Trial Outcomes & Findings for Optimal Strategy for the Management of ASCUS Cytology in Health Care Services of Medellin, Colombia (NCT NCT02067468)
NCT ID: NCT02067468
Last Updated: 2019-09-19
Results Overview
Cumulative Cervical Intraepithelial Neoplasia Grade 2 or higher (CIN2+) diagnosed by the community pathologists during the two years of follow-up. The first community-based CIN2+ diagnosis was adjudicated to the participant (including the exit visit if none community-based CIN2+ during the two years of follow-up). This outcome is used for the effectiveness analysis of the three strategies.
COMPLETED
NA
2661 participants
Two years since the enrolment to the exit visit (inclusive)
2019-09-19
Participant Flow
After a great effort, due to logistic issues, it was only possible to enroll 2661 participants instead of 3000 as it had been stated in the submitted protocol. Despite it, the trial had enough statistical power to answer the research questions.
Participant milestones
| Measure |
COLPOSCOPY
Women with ASC-US cytology are immediately referred to colposcopy
COLPOSCOPY: Colposcopy routine health services
|
CYTOLOGY
Women with ASC-US Cytology are follow-up with cytology at 6 and/or 12 months and be referred to colposcopy if any of these cytologies is ASC-US or higher
COLPOSCOPY: Colposcopy routine health services
Cytology: Cytology routine health services
|
HPV Test
Women with ASC-US cytology are HPV tested and those HPV positive are refer to Colposcopy
HPV test: QIAGEN - The Digene HPV test®
COLPOSCOPY: Colposcopy routine health services
|
|---|---|---|---|
|
Overall Study
STARTED
|
882
|
890
|
889
|
|
Overall Study
Followed-up Through Medical Records
|
882
|
890
|
889
|
|
Overall Study
Had at Least One Routine Colposcopy
|
772
|
372
|
462
|
|
Overall Study
COMPLETED
|
882
|
890
|
889
|
|
Overall Study
NOT COMPLETED
|
0
|
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 |
COLPOSCOPY
n=882 Participants
Women with ASC-US cytology are immediately referred to colposcopy
COLPOSCOPY: Colposcopy routine health services
|
CYTOLOGY
n=890 Participants
Women with ASC-US Cytology are follow-up with cytology at 6 and/or 12 months and be referred to colposcopy if any of these cytologies is ASC-US or higher
COLPOSCOPY: Colposcopy routine health services
cytology: Cytology routine health services
|
HPV Test
n=889 Participants
Women with ASC-US cytology are HPV tested and those HPV positive are referred to Colposcopy
HPV test: QIAGEN - The Digene HPV test®
COLPOSCOPY: Colposcopy routine health services
|
Total
n=2661 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.3 Years
STANDARD_DEVIATION 11 • n=882 Participants
|
37 Years
STANDARD_DEVIATION 11 • n=890 Participants
|
37.4 Years
STANDARD_DEVIATION 10.9 • n=889 Participants
|
37.3 Years
STANDARD_DEVIATION 11 • n=2661 Participants
|
|
Age, Customized
Age, years · 20-30
|
290 Participants
n=882 Participants
|
305 Participants
n=890 Participants
|
289 Participants
n=889 Participants
|
884 Participants
n=2661 Participants
|
|
Age, Customized
Age, years · 31-40
|
240 Participants
n=882 Participants
|
248 Participants
n=890 Participants
|
233 Participants
n=889 Participants
|
721 Participants
n=2661 Participants
|
|
Age, Customized
Age, years · 41-50
|
239 Participants
n=882 Participants
|
225 Participants
n=890 Participants
|
261 Participants
n=889 Participants
|
725 Participants
n=2661 Participants
|
|
Age, Customized
Age, years · 51-69
|
113 Participants
n=882 Participants
|
112 Participants
n=890 Participants
|
106 Participants
n=889 Participants
|
331 Participants
n=2661 Participants
|
|
Sex: Female, Male
Female
|
882 Participants
n=882 Participants
|
890 Participants
n=890 Participants
|
889 Participants
n=889 Participants
|
2661 Participants
n=2661 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=882 Participants
|
0 Participants
n=890 Participants
|
0 Participants
n=889 Participants
|
0 Participants
n=2661 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Colombia
|
882 Participants
n=882 Participants
|
890 Participants
n=890 Participants
|
889 Participants
n=889 Participants
|
