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Evaluation of Human Papilloma Virus (HPV) Self-testing to Increase Screening Uptake (EMA)

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ClinicalTrials.gov Identifier: NCT02095561
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : April 29, 2014
Last Update Posted : April 29, 2014
Sponsor:
Collaborators:
Ministerio de Salud de Jujuy
International Agency for Research on Cancer
National Council of Scientific and Technical Research, Argentina
Information provided by (Responsible Party):
Silvina Arrossi, National Council of Scientific and Technical Research, Argentina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Cervical Intraepithelial Neoplasia
Intervention Other: HPV self testing
Enrollment 6013
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HPV Self Testing HPV at Health Centers
Hide Arm/Group Description

HPV self testing offered by CHWs during home visits

HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it.

Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
Period Title: Overall Study
Started 3049 2964
Self-testing Acceptability 2616 0 [1]
HPV Self-tested Women 2519 0 [2]
HPV Tested at Health Centers 99 599
Completed 3049 [3] 2964 [3]
Not Completed 0 0
[1]
Acceptablity only applies to the group of women being offered self-testing.
[2]
HPV self-testing only applies to the HPV self-testing arm
[3]
All women are part of the study, independently of whether they were tested or not.
Arm/Group Title HPV Self Testing HPV at Health Centers Total
Hide Arm/Group Description

HPV self testing offered by CHWs during home visits

HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it.

Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers. Total of all reporting groups
Overall Number of Baseline Participants 3049 2964 6013
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3049 participants 2964 participants 6013 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2840
  93.1%
2787
  94.0%
5627
  93.6%
>=65 years
209
   6.9%
177
   6.0%
386
   6.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3049 participants 2964 participants 6013 participants
Female
3049
 100.0%
2964
 100.0%
6013
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Argentina Number Analyzed 3049 participants 2964 participants 6013 participants
3049 2964 6013
Education Level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3049 participants 2964 participants 6013 participants
Never went to school/Primary (incomplete) 488 472 960
Primary (complete)/Secondary (incomplete) 1373 1291 2664
Secondary complete 600 593 1193
Tertiary (incomplete/complete) 401 381 782
Missing cases 187 227 414
Health insurance  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3049 participants 2964 participants 6013 participants
Public system 1472 1555 3027
private/social security 1409 1241 2650
Missing cases 168 168 336
Pap test in last four years  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3049 participants 2964 participants 6013 participants
Yes 889 838 1727
No 2160 2126 4286
1.Primary Outcome
Title Screening Uptake
Hide Description The primary outcome was screening uptake, defined as: a) the proportion of participant women with any HPV test (self-test or HPV at health centers) in the information system, in the 6 months after the CHW visit, and b) the proportion of women in the intervention group with a self-test in SITAM, in the same 6 month period.
Time Frame within 6 months after the intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HPV Self Testing HPV at Health Centers
Hide Arm/Group Description:

HPV self testing offered by CHWs during home visits

HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it.

Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
Overall Number of Participants Analyzed 3049 2964
Measure Type: Number
Unit of Measure: participants
Self-tested women 2519 0
HPV-tested 2618 599
2.Secondary Outcome
Title Acceptability
Hide Description Defined as the proportion of women from the intervention group who were offered self-testing and accepted, as documented in the questionnaire, independently of if they ended up with a test in the information system.
Time Frame within 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HPV Self Testing HPV at Health Centers
Hide Arm/Group Description:

HPV self testing offered by CHWs during home visits

HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it.

Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
Overall Number of Participants Analyzed 3049 2964
Measure Type: Number
Unit of Measure: participants
2616 0
3.Secondary Outcome
Title CIN2+ Detection Rate
Hide Description calculated as the percentage of women with histologically confirmed CIN2+ over total number of tested women, both for women with self-testing and those HPV tests taken at health centers.
Time Frame within one year after the CHW visits
Hide Outcome Measure Data
Hide Analysis Population Description
Population included in the HPV self-testing group to calculate CIN2+ detection rate includes only women who were self-tested (n=2519). It excludes 99 women from this group who were not self-tested and were tested at health centers.
Arm/Group Title HPV Self Testing HPV at Health Centers
Hide Arm/Group Description:

HPV self testing offered by CHWs during home visits

HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it.

Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
Overall Number of Participants Analyzed 2519 599
Measure Type: Number
Unit of Measure: percentage of CIN2+/ women screened
1.15 1.17
4.Secondary Outcome
Title HPV Positivity
Time Frame within 6 months after the CHW visits
Hide Outcome Measure Data
Hide Analysis Population Description
Population included in the HPV self-testing group to calculate positivity includes only women who were self-tested (n=2519). It excludes 99 women from this group who were not self-tested and were tested at health centers.
Arm/Group Title HPV Self Testing HPV at Health Centers
Hide Arm/Group Description:

HPV self testing offered by CHWs during home visits

HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it.

Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
Overall Number of Participants Analyzed 2519 599
Measure Type: Number
Unit of Measure: percentage of positive tests/tested wome
11.8 11.9
Time Frame Overall study period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HPV Self Testing HPV at Health Centers
Hide Arm/Group Description

HPV self testing offered by CHWs during home visits

HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it.

Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
All-Cause Mortality
HPV Self Testing HPV at Health Centers
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HPV Self Testing HPV at Health Centers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3049 (0.00%)   0/2964 (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 Testing HPV at Health Centers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3049 (0.00%)   0/2964 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Silvina Arrossi, Phd
Organization: INSTITUTO NACIONAL DEL CÁNCER, ARGENTINA
Phone: 541152390562
Responsible Party: Silvina Arrossi, National Council of Scientific and Technical Research, Argentina
ClinicalTrials.gov Identifier: NCT02095561     History of Changes
Other Study ID Numbers: 01-1CU
First Submitted: March 21, 2014
First Posted: March 26, 2014
Results First Submitted: March 27, 2014
Results First Posted: April 29, 2014
Last Update Posted: April 29, 2014