Stakeholder-Informed RSV Prevention Economic Model in Botswana

N/AActive Not RecruitingNCT07756528

University of California, San Diego40 enrolled

Overview

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.

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria 1. Expertise or Role: 1. 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. 2. Funders: Employed by or affiliated with an organization that funds health services, immunization programs, or health research in Botswana or the region. 3. Healthcare providers: Licensed clinicians (e.g., pediatricians, nurses, midwives) with direct experience delivering maternal or child health services in Botswana. 4. Researchers: Active or recent experience in health economics, public health, or RSV-related research, with relevance to LMICs. 5. Patient representatives: Affiliated with or leading a civil society or patient advocacy organization focused on child health, immunization, or health equity in Botswana. 2. Geographic Relevance: Based in Botswana or with demonstrated experience working within Botswana's health system or policy landscape. 3. Language: Comfortable speaking and reading English or Setswana.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.