RSV ImmunizationNCT07856290
Artificial Intelligence-assisted Primary Care for RSV Prevention (AIPC-RSV) in China
A study testing RSV AI-assisted primary care intervention in people with RSV Immunization, run by Fudan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- RSV Immunization
- What is being tested?
- RSV AI-assisted primary care intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Artificial Intelligence-assisted Primary Care for RSV Prevention (AIPC-RSV) in China: A Randomized Trial and Implementation Study
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:
Read more
- 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?
- Is the AI-assisted primary care intervention acceptable, feasible, and potentially sustainable for RSV prevention?
- 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:
- 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.
- 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.
- Have their infants' RSV mAb uptake assessed at the end of the trial.
Read the detailed description
A randomized controlled trial will be conducted to evaluate the effectiveness of an AI-assisted primary care intervention to improve RSV mAb uptake among infants in China, with additional health economic and implementation evaluation to assess its cost-effectiveness and potential for scale-up.
The sample size calculation is based on the primary outcome measure (RSV mAb uptake rate) and the main analysis method (comparison of rates between two groups). Based on literature review and survey, the current RSV mAb uptake rate among infants is estimated to be approximately 10%. We assume that the uptake rate could increase to 15% following the intervention. Using the formula for comparing two independent proportions, the minimum required sample size is calculated to be 683 participants in each group, with a significance level (α) of 0.05 and a statistical power (1-β) of 0.80. To account for potential loss to follow-up, assuming a 10% loss to follow-up rate, each group will include 750 participants, with a total sample size of 1,500.
A randomized controlled design will be employed across China. Eligible parents of infants who provide written informed consent will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. The randomization sequence will be generated in advance by a statistician using a computer-generated random number method. At each study site, participants will be allocated sequentially according to their order of enrolment. Due to the nature of intervention, blinding of participants and on-site intervention implementers is not feasible. Local coordinators, outcome assessors, data managers, and statistical analysts will remain blinded to group allocation throughout the study to minimize assessment and analysis bias.
Building on the evaluation of intervention effectiveness, we will conduct a health economic evaluation to assess the economic value of the RSV AI-assisted primary care intervention. In addition, an implementation science study guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) will assess the real-world implementation of the RSV AI-assisted primary care intervention for RSV prevention.
Statistical Analysis
- Primary Outcome Analysis An intention-to-treat (ITT) approach will be used as the primary analysis strategy, with all randomly assigned participants analyzed according to their original group allocation. Between-group comparisons will be performed using t-tests for continuous variables and chi-square tests for categorical variables. The primary outcome is RSV mAb uptake among the infants of study participants within one and three months after the intervention. A log-binomial regression model will be used to estimate the relative risk (RR) and its 95% confidence interval (95% CI), with CHCs included as a fixed effect and adjustment for prespecified covariates. If the log-binomial model fails to converge, a modified Poisson regression model will be used instead. The adjusted absolute risk difference and its 95% CI will also be estimated from the regression model to evaluate the public health significance of the intervention. Prespecified covariates will include region, infants (sex, age in months, and singleton status) and their parents (parenthood, age, education level, occupation, enrollment in employee basic medical insurance, and household income). Pre-specified subgroup analyses will be conducted by including subgroup variables and their interaction terms with the intervention group in the primary analysis model, to assess heterogeneity of intervention effects across participant characteristics. Prespecified subgroups will include region, infants (sex, age in months, and singleton status) and their parents (parenthood, age, education level, occupation, enrollment in employee basic medical insurance, and household income).
- Secondary Outcomes Analysis Secondary outcomes include time to RSV mAb uptake among the infants of parents within three months following the intervention; parental perceived risk of RSV disease; parental RSV prevention literacy; parental confidence in RSV mAb; and willingness to use RSV mAb for their infants. Time-to-event analyses for time to RSV mAb uptake will be conducted using Kaplan-Meier methods and compared between groups with the log-rank test. Cox proportional hazards models will be used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs). Perceived risk of RSV disease, RSV mAb confidence, and willingness to use RSV mAb will be analyzed as binary outcomes using the same log-binomial or modified Poisson regression models as for the primary outcome, accounting for CHCs effects. Results will be reported as relative risks (RRs) and 95% CIs. RSV prevention literacy will be analyzed as a continuous outcome using linear regression models, accounting for CHC effects. Intervention effects will be estimated after adjustment for prespecified covariates, with results reported as adjusted mean differences (aMDs) and 95% CIs. Prespecified subgroup analyses will be performed by including subgroup variables and their interaction terms with intervention assignment in the analysis models to assess heterogeneity of intervention effects across participant characteristics. Prespecified subgroups will include region, infants (sex, age in months, and singleton status) and their parents (parenthood, age, education level, occupation, enrollment in employee basic medical insurance, and household income).
