Part 1: Clinical results
HPV self-sampling kits were distributed from September 2016 to June 2018 (21 months). The 215 women (80.8% of the targeted sample) that agreed to participate were all eligible and completed the HPV self-sample. Participation was highest amongst women aged 25-29 years (Figure 2).
One-fifth of participants (21.4%; 46) self-reported that they had never completed a Pap test and 32.1% (69) had previously completed a Pap test but more than 4 years ago, with the range since last Pap test being 4 to 20 years (Figure 3). A total of 26.0% (56) of participating women reported that they had been screened, but could not remember when, suggesting that it was more than 4 years ago. Of the 34 (15.8%) women that had been screened in the previous 4 years, all but thirteen (6%) had not been screened in the previous two years, and thus were due for screening. Last screen was not recorded or was unknown for 10 (4.7%) participants.
Eighteen percent (18.1%; 39) of women had a positive result: 4.2% (9) were HPV Positive 16/18 and 14% (30) HPV Positive other (defined as a high risk HPV type other than 16 or 18). Seventy-eight percent (78%; 168) had a negative result (two of which were the results of a second screen as the initial result was invalid), and 3.7% (8) had invalid results and did not complete a rescreen. Stratification by age group showed that women who tested positive were distributed across all of the age groups (Table 1).
Table 1: HPV test results stratified by age group
HPV Test Result
|
Negative
|
Positive for HPV 16/18 type
|
Positive for a type other than HPV 16/18
|
Age Group
|
|
|
|
< 25 years
|
8 (4.8%)
|
0
|
5 (12.8%)
|
25-29 years
|
27 (16.1%)
|
1 (11.1%)
|
10 (25.6%)
|
30-34 years
|
27 (16.1%)
|
1 (11.1%)
|
4 (10.3%)
|
35-39 years
|
22 (13.1%)
|
2 (22.2%)
|
6 (15.4%)
|
40-44 years
|
20 (11.9%)
|
0
|
5 (12.8%)
|
45-49 years
|
19 (11.3%)
|
2 (22.2%)
|
3 (7.7%)
|
50-54 years
|
18 (10.7%)
|
1 (11.1%)
|
2 (5.1%)
|
55-59 years
|
11 (6.5%)
|
0
|
2 (5.1%)
|
60-64 years
|
12 (7.1%)
|
2 (22.2%)
|
2 (5.1%)
|
65 years and over
|
4 (2.4%)
|
0
|
0
|
Eight of the nine women (88.9%) with a HPV Positive 16/18 result had attended a colposcopy appointment by mid-July 2018. The other woman failed to attend her appointments due to documented clinical and other issues. Just under half (46.7%; 14) of the women with a HPV Positive other result had attended an appointment for a cervical screen by mid-July 2018 when this study ended. Attendance at follow-up appointments was relatively similar regardless of cervical screening history (Figure 4).
Part 2: Women’s satisfaction and feedback
Almost all women (92.6%; 199) completed the follow-up evaluation survey. One completed the survey twice as her initial result was invalid (200 total surveys). More than 90% of women were highly satisfied with the HPV self-sampling kit and the process involved (Table 2). In response to whether results were presented in an easy to understand format, 13.2% (23) were unsatisfied or very unsatisfied. Further, some women that were highly satisfied with the format of results commented that they were unable to interpret the paper copy independently, but the PHCN explained the results well:
“The pathology made no sense to me but when the Nurse called and discussed I understood them”
Table 2: Participating women’s level of satisfaction with the HPV self-sampling program
Aspects of the self-sampling program
|
(5) very satisfied
|
(4) satisfied
|
(3) neither satisfied/ dissatisfied
|
(2) dissatisfied
|
(1) very dissatisfied
|
1.1 HPV self-sampling kit
|
|
|
|
|
|
The kit provided everything to complete the self-sampling test? (n=200)
|
199 (99.5%)
|
1 (0.5%)
|
-
|
-
|
-
|
Satisfaction with the self-sampling instructions (n=200)
|
196 (98.0%)
|
1 (0.5%)
|
1 (0.5%)
|
-
|
2 (1%)
|
1.2 HPV self-sampling process
|
|
|
|
|
|
Process clearly explained by the CEW (n=197)
|
188 (95.4%)
|
5 (2.5%)
|
3 (1.5%)
|
1 (0.5%)
|
-
|
Able to ask questions and receive answers in a timely manner? (n=186a)
|
183 (98.4%)
|
2 (1.1%)
|
-
|
1 (0.5%)
|
-
|
The process was simple (n=197)
|
187 (94.9%)
|
4 (2%)
|
4 (2%)
|
-
|
2 (1.0%)
|
Provided with privacy and confidentiality (n=197)
|
182 (92.4%)
|
6 (3.0%)
|
7 (3.6%)
|
2 (1.0%)
|
-
|
1.3 Results
|
|
|
|
|
|
Results were provided in an easy to understand format (n=174b)
|
136 (78.2%)
|
6 (3.4%)
|
9 (5.2%)
|
3 (1.7%)
|
20 (11.5%)
|
|
<2 weeks
|
<3 weeks
|
>3 weeks
|
Unsure
|
Not at time PHCN made contactc
|
Mailed results returned within 2 weeks (n=195)
|
148 (75.9%)
|
13 (6.7%)
|
6 (3.1%)
|
13 (6.7%)
|
15 (7.7%)
|
a Eight participants said they did not need to ask questions and six did not respond to this question.
b Some participants had not yet received results and thus not applicable or did not respond to this question.
c The hard copy paper results were not yet received by the participant at the time the PHCN provided the results verbally over the phone (this may have been within two weeks of the self-sampling test).
