Skip to main content
OpenTrials
Active, not recruiting

NCT Number: NCT07756528

Stakeholder-Informed RSV Prevention Economic Model 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:

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

RSV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Botswana Harvard Health Partnership

Gaborone, Botswana

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Stakeholder-rated quality of engagement

    Time frame: July 1, 2026 to December 30, 2027

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Botswana Harvard AIDS Institute Partnership

Registry information

Official study title

Developing a Stakeholder-informed Health Economic Model to Assess the Costs and Benefits of RSV Monoclonal Antibody Implementation for Infants in Botswana

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.