- Sensitivity Analysis A per-protocol (PP) analysis will be conducted as a sensitivity analysis to assess the robustness of the primary findings. The PP analysis will include intervention-group participants who complete the prescribed AI assisted primary care intervention, as well as participants in the control group. In addition, within the intervention group, intervention engagement will be assessed on the basis of AI assistant usage and physician recommendation. Participants will be categorized into high- and low-engagement groups. Differences in intervention effects between these engagement levels will then be compared to assess the association between intervention intensity and RSV mAb uptake.
- Conditions
- RSV Immunization
- Being tested
- RSV AI-assisted primary care intervention
- Keywords
- RSV, monoclonal antibodies (mAb), infants, AI assistant, randomized controlled trial, implementation science
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV AI-assisted primary care interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
RSV mAb uptake
Whether eligible infants receive RSV monoclonal antibody (mAb) during the study period, measured by official vaccination records.
Measured: Within one and three months after the intervention initiation
Secondary outcomes (5)
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.
Measured: 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. It is a binary variable and categorized as intended or unintended.
Measured: 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. It is a binary variable and categorized as high or low risk perception.
Measured: 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).
Measured: The same day after the intervention initiation
Confidence in RSV mAb
Parents' confidence in the importance, effectiveness, and safety of RSV monoclonal antibody (mAb), assessed by questionnaire. It is a binary variable and categorized as high or low confidence.
Measured: The same day after the intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start2 Oct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for RSV ImmunizationStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Zhiyuan Hou, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856290
- Sponsor's protocol ID
- Fudan AIPC-RSV chatbot
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant privacy concerns and institutional data protection policies.
Publications
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.
PubMed 39424963Passanante 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.
PubMed 37788057Cosma 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.
PubMed 39615346Hou 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.
PubMed 40195450Li 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.
PubMed 37146391Wang 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.
PubMed 38369712Ernst 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.
PubMed 38275017Lopez-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.
PubMed 38333937Jimeno 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.
PubMed 39460326Li 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.
PubMed 42022153Committee 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.
PubMed 40826311Li 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.
PubMed 35598608
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-assisted Primary Care for RSV Prevention (AIPC-RSV) in China: A Randomized Trial and Implementation Study
- ClinicalTrials.gov ID
- NCT07856290
- Acronym / sponsor ID
- Fudan AIPC-RSV chatbot
- Conditions
- RSV Immunization
- Keywords
- RSV, monoclonal antibodies (mAb), infants, AI assistant, randomized controlled trial, implementation science
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 2 Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- Is the AI-assisted primary care intervention acceptable, feasible, and potentially sustainable for RSV prevention?
- 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:
- 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.
- 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.
- Have their infants' RSV mAb uptake assessed at the end of the trial.
Detailed description
A randomized controlled trial will be conducted to evaluate the effectiveness of an AI-assisted primary care intervention to improve RSV mAb uptake among infants in China, with additional health economic and implementation evaluation to assess its cost-effectiveness and potential for scale-up.
The sample size calculation is based on the primary outcome measure (RSV mAb uptake rate) and the main analysis method (comparison of rates between two groups). Based on literature review and survey, the current RSV mAb uptake rate among infants is estimated to be approximately 10%. We assume that the uptake rate could increase to 15% following the intervention. Using the formula for comparing two independent proportions, the minimum required sample size is calculated to be 683 participants in each group, with a significance level (α) of 0.05 and a statistical power (1-β) of 0.80. To account for potential loss to follow-up, assuming a 10% loss to follow-up rate, each group will include 750 participants, with a total sample size of 1,500.
A randomized controlled design will be employed across China. Eligible parents of infants who provide written informed consent will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. The randomization sequence will be generated in advance by a statistician using a computer-generated random number method. At each study site, participants will be allocated sequentially according to their order of enrolment. Due to the nature of intervention, blinding of participants and on-site intervention implementers is not feasible. Local coordinators, outcome assessors, data managers, and statistical analysts will remain blinded to group allocation throughout the study to minimize assessment and analysis bias.
Building on the evaluation of intervention effectiveness, we will conduct a health economic evaluation to assess the economic value of the RSV AI-assisted primary care intervention. In addition, an implementation science study guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) will assess the real-world implementation of the RSV AI-assisted primary care intervention for RSV prevention.