The majority of participants (96.0%; 192) would use the HPV self-sampling kit again. Of the six women who stated they would not use it again, four were referred to the GP for a pap test and would thus go directly to the GP next time, and two experienced difficulties completing the sample. Almost all women (98.5%; 197) would recommend the HPV self-sampling kit to other women.
Women were grateful of, and highly satisfied with, the service (Table 3). There was overwhelming agreement that self-sampling removed the shame, intimidation, embarrassment, and pain that has historically been associated with clinician-collected Pap tests. Positive aspects included the ability to complete the test in the home, and thus the accessibility and privacy of cervical screening; the simplicity of the test; being in charge of Women’s business (an important consideration in Aboriginal culture where certain aspects of life are performed separately and termed Men’s and Women’s business17 – cervical screening falls into this category); the appropriateness of the self-sampling kit contents, with the exception of there not being a non-transparent bag to return the swab in; and the professionalism of the PHCN. Women felt they would not have completed cervical screening had this service not been available.
“I could do it myself. No pain. I ended up having to go to the GP for a Pap test but I would have never done that if I didn’t have a self-sample, may have saved my life. I recommend this to everyone. The government needs to give all women the choice to self-sample”
Table 3: Participating women’s experiences with HPV self-sampling
Themes
|
Description
|
Location of self-sample
|
In the home: Women felt it was a more private, confidential and comfortable experience; they could complete it without embarrassment and shame.
|
|
Out of the home: There was mixed feelings regarding privacy and confidentiality when completed out of the home (e.g. park, LALC, mother’s groups).
|
Accessible
|
Accessible (in the home) and free. No need to travel long distances for a female GP, or wait and pay at a General Practice.
|
Privacy and confidentiality – shame and embarrassment
|
Self-sampling was private and confidential, with no shame or embarrassment. Women did not feel violated or lose their dignity.
|
Simplicity
|
Self-sampling was described as simple, easy, convenient, quick, and not too daunting.
Several women experienced some difficulty completing the test themselves.
|
In charge of Aboriginal women’s business*
|
Women felt a sense of control over their own women’s business, health and wellbeing. Women found it to be a positive and personal experience, and they felt comfortable and at ease.
|
Comparison of HPV self-sampling to Pap test
|
Pap test – uncomfortable, painful, humiliating, daunting, shameful, embarrassing, degrading, intimidating, not confidential. Women do not like going to the Doctor and do not want a man involved in women’s business.
HPV self-sampling – easier, more private, discreet, comfortable, personal, dignified, appropriate, and quicker. Not as intrusive, evasive or awkward.
|
Self-sampling kit contents
|
High importance was place on the quality of the instruction cards:
- They were clear, easy to understand, straight forward – not having to sift through unnecessary readings.
- Illustrations for black women were good.
In the case a woman could not read, the Nurse could clearly explain the process and the picture cards supported this.
|
|
The women were happy they could keep the case the kit came in.
|
|
A non-transparent bag needs to be included in the kit for the sample to be returned to improve privacy and remove any shame.
|
The PHCN gave the women confidence in the service being professional
|
Women placed high importance on a trained professional (i.e. the PHCN) being present throughout the program, giving them confidence that it was accurate and professional. Some women would have preferred the PHCN (instead of the CEW) to explain the kit/process and take the completed sample.
|
Verbal communication of results
|
Women appreciated the verbal communication of results from the PHCN, particularly as many women could not understand them. This was described as ‘caring’ and gave women confidence in the entire program.
|
Unlikely that women would have completed a cervical screen had the HPV self-sampling test not been offered
|
Women commented on: never having completed a cervical screen until participating in this study; being hesitant, reluctant, frightened, or scared to go to the Doctor to have a cervical screen, even in the case that one woman had a family history of cervical cancer and understood the risks; postponing Pap tests, with women suggesting anywhere between 1 and 20 years before they thought they would be screened again.
|
Grateful of a potential lifesaving experience
|
Women (irrelevant of results) were grateful and happy they had been offered the self-sampling kit, and that it could have saved their lives.
|
Initial concerns with the Program
|
Women were not always forthcoming to completing the self-sampling, describing that they were initially nervous (e.g. unsure of accuracy of the test; previous painful experience with a pap test; worried of a positive result). However, these comments were followed by positive feedback about the test and increased confidence to complete the test next time.
|
* In Aboriginal culture, certain aspects of life are performed separately for men and women, and are termed Men’s business and Women’s business17; cervical screening and related items fall into this category