Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to help people who have missed their regular cervical cancer screening. The investigators are evaluating whether mailing an HPV self-sampling kit to participant home makes it easier and more convenient for people to get screened for cervical cancer. This study will also help to understand if people find this process acceptable and whether it is an effective way to improve screening rates.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Pap Smear | Active Comparator | Participants will have the option to choose a standard pap smear for cervical cancer screening |
|
| HPV Self-Sampling Test | Experimental | Participants are able to opt-in for an at-home self-sampling HPV test for cervical cancer screening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BD Onclarity HPV test | Diagnostic Test | Self-collected cervicovaginal sample |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of CC screening within 6 months of initial outreach. | Defined as either (a) return of a valid HPV self-sample kit to the processing laboratory, or (b) attendance for a clinic-based Pap test documented in the medical record. | Outcome will be measured at 6 months post-initial outreach call. |
| Measure | Description | Time Frame |
|---|---|---|
| Screening Pathway Choices and Performance | Proportion of participants selecting self-sampling vs clinic-based Pap test (percentage of women choosing each modality after initial outreach) | From enrollment to the end of participation at 9 months |
| Screening Pathway Choices and Performance |
| Measure | Description | Time Frame |
|---|---|---|
| Reach and Adoption | Proportion of eligible participants successfully contacted and offered the intervention. | From enrollment to the end of participation at 9 months |
| Reach and Adoption | Participant acceptance vs refusal rates, stratified by screening modality. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Tergas, MD, MPH | Contact | 973-972-5055 | ana.tergas@rutgers.edu | |
| Yenny Tavarez, MPH | Contact | yenny.tavarez@rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ana Tergas, MD, MPH | Rutgers, The State University of New Jersey | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will have the option to op-in for an at-home HPV sampling test or receive a standard pap smear.
Not provided
Not provided
Not provided
Not provided
| Standard Pap Smear |
| Diagnostic Test |
Healthcare provider collected (in a hospital or clinical setting) cervicovaginal sample |
|
Timeliness of screening completion (measured as days from outreach to Pap attendance or kit return). |
| From enrollment to the end of participation at 9 months |
| Screening Pathway Choices and Performance | Screening test result distribution (categorized as negative, positive, or inadequate, stratified by modality). | From enrollment to the end of participation at 9 months |
| Screening Pathway Choices and Performance | HPV genotype distribution among positive samples (individual and group reporting per lab protocol) | From enrollment to the end of participation at 9 months |
| Clinical Follow-Up and Downstream Outcomes | Clinical follow-up completion after abnormal results (attendance at colposcopy or initiation of treatment). | From enrollment to the end of participation at 9 months |
| Clinical Follow-Up and Downstream Outcomes | Detection of histologically confirmed cervical intraepithelial neoplasia grade 2 or higher (CIN2+) or invasive cervical cancer. | From enrollment to the end of participation at 9 months |
| Clinical Follow-Up and Downstream Outcomes | Treatment initiation and completion rates among those diagnosed with CIN2+ or cancer. | From enrollment to the end of participation at 9 months |
| Exploratory and Patient-Reported Outcomes | Associations between demographic/clinical factors and screening completion (e.g., race/ethnicity, insurance status, education, prior screening history). | From enrollment to the end of participation at 9 months |
| Exploratory and Patient-Reported Outcomes | Patient-reported experiences including satisfaction, ease of kit use, clarity of instructions, stress/anxiety during self-sampling, trust in results, and willingness to undergo self-sampling in future screening. | From enrollment to the end of participation at 9 months |
| From enrollment to the end of participation at 9 months |
| Reach and Adoption | Equity assessment: Differences in screening uptake across demographic and socioeconomic subgroups. | From enrollment to the end of participation at 9 months |
| Feasibility and Fidelity | Return rate of mailed self-sampling kits (valid, invalid, and late returns). | From enrollment to the end of participation at 9 months |
| Feasibility and Fidelity | Proportion requiring replacement kits. | From enrollment to the end of participation at 9 months |
| Feasibility and Fidelity | Staff adherence to outreach protocol (number, spacing, and mode of call attempts and reminders per protocol). | From enrollment to the end of participation at 9 months |
| Acceptability and Sustainability | Barriers and facilitators to participation identified via telephone structured surveys. | From enrollment to the end of participation at 9 months |
| Acceptability and Sustainability | Acceptability of self-sampling as routine care (participant endorsement of future use of mail-based HPV kits). | From enrollment to the end of participation at 9 months |
| Acceptability and Sustainability | Institutional ability to sustain or scale implementation strategies (assessed through staff feedback and system-level considerations). | From enrollment to the end of participation at 9 months |