Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640868
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Promotion of RSV Immunization Through Multiple Efforts
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Sequential Multiple Assignment Randomized Trial for RSV Vaccine Uptake in Pregnancy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIME
Brief Summary:
Central hypothesis a multimodal approach is needed to enhance RSV vaccine uptake in pregnancy rather than the current standard of care that relies solely on physician recommendations at routine prenatal visits andor mass messaging to the public The investigators propose a pilot sequential multiple assignment randomized trial SMART to evaluate the effectiveness of a bundle of evidence-based and sequential strategies to test early 28-30 weeks gestation and late 34-36 weeks gestation efficacy to increase RSV vaccination during pregnancy
Detailed Description:
Respiratory syncytial virus RSV is the leading cause of hospitalization and death among infants Each year up to 80000 children are hospitalized due to RSV-associated lower respiratory tract infection with infants having the highest risk 50 of childhood deaths from RSV are in infants 6 months old 1 in every 28 deaths among children aged 28 days to 6 months are attributed to RSV Childhood RSV is also associated with long-term morbidity particularly a 12-fold higher risk of developing asthma RSV prevention strategies are urgently needed to protect young infants particularly given their vulnerable immunity at birth Passive immunity via transfer of IgG antibodies from immunized pregnant women offers an evidence-based solution and is endorsed by the American College of Obstetricians and Gynecologists and the Centers for Disease Control In 2023 the FDA approved the RSVpreF vaccine for use during 32-36 weeks of pregnancy to protect infants from RSV-associated respiratory infection
Despite the availability of the RSVpreF vaccine and formal guidelines recommending this vaccine in pregnancy during the 2023 RSV season RSV vaccine uptake among pregnant individuals at our center was astoundingly low In a review of 676 eligible patients less than 10 received the RSV vaccine Similar trends were seen with the COVID-19 and influenza vaccines in pregnancy where pregnant individuals were vaccinated at half of the rate of non-pregnant individuals General barriers and facilitators for antenatal vaccine uptake have been well studied and are centered on provider recommendation womens knowledge and beliefs about the safety of the vaccine and logistical barriers such as on site availability However a recent initiative to offer on-site COVID-19 vaccination at a high risk pregnancy clinic resulted in only a 3 uptake of the vaccine among eligible high-risk obstetric patients suggesting that vaccine hesitancy not availability is a critical driver of the low vaccination rates in this population Therefore novel and multiple interventions are needed to address patient motivation and hesitancy in addition to vaccine availability to optimize vaccine uptake in pregnancy
The central hypothesis is that a multimodal approach is needed to enhance RSVpreF vaccine uptake in pregnancy rather than the current standard of care that relies solely on physician recommendations at routine prenatal visits andor mass messaging to the public The investigators propose a pilot sequential multiple assignment randomized trial SMART to evaluate the effectiveness of a bundle of evidence-based and sequential strategies and test the following aims
Aim 1 Assess the effectiveness of early 28-30 week and low-intensity interventions to increase prenatal RSV vaccination uptake The investigators will compare vaccination uptake rates among pregnant patients 28-30 weeks gestation who are randomized to receive one of two low-intensity and universally acceptable interventions physician counseling at prenatal visits vs routine counseling patient visual aid administration Figure 1 The investigators hypothesize that the combination of a visual aid with routine counseling will increase vaccination uptake rates by 34 weeks gestation The investigators will explore whether demographic clinical or psychosocial factors modify the effects of each intervention
Aim 2 Assess the effectiveness of late 34-36 week higher-intensity interventions to increase prenatal RSV vaccination uptake for those who remain unvaccinated at 34 weeks gestation The investigators will compare vaccination uptake rates in patients who remain unvaccinated at 34 weeks between two higher-intensity interventions targeted patient phone calls encouraging vaccination versus individual physician reminders on the day of patient appointment The investigators hypothesize that targeted patient calls will result in the highest vaccination uptake rates due to prior literature supporting the efficacy of this intervention The investigators will explore whether demographic clinical or psychosocial factors modify the effects of each intervention
Despite the availability of the RSVpreF vaccine and formal guidelines recommending this vaccine in pregnancy during the 2023 RSV season RSV vaccine uptake among pregnant individuals at our center was astoundingly low In a review of 676 eligible patients less than 10 received the RSV vaccine Similar trends were seen with the COVID-19 and influenza vaccines in pregnancy where pregnant individuals were vaccinated at half of the rate of non-pregnant individuals General barriers and facilitators for antenatal vaccine uptake have been well studied and are centered on provider recommendation womens knowledge and beliefs about the safety of the vaccine and logistical barriers such as on site availability However a recent initiative to offer on-site COVID-19 vaccination at a high risk pregnancy clinic resulted in only a 3 uptake of the vaccine among eligible high-risk obstetric patients suggesting that vaccine hesitancy not availability is a critical driver of the low vaccination rates in this population Therefore novel and multiple interventions are needed to address patient motivation and hesitancy in addition to vaccine availability to optimize vaccine uptake in pregnancy
The central hypothesis is that a multimodal approach is needed to enhance RSVpreF vaccine uptake in pregnancy rather than the current standard of care that relies solely on physician recommendations at routine prenatal visits andor mass messaging to the public The investigators propose a pilot sequential multiple assignment randomized trial SMART to evaluate the effectiveness of a bundle of evidence-based and sequential strategies and test the following aims
Aim 1 Assess the effectiveness of early 28-30 week and low-intensity interventions to increase prenatal RSV vaccination uptake The investigators will compare vaccination uptake rates among pregnant patients 28-30 weeks gestation who are randomized to receive one of two low-intensity and universally acceptable interventions physician counseling at prenatal visits vs routine counseling patient visual aid administration Figure 1 The investigators hypothesize that the combination of a visual aid with routine counseling will increase vaccination uptake rates by 34 weeks gestation The investigators will explore whether demographic clinical or psychosocial factors modify the effects of each intervention
Aim 2 Assess the effectiveness of late 34-36 week higher-intensity interventions to increase prenatal RSV vaccination uptake for those who remain unvaccinated at 34 weeks gestation The investigators will compare vaccination uptake rates in patients who remain unvaccinated at 34 weeks between two higher-intensity interventions targeted patient phone calls encouraging vaccination versus individual physician reminders on the day of patient appointment The investigators hypothesize that targeted patient calls will result in the highest vaccination uptake rates due to prior literature supporting the efficacy of this intervention The investigators will explore whether demographic clinical or psychosocial factors modify the effects of each intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None