Cervical Cancer, Human Papillomavirus Infection
Conditions
Keywords
Screening, Human Papillomavirus Infection, Self-Testing
Brief summary
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women. This study evaluates if mailing and testing self-sampled kits for high-risk human papillomavirus (HPV) can cost-effectively increase screening participation among underserved minority women in a safety-net health system.
Detailed description
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women. Using mailed self-sampling kits to test for high-risk human papillomavirus (HPV), the virus that causes cervical cancer, may overcome multiple barriers to clinic-based screening. This study is a randomized controlled trial to compare the effectiveness of three outreach interventions to increase primary screening participation and clinical follow-up among underscreened women a in a safety net health system. The three strategies that will be evaluated are: 1) telephone recall; 2) telephone recall with mailed self-sample HPV testing kits; and 3) telephone recall with mailed self-sample HPV testing kits and patient navigation.
Interventions
BEHAVIORALTelephone Recall
Participants receive a scripted telephone recall from a trained patient navigator.
BEHAVIORALMailed HPV Self-Sampling Kit
Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.
BEHAVIORALPatient Navigation
Participant receives telephone call from patient navigator within 3-5 days of receipt of self-collection kit. Patient navigator provides one-on-one education on cervical cancer screening and self-collection of cervical sample.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* no history of hysterectomy or cervical cancer * no Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years * patient of Harris Health System in Harris County (Houston), Texas * have at least 2 visits to ambulatory care within Harris Health System in the past 5 years * be currently enrolled in a healthcare coverage or financial assistance plan accepted by Harris Health System or have been enrolled in a Harris Health coverage plan in the past 12 months
Exclusion criteria
* no valid telephone contact information * unable to communicate in English or Spanish\* * currently pregnant * history of cervical dysplasia in the past 3.5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Screening Participation | within 6 months of randomization | cervical cancer screening participation within 6 months, defined as return of a mailed HPV self-collection kit or attendance for clinic-based screening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Screening Tests Results | within 6 months of randomization | Results of HPV test using self-collected samples (positive, negative, or inadequate) |
| Completion of Clinical Follow-up Among Women With an Abnormal Screening Test Result | Attendance to clinical follow up was assessed within 12 months of screening test result, up to 18 months post randomization. | Electronic medical record (EMR)-confirmed attendance for colposcopy among participants who had a positive test by clinic-based screening; EMR- confirmed attendance for colposcopy or subsequent clinic-based screening among those who had a positive test by self-sampling |
Countries
United States
Participant flow
Recruitment details
Trial enrollment began February 20,2020, then paused March 27, 2020, due to clinic closures and restrictions on human participant research following the declaration of the COVID-19 pandemic. Trial enrollment resumed August 3,2020 and continued through August 31, 2023.
Participants by arm
| Arm | Count |
|---|---|
| Telephone Recall Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System.
Telephone Recall: Participants receive a scripted telephone recall from a trained patient navigator. | 828 |
| Mailed HPV Self-Sampling Kit Participants receive a scripted telephone recall from a patient navigator on behalf of Harris Health System and receive a mailed HPV self-sampling kit with a pre-paid return envelope.
Telephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.
Mailed HPV Self-Sampling Kit: Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing. | 828 |
| Mailed HPV Self-Sampling Kit + Patient Navigation Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education.
Telephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.
Mailed HPV Self-Sampling Kit: Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.