2661 Participants
n=2661 Participants
|
|
Healthcare Management Organization (Secondary centers)
Healthcare Management Organization #1
|
196 Participants
n=882 Participants
|
233 Participants
n=890 Participants
|
207 Participants
n=889 Participants
|
636 Participants
n=2661 Participants
|
|
Healthcare Management Organization (Secondary centers)
Healthcare Management Organization #2
|
461 Participants
n=882 Participants
|
442 Participants
n=890 Participants
|
461 Participants
n=889 Participants
|
1364 Participants
n=2661 Participants
|
|
Healthcare Management Organization (Secondary centers)
Healthcare Management Organization #3
|
225 Participants
n=882 Participants
|
215 Participants
n=890 Participants
|
221 Participants
n=889 Participants
|
661 Participants
n=2661 Participants
|
|
Marital Satus
Married/cohabiting
|
420 Participants
n=882 Participants
|
440 Participants
n=890 Participants
|
446 Participants
n=889 Participants
|
1306 Participants
n=2661 Participants
|
|
Marital Satus
Divorced/separated
|
70 Participants
n=882 Participants
|
83 Participants
n=890 Participants
|
83 Participants
n=889 Participants
|
236 Participants
n=2661 Participants
|
|
Marital Satus
Widowed
|
31 Participants
n=882 Participants
|
34 Participants
n=890 Participants
|
25 Participants
n=889 Participants
|
90 Participants
n=2661 Participants
|
|
Marital Satus
Single
|
361 Participants
n=882 Participants
|
333 Participants
n=890 Participants
|
335 Participants
n=889 Participants
|
1029 Participants
n=2661 Participants
|
|
Education
Complete/some elementary school
|
220 Participants
n=882 Participants
|
236 Participants
n=890 Participants
|
246 Participants
n=889 Participants
|
702 Participants
n=2661 Participants
|
|
Education
Complete/some secondary school
|
426 Participants
n=882 Participants
|
430 Participants
n=890 Participants
|
418 Participants
n=889 Participants
|
1274 Participants
n=2661 Participants
|
|
Education
Technician
|
150 Participants
n=882 Participants
|
147 Participants
n=890 Participants
|
144 Participants
n=889 Participants
|
441 Participants
n=2661 Participants
|
|
Education
Professional or higher
|
86 Participants
n=882 Participants
|
77 Participants
n=890 Participants
|
81 Participants
n=889 Participants
|
244 Participants
n=2661 Participants
|
|
Frequency of cytology use
Once or more than once every year
|
608 Participants
n=882 Participants
|
593 Participants
n=890 Participants
|
590 Participants
n=889 Participants
|
1791 Participants
n=2661 Participants
|
|
Frequency of cytology use
Once every 2-3 years
|
174 Participants
n=882 Participants
|
181 Participants
n=890 Participants
|
176 Participants
n=889 Participants
|
531 Participants
n=2661 Participants
|
|
Frequency of cytology use
Once every 4-5 years
|
54 Participants
n=882 Participants
|
59 Participants
n=890 Participants
|
64 Participants
n=889 Participants
|
177 Participants
n=2661 Participants
|
|
Frequency of cytology use
Once every 6-10 years
|
24 Participants
n=882 Participants
|
25 Participants
n=890 Participants
|
22 Participants
n=889 Participants
|
71 Participants
n=2661 Participants
|
|
Frequency of cytology use
Less than once every 10 years
|
6 Participants
n=882 Participants
|
6 Participants
n=890 Participants
|
9 Participants
n=889 Participants
|
21 Participants
n=2661 Participants
|
|
Frequency of cytology use
Do not know/Do not answer
|
16 Participants
n=882 Participants
|
26 Participants
n=890 Participants
|
28 Participants
n=889 Participants
|
70 Participants
n=2661 Participants
|
PRIMARY outcome
Timeframe: Two years since the enrolment to the exit visit (inclusive)Population: Cumulative cases of CIN2+ diagnosed by the community pathologists from the healthcare institutions according to arm
Cumulative Cervical Intraepithelial Neoplasia Grade 2 or higher (CIN2+) diagnosed by the community pathologists during the two years of follow-up. The first community-based CIN2+ diagnosis was adjudicated to the participant (including the exit visit if none community-based CIN2+ during the two years of follow-up). This outcome is used for the effectiveness analysis of the three strategies.
