An observational study in Malaria, sponsored by Novartis Pharmaceuticals. Not yet recruiting. Open to participants aged 10 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational
This non-interventional qualitative study will examine factors that influence the adoption of a novel malaria treatment in Côte d'Ivoire, Ghana, and Rwanda. One-time, in-depth interviews will be conducted with patients, caregivers, healthcare providers, pharmacists, and community health workers, who have received anti-malarial treatment in the past malarial season. The interviews will explore individual, community, health-system, and policy-level barriers and facilitators related to malaria treatment acceptability, treatment-seeking behavior, prescribing and dispensing practices, correct treatment use, and adherence. The findings will inform strategies to support the introduction and adoption of a novel malaria treatment in malaria-endemic settings.
Malaria remains a major public health concern in sub-Saharan Africa. Emerging antimalarial drug resistance, barriers to treatment access, and challenges with correct treatment use and adherence may affect the successful introduction of new malaria therapies. The adoption of a new treatment may be influenced by factors operating at multiple levels, including patient and caregiver beliefs, community norms, healthcare-provider practices, treatment availability, health-system capacity, supply arrangements, and national policy considerations.
This is a non-interventional qualitative study involving primary data collection in selected regions of Côte d'Ivoire, Ghana, and Rwanda. Approximately 184 participants will be recruited, including adult and adolescent patients who received oral treatment for uncomplicated malaria during the most recent malaria season, caregivers of children treated for uncomplicated malaria, healthcare providers, pharmacists and other antimalarial dispensers, and community health workers.
Participants will take part in one individual, semi-structured, in-depth interview lasting approximately 75 minutes. Patient, caregiver, and community health worker interviews will generally be conducted in person. Healthcare-provider interviews may be conducted in person or virtually, depending on participant availability and preference. Interviews will be conducted in English in Ghana, French in Côte d'Ivoire, and English or Kinyarwanda in Rwanda, as appropriate. With participant consent, interviews will be audio-recorded, transcribed verbatim, translated into English when required, and de-identified before analysis.
The interviews will explore participants' experiences with malaria diagnosis and treatment, barriers to obtaining and completing treatment, acceptability of current and future malaria treatments, treatment-seeking and prescribing behaviors, and anticipated practical considerations associated with a novel powder-in-sachet malaria treatment. The discussions will also identify potential support measures for treatment preparation, dosing, adherence, communication, training, distribution, and implementation.
Qualitative thematic analysis will be conducted using a hybrid inductive and deductive approach. The Consolidated Framework for Implementation Research and the Capability, Opportunity, Motivation-Behavior model will guide the identification and interpretation of behavioral, contextual, and health-system factors. Analyses will first be conducted within each country and participant group, followed by group-specific and cross-country comparisons. Findings will be triangulated across patients, caregivers, and treatment providers to identify shared and context-specific barriers, facilitators, and potential implementation strategies.
1,316 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's planned enrollment of 184 is below the median of 600 across 220 observational studies indexed under Malaria.
Browse Malaria studies →Novartis Pharmaceuticals is the lead sponsor of 2,712 studies on the registry; 219 are open to participants now.
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The study population will include adult and adolescent patients treated with an oral antimalarial for uncomplicated malaria during the most recent malaria season; caregivers of children treated for uncomplicated malaria; healthcare providers who diagnose, treat, prescribe, administer, or dispense treatment for uncomplicated malaria; pharmacists and other antimalarial dispensers; and community health workers involved in malaria diagnosis, treatment, follow-up, education, supply, or supervision. Participants will be recruited from selected regions of Côte d'Ivoire, Ghana, and Rwanda using purposive sampling to capture variation in participant characteristics, professional roles, malaria epidemiology, healthcare settings, and urban, peri-urban, and rural contexts.
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.
Patients:
Caregivers:
Healthcare providers:
Community health personnel:
Exclusion criteria:
Patients and caregivers:
Healthcare providers and community health personnel:
Patients Treated for Uncomplicated Malaria: 1. Adults aged 18 to under 65 years and adolescents aged 13 to 17 years who reside in a selected study region, had at least one episode of uncomplicated malaria during the most recent malaria season, and received at least one oral antimalarial treatment. 2. Adolescents aged 10 to 12 years will not be interviewed independently; a caregiver will respond on their behalf.
Caregivers of Children Treated for Uncomplicated Malaria: 1. Adults aged 18 to 65 years who identify as a non-professional caregiver of a child treated with an oral antimalarial for uncomplicated malaria during the most recent malaria season. 2. Caregivers may also respond on behalf of adolescents aged 10 to 12 years, in accordance with applicable consent and assent requirements.
Healthcare Providers Managing Uncomplicated Malaria: Primary care physicians, pediatricians, nurses, nurse practitioners, and applicable country-specific professional groups, including midwives and physician assistants, who diagnose, treat, prescribe, prepare, or administer treatment for uncomplicated malaria.
Pharmacists and Antimalarial Treatment Dispensers: Pharmacists, pharmacy personnel, and applicable country-specific dispenser groups involved in stocking, preparing, dispensing, or supporting the use of treatments for uncomplicated malaria. This group includes over-the-counter medicine sellers in Ghana where applicable.
Community Health Personnel Supporting Uncomplicated Malaria Care: Community health workers and applicable country-specific personnel involved in malaria diagnosis, treatment, follow-up, patient education, supply, or supervision, including community health officers in Ghana and community environment and health officers in Rwanda.
Multilevel Barriers and Facilitators Influencing Adoption of a Novel Malaria Treatment
Individual-, community-, healthcare-provider-, health-system-, and policy-level barriers and facilitators influencing the anticipated adoption of a novel malaria treatment will be identified through thematic analysis of one-time, semi-structured, in-depth interviews with patients, caregivers, healthcare providers, pharmacists, other antimalarial dispensers, and community health personnel. Findings will be organized using the Consolidated Framework for Implementation Research and the Capability, Opportunity, Motivation-Behavior model.
Time frame: At the one-time interview, lasting approximately 75 minutes
Barriers and Facilitators Affecting Treatment-Seeking Behavior
Barriers and facilitators affecting recognition of malaria symptoms, decisions to seek care, selection of treatment sources, treatment access, and delays in obtaining care will be identified through thematic analysis of participant interviews.
Time frame: At the one-time interview, lasting approximately 75 minutes.
Factors Affecting Acceptability of a Novel Malaria Treatment
Participant perceptions of the acceptability of a novel powder-in-sachet malaria treatment will be assessed through interview discussions addressing formulation, dosing schedule, preparation, administration, taste, packaging, instructions, storage, and suitability across patient groups and care settings.
Time frame: At the one-time interview, lasting approximately 75 minutes.
Barriers and Facilitators Affecting Malaria Treatment Adherence
Patient-, caregiver-, provider-, community-, and health-system-related factors that may influence correct treatment preparation, dosing, persistence, and completion of malaria treatment will be identified through thematic analysis of participant interviews.
Time frame: At the one-time interview, lasting approximately 75 minutes.
Factors Affecting Provider Prescribing and Treatment-Support Practices
Factors influencing healthcare-provider and community-health-worker diagnosis, prescribing, dispensing, treatment administration, counselling, and adherence-support practices for uncomplicated malaria will be identified through thematic analysis of interviews.
Time frame: At the one-time interview, lasting approximately 75 minutes.
Implementation Options to Support Adoption of a Novel Malaria Treatment
Stakeholder-informed implementation options will be identified from interview data, including potential approaches related to training, communication, patient instructions, treatment preparation, supply and distribution, health-system readiness, and community support.
Time frame: At the one-time interview, lasting approximately 75 minutes.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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