, the incidence of clinical falciparum episodes will be monitored by the village
MP. In group 1, a comparison of the prevalence at baseline and 12 months after MSAT
intervention will be performed through a second URDT survey, in addition to which both
baseline and 12-month surveys will include the collection of a 200µL capillary blood sample
for reference detection in the laboratory.
The intervention will be evaluated primarily on its ability to reduce yearly cumulative
incidence of clinical falciparum malaria compared to year before intervention. Additional
evaluations of the impact of MSAT will include: in group 1, comparison of asymptomatic
infection prevalence; and in group 2, modifications of the shape of the incidence curve
following intervention.
Funder: Wellcome Trust grant reference 106698/B/14/Z
Description:
STUDY DESIGN
Stepped-wedge open-label, non-randomized, cluster intervention.
This study will be performed in clusters (hamlet (isolated group of household, village, or
group of village). The intervention will be conducted in two types of clusters, both
corresponding to locations where an excess of case was detected.
Group 1: Sustained high incidence clusters, characterized by a yearly cumulative incidence
>84 cases/1000/year
Villages in group 1 will be attributed an intervention a given year based on the cumulative
incidence over the previous 12 months (METF stratification January, including the last 2
transmission seasons). The order of intervention will be decided based on logistic
constraints and highest incidence.
Group 2: Focal transmission clusters, corresponding to locations where an epidemic alert has
been signalled and confirmed (see definition of thresholds).
Villages in group 2 will be attributed an intervention based on P. falciparum incidence in
the previous 4 weeks. In near-0 transmission area, an intervention will be conducted in each
likely source location of transmission of a locally acquired case. In the other areas
(METF1+METF2), the intervention will be triggered when the incidence is above the pre-defined
epidemic threshold.
In each cluster, all inhabitants will be invited to undergo an URDT test to identify their
infection status, and will receive the appropriate treatment according to their
characteristics. Information on village inhabitants absent during the MSAT activities will be
obtained from village population lists provided by the village headman and from household
member declarations. During the URDT screening, all individuals will receive a unique
identifying number that will be used to record demographic data in the MSAT paper logbook and
to label URDT and reference sample.
Before and after MSAT intervention, incidence of clinical malaria episodes will be recorded
at the MP (1 or several) serving the cluster receiving the intervention. No individual data
will be collected to link clinical case participation, infection status and incidence of
clinical episodes.
Participants from group 1 clusters will be invited to participate in a prevalence survey
during MSAT and 12 months after, in order to evaluate the impact of the MSAT campaign on the
asymptomatic carriage prevalence. This will require collection of a 200µL sample during the
MSAT campaign and a second round of URDT screening with the collection of a 200µL sample, 12
months after MSAT.
STUDY PARTICIPANTS
Populations of villages with high P. falciparum incidence located in Eastern Kayin State,
Myanmar.
SUMMARY RESULTS
In 2018, two rounds of mass screening and treatment (MSAT) using ultrasensitive RDT (hsRDT)
were conducted in 17 villages. The first round was carried out in 10 villages. Despite
relatively high screening numbers with an average village screening coverage of 80.5% (min=
74.2%, max= 86%), equivalent to 1,364 people in total, only 1.1% of those screened were P.
falciparum positive by hsRDT (ultrasensitive malaria RDT). In the second round of MSAT, 6
villages in underwent hsRDT screening. Screening numbers in this round were lower than in
round 1 with an average of 70% (min= 47.1%, max= 90.8%) of villagers screened, or 1,104
people in total, however a higher positivity rate by hsRDT was detected with 5.38% of all
tests returning a positive P. falciparum result.
In 2019, MSAT was conducted in 12 villages. This round had a high hsRDT screening coverage
with an average coverage of 95% (min = 92%, max= 98%) in 12 villages, equivalent to 3,074
people. However, only 2.67% of hsRDTs returned a positive result for P. falciparum.
The primary intervention and outcome were completed in 31th Dec 2019. During the observation
period post MSAT period in 2020. We have found the limited evidence for sustained impact of
MSAT at low levels of P. falciparum detection in following post MSAT months by using hsRDT.