Outcome measures
| Measure |
COLPOSCOPY
n=882 Participants
Women with ASC-US cytology are immediately refer to colposcopy
COLPOSCOPY: Colposcopy routine health services
|
CYTOLOGY
n=890 Participants
Women with ASC-US Cytology are follow-up with cytology at 6 and/or 12 months and be referred to colposcopy if any of these cytologies is ASC-US or higher
COLPOSCOPY: Colposcopy routine health services
cytology: Cytology routine health services
|
HPV Test
n=889 Participants
Women with ASC-US cytology are HPV tested and those HPV positive are refer to Colposcopy
HPV test: QIAGEN - The Digene HPV test®
COLPOSCOPY: Colposcopy routine health services
|
|---|---|---|---|
|
Cumulative Number of Participants Diagnosed by the Community Pathologist With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Community-based CIN2+"
Community-based <CIN2
|
847 Participants
|
835 Participants
|
848 Participants
|
|
Cumulative Number of Participants Diagnosed by the Community Pathologist With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Community-based CIN2+"
Community-based CIN2
|
30 Participants
|
43 Participants
|
31 Participants
|
|
Cumulative Number of Participants Diagnosed by the Community Pathologist With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Community-based CIN2+"
Community-based CIN3
|
4 Participants
|
11 Participants
|
10 Participants
|
|
Cumulative Number of Participants Diagnosed by the Community Pathologist With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Community-based CIN2+"
Community-based Cancer
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Two years since the enrolment to the exit visit (inclusive)Population: Cumulative cases of CIN2+ diagnosed by a panel of external expert pathologists according to arm
Cumulative Cervical Intraepithelial Neoplasia Grade 2 or higher (CIN2+) diagnosed by a panel of external experts obtained after histological review of biopsies emitted by the community pathologists. Biopsies obtained during the two years of follow-up and the exit visit were reviewed by a panel of two external experts and a final result was adjudicated to each participant based on the panel of experts and the community of pathologists. This outcome is used for the effectiveness analysis of the three strategies.
Outcome measures
| Measure |
COLPOSCOPY
n=882 Participants
Women with ASC-US cytology are immediately refer to colposcopy
COLPOSCOPY: Colposcopy routine health services
|
CYTOLOGY
n=890 Participants
Women with ASC-US Cytology are follow-up with cytology at 6 and/or 12 months and be referred to colposcopy if any of these cytologies is ASC-US or higher
COLPOSCOPY: Colposcopy routine health services
cytology: Cytology routine health services
|
HPV Test
n=889 Participants
Women with ASC-US cytology are HPV tested and those HPV positive are refer to Colposcopy
HPV test: QIAGEN - The Digene HPV test®
COLPOSCOPY: Colposcopy routine health services
|
|---|---|---|---|
|
Cumulative Number of Participants Diagnosed by a Panel of External Experts With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Reviewed CIN2+"
Reviewed <CIN2
|
813 Participants
|
809 Participants
|
827 Participants
|
|
Cumulative Number of Participants Diagnosed by a Panel of External Experts With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Reviewed CIN2+"
Reviewed CIN2
|
51 Participants
|
61 Participants
|
48 Participants
|
|
Cumulative Number of Participants Diagnosed by a Panel of External Experts With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Reviewed CIN2+"
Reviewed CIN3
|
16 Participants
|
18 Participants
|
14 Participants
|
|
Cumulative Number of Participants Diagnosed by a Panel of External Experts With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Reviewed CIN2+"
Reviewed Cancer
|
2 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Exit visit (two years after the enrolment)Population: Exit-reviewed CIN2+ detected at the exit visit (2 years after the enrolment) of women with ASC-US cytology stratified by arm
Cervical Intraepithelial Neoplasia Grade 2 or higher (CIN2+) diagnosed by a panel of external experts after reviewing biopsies collected at the exit visit, two years after the enrolment. This outcome is an estimate of the remaining disease that was not detected by the strategies during the 2 years of follow-up. The outcome was obtained after the review of all the biopsies taken during the exit visit. Biopsies were taken using a standardized research protocol to ensure the completeness of the remaining disease. Basically, all women attending the exit visit were tested with HPV testing and Pap and referred to colposcopy if any HPV positive or abnormal cytology. The colposcopy was performed by a researcher of the study team who took up to two biopsies from the observed lesion plus one or two at random if none lesion was observed. All biopsies were reviewed by the external panel. This outcome is used for the efficiency analysis of the three strategies.
