Postpartum HPV Vaccination

Study Overview
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Brief Summary
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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.

Official Title
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Postpartum HPV Vaccination: Acceptability, Uptake and Immunogenicity

Conditions
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HPV-Related Malignancy

Intervention / Treatment
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* Drug: Gardasil9


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gardasil9<br> | Drug: Gardasil9<br>* Gardasil 9<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Indication of Willingness to Accept the Vaccine Based on Survey | This was established using a survey to indicate willingness to receive vaccine. | 1 day (at the time of initial recruitment /survey) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of the Vaccine Doses | Those that actually received the vaccine and each time point. | at baseline | 
| Uptake of the Vaccine Doses | Those that actually received the vaccine and each time point. | at 3 months | 
| Uptake of the Vaccine Doses | Those that actually received the vaccine and each time point. | at 6 months | 
| Serum Titers of Vaccine-specific HPV Types | Immunogenicity | baseline and 7 months |