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Acceptability of Human Papillomavirus (HPV) Self-sampling Tools for Cervical Cancer Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03613493
Recruitment Status : Terminated (Budgetary and Timing Constraints)
First Posted : August 3, 2018
Results First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Susan Morgan, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Cervical Cancer
Interventions Diagnostic Test: HPV self-sampling kit
Behavioral: Culturally-targeted Fear Appeal Message
Behavioral: Fear Appeal Message
Behavioral: Interview
Enrollment 175
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HPV Self-sampling Kit + Interview Culturally-targeted Fear Appeal Message HPV Self-sampling Kit Fear Appeal Message HPV Self-sampling Kit HPV Self-sampling Kit
Hide Arm/Group Description

Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool.

HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Interview: Participants will be interviewed about experiences using the self-sampling tool (qualitative).

Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message

HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Culturally-targeted Fear Appeal Message: Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit.

Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message

HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Fear Appeal Message: Participants will receive fear appeal messages (only) in a graphically designed kit.

Participants will receive an HPV self-sampling kit to screen for HPV

HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Period Title: Overall Study
Started 10 75 0 90
Enrollment Criteria Met 10 74 0 89
Completed 10 73 0 83
Not Completed 0 2 0 7
Arm/Group Title HPV Self-sampling Kit + Interview Culturally-targeted Fear Appeal Message HPV Self-sampling Kit Fear Appeal Message HPV Self-sampling Kit HPV Self-sampling Kit Total
Hide Arm/Group Description

Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool.

HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Interview: Participants will be interviewed about experiences using the self-sampling tool (qualitative).

Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message

HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Culturally-targeted Fear Appeal Message: Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit.

Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message

HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Fear Appeal Message: Participants will receive fear appeal messages (only) in a graphically designed kit.

Participants will receive an HPV self-sampling kit to screen for HPV

HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Total of all reporting groups
Overall Number of Baseline Participants 10 74 0 89 173
Hide Baseline Analysis Population Description
Due to budgetary constraints, participants were not enrolled into the Fear Appeal HPV self-sampler kit arm.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 74 participants 0 participants 89 participants 173 participants
47.40  (9.442) 45.01  (9.099) 41.09  (10.222) 44.50  (9.587)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 74 participants 0 participants 89 participants 173 participants
Female
10
 100.0%
74
 100.0%
0
89
 100.0%
173
 100.0%
Male
0
   0.0%
0
   0.0%
0
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 74 participants 0 participants 89 participants 173 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
0
   0.0%
0
   0.0%
Not Hispanic or Latino
10
 100.0%
74
 100.0%
0
89
 100.0%
173
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 74 participants 0 participants 89 participants 173 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
0
   0.0%
0
   0.0%
Black or African American
10
 100.0%
74
 100.0%
0
89
 100.0%
173
 100.0%
White
0
   0.0%
0
   0.0%
0
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
0
   0.0%
0
   0.0%
Prior pap test experience  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 74 participants 0 participants 89 participants 173 participants
7 64 72 143
1.Primary Outcome
Title Number of Participants That Used and Returned Their Self-sampler Kit.
Hide Description Number of participants that used and returned their self-sampler kit was evaluated.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for the fear appeal message HPV self-sampling condition due to lack of funding.
Arm/Group Title Culturally-targeted Fear Appeal Message HPV Self-sampling Kit Fear Appeal Message HPV Self-sampling Kit HPV Self-sampling Kit HPV Self-sampling Kit + Interview
Hide Arm/Group Description:

Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message

HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Culturally-targeted Fear Appeal Message: Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit.

Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message

HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Fear Appeal Message: Participants will receive fear appeal messages (only) in a graphically designed kit.

Participants will receive an HPV self-sampling kit to screen for HPV

HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool.

HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Interview: Participants will be interviewed about experiences using the self-sampling tool (qualitative).

Overall Number of Participants Analyzed 74 0 89 10
Measure Type: Count of Participants
Unit of Measure: Participants
73
  98.6%
83
  93.3%
10
 100.0%
Time Frame 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HPV Self-sampling Kit + Interview Culturally-targeted Fear Appeal Message HPV Self-sampling Kit HPV Self-sampling Kit
Hide Arm/Group Description

Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool.

HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Interview: Participants will be interviewed about experiences using the self-sampling tool (qualitative).

Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message

HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

Culturally-targeted Fear Appeal Message: Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit.

Participants will receive an HPV self-sampling kit to screen for HPV

HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.

All-Cause Mortality
HPV Self-sampling Kit + Interview Culturally-targeted Fear Appeal Message HPV Self-sampling Kit HPV Self-sampling Kit
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/74 (0.00%)   0/89 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
HPV Self-sampling Kit + Interview Culturally-targeted Fear Appeal Message HPV Self-sampling Kit HPV Self-sampling Kit
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/74 (0.00%)   0/89 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HPV Self-sampling Kit + Interview Culturally-targeted Fear Appeal Message HPV Self-sampling Kit HPV Self-sampling Kit
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/74 (0.00%)   0/89 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Susan Morgan
Organization: University of Miami
Phone: 7654094919
EMail: semorgan@miami.edu
Layout table for additonal information
Responsible Party: Susan Morgan, University of Miami
ClinicalTrials.gov Identifier: NCT03613493     History of Changes
Other Study ID Numbers: 20180033
First Submitted: June 17, 2018
First Posted: August 3, 2018
Results First Submitted: July 10, 2019
Results First Posted: August 2, 2019
Last Update Posted: August 2, 2019