Trial Outcomes & Findings for Using CHWs or Mailing Self Sampling Home Tests to Increase Cervical Cancer Screening in South Florida (NCT NCT02202109)
NCT ID: NCT02202109
Last Updated: 2018-12-19
Results Overview
The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
602 participants
Primary outcome timeframe
2 to 6 months
Results posted on
2018-12-19
Participant Flow
Participant milestones
| Measure |
CHWs Facilited Self-Sampling
CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test
CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.
|
Mailed Self-Sampler
Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone
Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;
|
|---|---|---|
|
Overall Study
STARTED
|
302
|
300
|
|
Overall Study
COMPLETED
|
212
|
213
|
|
Overall Study
NOT COMPLETED
|
90
|
87
|
Reasons for withdrawal
| Measure |
CHWs Facilited Self-Sampling
CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test
CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.
|
Mailed Self-Sampler
Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone
Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
88
|
87
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Using CHWs or Mailing Self Sampling Home Tests to Increase Cervical Cancer Screening in South Florida
Baseline characteristics by cohort
| Measure |
CHWs Facilited Self-Sampling
n=302 Participants
CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test
CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.
|
Mailed Self-Sampler
n=300 Participants
Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone
Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;
|
Total
n=602 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
302 Participants
n=5 Participants
|
300 Participants
n=7 Participants
|
602 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
302 Participants
n=5 Participants
|
300 Participants
n=7 Participants
|
602 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
198 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
395 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
106 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
141 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
54 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 to 6 monthsPopulation: Participants were given up to 6 months to complete HPV self-sampling.
The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days.
Outcome measures
| Measure |
CHWs Facilited Self-Sampling
n=272 Participants
CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test
CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.
|
Mailed Self-Sampler
n=257 Participants
Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone
Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;
|
|---|---|---|
|
Number of Participants Completing a Self-sampling Test
|
272 Participants
|
257 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsCervical cancer knowledge was measured with a series of questions asked at both pre(baseline) and post (exit). The questions were designed to measure participant's knowledge of cervical cancer prior to the study intervention and following the intervention. Cervical cancer knowledge is defined by participants answering 3 out 5 questions correctly.
Outcome measures
| Measure |
CHWs Facilited Self-Sampling
n=212 Participants
CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test
CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.
|
Mailed Self-Sampler
n=213 Participants
Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone
Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;
|
|---|---|---|
|
Proportion of Change in Cervical Cancer Knowledge Among Participants
|
0.033 proportion of participants
Interval -0.038 to 0.104
|
0.089 proportion of participants
Interval 0.017 to 0.162
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: Only participants with complete information on access to care were included in the analysis.
Access to care was defined as having a routine source of care and measured at both pre(baseline) and post (exit).
Outcome measures
| Measure |
CHWs Facilited Self-Sampling
n=212 Participants
CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test
CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.
|
Mailed Self-Sampler
n=211 Participants
Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone
Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;
|
|---|---|---|
|
Proportion of Participants With a Change in Access to Care
|
0.160 proportion of participants
Interval 0.092 to 0.23
|
0.166 proportion of participants
Interval 0.088 to 0.244
|
Adverse Events
CHWs Facilited Self-Sampling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mailed Self-Sampler
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