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

NCT07856290 | Not Yet Recruiting DMC

• 1 other identifier: Fudan AIPC-RSV chatbot
• Study Type: interventional
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 2.Is the AI-assisted primary care intervention acceptable, feasible, and potentially sustainable for RSV prevention?
3. 3.Is the AI-assisted primary care intervention cost-effective compared with conventional health education, and what factors may facilitate or hinder its implementation?
4. 4.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.
5. 5.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.
6. 6.Have their infants' RSV mAb uptake assessed at the end of the trial.

Conditions

RSV Immunization

Keywords

RSV; monoclonal antibodies (mAb); infants; AI assistant; randomized controlled trial; implementation science

Outcome Measures

Primary Outcomes (1)

• RSV mAb uptake

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

  Within one and three months after the intervention initiation

Secondary Outcomes (5)

• Time to RSV mAb uptake

  Within three months after the intervention initiation

• Intention to Use RSV mAb

  The same day after the intervention initiation

• Risk Perception on RSV Disease

  The same day after the intervention initiation

• RSV prevention literacy

  The same day after the intervention initiation

• Confidence in RSV mAb

  The same day after the intervention initiation

Other Outcomes (2)

• Usability of AI-assisted primary care intervention

  The same day after the intervention initiation

• Cost of AI-assisted primary care intervention

  Within three months after the intervention initiation

Study Arms (2)

RSV AI-assisted primary care Intervention Group

EXPERIMENTAL

Primary care physicians will provide brief health education to parents of infants on RSV prevention and will recommend the use of the RSV AI assistant via an educational pamphlet. Participants will interact with the AI assistant on site 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. Participants who do not complete mAb injection on site will subsequently receive phone reminders to schedule an appointment and complete injection. In addition, primary care physicians will establish WeChat groups to deliver intervention reinforcement. Brief health-education information cards with access links to the AI assistant will be sent to participants on the day of the intervention and at two weeks, one month, and two months thereafter as reminders.

Behavioral: RSV AI-assisted primary care intervention

Control Group

NO INTERVENTION

Participants will receive only routine health education without additional intervention. After completion of the study, access to the RSV AI assistant will be made available to participants in the control group.

Interventions

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.

RSV AI-assisted primary care Intervention Group

Eligibility Criteria

• Age: 0 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead
• Sanofi: collaborator

Related Publications (12)

• Brown D, Barrera A, Ibanez L, Budassi I, Murphy B, Shrestha P, Salomon-Ballada S, Kriscovich J, Torrente F. A behaviourally informed chatbot increases vaccination rates in Argentina more than a one-way reminder. Nat Hum Behav. 2024 Dec;8(12):2314-2321. doi: 10.1038/s41562-024-01985-7. Epub 2024 Oct 18.

  PMID: 39424963 BACKGROUND

• Passanante A, Pertwee E, Lin L, Lee KY, Wu JT, Larson HJ. Conversational AI and Vaccine Communication: Systematic Review of the Evidence. J Med Internet Res. 2023 Oct 3;25:e42758. doi: 10.2196/42758.

  PMID: 37788057 BACKGROUND

• Cosma C, Radi A, Cattano R, Zanobini P, Bonaccorsi G, Lorini C, Del Riccio M. Exploring Chatbot contributions to enhancing vaccine literacy and uptake: A scoping review of the literature. Vaccine. 2025 Jan 12;44:126559. doi: 10.1016/j.vaccine.2024.126559. Epub 2024 Nov 30.

  PMID: 39615346 BACKGROUND

• Hou Z, Wu Z, Qu Z, Gong L, Peng H, Jit M, Larson HJ, Wu JT, Lin L. A vaccine chatbot intervention for parents to improve HPV vaccination uptake among middle school girls: a cluster randomized trial. Nat Med. 2025 Jun;31(6):1855-1862. doi: 10.1038/s41591-025-03618-6. Epub 2025 Apr 7.

  PMID: 40195450 BACKGROUND

• Li Y, Liang S, Zhu B, Liu X, Li J, Chen D, Qin J, Bressington D. Feasibility and effectiveness of artificial intelligence-driven conversational agents in healthcare interventions: A systematic review of randomized controlled trials. Int J Nurs Stud. 2023 Jul;143:104494. doi: 10.1016/j.ijnurstu.2023.104494. Epub 2023 Apr 5.

  PMID: 37146391 BACKGROUND

• Wang Q, Xiu S, Yang L, Li L, Yang M, Wang X, Shen Y, Wang W, Lin L. Perceptions about respiratory syncytial virus (RSV) and attitudes toward the RSV vaccine among the general public in China: A cross-sectional survey. Hum Vaccin Immunother. 2024 Dec 31;20(1):2310916. doi: 10.1080/21645515.2024.2310916. Epub 2024 Feb 18.

