NCT03972813

Optimizing HPV Vaccine Introduction in Shanghai, China

Terminated NA Results posted Last updated 15 January 2025

What this trial tests

NA trial testing Broadened information about cancers in Vaccine Refusal in 1,021 participants. Terminated before completion.

Timeline

28 May 2019

Primary endpoint
31 August 2019

31 August 2019

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	prevention
Enrollment	1,021
Start date	28 May 2019
Primary completion	31 August 2019
Estimated completion	31 August 2019
Sites	1 location across China

Drugs / interventions tested

• Broadened information about cancers
• Information about STDs
• Information about infectious disease
• Recommendation for children 12 years old
• Recommendation for children 18 years old
• Standard age information
• Cervical cancer
• Blank information about communicability

Conditions studied

• Vaccine Refusal — all drugs for Vaccine Refusal →

Sponsor

University of Michigan

Who can join

18 and older, any sex, with Vaccine Refusal. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it Primary · same day as intervention

Immediately after the experimental component, parents will respond to the question "If you had a daughter, how willing would you be to give your daughter an HPV vaccine at 12 years of age?" This will be assessed on a 5-point scale from "not at all willing" (1) to "very willing" (5). The proportion of parents who select "somewhat" (4) or "very willing" (5) will be tallied as the primary outcome measure.

Group	Value	95% CI
Cervical Cancer - Sexually Transmitted (STD) - Standard	46
Cervical Cancer - STD - 12 Years Old (y.o.)	31
Cervical Cancer - STD - 18 y.o.	29
Cervical Cancer - Infectious - Standard	21
Cervical Cancer - Infectious - 12 y.o.	28
Cervical Cancer - Infectious - 18 y.o.	26
Cervical Cancer - Blank - Standard	28
Cervical Cancer - Blank - 12 y.o.	23
Cervical Cancer - Blank - 18 y.o.	31
Many Cancers - STD - Standard	35
Many Cancers - STD - 12 y.o.	33
Many Cancers - STD - 18 y.o.	27

Sponsor's own description

Within low, middle, and upper income countries, low vaccine coverage results from both obstacles to vaccine access and low confidence in vaccine programs. Thus, it is critical to determine how best to enhance trust in vaccines as increasing numbers of vaccines are recommended for use. Even though the context accompanying the initial roll-out of a vaccine can have a large impact on people's perceptions of the vaccine and the corresponding disease, it is not clear how to best introduce a vaccine to increase public confidence and enhance uptake. The US roll-out of the human papillomavirus (HPV) vaccine framed HPV as a sexually transmitted infection, which proved to be an impediment to efforts to increase vaccine uptake \>10 years after its introduction. This study will use an educational experiment, where parents of children will be exposed to information about the HPV vaccination in different ways. Parents will be introduced to the HPV vaccine through different scenarios with varying emphases (i.e., age at vaccination, types of transmission, type of cancer prevention). The aim will be to determine how the framing of the HPV vaccination across several dimensions affects short-term willingness to receive it.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of the framing of HPV vaccination on parents' willingness to accept an HPV vaccine.
   Huang Z, Ji M, Ren J, Sun X, et al · · 2022 · cited 7× · PMID 34996644 · DOI 10.1016/j.vaccine.2021.12.051