Outcome measures
| Measure |
COLPOSCOPY
n=882 Participants
Women with ASC-US cytology are immediately refer to colposcopy
COLPOSCOPY: Colposcopy routine health services
|
CYTOLOGY
n=890 Participants
Women with ASC-US Cytology are follow-up with cytology at 6 and/or 12 months and be referred to colposcopy if any of these cytologies is ASC-US or higher
COLPOSCOPY: Colposcopy routine health services
cytology: Cytology routine health services
|
HPV Test
n=889 Participants
Women with ASC-US cytology are HPV tested and those HPV positive are refer to Colposcopy
HPV test: QIAGEN - The Digene HPV test®
COLPOSCOPY: Colposcopy routine health services
|
|---|---|---|---|
|
Number of Participants Diagnosed by a Panel of External Experts With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+) at the Exit Visit, Two Years After the Enrolment: "Exit-reviewed CIN2+"
Exit-reviewed <CIN2
|
852 Participants
|
851 Participants
|
866 Participants
|
|
Number of Participants Diagnosed by a Panel of External Experts With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+) at the Exit Visit, Two Years After the Enrolment: "Exit-reviewed CIN2+"
Exit-reviewed CIN2+
|
30 Participants
|
39 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Two years since the enrolment to before the exit visit (i.e., excluding clinical records collected at the exit visit)Population: Utilization of cytology, colposcopy and histology during the routine follow-up of women with ASC-US cytology stratified by arm
The outcome is defined as the number of cytologies, colposcopies, and histologies routinely performed during the two years of follow-up. Records were identified in databases or manually searched from clinical records. This outcome will be used for the analysis of the efficiency of the three strategies.
Outcome measures
| Measure |
COLPOSCOPY
n=882 Participants
Women with ASC-US cytology are immediately refer to colposcopy
COLPOSCOPY: Colposcopy routine health services
|
CYTOLOGY
n=890 Participants
Women with ASC-US Cytology are follow-up with cytology at 6 and/or 12 months and be referred to colposcopy if any of these cytologies is ASC-US or higher
COLPOSCOPY: Colposcopy routine health services
cytology: Cytology routine health services
|
HPV Test
n=889 Participants
Women with ASC-US cytology are HPV tested and those HPV positive are refer to Colposcopy
HPV test: QIAGEN - The Digene HPV test®
COLPOSCOPY: Colposcopy routine health services
|
|---|---|---|---|
|
Number of Clinical Records (Cytologies, Colposcopies, and Histologies): "Health Care Utilization"
Cytology utilization
|
904 Clinical records
|
1218 Clinical records
|
816 Clinical records
|
|
Number of Clinical Records (Cytologies, Colposcopies, and Histologies): "Health Care Utilization"
Colposcopy utilization
|
964 Clinical records
|
509 Clinical records
|
633 Clinical records
|
|
Number of Clinical Records (Cytologies, Colposcopies, and Histologies): "Health Care Utilization"
Total utilization
|
2440 Clinical records
|
2076 Clinical records
|
1850 Clinical records
|
|
Number of Clinical Records (Cytologies, Colposcopies, and Histologies): "Health Care Utilization"
Histology utilization
|
572 Clinical records
|
349 Clinical records
|
401 Clinical records
|
SECONDARY outcome
Timeframe: Two years between the enrolment and the exit visitPopulation: This is a nested analysis that included 394 subjects of the ASCUS-COL trial (142 in COLPOSCOPY, 103 in CYTOLOGY, and 149 HPV) who accepted to participate and completed the follow-up of three measurements over time.
Self-esteem corresponds to the self-assessment of a positive or negative evaluation toward oneself. This outcome was measured using the Rosenberg Scale through 10 Likert-type questions with scores varying between 1 and 4 (1=strongly agree, 2=agree, 3=disagree, 4=strongly disagree). Total values range between 10 and 40 where lower scores suggest lower self-esteem. This outcome was measured at the enrollment visit, between two weeks and two months after receiving the triage result, and after one year of receiving the triage result.
