Prospective Evaluation of Self-Testing to Increase Screening | NCT03898167

ID	Type	Description	Link
R01MD013715	U.S. NIH Grant/Contract		View source
R01MD013715-04S2	U.S. NIH Grant/Contract		View source

Prospective Evaluation of Self-Testing to Increase Screening | NCT03898167 | Trialant

Sponsor/Collaborators Module

Name	Class
National Institute on Minority Health and Health Disparities (NIMHD)	NIH

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Telephone Recall	Active Comparator	Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System.	Behavioral: Telephone Recall
Mailed HPV Self-Sampling Kit	Experimental	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.	Behavioral: Telephone Recall Behavioral: Mailed HPV Self-Sampling Kit
Mailed HPV Self-Sampling Kit + Patient Navigation	Experimental	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.	Behavioral: Telephone Recall Behavioral: Mailed HPV Self-Sampling Kit Behavioral: Patient Navigation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Telephone Recall	Behavioral	Participants receive a scripted telephone recall from a trained patient navigator.	Mailed HPV Self-Sampling Kit Mailed HPV Self-Sampling Kit + Patient Navigation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	within 6 months of randomization

Secondary Outcomes

Measure	Description	Time Frame
Screening Tests Results	Results of HPV test using self-collected samples (positive, negative, or inadequate)	within 6 months of randomization
Completion of Clinical Follow-up Among Women With an Abnormal Screening Test Result

Contacts/Locations Module

Name	Affiliation	Role
Jane R Montealegre, PhD	M.D. Anderson Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Harris Health System		Houston	Texas	77030	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33087164	Background	Montealegre JR, Anderson ML, Hilsenbeck SG, Chiao EY, Cantor SB, Parker SL, Daheri M, Bulsara S, Escobar B, Deshmukh AA, Jibaja-Weiss ML, Zare M, Scheurer ME. Mailed self-sample HPV testing kits to improve cervical cancer screening in a safety net health system: protocol for a hybrid effectiveness-implementation randomized controlled trial. Trials. 2020 Oct 21;21(1):872. doi: 10.1186/s13063-020-04790-5.
37316815	Background	Amboree TL, Parker SL, Bulsara S, Anderson ML, Schmeler KM, Chiao EY, Montealegre JR. Cervical cancer screening among English- and Spanish-speaking Hispanic women in an urban safety net health system, 2015-2020. BMC Womens Health. 2023 Jun 15;23(1):309. doi: 10.1186/s12905-023-02448-3.

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	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.
FG002	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.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000828 subjects FG001828 subjects FG002818 subjects
COMPLETED		FG000821 subjects FG001737 subjects FG002715 subjects
NOT COMPLETED		FG0007 subjects FG00191 subjects FG002103 subjects

Type	Comment	Reasons
Terminated phone call early		FG0007 subjects FG0010 subjects FG0020 subjects
Terminated phone call early or requested to not receive a kit		FG000

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	Mailed HPV Self-Sampling Kit

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Median

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Posted

Count of Participants

Participants

within 6 months of randomization

ID	Title	Description
OG000	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.
OG001	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Pain	General disorders		Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Dr. Jane Montealegre	The University of Texas MD Anderson Cancer Center	713-792-0919		jrmontealegre@mdanderson.org

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 25, 2025	Jul 18, 2025	Prot_SAP_000.pdf

Condition Browse Module

ID	Term
D002583	Uterine Cervical Neoplasms
D030361	Papillomavirus Infections

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Intervention Browse Module

ID	Term
D062526	Patient Navigation

ID	Term
D018802	Patient-Centered Care
D011320	Primary Health Care
D003191	Comprehensive Health Care
D010346	Patient Care Management

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG000578 BG001548 BG002529 BG0031655
Non-Hispanic Asian	BG00027 BG00129 BG00226 BG00382
Non-Hispanic Black or African American	BG000163 BG001173 BG002199 BG003535
Non-Hispanic White	BG00050 BG00157 BG00242 BG003149
Non-Hispanic Other or Unknown	BG00010 BG00121 BG00222 BG00353

Type of health care coverage

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Private insurance	BG000246 BG001246 BG002245 BG003737
Publicly funded financial assistance plan	BG000476 BG001461 BG002451 BG0031388
Medicaid	BG00060 BG00169 BG00274 BG003203
Medicare	BG00027 BG00130 BG00223 BG00380
Other	BG00019 BG00122 BG00225 BG00366

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002	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% CIs were calculated.	Relative Participation	2.36			2-Sided	95	1.99	2.80					Other

Secondary

Screening Tests Results

Results of HPV test using self-collected samples (positive, negative, or inadequate)

Participated in cervical cancer screening

Posted

Count of Participants

Participants

within 6 months of randomization

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Units	Counts
Participants	OG000144 OG001340 OG002381

Title

Denominators

Categories

Title	Measurements
Positive	OG0006 OG00138 OG00249
Negative

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

Participants with an abnormal screening result, including those received from a clinic-based screening or mailed HPV self-sampling kit.

Posted

Count of Participants

Participants

Attendance to clinical follow up was assessed within 12 months of screening test result, up to 18 months post randomization.

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Units	Counts
Participants	OG0006 OG00136 OG00248

Title

Denominators

Categories

Title	Measurements
Attended follow up	OG0002 OG00122 OG00233
Did not attend follow up