Patient Navigation: Participant receives telephone call from patient navigator within 3-5 days of receipt of self-collection kit. Patient navigator provides one-on-one education on cervical cancer screening and self-collection of cervical sample. | 818 |
| Total | 2,474 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Terminated phone call early | 7 | 0 | 0 |
| Overall Study | Terminated phone call early or requested to not receive a kit | 0 | 91 | 103 |
Baseline characteristics
| Characteristic | Telephone Recall | Mailed HPV Self-Sampling Kit | Mailed HPV Self-Sampling Kit + Patient Navigation | Total |
|---|---|---|---|---|
| Age, Continuous | 48 Years | 49 Years | 48 Years | 49 Years |
| Race/Ethnicity, Customized Hispanic or Latino | 578 Participants | 548 Participants | 529 Participants | 1655 Participants |
| Race/Ethnicity, Customized Non-Hispanic Asian | 27 Participants | 29 Participants | 26 Participants | 82 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black or African American | 163 Participants | 173 Participants | 199 Participants | 535 Participants |
| Race/Ethnicity, Customized Non-Hispanic Other or Unknown | 10 Participants | 21 Participants | 22 Participants | 53 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 50 Participants | 57 Participants | 42 Participants | 149 Participants |
| Region of Enrollment United States | 828 participants | 828 participants | 818 participants | 2474 participants |
| Sex: Female, Male Female | 828 Participants | 828 Participants | 818 Participants | 2474 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Type of health care coverage Medicaid | 60 Participants | 69 Participants | 74 Participants | 203 Participants |
| Type of health care coverage Medicare | 27 Participants | 30 Participants | 23 Participants | 80 Participants |
| Type of health care coverage Other | 19 Participants | 22 Participants | 25 Participants | 66 Participants |
| Type of health care coverage Private insurance | 246 Participants | 246 Participants | 245 Participants | 737 Participants |
| Type of health care coverage Publicly funded financial assistance plan | 476 Participants | 461 Participants | 451 Participants | 1388 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 828 | 0 / 828 | 0 / 818 |
| other Total, other adverse events | 0 / 828 | 0 / 828 | 1 / 818 |
| serious Total, serious adverse events | 0 / 828 | 0 / 828 | 0 / 818 |
Outcome results
Primary
Primary Screening Participation
cervical cancer screening participation within 6 months, defined as return of a mailed HPV self-collection kit or attendance for clinic-based screening.
Time frame: within 6 months of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telephone Recall | Primary Screening Participation | 144 Participants |
| Mailed HPV Self-Sampling Kit | Primary Screening Participation | 340 Participants |
| Mailed HPV Self-Sampling Kit + Patient Navigation | Primary Screening Participation | 381 Participants |
Comparison: Bivariable tables, Pearson chi-square and Kruskal-Wallis nonparametric tests were used to compare demographic/health care characteristics by study group. Log binomial regression was used to calculate screening proportion, participation difference, and relative participation (calculated as relative risk), with 95% CIs. Overall participation difference and relative participation for SC and SC with patient navigation vs TR were calculated by combining numerators and denominators from each group.95% CI: [1.99, 2.8]
Secondary
Completion of Clinical Follow-up Among Women With an Abnormal Screening Test Result
Electronic medical record (EMR)-confirmed attendance for colposcopy among participants who had a positive test by clinic-based screening; EMR- confirmed attendance for colposcopy or subsequent clinic-based screening among those who had a positive test by self-sampling
Time frame: Attendance to clinical follow up was assessed within 12 months of screening test result, up to 18 months post randomization.
Population: Participants with an abnormal screening result, including those received from a clinic-based screening or mailed HPV self-sampling kit.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Telephone Recall | Completion of Clinical Follow-up Among Women With an Abnormal Screening Test Result | Attended follow up | 2 Participants |
| Telephone Recall | Completion of Clinical Follow-up Among Women With an Abnormal Screening Test Result | Did not attend follow up | 4 Participants |
| Mailed HPV Self-Sampling Kit | Completion of Clinical Follow-up Among Women With an Abnormal Screening Test Result | Attended follow up | 22 Participants |
| Mailed HPV Self-Sampling Kit | Completion of Clinical Follow-up Among Women With an Abnormal Screening Test Result | Did not attend follow up | 14 Participants |
| Mailed HPV Self-Sampling Kit + Patient Navigation | Completion of Clinical Follow-up Among Women With an Abnormal Screening Test Result | Attended follow up | 33 Participants |
| Mailed HPV Self-Sampling Kit + Patient Navigation | Completion of Clinical Follow-up Among Women With an Abnormal Screening Test Result | Did not attend follow up | 15 Participants |
Secondary
Screening Tests Results
Results of HPV test using self-collected samples (positive, negative, or inadequate)
Time frame: within 6 months of randomization
Population: Participated in cervical cancer screening
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Telephone Recall | Screening Tests Results | Negative | 138 Participants |
| Telephone Recall | Screening Tests Results | Positive | 6 Participants |
| Telephone Recall | Screening Tests Results | Inadequate | 0 Participants |
| Mailed HPV Self-Sampling Kit | Screening Tests Results | Negative | 288 Participants |
| Mailed HPV Self-Sampling Kit | Screening Tests Results | Positive | 38 Participants |
| Mailed HPV Self-Sampling Kit | Screening Tests Results | Inadequate | 14 Participants |
| Mailed HPV Self-Sampling Kit + Patient Navigation | Screening Tests Results | Positive | 49 Participants |
| Mailed HPV Self-Sampling Kit + Patient Navigation | Screening Tests Results | Inadequate | 20 Participants |
| Mailed HPV Self-Sampling Kit + Patient Navigation | Screening Tests Results | Negative | 312 Participants |