RSVNCT07756528
Stakeholder-Informed RSV Prevention Economic Model in Botswana
An observational study of RSV, run by University of California, San Diego at 1 site in Botswana.
Trial summary
The goal of this mixed methods study is to engage stakeholders to develop a health economic model to estimate the costs, health benefits, and value of respiratory syncytial virus (RSV) prevention strategies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- RSV
- How many people
- 40 participants
- Where
- 1 siteBotswana
- Study dates
- 1 Jul 2026to 30 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will establish a 20-member stakeholder advisory board representing policymakers (n=5), funders (n=3), healthcare providers (n=5), researchers (n=2), and leaders representing patient groups (n=5).
Who may be able to join
- Expertise or Role:
- Policymakers: Currently employed in or recently retired from a government health agency, Ministry of Health, or other institution with responsibility for health policy, immunization, or maternal/child health.
- Funders: Employed by or affiliated with an organization that funds health services, immunization programs, or health research in Botswana or the region.
- Healthcare providers: Licensed clinicians (e.g., pediatricians, nurses, midwives) with direct experience delivering maternal or child health services in Botswana.
- Researchers: Active or recent experience in health economics, public health, or RSV-related research, with relevance to LMICs.
- Patient representatives: Affiliated with or leading a civil society or patient advocacy organization focused on child health, immunization, or health equity in Botswana.
- Geographic Relevance: Based in Botswana or with demonstrated experience working within Botswana's health system or policy landscape.
- Language: Comfortable speaking and reading English or Setswana.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Stakeholder-informed Health Economic Model to Assess the Costs and Benefits of RSV Monoclonal Antibody Implementation for Infants in Botswana
The goal of this mixed methods study is to engage stakeholders to develop a health economic model to estimate the costs, health benefits, and value of respiratory syncytial virus (RSV) prevention strategies. The model will help decision-makers in Botswana determine whether and how to introduce RSV prevention interventions for infants, including monoclonal antibodies.
The main questions the study aims to answer are:
Read more
How could RSV prevention strategies be delivered to infants in Botswana?
What costs, health benefits, and implementation factors should be included in a health economic model?
What information do policymakers, healthcare providers, funders, researchers, and other stakeholders need to make decisions about RSV prevention?
Participants will include key stakeholders involved in health policy, clinical care, financing, research, and child health in Botswana. Participants may be asked to complete an interview, take part in a stakeholder workshop, complete a survey, and help review or interpret model findings. The study will not test an RSV product in infants or provide medical treatment.
Read the detailed description
This mixed-methods observational study will develop a stakeholder-informed health economic model to evaluate potential respiratory syncytial virus (RSV) prevention strategies for infants in Botswana, including RSV monoclonal antibodies. The study will not administer an RSV prevention product to infants or assign participants to a medical intervention.
The study will engage policymakers, healthcare providers, funders, researchers, and patient representatives to identify the information needed to support decision-making about RSV prevention in Botswana. Study activities will include stakeholder advisory group meetings, semi-structured interviews, a structured stakeholder workshop, surveys, and model review activities.
Stakeholder input will be used to define key features of the health economic model, including target populations, delivery settings, implementation strategies, time horizon, costs, health outcomes, equity considerations, and uncertainty analyses. The model will estimate the potential cost-effectiveness and budget impact of RSV monoclonal antibody implementation among infants in Botswana, including strategies for all eligible infants and for higher-risk groups such as infants born preterm, infants exposed to HIV, and infants born during RSV season.
The study will also evaluate the stakeholder engagement process. Stakeholder advisory group members will be asked about their experiences participating in model development and their perceptions of whether the final model is relevant, usable, credible, and helpful for country-level decision-making. Findings will be used to refine the model and develop materials to support future stakeholder-engaged health economic modeling in Botswana and similar settings.
- Conditions
- RSV
- Keywords
- Respiratory syncytial virus, RSV monoclonal antibody, Health economic model, Budget impact, Cost-effectiveness, Stakeholder engagement, Decision analysis
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 |
|---|---|---|
| Stakeholder group representing policymakers, healthcare providers, researchers, funders, an | Up to 40 stakeholders will participate in an interview and up to 20 will participate in a workshop on health economic modeling and a pre/post survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of a stakeholder-informed health economic model to evaluate RSV prevention strategies for infants in Botswana.
Model completion will be measured as the number of pre-specified model development milestones completed. Milestones include: finalizing the model structure; identifying and documenting model input parameters; programming the model; conducting internal model checks; generating base-case results; conducting sensitivity analyses; reviewing model assumptions and preliminary results with stakeholders; and producing final model outputs for dissemination.