Outcome measures
| Measure |
COLPOSCOPY
n=142 Participants
Women with ASC-US cytology are immediately refer to colposcopy
COLPOSCOPY: Colposcopy routine health services
|
CYTOLOGY
n=103 Participants
Women with ASC-US Cytology are follow-up with cytology at 6 and/or 12 months and be referred to colposcopy if any of these cytologies is ASC-US or higher
COLPOSCOPY: Colposcopy routine health services
cytology: Cytology routine health services
|
HPV Test
n=149 Participants
Women with ASC-US cytology are HPV tested and those HPV positive are refer to Colposcopy
HPV test: QIAGEN - The Digene HPV test®
COLPOSCOPY: Colposcopy routine health services
|
|---|---|---|---|
|
Self-esteem
Self-esteem at enrollment
|
32.9 score on a scale
Standard Deviation 4.40
|
33.0 score on a scale
Standard Deviation 4.25
|
32.8 score on a scale
Standard Deviation 4.17
|
|
Self-esteem
Self-esteem after receiving the triage result
|
34.8 score on a scale
Standard Deviation 4.84
|
33.9 score on a scale
Standard Deviation 4.38
|
34.4 score on a scale
Standard Deviation 4.78
|
|
Self-esteem
Self-esteem after one year of the triage result
|
35.4 score on a scale
Standard Deviation 4.43
|
35.5 score on a scale
Standard Deviation 5.26
|
35.2 score on a scale
Standard Deviation 4.84
|
SECONDARY outcome
Timeframe: Two years between the enrolment and the exit visitPopulation: This is a nested analysis that included 394 subjects of the ASCUS-COL trial (142 in COLPOSCOPY, 103 in CYTOLOGY, and 149 HPV) who accepted to participate and completed the follow-up of three measurements over time.
Trait anxiety refers to the sustainable tendency to experience negative emotions (such as fears, worries, and anxiety) in various situations. This outcome was measured using the Spielberger State-Trait-Anxiety Inventory (STAI) through 20 Likert-type questions with scores varying between 0 and 3 (0=not at all, 1=somewhat, 2=moderately, 3=very much). Total values range between 0 and 60 where higher scores suggest higher levels of anxiety. This outcome was measured at the enrollment visit, between two weeks and two months after receiving the triage result, and after one year of receiving the triage result.
Outcome measures
| Measure |
COLPOSCOPY
n=142 Participants
Women with ASC-US cytology are immediately refer to colposcopy
COLPOSCOPY: Colposcopy routine health services
|
CYTOLOGY
n=103 Participants
Women with ASC-US Cytology are follow-up with cytology at 6 and/or 12 months and be referred to colposcopy if any of these cytologies is ASC-US or higher
COLPOSCOPY: Colposcopy routine health services
cytology: Cytology routine health services
|
HPV Test
n=149 Participants
Women with ASC-US cytology are HPV tested and those HPV positive are refer to Colposcopy
HPV test: QIAGEN - The Digene HPV test®
COLPOSCOPY: Colposcopy routine health services
|
|---|---|---|---|
|
Trait Anxiety
Trait anxiety at enrollment
|
17.5 score on a scale
Standard Deviation 13.27
|
17.4 score on a scale
Standard Deviation 11.34
|
17.7 score on a scale
Standard Deviation 11.10
|
|
Trait Anxiety
Trait anxiety after receiving the triage result
|
16.3 score on a scale
Standard Deviation 13.14
|
16.8 score on a scale
Standard Deviation 12.08
|
17.7 score on a scale
Standard Deviation 12.80
|
|
Trait Anxiety
Trait anxiety after one year of the triage result
|
14.9 score on a scale
Standard Deviation 11.95
|
13.4 score on a scale
Standard Deviation 11.15
|
14.9 score on a scale
Standard Deviation 12.51
|
SECONDARY outcome
Timeframe: Two years between the enrolment and the exit visitPopulation: This is a nested analysis that included 394 subjects of the ASCUS-COL trial (142 in COLPOSCOPY, 103 in CYTOLOGY, and 149 HPV) who accepted to participate and completed the follow-up of three measurements over time.
State anxiety refers to the transitory tendency to experience negative emotions (such as fears, worries, and anxiety). This outcome was measured using the Spielberger State-Trait-Anxiety Inventory (STAI) through 20 Likert-type questions with scores varying between 0 and 3 (0=not at all, 1=somewhat, 2=moderately, 3=very much). Total values range between 0 and 60 where higher scores suggest higher levels of anxiety. This outcome was measured at the enrollment visit, between two weeks and two months after receiving the triage result, and after one year of receiving the triage result.
