Trial Outcomes & Findings for Evaluation of Human Papilloma Virus (HPV) Self-testing to Increase Screening Uptake (NCT NCT02095561)
NCT ID: NCT02095561
Last Updated: 2020-09-09
Results Overview
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.
COMPLETED
NA
6013 participants
within 6 months after the intervention
2020-09-09
Participant Flow
Participant milestones
| Measure |
HPV Self Testing
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.
|
HPV at Health Centers
Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
|
|---|---|---|
|
Overall Study
STARTED
|
3049
|
2964
|
|
Overall Study
Self-testing Acceptability
|
2616
|
0
|
|
Overall Study
HPV Self-tested Women
|
2519
|
0
|
|
Overall Study
HPV Tested at Health Centers
|
99
|
599
|
|
Overall Study
COMPLETED
|
3049
|
2964
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Human Papilloma Virus (HPV) Self-testing to Increase Screening Uptake
Baseline characteristics by cohort
| Measure |
HPV Self Testing
n=3049 Participants
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.
|
HPV at Health Centers
n=2964 Participants
Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
|
Total
n=6013 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2840 Participants
n=99 Participants
|
2787 Participants
n=107 Participants
|
5627 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
209 Participants
n=99 Participants
|
177 Participants
n=107 Participants
|
386 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
3049 Participants
n=99 Participants
|
2964 Participants
n=107 Participants
|
6013 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Argentina
|
3049 participants
n=99 Participants
|
2964 participants
n=107 Participants
|
6013 participants
n=206 Participants
|
|
Education Level
Never went to school/Primary (incomplete)
|
488 participants
n=99 Participants
|
472 participants
n=107 Participants
|
960 participants
n=206 Participants
|
|
Education Level
Primary (complete)/Secondary (incomplete)
|
1373 participants
n=99 Participants
|
1291 participants
n=107 Participants
|
2664 participants
n=206 Participants
|
|
Education Level
Secondary complete
|
600 participants
n=99 Participants
|
593 participants
n=107 Participants
|
1193 participants
n=206 Participants
|
|
Education Level
Tertiary (incomplete/complete)
|
401 participants
n=99 Participants
|
381 participants
n=107 Participants
|
782 participants
n=206 Participants
|
|
Education Level
Missing cases
|
187 participants
n=99 Participants
|
227 participants
n=107 Participants
|
414 participants
n=206 Participants
|
|
Health insurance
Public system
|
1472 participants
n=99 Participants
|
1555 participants
n=107 Participants
|
3027 participants
n=206 Participants
|
|
Health insurance
private/social security
|
1409 participants
n=99 Participants
|
1241 participants
n=107 Participants
|
2650 participants
n=206 Participants
|
|
Health insurance
Missing cases
|
168 participants
n=99 Participants
|
168 participants
n=107 Participants
|
336 participants
n=206 Participants
|
|
Pap test in last four years
Yes
|
889 participants
n=99 Participants
|
838 participants
n=107 Participants
|
1727 participants
n=206 Participants
|
|
Pap test in last four years
No
|
2160 participants
n=99 Participants
|
2126 participants
n=107 Participants
|
4286 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: within 6 months after the interventionThe 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.
Outcome measures
| Measure |
HPV Self Testing
n=3049 Participants
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.
|
HPV at Health Centers
n=2964 Participants
Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
|
|---|---|---|
|
Screening Uptake
Self-tested women
|
2519 participants
|
0 participants
|
|
Screening Uptake
HPV-tested
|
2618 participants
|
599 participants
|
SECONDARY outcome
Timeframe: within 6 monthsDefined 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.
Outcome measures
| Measure |
HPV Self Testing
n=3049 Participants
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.
|
HPV at Health Centers
n=2964 Participants
Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
|
|---|---|---|
|
Acceptability
|
2616 participants
|
0 participants
|
SECONDARY outcome
Timeframe: within one year after the CHW visitsPopulation: 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.
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.
Outcome measures
| Measure |
HPV Self Testing
n=2519 Participants
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.
|
HPV at Health Centers
n=599 Participants
Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
|
|---|---|---|
|
CIN2+ Detection Rate
|
1.15 percentage of CIN2+/ women screened
|
1.17 percentage of CIN2+/ women screened
|
SECONDARY outcome
Timeframe: within 6 months after the CHW visitsPopulation: 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.
Calculated as the percentage of women with positive HPV test over total number of tested women, both for women with self-testing and those HPV tests taken at health centers.
Outcome measures
| Measure |
HPV Self Testing
n=2519 Participants
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.
|
HPV at Health Centers
n=599 Participants
Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
|
|---|---|---|
|
HPV Positivity
|
11.8 percentage of positive tests/tested wome
|
11.9 percentage of positive tests/tested wome
|
Adverse Events
HPV Self Testing
HPV at Health Centers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Silvina Arrossi, Phd
INSTITUTO NACIONAL DEL CÁNCER, ARGENTINA
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place