NCT07756528

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
17mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jul 2026Dec 2027

Study Start

First participant enrolled

July 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

August 10, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

August 6, 2026

Last Update Submit

August 6, 2026

Conditions

Keywords

Respiratory syncytial virusRSV monoclonal antibodyHealth economic modelBudget impactCost-effectivenessStakeholder engagementDecision analysis

Outcome Measures

Primary Outcomes (1)

  • 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.

    July 1, 2026 to December 30, 2027

Secondary Outcomes (1)

  • Stakeholder-rated quality of engagement

    July 1, 2026 to December 30, 2027

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Botswana Harvard Health Partnership

Gaborone, Gaborone, Botswana

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 10, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

August 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations