Cervical Carcinoma, Human Papillomavirus Infection
Conditions
Brief summary
This trial studies how well a multilevel human papillomavirus (HPV) self-testing intervention works in increasing cervical cancer screening among women in Appalachia. Most cases of cervical cancer occur among unscreened and underscreened women. A multilevel HPV self-testing intervention may help to improve cervical cancer screening rates.
Detailed description
PRIMARY OBJECTIVES: Determine the effectiveness of the intervention in increasing cervical cancer screening. OUTLINE: Participants are randomized to 1 of 2 groups. GROUP I: Participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive telephone-based patient navigation. GROUP II: Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.
Interventions
OTHERBest Practice
Receive usual care
PROCEDUREHPV Self-Collection
Receive HPV self-testing intervention
OTHERInformational Intervention
Receive information about cervical cancer
BEHAVIORALPatient Navigation Program
Receive telephone-based patient navigation
Sponsors
National Cancer Institute (NCI)
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Not within recommended cervical cancer screening guidelines for women in this age range (i.e., no Papanicolaou \[Pap\] test in last 3 years or no Pap test plus clinic-based HPV test in last 5 years) * Resident of an Appalachian county * Not currently pregnant * Intact cervix * No history of invasive cervical cancer * Seen in a participating clinic/health system in last 2 years (i.e., active patient) * Have a working telephone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Human Papillomavirus (HPV) Intervention | Up to 1 years | The patient-level effectiveness will be whether or not women get screened during the project. Will examine the proportion of women screened, and use an intent-to-treat approach. To compare treatment groups (Group 1 versus Group 2), will use generalized linear mixed models (GLMMs) to account for the correlation between women from the same health system. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group I (Intervention) Participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive patient navigation.
HPV Self-Collection: Receive HPV self-testing intervention
Informational Intervention: Receive information about cervical cancer
Patient Navigation Program: Receive patient navigation | 464 |
| Group II (Usual Care Continued) Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.
Best Practice: Receive usual care
Informational Intervention: Receive information about cervical cancer | 338 |
| Total | 802 |
Baseline characteristics
| Characteristic | Group II (Usual Care Continued) | Total | Group I (Intervention) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 338 Participants | 802 Participants | 464 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 338 participants | 802 participants | 464 participants |
| Sex: Female, Male Female | 338 Participants | 802 Participants | 464 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 464 | 0 / 338 |
| other Total, other adverse events | 0 / 464 | 0 / 338 |
| serious Total, serious adverse events | 0 / 464 | 0 / 338 |
Outcome results
Primary
Effectiveness of Human Papillomavirus (HPV) Intervention
The patient-level effectiveness will be whether or not women get screened during the project. Will examine the proportion of women screened, and use an intent-to-treat approach. To compare treatment groups (Group 1 versus Group 2), will use generalized linear mixed models (GLMMs) to account for the correlation between women from the same health system.
Time frame: Up to 1 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group I (Intervention) | Effectiveness of Human Papillomavirus (HPV) Intervention | 69 Participants |
| Group II (Usual Care Continued) | Effectiveness of Human Papillomavirus (HPV) Intervention | 17 Participants |