Measured: July 1, 2026 to December 30, 2027
Secondary outcomes (1)
Stakeholder-rated quality of engagement
Stakeholder engagement will be assessed using a survey adapted from established engagement domains, including respect, trust, legitimacy, fairness, competence, and accountability. Participants involved in workshops and model-development activities will be asked to rate the extent to which the engagement process was inclusive, transparent, respectful, and useful for shaping the health economic model and its outputs.
Measured: July 1, 2026 to December 30, 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Jul 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSVStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Botswana Harvard AIDS Institute Partnership
- Responsible party
- Principal investigator, Adriane Wynn, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756528
- Sponsor's protocol ID
- 814288
- Other IDs
- 318586-00001
- Status last verified
- Jul 2026
- First submitted
- 6 Aug 2026
- Last updated
- 10 Aug 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Stakeholder-informed Health Economic Model to Assess the Costs and Benefits of RSV Monoclonal Antibody Implementation for Infants in Botswana
- ClinicalTrials.gov ID
- NCT07756528
- Acronym / sponsor ID
- 814288
- Conditions
- RSV
- Keywords
- Respiratory syncytial virus, RSV monoclonal antibody, Health economic model, Budget impact, Cost-effectiveness, Stakeholder engagement, Decision analysis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Botswana Harvard AIDS Institute Partnership
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 10 Aug 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.
The goal of this mixed methods study is to engage stakeholders to develop a health economic model to estimate the costs, health benefits, and value of respiratory syncytial virus (RSV) prevention strategies. The model will help decision-makers in Botswana determine whether and how to introduce RSV prevention interventions for infants, including monoclonal antibodies.
The main questions the study aims to answer are:
How could RSV prevention strategies be delivered to infants in Botswana?
What costs, health benefits, and implementation factors should be included in a health economic model?
What information do policymakers, healthcare providers, funders, researchers, and other stakeholders need to make decisions about RSV prevention?
Participants will include key stakeholders involved in health policy, clinical care, financing, research, and child health in Botswana. Participants may be asked to complete an interview, take part in a stakeholder workshop, complete a survey, and help review or interpret model findings. The study will not test an RSV product in infants or provide medical treatment.
Detailed description
This mixed-methods observational study will develop a stakeholder-informed health economic model to evaluate potential respiratory syncytial virus (RSV) prevention strategies for infants in Botswana, including RSV monoclonal antibodies. The study will not administer an RSV prevention product to infants or assign participants to a medical intervention.
The study will engage policymakers, healthcare providers, funders, researchers, and patient representatives to identify the information needed to support decision-making about RSV prevention in Botswana. Study activities will include stakeholder advisory group meetings, semi-structured interviews, a structured stakeholder workshop, surveys, and model review activities.
Stakeholder input will be used to define key features of the health economic model, including target populations, delivery settings, implementation strategies, time horizon, costs, health outcomes, equity considerations, and uncertainty analyses. The model will estimate the potential cost-effectiveness and budget impact of RSV monoclonal antibody implementation among infants in Botswana, including strategies for all eligible infants and for higher-risk groups such as infants born preterm, infants exposed to HIV, and infants born during RSV season.
The study will also evaluate the stakeholder engagement process. Stakeholder advisory group members will be asked about their experiences participating in model development and their perceptions of whether the final model is relevant, usable, credible, and helpful for country-level decision-making. Findings will be used to refine the model and develop materials to support future stakeholder-engaged health economic modeling in Botswana and similar settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stakeholder group representing policymakers, healthcare providers, researchers, funders, an | – | –Up to 40 stakeholders will participate in an interview and up to 20 will participate in a workshop on health economic modeling and a pre/post survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will establish a 20-member stakeholder advisory board representing policymakers (n=5), funders (n=3), healthcare providers (n=5), researchers (n=2), and leaders representing patient groups (n=5).
Key inclusion criteria (8 listed)
- Expertise or Role:
- Geographic Relevance: Based in Botswana or with demonstrated experience working within Botswana's health system or policy landscape.
- Language: Comfortable speaking and reading English or Setswana.
Key exclusion criteria (0 listed)
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
Completion of a stakeholder-informed health economic model to evaluate RSV prevention strategies for infants in Botswana.
Time frame: July 1, 2026 to December 30, 2027
Model completion will be measured as the number of pre-specified model development milestones completed. Milestones include: finalizing the model structure; identifying and documenting model input parameters; programming the model; conducting internal model checks; generating base-case results; conducting sensitivity analyses; reviewing model assumptions and preliminary results with stakeholders; and producing final model outputs for dissemination.
1 secondary outcome
Stakeholder-rated quality of engagement
Time frame: July 1, 2026 to December 30, 2027
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 10 Aug 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RSV, run by University of California, San Diego at 1 site in Botswana.
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 8 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of a stakeholder-informed health economic model to evaluate RSV prevention strategies for infants in Botswana. (time frame: July 1, 2026 to December 30, 2027). 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 10 Aug 2026.