Trial Outcomes & Findings for Prospective Evaluation of Self-Testing to Increase Screening (NCT NCT03898167)
NCT ID: NCT03898167
Last Updated: 2025-09-04
Results Overview
cervical cancer screening participation within 6 months, defined as return of a mailed HPV self-collection kit or attendance for clinic-based screening.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2474 participants
Primary outcome timeframe
within 6 months of randomization
Results posted on
2025-09-04
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
828
|
828
|
818
|
|
Overall Study
COMPLETED
|
821
|
737
|
715
|
|
Overall Study
NOT COMPLETED
|
7
|
91
|
103
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
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
Prospective Evaluation of Self-Testing to Increase Screening
Baseline characteristics by cohort
| Measure |
Telephone Recall
n=828 Participants
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.
|
Mailed HPV Self-Sampling Kit
n=828 Participants
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.
|
Mailed HPV Self-Sampling Kit + Patient Navigation
n=818 Participants
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.
|
Total
n=2474 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48 Years
n=5 Participants
|
49 Years
n=7 Participants
|
48 Years
n=5 Participants
|
49 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
828 Participants
n=5 Participants
|
828 Participants
n=7 Participants
|
818 Participants
n=5 Participants
|
2474 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
578 Participants
n=5 Participants
|
548 Participants
n=7 Participants
|
529 Participants
n=5 Participants
|
1655 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Asian
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black or African American
|
163 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
535 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
50 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Other or Unknown
|
10 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
828 participants
n=5 Participants
|
828 participants
n=7 Participants
|
818 participants
n=5 Participants
|
2474 participants
n=4 Participants
|
|
Type of health care coverage
Private insurance
|
246 Participants
n=5 Participants
|
246 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
737 Participants
n=4 Participants
|
|
Type of health care coverage
Publicly funded financial assistance plan
|
476 Participants
n=5 Participants
|
461 Participants
n=7 Participants
|
451 Participants
n=5 Participants
|
1388 Participants
n=4 Participants
|
|
Type of health care coverage
Medicaid
|
60 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
203 Participants
n=4 Participants
|
|
Type of health care coverage
Medicare
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Type of health care coverage
Other
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: within 6 months of randomizationcervical cancer screening participation within 6 months, defined as return of a mailed HPV self-collection kit or attendance for clinic-based screening.
Outcome measures
| Measure |
Telephone Recall
n=828 Participants
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.
|
Mailed HPV Self-Sampling Kit
n=828 Participants
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.
|
Mailed HPV Self-Sampling Kit + Patient Navigation
n=818 Participants
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.
|
|---|---|---|---|
|
Primary Screening Participation
|
144 Participants
|
340 Participants
|
381 Participants
|
SECONDARY outcome
Timeframe: within 6 months of randomizationPopulation: Participated in cervical cancer screening
Results of HPV test using self-collected samples (positive, negative, or inadequate)
Outcome measures
| Measure |
Telephone Recall
n=144 Participants
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.
|
Mailed HPV Self-Sampling Kit
n=340 Participants
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.
|
Mailed HPV Self-Sampling Kit + Patient Navigation
n=381 Participants
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.
|
|---|---|---|---|
|
Screening Tests Results
Positive
|
6 Participants
|
38 Participants
|
49 Participants
|
|
Screening Tests Results
Negative
|
138 Participants
|
288 Participants
|
312 Participants
|
|
Screening Tests Results
Inadequate
|
0 Participants
|
14 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Telephone Recall
n=6 Participants
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.
|
Mailed HPV Self-Sampling Kit
n=36 Participants
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.
|
Mailed HPV Self-Sampling Kit + Patient Navigation
n=48 Participants
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.
|
|---|---|---|---|
|
Completion of Clinical Follow-up Among Women With an Abnormal Screening Test Result
Did not attend follow up
|
4 Participants
|
14 Participants
|
15 Participants
|
|
Completion of Clinical Follow-up Among Women With an Abnormal Screening Test Result
Attended follow up
|
2 Participants
|
22 Participants
|
33 Participants
|
Adverse Events
Telephone Recall
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mailed HPV Self-Sampling Kit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mailed HPV Self-Sampling Kit + Patient Navigation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Telephone Recall
n=828 participants at risk
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.
|
Mailed HPV Self-Sampling Kit
n=828 participants at risk
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.
|
Mailed HPV Self-Sampling Kit + Patient Navigation
n=818 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Pain
|
0.00%
0/828 • Within 6 months post randomization
Study participants were asked to report any adverse events during the use of the HPV self-collection kit. Reported AEs were assessed within 6 months of randomization.\*\* \*\*AEs are for when participants are "on treatment" so would have been within 6 months post randomization.
|
0.00%
0/828 • Within 6 months post randomization
Study participants were asked to report any adverse events during the use of the HPV self-collection kit. Reported AEs were assessed within 6 months of randomization.\*\* \*\*AEs are for when participants are "on treatment" so would have been within 6 months post randomization.
|
0.12%
1/818 • Number of events 1 • Within 6 months post randomization
Study participants were asked to report any adverse events during the use of the HPV self-collection kit. Reported AEs were assessed within 6 months of randomization.\*\* \*\*AEs are for when participants are "on treatment" so would have been within 6 months post randomization.
|
Additional Information
Dr. Jane Montealegre
The University of Texas MD Anderson Cancer Center
Phone: 713-792-0919
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place