Outcome measures
| Measure |
COLPOSCOPY
n=142 Participants
Women with ASC-US cytology are immediately refer to colposcopy
COLPOSCOPY: Colposcopy routine health services
|
CYTOLOGY
n=103 Participants
Women with ASC-US Cytology are follow-up with cytology at 6 and/or 12 months and be referred to colposcopy if any of these cytologies is ASC-US or higher
COLPOSCOPY: Colposcopy routine health services
cytology: Cytology routine health services
|
HPV Test
n=149 Participants
Women with ASC-US cytology are HPV tested and those HPV positive are refer to Colposcopy
HPV test: QIAGEN - The Digene HPV test®
COLPOSCOPY: Colposcopy routine health services
|
|---|---|---|---|
|
State Anxiety
State anxiety at enrollment
|
15.3 score on a scale
Standard Deviation 13.23
|
13.6 score on a scale
Standard Deviation 11.03
|
14.3 score on a scale
Standard Deviation 11.45
|
|
State Anxiety
State anxiety after receiving the triage result
|
14.1 score on a scale
Standard Deviation 14.11
|
13.4 score on a scale
Standard Deviation 12.55
|
14.1 score on a scale
Standard Deviation 13.65
|
|
State Anxiety
State anxiety after one year of the triage result
|
9.8 score on a scale
Standard Deviation 10.79
|
10.8 score on a scale
Standard Deviation 11.76
|
9.5 score on a scale
Standard Deviation 11.38
|
SECONDARY outcome
Timeframe: Two years between the enrolment and the exit visitPopulation: This is a nested analysis that included 394 subjects of the ASCUS-COL trial (142 in COLPOSCOPY, 103 in CYTOLOGY, and 149 HPV) who accepted to participate and completed the follow-up of three measurements over time.
This outcome was measured using the HPV Impact Profile (HIP) scale through the following five domains: concerns about cancer and loss of fertility; emotional impact (depression and anxiety); self-image; interaction with the medical staff (pain or discomfort during the visit); and impact upon the life and its control. The response to each domain was measured on a scale from 0 to 10 (0=not at all, 1-3=a little, 4-6=somewhat, 7-9=a great deal, 10=extremely) and was then transformed to a scale from 0 to 100. A total score was calculated by adding all the items. Values \<40 indicate no or little impact, between 40 and 70 moderate impact, and \>70 indicate high psychosocial impact. This outcome was measured at the enrollment visit, between two weeks and two months after receiving the triage result, and after one year of receiving the triage result.
Outcome measures
| Measure |
COLPOSCOPY
n=142 Participants
Women with ASC-US cytology are immediately refer to colposcopy
COLPOSCOPY: Colposcopy routine health services
|
CYTOLOGY
n=103 Participants
Women with ASC-US Cytology are follow-up with cytology at 6 and/or 12 months and be referred to colposcopy if any of these cytologies is ASC-US or higher
COLPOSCOPY: Colposcopy routine health services
cytology: Cytology routine health services
|
HPV Test
n=149 Participants
Women with ASC-US cytology are HPV tested and those HPV positive are refer to Colposcopy
HPV test: QIAGEN - The Digene HPV test®
COLPOSCOPY: Colposcopy routine health services
|
|---|---|---|---|
|
Concerns About Fertility, Cancer, and Gynecological Health
Concerns at enrollment
|
35.3 score on a scale
Standard Deviation 15.23
|
38.1 score on a scale
Standard Deviation 15.45
|
36.0 score on a scale
Standard Deviation 14.72
|
|
Concerns About Fertility, Cancer, and Gynecological Health
Concerns after receiving the triage result
|
25.0 score on a scale
Standard Deviation 16.48
|
25.7 score on a scale
Standard Deviation 15.42
|
27.2 score on a scale
Standard Deviation 18.11
|
|
Concerns About Fertility, Cancer, and Gynecological Health
Concerns after one year of the triage result
|
18.7 score on a scale
Standard Deviation 13.07
|
18.4 score on a scale
Standard Deviation 14.38
|
17.9 score on a scale
Standard Deviation 12.79
|
Adverse Events
COLPOSCOPY
CYTOLOGY
HPV Test
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