Clinical Trials Logo

Clinical Trial Summary

Infections with human papillomavirus (HPV) can cause cancer of the cervix, vagina, anus, throat, mouth, and penis. Prevention of these HPV-related cancers could be achieved by immunization with the nonavalent (HPV6,11,16,18,31,33,45,52,58) vaccine currently commercially available. However, in the U.S. approximately only 30% of females and 20% of males in the recommended age group receive the complete, three-dose HPV vaccine. Furthermore, data from the Los Angeles county suggest that HPV vaccination rates among these groups are lower than the national average. Significant barriers clearly remain including knowledge of the vaccine, transportation, number of doses and concern of side effects. Several programs worldwide have shown that schools remain an important venue for education as well as vaccination. In the US, vaccination within schools remains difficult because of many barriers including lack of nursing, insurance reimbursement, and liability. However, the school remains an important access to educational formats. The objective of this study is to evaluate the effectiveness of educational sessions on the HPV vaccine among parents with children of vaccination age as a strategy to increase HPV vaccine uptake, by comparing HPV vaccination rates before and after the intervention. It is hypothesized HPV vaccine uptake will improve through the receipt of educational sessions to the parents of middle school children about the importance of the anti-cancer vaccine, the HPV vaccine. Three schools within Cedars-Sinai catchment area with whom Cedars-Sinai already has a Memorandum of Understanding in place: Berendo, Drew, and Carver Middle Schools in Los Angeles (SPA 4, SPA 6) will be recruited to the study. HPV vaccination rates will be compared before and after the intervention at the end of the observation period (12 months).


Clinical Trial Description

Rationale and Significance

Infections with human papillomavirus (HPV) can cause cancer of the cervix, vagina, anus, throat, mouth, and penis. Prevention of these HPV-related cancers could be achieved by immunization with the nonavalent (HPV6,11,16,18,31,33,45,52,58) vaccine currently commercially available. However, in the U.S. approximately only 30% of females and 20% of males in the recommended age group receive the complete, three-dose HPV vaccine. The vaccine is covered under Vaccine for Children Program so the underinsured and uninsured have access. Furthermore, data from the Los Angeles county suggest that HPV vaccination rates among these groups are lower than the national average. Significant barriers clearly remain including knowledge of the vaccine, transportation, number of doses and concern of side effects. Several programs worldwide have shown that schools remain an important venue for education as well as vaccination. In the US, vaccination within schools remains difficult because of many barriers including lack of nursing, insurance reimbursement, and liability. However, the school remain an important access to educational formats. Barriers associated with the HPV vaccine uptake is the initial stigmatizing information created by anti-vaccine groups, providers not recommending the vaccine and not understanding the cancer prevention strategies (i.e. getting vaccination prior to exposure).

Barriers to HPV vaccination

Although the US has invested in a large national effort toward improvement of HPV vaccination rates, little progress has been achieved since 2006. While financial access should not be a barrier to vaccination for most children, some insurance plans do not cover vaccines. Several factors appear to influence vaccination rates: a) limited understanding of HPV and HPV-related diseases by parents and patients; b) parental safety concerns about the vaccine; c) provider discomfort talking about sexual behavior; d) providers lack of time for discussions about the vaccine; e) parental perception that there is no clear recommendation from a health care provider; f) parental belief that son or daughter is too young for the vaccine because they are not sexually active; and g) provider concern that there is lack of adequate reimbursement. In LA County, lack of knowledge that a cancer vaccine exists, lack of transportation, and fear of immigration status disclosure are further barriers to vaccination.

We hypothesize HPV vaccine uptake will be improved through the receipt of educational sessions to the parents of middle school children about the importance of the anti-cancer vaccine, the HPV vaccine.

Such sessions will increase knowledge about HPV vaccine availability, as well as improve the perceptions around HPV vaccination. Vaccination rates are lower in the Service Planning areas (SPA) 4 and 6 compared to SAP 5 (West LA).

Primary Objectives

To evaluate the ability of educational sessions about the HPV vaccine to increase HPV vaccine uptake, by comparing HPV vaccination rates before and after the intervention.

Endpoints

The primary outcome will be HPV vaccination rates. Vaccination rates will be compared between before (baseline) and after the intervention at the end of the observation period (12 months). We expect to find higher HPV vaccine rates after the intervention.

Study Design

We will recruit 3 schools within Cedars-Sinai catchment area with whom Cedars-Sinai already has a Memorandum of Understanding in place: Berendo, Drew, and Carver Middle Schools in Los Angeles (SPA 4, SPA 6). These MOUs were obtained through the Cedars-Sinai Coach-for Kids Program Director, Michele Rigsby-Pauley, a co-investigator in this study. We will first conduct focus group interviews with parents to learn about parents' concerns about the HPV vaccine and to identify important messages for parents. These would also include strategies for dissemination of information (PTA meetings, text messages to parents, online education). HPV vaccination rates will be compared before and after the intervention at the end of the observation period (12 months). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03953911
Study type Interventional
Source Cedars-Sinai Medical Center
Contact Charlene Chang, MA, MPH
Phone 6266899335
Email charlenechang@mednet.ucla.edu
Status Not yet recruiting
Phase Early Phase 1
Start date May 28, 2019
Completion date June 30, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT05329961 - Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old, An Exploratory Immunogenicity Study Early Phase 1
Completed NCT05862844 - Promise Women Project N/A
Active, not recruiting NCT04199078 - Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions. N/A
Recruiting NCT05566106 - Anal Follow-up of Patients With a Gynecological History of High-grade Lesion and More Induced HPV
Not yet recruiting NCT06436274 - Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV. Phase 4
Not yet recruiting NCT06229353 - Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department
Completed NCT01757392 - Candin Safety & Efficacy Study for the Treatment of Warts Phase 2
Active, not recruiting NCT04716127 - A Proximity-incentive Strategy for Cervical Cancer Screening N/A
Recruiting NCT05210348 - Clinical Evaluation of Detection of High Risk HPV in Urine
Recruiting NCT05835947 - Anal Cancer Risk In Women
Not yet recruiting NCT03947775 - HPV-SAVE_Merck_Sub-Study for Preventing Recurrence of HSIL Phase 2
Terminated NCT03404310 - Zinc Sulfate for Human Papillomavirus (HPV) N/A
Recruiting NCT03302858 - A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRXâ„¢ Anorectal Wand Phase 2
Completed NCT03082950 - HPV Infections, Cancer of the Vulva and Therapeutical Success
Active, not recruiting NCT04950101 - Prevalence of Anal High-risk Human Papilloma Virus Infection and Abnormal Anal Cytology in Men Who Have Sex With Men Using Pre Exposure Prophylaxis N/A
Recruiting NCT05146895 - A Cohort Study of Hyperthermia and Imiquimod for the Treatment of Flat Warts N/A
Completed NCT04002154 - Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV N/A
Recruiting NCT04232917 - Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections. Phase 4
Active, not recruiting NCT03729518 - TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck N/A
Recruiting NCT05640700 - Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia