Trial Outcomes & Findings for Multilevel HPV Self-Testing Intervention for the Increase of Cervical Cancer Screening Among Women in Appalachia (NCT NCT04411849)
NCT ID: NCT04411849
Last Updated: 2025-09-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
802 participants
Primary outcome timeframe
Up to 1 years
Results posted on
2025-09-10
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
464
|
338
|
|
Overall Study
COMPLETED
|
464
|
338
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group I (Intervention)
n=464 Participants
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
|
Group II (Usual Care Continued)
n=338 Participants
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
|
Total
n=802 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=464 Participants
|
0 Participants
n=338 Participants
|
0 Participants
n=802 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
464 Participants
n=464 Participants
|
338 Participants
n=338 Participants
|
802 Participants
n=802 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=464 Participants
|
0 Participants
n=338 Participants
|
0 Participants
n=802 Participants
|
|
Sex: Female, Male
Female
|
464 Participants
n=464 Participants
|
338 Participants
n=338 Participants
|
802 Participants
n=802 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=464 Participants
|
0 Participants
n=338 Participants
|
0 Participants
n=802 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
464 participants
n=464 Participants
|
338 participants
n=338 Participants
|
802 participants
n=802 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearsThe 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.
Outcome measures
| Measure |
Group I (Intervention)
n=464 Participants
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
|
Group II (Usual Care Continued)
n=338 Participants
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
|
|---|---|---|
|
Effectiveness of Human Papillomavirus (HPV) Intervention
|
69 Participants
|
17 Participants
|
Adverse Events
Group I (Intervention)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group II (Usual Care Continued)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place