Qualifications

Purpose of Consultancy

To provide quality assurance through training and clinical monitoring for the conduct of therapeutic
efficacy studies for first- and second-line malaria medicines in countries in South Sudan

Background

Malaria remains the most significant public health problem in South Sudan accounting for 66.8%.
of outpatient consultations, 30% admissions and 50% of deaths. About 50% of the population will
have at least one episode of malaria annually while about 2.5 million under-fives will have 2 to 4.
attacks of malaria annually [2]. World Malaria Report estimates that there are about 8750 malarias.
cases daily and 20 people die of malaria daily in South Sudan. In 2017, malaria prevalence was.
measured to be 32%. Transmission is all year round with peaks between July and November.
Plasmodium falciparum is the dominant species accounting for 93.1 % of infections.
Malaria case management, encompassing prompt diagnosis (either by microscopy or RDT) and
treatment with an effective antimalarial, aims to cure the patient and reduce the number of
individuals that progress to severe disease and death. In 2015 the Ministry of Health changed the
treatment policy for uncomplicated malaria to the Artesunate Amodiaquine Combination Therapy
(ACT) in keeping with the WHO recommendations. Significant progress has been made in scaling.
up the procurement and distribution of RDTs and ACTs to health facilities in the country with
cases being managed in both public and private facilities. However, the current therapeutic
efficacy of the first- and second-line treatment is not known. It is against this background that the
Ministry of Health in South Sudan is planning to assess the therapeutic efficacy of artesunate.
amodiaquine and artemether-lumefantrine treatment currently in use for management of
uncomplicated malaria. The results of this study will be used to assist the Ministry of Health of
South Sudan in assessing the current national treatment guidelines for uncomplicated P.
falciparum malaria and to update the policy if necessary. The general objective of this study is to
assess the therapeutic efficacy and safety of artesunate/amodiaquine and
artemether/lumefantrine for the treatment of uncomplicated P. falciparum malaria in Juba, Wau
and Rubkona, counties of South Sudan
Antimalarial drug efficacy is assessed through therapeutic efficacy studies (TES), the results of
which are used by national malaria programmes as their primary reference to determine national?
treatment policies. TES are conducted in a controlled environment in which drug administration.
is supervised, the results of microscopic examinations of blood films are validated, and the origin.
and quality of the drugs are verified. TES are prospective evaluations of patients’ clinical and
parasitological responses to directly observed treatment for uncomplicated malaria. Studies at
regular intervals at the same sites allow for the early detection of resistance and provide evidence.
for guiding national malaria treatment policy.
Resistance of Plasmodium falciparum to antimalarial drugs, including artemisinin poses a serious
threat in the fight against malaria. The threat was first reported in the Greater Mekong sub-region.
in Southeast Asia, where resistance to artemisinin combination therapies (ACTs) has emerged.
and spread, leading to treatment failure and an increase in malaria illness. Partial artemisinin
resistance is mediated by mutations in the PfKelch13 propeller gene of the malaria parasite.
Parasites with these mutations are widespread in Southeast Asia and some Pacific Islands. Since
2018, countries in Africa have documented confirmed mutations conferring partial artemisinin
resistance (Rwanda, Eritrea, Uganda) although these have not been shown to affect antimalarial efficacy yet because the partner antimalarial medicines remain effective. In the WHO African
Region, the efficacy rates of artemisinin combination therapies (ACTs) for the treatment of P.
falciparum malaria – artemether-lumefantrine (AL), artesunate amodiaquine (AS-AQ) and
dihydroartemisinin-piperaquine (DHA-PPQ) – have remained high (over 90%). It is for this reason.
that WHO recommends routine monitoring of efficacy of first and second line ACTs every two.
years at sentinel sites in each country, to detect and counteract emerging threats. In vivo
therapeutic efficacy studies (TES), although routine, should be conducted with the same rigor as
clinical trials.
Quality control monitoring is an essential part of the conduct of high-quality therapeutic efficacy.
studies. By visiting study sites at the beginning, during and at the end of a study, quality control
monitors help to ensure that a study site is appropriate, that clinical and laboratory resources are.
adequate, that data processing is complete, and that reporting is underway. To facilitate this
process, WHO has developed 3 separate template checklists for quality control monitoring (see
annexes 1, 2 & 3). The templates can be used as provided or adapted according to local.
conditions and sponsor requirements.
Clinical monitoring is mostly independent oversight provided during a clinical trial. It comprises.
quality assurance procedural activities that commence before a trial and occur throughout the
duration of that trial to ensure that the trial is conducted, recorded, and reported in accordance.
with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the
applicable regulatory requirement(s). TES Monitoring is defined as the act of overseeing the start,
progress of the study, and of ensuring that it is conducted, recorded, and reported in accordance.
with the approved study protocol.

Objectives
The overall objective is to ensure that high quality therapeutic efficacy studies are conducted and
reported to guide national treatment policy. Specifically, to:
1. To assess the readiness of the selected study sites for the conduct of the therapeutic
efficacy studies (before the study starts).
2. To determine / establish that procedures related to ethics, patient recruitment and follow-up, protocol compliance and case record forms (CRFs), laboratory (and microscopy) and
data entry are adhered to according to the required standards (during the implementation
of the study).
3. To verify that all the procedures related to the conduct of the therapeutic efficacy studies
in all the sites are implemented according to the required standards and the outcomes
reported to the relevant authorities (at the end of the study).
4. To document inadequacies in the conduct of the therapeutic efficacy study at the
selected sites and develop an action plan to address the gaps/inadequacies.
observed.
5. To train site staff including national level staff on the conduct of a therapeutic
efficacy study.

Tasks to be undertaken.
Using the WHO clinical monitoring tools, the therapeutic efficacy study protocol and any other
standard operating procedures (SOPs) as appropriate to:
• Facilitate training in the conduct of the therapeutic efficacy study.
• Identify gaps and weaknesses in the conduct of the therapeutic efficacy studies at the
various study sites and provide relevant recommendations.
• Document inadequacies and develop action plan (s) to address the identified observed
gaps/issues and challenges to ensure high quality conduct of the therapeutic efficacy.
studies.
• Conduct entry and exit meetings with the study PIs and team at central level and with the
investigators / coordinators and other team members at each of the study sites.
• Provide support to the study team (s) and discuss potential solutions to any identified
issues/challenges to be addressed by the study Principal Investigators (PIs) and team.
members.
• Follow – up on any issues identified during previous visits as appropriate.
Deliverables
1. Monitoring visit report (including agreed action plan (s) with the Study PIs and team to
address identified inadequacies/ issues).
2. Travel report
Duration
Total duration 45 days
Seven (7) days per visit
Number of visits – Three (3)

Specific requirements
Qualifications
Master’s degree in public health, parasitology, or infectious diseases
Experience required.
At least 3 years’ experience in the field at global or regional level with proven experience for
design, conduct and or implementation of therapeutic efficacy studies, and in conducting training.
in malaria case management and therapeutic efficacy studies.

Technical skills and knowledge
High level of experience in malaria case management
Language requirements
Languages and level required (Read-Write-Speak/ Expert or Intermediate)
English/Expert

Additional Information (For HR use only):

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