Clinical trial · Interventional
An Intervention Promoting HPV Vaccination in Safety-net Clinics
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized controlled trial is designed to evaluate whether a behavioral intervention that includes three components: 1) reminder letters and education materials delivered before the clinic visit, 2) telephone recalls after the visit for those who originally decline the vaccine, and 3) telephone reminders for those who miss the 2nd and/or 3rd doses, increases 1 and 3 dose coverage of the human papillomavirus (HPV) vaccine series among adolescent girls attending four Parkland primary care clinics in Dallas county. Hypothesis 1: Investigators expect higher 1 dose HPV vaccine coverage among patients in the Intervention group than those in the General Adolescent Vaccine Brochure group. Hypothesis 2: Investigators expect significantly higher 1 dose HPV vaccine coverage among patients in the Intervention group who initially declined the vaccine than those in the General Adolescent Vaccine Brochure group who initially declined. Hypothesis 3: Investigators expect significantly higher 3 dose HPV vaccine coverage among the Intervention group than those in the General Adolescent Vaccine Brochure group.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papilloma Virus-Related Cervical Carcinoma | Human Papillomavirus-Related Cervical Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| General Adolescent Vaccine Brochure | Behavioral | — | UNRESOLVED |
| HPV brochure, recall, reminders | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- General Adolescent Vaccine Brochure
- description
- Participants were mailed a brochure describing the 4 recommended adolescent vaccines (HPV, meningococcal, tetanus diptheria acellular pertussis (TDAP), and influenza) 1-2 weeks before a clinic visit
- interventionNames
- Behavioral: General Adolescent Vaccine Brochure
- type
- EXPERIMENTAL
- label
- HPV brochure, recall, reminders
- description
- * HPV-vaccine specific brochure mailed before clinic visit * Telephone recalls after visit for those who complete pre-clinic survey and decline the vaccine * Telephone reminders for those who complete the pre-clinic survey and are late for receiving the 2nd and/or 3 doses
- interventionNames
- Behavioral: HPV brochure, recall, reminders
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 11 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 11-18 year old female patients and their parent * Patient has an upcoming appointment at one of four Parkland clinics * Patient has not initiated the HPV vaccine series Exclusion Criteria: * Adolescent patient was currently pregnant * Parent Participated in Phase 1 Cognitive Interviews * Sibling already enrolled in study * Parent opted out or was not interested in the study * Parent did not have a working address
References
Publications (1)
- DERIVEDTiro JA, Sanders JM, Pruitt SL, Stevens CF, Skinner CS, Bishop WP, Fuller S, Persaud D. Promoting HPV Vaccination in Safety-Net Clinics: A Randomized Trial. Pediatrics. 2015 Nov;136(5):850-9. doi: 10.1542/peds.2015-1563. Epub 2015 Oct 19. PMID 26482674