Postpartum HPV Vaccination: Acceptability, Uptake and Immunogenicity
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 195
- Locations
- 1
- Primary Endpoint
- Patient Indication of Willingness to Accept the Vaccine Based on Survey
Study Overview
Brief Summary
Human papillomavirus (HPV)-related cancers are on the rise in the United States. Furthermore, greater than 90% of cervical cancer cases are attributable to HPV, and cervical cancer disproportionately affects women of color in both incidence and mortality. Due to low HPV vaccine uptake in the US, innovative approaches to vaccinating vulnerable populations are necessary in order to maximize the cancer prevention potential of this vaccine. The puerperium is a time period when women are engaged in the healthcare system and have almost universal access to affordable health care. Two prior studies have shown that postpartum HPV vaccination is acceptable to patients, and high rates of vaccination were achieved in these primarily Hispanic populations. However, data show that the immune response in young women is less robust than in adolescents, and no studies have examined immunogenicity in postpartum women specifically. We propose an HPV vaccination pilot study in women who receive postpartum care at University of Alabama at Birmingham (UAB) hospital. We will examine the acceptability, uptake and immunogenicity of the vaccine in the postpartum setting.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 26 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •postpartum day 0-4 after vaginal or Cesarean delivery at UAB hospital
- •Exclusion criteria
- •Fetal demise or miscarriage, autoimmune disorder, HIV, Hepatitis B/C, chronic steroid use, preeclampsia, non-English speaking
Exclusion Criteria
- Not provided
Arms & Interventions
Gardasil9
Intervention: Gardasil9 (Drug)
Outcomes
Primary Outcomes
Patient Indication of Willingness to Accept the Vaccine Based on Survey
Time Frame: 1 day (at the time of initial recruitment /survey)
This was established using a survey to indicate willingness to receive vaccine.
Secondary Outcomes
- Serum Titers of Vaccine-specific HPV Types(baseline and 7 months)
- Uptake of the Vaccine Doses(at 6 months)
Investigators
Haller Smith
Professor
University of Alabama at Birmingham