Statistical Analysis
- Primary Outcome Analysis An intention-to-treat (ITT) approach will be used as the primary analysis strategy, with all randomly assigned participants analyzed according to their original group allocation. Between-group comparisons will be performed using t-tests for continuous variables and chi-square tests for categorical variables. The primary outcome is RSV mAb uptake among the infants of study participants within one and three months after the intervention. A log-binomial regression model will be used to estimate the relative risk (RR) and its 95% confidence interval (95% CI), with CHCs included as a fixed effect and adjustment for prespecified covariates. If the log-binomial model fails to converge, a modified Poisson regression model will be used instead. The adjusted absolute risk difference and its 95% CI will also be estimated from the regression model to evaluate the public health significance of the intervention. Prespecified covariates will include region, infants (sex, age in months, and singleton status) and their parents (parenthood, age, education level, occupation, enrollment in employee basic medical insurance, and household income). Pre-specified subgroup analyses will be conducted by including subgroup variables and their interaction terms with the intervention group in the primary analysis model, to assess heterogeneity of intervention effects across participant characteristics. Prespecified subgroups will include region, infants (sex, age in months, and singleton status) and their parents (parenthood, age, education level, occupation, enrollment in employee basic medical insurance, and household income).
- Secondary Outcomes Analysis Secondary outcomes include time to RSV mAb uptake among the infants of parents within three months following the intervention; parental perceived risk of RSV disease; parental RSV prevention literacy; parental confidence in RSV mAb; and willingness to use RSV mAb for their infants. Time-to-event analyses for time to RSV mAb uptake will be conducted using Kaplan-Meier methods and compared between groups with the log-rank test. Cox proportional hazards models will be used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs). Perceived risk of RSV disease, RSV mAb confidence, and willingness to use RSV mAb will be analyzed as binary outcomes using the same log-binomial or modified Poisson regression models as for the primary outcome, accounting for CHCs effects. Results will be reported as relative risks (RRs) and 95% CIs. RSV prevention literacy will be analyzed as a continuous outcome using linear regression models, accounting for CHC effects. Intervention effects will be estimated after adjustment for prespecified covariates, with results reported as adjusted mean differences (aMDs) and 95% CIs. Prespecified subgroup analyses will be performed by including subgroup variables and their interaction terms with intervention assignment in the analysis models to assess heterogeneity of intervention effects across participant characteristics. Prespecified subgroups will include region, infants (sex, age in months, and singleton status) and their parents (parenthood, age, education level, occupation, enrollment in employee basic medical insurance, and household income).
- Sensitivity Analysis A per-protocol (PP) analysis will be conducted as a sensitivity analysis to assess the robustness of the primary findings. The PP analysis will include intervention-group participants who complete the prescribed AI assisted primary care intervention, as well as participants in the control group. In addition, within the intervention group, intervention engagement will be assessed on the basis of AI assistant usage and physician recommendation. Participants will be categorized into high- and low-engagement groups. Differences in intervention effects between these engagement levels will then be compared to assess the association between intervention intensity and RSV mAb uptake.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSV AI-assisted primary care Intervention Group | Experimental | Behavioral: RSV AI-assisted primary care interventionPrimary 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. |
| 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. |
Who may qualify
- Ages
- 0 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSV AI-assisted primary care interventionPrimary 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. | Behavioural | RSV AI-assisted primary care Intervention Group |
Primary outcome
RSV mAb uptake
Time frame: Within one and three months after the intervention initiation
Whether eligible infants receive RSV monoclonal antibody (mAb) during the study period, measured by official vaccination records.
5 secondary outcomes
Time to RSV mAb uptake
Time frame: Within three months after the intervention initiation
Intention to Use RSV mAb
Time frame: The same day after the intervention initiation
Risk Perception on RSV Disease
Time frame: The same day after the intervention initiation
RSV prevention literacy
Time frame: The same day after the intervention initiation
Confidence in RSV mAb
Time frame: The same day after the intervention initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 39424963Brown 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.
- Background: PubMed 37788057Passanante 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.
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- Individual participant dataSharing planned: No. Individual participant data will not be shared due to participant privacy concerns and institutional data protection policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing RSV AI-assisted primary care intervention in people with RSV Immunization, run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiyuan Hou, PhD (86+21 54231112, zyhou@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RSV mAb uptake (time frame: Within one and three months after the intervention initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07856290, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.