Clinical trial · Interventional
Integrating Primary & Secondary Interventions for Cervical Cancer Prevention in Primary Care Settings
A Single-arm Proof of Concept, Open Trial Clinical Study Investigating the Feasibility and Efficacy of Integrating Behavioral and Mobile Health Educational Interventions for Primary and Secondary Prevention in the Primary Care Setting
- 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)
The purpose of this study is to determine whether a mobile health educational intervention for Human PapillomaVirus (HPV) Vaccination promotion and cervical cancer screening in Primary Care settings is a feasible behavioral intervention to integrate as a primary and secondary cervical cancer prevention approach.Study Design: The investigators will conduct an open feasibility proof-of-concept trial using a single experimental group with all subjects receiving the behavioral intervention being studied. Outcome measures. The primary outcome of interest is receipt of the first dose and completion of the three-dose series of HPV vaccine within 6 month of intervention, this will be evaluated by Electronic medical review review.
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 |
|---|---|---|---|
| HPV-Related Carcinoma | Human Papillomavirus-Related Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brief negotiated mobile application | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single
- description
- single arm- behavioral educational intervention of a brief negotiated mobile application
- interventionNames
- Behavioral: brief negotiated mobile application
Primary outcomes (1)
- measure
- Number of participants who received the first dose and completed the vaccine series as measured electronic medical record review
- timeFrame
- up to 6 months
- description
- The primary outcome of interest is receipt of the first dose and completion of the three or two-dose series of HPV vaccine by participants within 6 month of intervention, this will be evaluated by Electronic Measure Review. Unit of measure: Number of participants who received the first doses and who competed the total number of does based - recorded as percentage who receive the first dose, and completed the two or 3 doses.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 9 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * AFG ages 30 years and older who receive primary care at the study sites. * AFG consent to have cervical cancer screening status checked in Electronic Medical Record. * AFG has a daughter between the ages of 11 to 17 who receive primary care at either * Family Medicine or Pediatric and Adolescent primary care clinic at Boston Medical Center. * AFG consent to have daughter's HPV vaccination status checked in Electronic Medical Record. * AFG's daughter has neither initiated the HPV vaccine nor completed the three vaccine series * AFG and daughter have the ability to read and write in English. * AFG and daughter each have a cell phone with text messages capabilities. Exclusion Criteria: * The investigators will exclude based on the following criteria: * AFG being seen for a sick visit. * AFG has an adolescent daughter who is pregnant or is a mother. * AFG has a daughter who has completed the three dose HPV vaccine series. * AFG, in the opinion of the clinical staff, is cognitively impaired and unable to give informed consent and may not participate.
References
Publications (0)
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