MalariaNCT07896746
Factors Influencing Adoption of a Novel Malaria Treatment in Côte d'Ivoire, Ghana, and Rwanda
An observational study of Malaria, run by Novartis Pharmaceuticals.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- Type of treatment
- Pill or oral medicine
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 30 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Patients:
- Resident of Ghana, Côte d'Ivoire, or Rwanda and living in a selected study region.
- Adult aged 18 to under 65 years or adolescent aged 10 to 17 years.
- Had at least one diagnosis of uncomplicated malaria during the most recent malaria season.
- Received at least one oral antimalarial treatment during the most recent malaria season.
- Able to participate in an interview in an applicable study language.
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- Willing and able to provide informed consent; for adolescents, documented parental or legal-guardian permission and adolescent assent will be obtained as required.
- Adolescents aged 10 to 12 years will not be interviewed independently; a caregiver will respond on their behalf.
- Caregivers:
- Resident of Ghana, Côte d'Ivoire, or Rwanda and living in a selected study region.
- Aged 18 to 65 years.
- Parent, sibling, friend, or neighbor who provides non-professional care to an eligible child or adolescent.
- Care recipient had uncomplicated malaria during the most recent malaria season.
- Care recipient received at least one oral antimalarial treatment during the most recent malaria season.
- Able to participate in an interview in an applicable study language.
- Willing and able to provide informed consent.
- Healthcare providers:
- Based in Ghana, Côte d'Ivoire, or Rwanda and practicing in a selected study region and facility.
- Eligible professional role according to the country-specific recruitment plan.
- At least 2 years of relevant professional experience.
- Personally involved in the diagnosis, treatment, prescribing, preparation, administration, dispensing, follow-up, education, supply, or supervision of care for patients with uncomplicated malaria, as applicable to the professional role.
- Meets protocol-defined minimum malaria patient-care or treatment-volume requirements.
- Able to participate in an interview in an applicable study language.
- Willing and able to provide informed consent.
- Community health personnel:
- Based in Ghana, Côte d'Ivoire, or Rwanda and working in a selected study region.
- Eligible community health role according to the country-specific recruitment plan.
- At least 2 years of experience in the role.
- Involved in diagnosis, treatment, follow-up, education, supply, or supervision relating to uncomplicated malaria, as applicable.
- Meets protocol-defined minimum malaria-care requirements where applicable.
- Able to participate in an interview in an applicable study language.
- Willing and able to provide informed consent.
Who cannot join
- Patients and caregivers:
- Not resident in a target country or selected study region.
- Patient or care recipient did not have uncomplicated malaria during the most recent malaria season.
- Patient or care recipient did not use an oral antimalarial treatment during the most recent malaria season.
- Patient currently reports being pregnant or having been pregnant within the previous 6 months.
- Currently employed by a pharmaceutical company outside clinical-trial work.
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- Participated in a clinical study testing a new malaria treatment during the previous 3 months.
- Professional caregiver.
- Unable to participate in an applicable study language.
- Unwilling or unable to provide the required consent, parental permission, or assent.
- Healthcare providers and community health personnel:
- Based outside Ghana, Côte d'Ivoire, and Rwanda or outside the selected study regions.
- Not involved in relevant care, treatment, dispensing, follow-up, education, supply, or supervision for uncomplicated malaria.
- Works exclusively in a setting outside the protocol-defined eligible settings.
- Limited or no involvement in antimalarial stocking decisions where this is required for the role.
- Currently employed by a pharmaceutical company outside clinical-trial work.
- Unable to participate in an applicable study language.
- Unwilling or unable to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
About this study
Official title: An Analysis of Multilevel Influences on the Adoption of a Novel Malaria Treatment in Côte d'Ivoire, Ghana, and Rwanda: A Qualitative Study Including Patients, Caregivers, and Healthcare Providers
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.
Read the detailed description
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.
- Conditions
- Malaria
- Keywords
- Antimalarial Drug Resistance, Malaria, Uncomplicated malaria, Antimalarial treatment, Treatment adoption, Treatment acceptability, Treatment adherence, Treatment-seeking behavior, Implementation science, Qualitative research, Healthcare providers, Community health workers, Patients, Caregivers, Consolidated framework for implementation research (CFIR), Capability, Opportunity, Motivation-Behavioral model (COM-B), Côte d'Ivoire, Ghana, Rwanda
- Medical subject headings
- Malaria, Treatment Adherence and Compliance, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Adult and adolescent patients | 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. | |
| Group 2: Caregivers of children and younger adolescents | 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. | |
| Group 3: Healthcare providers | 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. | |
| Group 4: Pharmacists and other antimalarial dispensers | 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. | |
| Group 5: Community health workers and related community health personnel | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the one-time interview, lasting approximately 75 minutes
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the one-time interview, lasting approximately 75 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896746
- Sponsor's protocol ID
- CKLU156A12001
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of Multilevel Influences on the Adoption of a Novel Malaria Treatment in Côte d'Ivoire, Ghana, and Rwanda: A Qualitative Study Including Patients, Caregivers, and Healthcare Providers
- ClinicalTrials.gov ID
- NCT07896746
- Acronym / sponsor ID
- CKLU156A12001
- Conditions
- Malaria
- Keywords
- Antimalarial Drug Resistance, Malaria, Uncomplicated malaria, Antimalarial treatment, Treatment adoption, Treatment acceptability, Treatment adherence, Treatment-seeking behavior
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1: Adult and adolescent patients | – | –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. |
| Group 2: Caregivers of children and younger adolescents | – | –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. |
| Group 3: Healthcare providers | – | –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. |
| Group 4: Pharmacists and other antimalarial dispensers | – | –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. |
| Group 5: Community health workers and related community health personnel | – | –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. |
Who may qualify
- Ages
- 10 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (32 listed)
- Patients:
- Caregivers:
- Healthcare providers:
- Community health personnel:
Key exclusion criteria (18 listed)
- Patients and caregivers:
- Healthcare providers and community health personnel:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Multilevel Barriers and Facilitators Influencing Adoption of a Novel Malaria Treatment
Time frame: At the one-time interview, lasting approximately 75 minutes
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.
5 secondary outcomes
Barriers and Facilitators Affecting Treatment-Seeking Behavior
Time frame: At the one-time interview, lasting approximately 75 minutes.
Factors Affecting Acceptability of a Novel Malaria Treatment
Time frame: At the one-time interview, lasting approximately 75 minutes.
Barriers and Facilitators Affecting Malaria Treatment Adherence
Time frame: At the one-time interview, lasting approximately 75 minutes.
Factors Affecting Provider Prescribing and Treatment-Support Practices
Time frame: At the one-time interview, lasting approximately 75 minutes.
Implementation Options to Support Adoption of a Novel Malaria Treatment
Time frame: At the one-time interview, lasting approximately 75 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multilevel Barriers and Facilitators Influencing Adoption of a Novel Malaria Treatment (time frame: At the one-time interview, lasting approximately 75 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.