Human Papillomavirus (HPV) self-sampling among un- and under-screened Maori, Pacific and Asian women: a randomised controlled community trial to examine the effect of self-sampling on participation in cervical-cancer screening

• Register: ANZCTR
• Last refreshed on: 12 April 2021
• Main ID: ACTRN12618000367246
• Date of registration: 12/03/2018
• Prospective Registration: Yes
• Primary sponsor: Centre for Public Health Research, Massey University
• Public title: Human Papillomavirus (HPV) self-sampling among un- and under-screened Maori, Pacific and Asian women: a randomised controlled community trial to examine the effect of self-sampling on participation in cervical-cancer screening
• Scientific title: Comparison of two invitation-based methods for Human Papillomavirus (HPV) self-sampling with standard recall for usual care among un- and under-screened Maori, Pacific and Asian women: a randomised controlled community trial to examine the effect of self-sampling on participation in cervical-cancer screening
• Date of first enrolment: 08/06/2018
• Target sample size: 5598
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12618000367246.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

New Zealand

Contacts

• Name: Dr Naomi Brewer

• Name: Dr Naomi Brewer

Key inclusion & exclusion criteria

Inclusion criteria: Age 30-69
Never-screened or under-screened (at least 5 years from previous test)
Maori, Pacific or Asian ethnicity
Resident in Waitemata District Health Board (DHB), Auckland DHB or Capital & Coast DHB
Enrolled in an Auckland or Wellington general practice
Exclusion criteria: Exclusions as per New Zealand National Cervical Screening Programme Guidelines, including women:
1. who have had a benign total hysterectomy
2. who have previously or currently have cervical cancer
3. who are symptomatic (abnormal bleeding, pelvic pain, or symptoms of a sexually transmitted infection).

In addition, women:
1. who have previously had a high-grade lesion and have not attended for colposcopy (remaining at high clinical risk)
2. who are currently pregnant.


Age minimum: 30 Years
Age maximum: 69 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Cancer - Cervical (cervix)

Public Health - Health service research

Cervical-cancer screening;Human papilloma virus;Self-sampling;
Cervical-cancer screening
Human papilloma virus
Self-sampling

Infection - Other infectious diseases

Infection - Sexually transmitted infections

Public Health - Epidemiology

Intervention(s)

Assessing uptake and acceptability of a new human papilloma virus (HPV) detection method (low vaginal self-sampling with cotton swab and HPV molecular testing with the Roche cobas 4800 platform) in comparison to (minimally altered) usual care, for primary cervical-cancer screening. Invitation through the primary care clinic (monthly matched lists between primary care enrolled patient and cervical screening register is routine practice, these lists will be used for identifying eligible women). Women will be randomised to one of three arms: clinic-based self-sampling (clinic-based SS), mail-out self-sampling (mail-out SS) or usual care. Clinic-based SS women will be invited to attend the clinic, discuss the study, consent, and complete a questionnaire. Clinic-based SS women able to complete the self-sampling at the clinic (in the bathroom) during this visit or, to ensure clinical safety, they will be able to take the kit home and return it to the clinic, but this will be recorded and analysed separately. Mail-out SS women will be posted a kit (to their home) and asked to complete the consent & laboratory forms, take the sample, complete the questionnaire, and arrange (free) courier pick-up of the completed kit, or to take the completed kit to a community laboratory.
Uptake of the invitation to participate will be monitored via receipt of test results into the study IT system and, for the clinic-based SS group, via clinic attendance record. Four weeks after the invitation letters have been sent, all non-responding women will be sent a reminder text message. The reminder text message for the mail-out SS group will include a telephone number that the woman can use to request that a second sampling kit be sent. Contact details for research nurses are included in the invit

Primary Outcome(s)

Participation rate (uptake) of HPV self-sampling in both study intervention arms, in comparison with control arm (usual care; cytology). Uptake will be assessed as the proportion of eligible women who were able to be contacted, who perform/have the test and for whom a laboratory test result is received. This will be assessed by ethnicity, age, sampling group and screening history. [3 months post offer of test.]

Prevalence of high risk HPV genotypes from self-sampled low vaginal swab, as detected by the Roche cobas 4800 platform (negative, positive for HPV16/18, or positive for HPV 'other' risk risk type), and the prevalence of cervical abnormalities in the usual care group.[12 months post offer of self-sampling or cytology.]

Secondary Outcome(s)

Follow-up proportion of high risk HPV positive women for cytology with primary care provider or colposcopy at hospital clinic, as assessed by National Cervical Screening Programme Register (records all cytology and histology events), primary care electronic health records, and colposcopy clinical electronic records.[6 months post high risk HPV positive test result.]

Experience of the test, enablers/barriers of screening, and factors associated with screening preferences (from the acceptability questionnaire, described in Secondary Outcome 3).[End of study]

Number of women who opt-out of the study prior to randomisation, defined as the number of women who contact the study requesting to opt-out, after receiving their pre-invite letter but before they have been randomised. This will be recorded in the study database.[End of study]

Time for return of sample from mail-out group women (number of days from when sample taken to when sample received by laboratory).[End of study]

To determine the level of support needed to achieve the aim of at least 90% follow-up of high risk HPV positive women to attend for cytology or colposcopy.

Level of support required to ensure 90% follow-up of high risk HPV positive women will be determined using a tracking tool within the study database. Women who have a high risk HPV positive result will be flagged in the database as requiring action. The research nurses will work with the women, primary care and the support-to-services provider to ensure a high level of follow-up. Follow-up interactions/attempts will be recorded in the study database, including the type of support provided, e.g. phone calls, transport, childcare, visit attendance support, etc. Analysis at the completion of the study will determine numbers of women requiring either cytology or colposcopy and the type of support required.[6 months post high risk HPV positive result recorded on the National Cervical Screening Programme Register]

Number of women who cannot be contacted, defined as the number of women whose pre-invite letter is returned to the study marked 'gone, no address', 'return to sender' or similar. This will be recorded in the study database.[End of study]

Percentage of unsatisfactory cytology tests, HPV tests and colposcopy examinations.

The proportion of unsatisfactory HPV tests will be measured by the rate of internal control failure on Roche cobas 4800 testing. All invalid samples will be reported and a repeat sample requested. All follow-up of invalid tests will be managed by the research nurses.

The proportion of unsatisfactory cytology tests will be assessed by the proportion recorded as unsatisfactory (in accordance with New Zealand standard practice) on the National Cervical Screening Programme (NCSP) Register .

The proportion of colposcopy tests reported as unsatisfactory will be assessed by the proportion recorded as unsatisfactory (in accordance with New Zealand standard practice) on the colposcopy report.[End of study]

Association between acceptance of self-sampling and demographic and other factors, assessed through the acceptability questionnaire. The acceptability questionnaire has been specifically designed for this study. It is based on the questionnaire used for the comparable iPAP trial (ACTRN12613001104741) in Australia (with permission), however, it has been adapted to the New Zealand context following feedback from women and research nurses involved in a local feasibility study (ACTRN12616001401448 (HPV-SS)).[End of study]

Secondary ID(s)

HRC 16/405

Source(s) of Monetary Support

Health Research Council of New Zealand

Ethics review

Status: Approved
Approval date: 26/10/2017
Contact:

Northern B Health and Disability Ethics Committee

Results

• Results available: Yes
• Date Posted: 31/03/2021
• Date Completed: 04/01/2021