  PMID: 38369712 BACKGROUND

• Ernst C, Bejko D, Gaasch L, Hannelas E, Kahn I, Pierron C, Del Lero N, Schalbar C, Do Carmo E, Kohnen M, Andlauer E, Hublart P, Masi S, de la Fuente Garcia I, Vergison A, Mossong J. Impact of nirsevimab prophylaxis on paediatric respiratory syncytial virus (RSV)-related hospitalisations during the initial 2023/24 season in Luxembourg. Euro Surveill. 2024 Jan;29(4):2400033. doi: 10.2807/1560-7917.ES.2024.29.4.2400033.

  PMID: 38275017 BACKGROUND

• Lopez-Lacort M, Munoz-Quiles C, Mira-Iglesias A, Lopez-Labrador FX, Mengual-Chulia B, Fernandez-Garcia C, Carballido-Fernandez M, Pineda-Caplliure A, Mollar-Maseres J, Shalabi Benavent M, Sanz-Herrero F, Zornoza-Moreno M, Perez-Martin JJ, Alfayate-Miguelez S, Perez Crespo R, Bastida Sanchez E, Menasalvas-Ruiz AI, Tellez-Gonzalez MC, Esquiva Soto S, Del Toro Saravia C, Sanz-Munoz I, Eiros JM, Matias Del Pozo V, Toquero-Asensi M, Pastor-Villalba E, Lluch-Rodrigo JA, Diez-Domingo J, Orrico-Sanchez A. Early estimates of nirsevimab immunoprophylaxis effectiveness against hospital admission for respiratory syncytial virus lower respiratory tract infections in infants, Spain, October 2023 to January 2024. Euro Surveill. 2024 Feb;29(6):2400046. doi: 10.2807/1560-7917.ES.2024.29.6.2400046.

  PMID: 38333937 BACKGROUND

• Jimeno Ruiz S, Pelaez A, Labourt A, Acuna FM, Linares L, Llana Martin I, Calle Gomez A, Martinez SN. Evaluating the Effectiveness of Nirsevimab in Reducing Pediatric RSV Hospitalizations in Spain. Vaccines (Basel). 2024 Oct 11;12(10):1160. doi: 10.3390/vaccines12101160.

  PMID: 39460326 BACKGROUND

• Li J, Suo L, Wei L, Cao Z, Lu F, Xu H, Luo J, Shen Y, Gao P, Wu D, Feng Z, Yu R, Guo M, Wang Q, Yang P. Real-world effectiveness of nirsevimab against RSV hospitalisation in infants during a season with low coverage and delayed circulation in Beijing, China: a population-based retrospective cohort study. Lancet Reg Health West Pac. 2026 Apr 17;69:101861. doi: 10.1016/j.lanwpc.2026.101861. eCollection 2026 Apr.

  PMID: 42022153 BACKGROUND

• Committee on Infectious Diseases. Recommendations for the Prevention of RSV Disease in Infants and Children: Policy Statement. Pediatrics. 2025 Nov 1;156(5):e2025073923. doi: 10.1542/peds.2025-073923. No abstract available.

  PMID: 40826311 BACKGROUND

• Li Y, Wang X, Blau DM, Caballero MT, Feikin DR, Gill CJ, Madhi SA, Omer SB, Simoes EAF, Campbell H, Pariente AB, Bardach D, Bassat Q, Casalegno JS, Chakhunashvili G, Crawford N, Danilenko D, Do LAH, Echavarria M, Gentile A, Gordon A, Heikkinen T, Huang QS, Jullien S, Krishnan A, Lopez EL, Markic J, Mira-Iglesias A, Moore HC, Moyes J, Mwananyanda L, Nokes DJ, Noordeen F, Obodai E, Palani N, Romero C, Salimi V, Satav A, Seo E, Shchomak Z, Singleton R, Stolyarov K, Stoszek SK, von Gottberg A, Wurzel D, Yoshida LM, Yung CF, Zar HJ; Respiratory Virus Global Epidemiology Network; Nair H; RESCEU investigators. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet. 2022 May 28;399(10340):2047-2064. doi: 10.1016/S0140-6736(22)00478-0. Epub 2022 May 19.

  PMID: 35598608 BACKGROUND

Central Study Contacts

Zhiyuan Hou, PhD

CONTACT

86+21 54231112; zyhou@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: October 2, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share