Artificial Intelligence-assisted Primary Care for RSV Prevention (AIPC-RSV) in China

ConditionRSV Immunization

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age0-6

SponsorFudan University

About this trial

The goal of this clinical trial is to evaluate whether an AI-assisted primary care intervention for parents can increase RSV monoclonal antibody (mAb) uptake among infants, and to assess the cost-effectiveness and potential for implementing the intervention in routine primary care.

The main questions it aims to answer are:

1. Does the RSV AI-assisted primary care intervention increase parents' perceived risk of RSV disease, RSV prevention literacy, confidence in using RSV mAb, willingness to use RSV mAb for their infants, and RSV mAb uptake among infants? 2. Is the AI-assisted primary care intervention acceptable, feasible, and potentially sustainable for RSV prevention? 3. Is the AI-assisted primary care intervention cost-effective compared with conventional health education, and what factors may facilitate or hinder its implementation?

Researchers will compare parents of infants who receive the RSV AI-assisted primary care intervention with those who do not receive it to determine whether the intervention improves parents' literacy, confidence, and willingness to use RSV mAb and increases RSV mAb uptake among their infants.

Participants will:

1. Be recruited and randomly assigned to the intervention group or control group. Participants in the intervention group will have access to an AI assistant for RSV mAb-related health information and get a RSV mAb recommendation from primary care physicians, while participants in the control group will receive routine health education. 2. Complete a survey questionnaire assessing parents' perceived risk of RSV disease, RSV prevention literacy, confidence in using RSV mAb, and willingness to use RSV mAb for their infants. 3. Have their infants' RSV mAb uptake assessed at the end of the trial.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Infants born on or after May 1, 2026;

Infants who have not received RSV mAb and are eligible for RSV mAb administration;

Parents who have access to an electronic device that can be used to scan QR codes and are able to participate in the study activities;

Parents who provide written informed consent and voluntarily agree to participate in the study.

Disqualifiers

Infants born before May 1, 2026;

Infants who have already received RSV mAb or are not eligible for RSV mAb administration;

Parents who do not have access to an electronic device capable of scanning QR codes or who are unable to participate in the study activities;

Parents who do not provide written informed consent or do not voluntarily agree to participate in the study.

Trial design

Design model

Parallel

Treatments tested in this trial

RSV AI-assisted primary care intervention
Behavioral
Primary care physicians will provide brief health education to parents of infants on RSV prevention and will recommend the use of an AI-powered RSV Chatbot for at least 5 minutes. For those who are eligible and express willingness to use RSV mAb for their children, primary care physicians will assist with appointment scheduling and administration for RSV mAb. The AI-powered RSV Chatbot is designed to provide information and health education about RSV prevention. It is powered by large language models and is trained on an expert-validated knowledge base derived from authoritative sources such as the National Health Commission and China CDC to ensure accuracy. The chatbot engages users in interactive, conversational dialogue to answer questions and address concerns regarding RSV prevention. It is delivered via WeChat or a web browser for user access and offers both conversational and navigational interaction modes, supporting text and voice input.

Treatment groups

1,500 Participants

are divided into 2 treatment groups

Group A: RSV AI-assisted primary care Intervention GroupExperimental treatment 1 intervention

Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

RSV mAb uptake

Whether eligible infants receive RSV monoclonal antibody (mAb) during the study period, measured by official vaccination records.

Time frame

Within one and three months after the intervention initiation

Secondary outcomes

Time to RSV mAb uptake

Time from the intervention initiation to RSV mAb uptake among eligible infants, measured by official vaccination records. Unit of Measure: days.

Time frame

Within three months after the intervention initiation

Intention to Use RSV mAb

Whether a participant plan to use RSV mAb for his infants within the RSV season, assessed by questionnaire and categorized as intended or unintended.

Time frame

The same day after the intervention initiation

Risk Perception on RSV Disease

Perceived susceptibility to and severity of RSV disease among parents, assessed by questionnaire and categorized as high or low risk perception.

Time frame

The same day after the intervention initiation

RSV prevention literacy

Parents' RSV prevention literacy, assessed by the total number of correct answers on a series of questions about RSV and RSV monoclonal antibody (mAb).

Time frame

The same day after the intervention initiation

Other outcomes

Usability of AI-assisted primary care intervention

The usability of the AIPC intervention will be evaluated using a series of questions on its acceptability, feasibility, and sustainability, including AI chatbot and primary care physician recommendation. The Likert 5-point scale is used, with scores ranging from 1 to 5 on a scale of "completely disagree" to "completely agree". Higher scores indicating greater perceived usability of the AIPC intervention.

Time frame

The same day after the intervention initiation

Cost of AI-assisted primary care intervention

The cost of designing and implementing the RSV AI-assisted primary care intervention. Unit of Measure: Chinese Yuan (CNY).

Time frame

Within three months after the intervention initiation

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Sanofi

Collaborator

Source ClinicalTrials.gov

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