Cervical CancerREACH-UPNCT04155294
Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention in Women Living With HIV
An observational study of Cervical Cancer and HPV Infection, run by University of Oxford at 6 sites in United Kingdom.
Trial summary
Current British HIV Association (BHIVA) guidelines recommend annual cervical screening (with a cervical smear) for women living with HIV (WLWH). NHS guidelines for women in England will, however, change soon. Read more about this study
- Who is it for?
- Ages 25 to 64 years, women only
- Conditions the study is for
- Cervical Cancer, HPV Infection, HIV Infections
- How many people
- 71 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 28 Oct 2019to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- Women only
- No healthy volunteers
- Adult
Study population: Women aged 25-64 years living with HIV for at least 6 months with annual cervical smear due, in accordance with national guidelines. The majority of HIV women >25 years in 2019 will not have been vaccinated against HPV.
Who may be able to join
- Women aged 25-64
- HIV diagnosis ≥ 6 months
- No previous diagnosis of CIN 2/3 and/or treatment for cervical dysplasia
- Last smear test done ≥1 year before baseline
- Able to speak and understand English
- Willing and able to provide informed consent
Who cannot join
- Suspected or known invasive cervical malignancy
- Currently pregnant or breast-feeding
- Any other condition, which, in the opinion of the Investigator, would make participation in the study unsafe or interfere with interpretation of the study outcomes.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Buckinghamshire Healthcare NHS Trust
High Wycombe
Royal Free Hospital Nhs Foundation Trust
London, NW3 2QG
GUY's AND ST THOMAS' NHS FOUNDATION TRUSTS
London, SE1 9RT
Milton Keynes University NHS Foundation Trust
Milton Keynes
Oxford University Hospital NHS Foundation Trust
Oxford, Oxfordshire, OX3 9DU
ROYAL BERKSHIRE NHS FOUNDATION TRUST, Upton Hospital, Albert Street
Slough, SL1 2BJ
About this study
Official title: Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention (REACH-UP): a Feasibility Study in Women Living With HIV
Current British HIV Association (BHIVA) guidelines recommend annual cervical screening (with a cervical smear) for women living with HIV (WLWH). NHS guidelines for women in England will, however, change soon. Women will initially be tested for human papilloma virus (HPV), a virus which causes virtually all cervical cancer. Only those who are infected with HPV will then undergo the smear testing. The BHIVA guidelines, however, taking the view that HIV infection (and its ability to weaken the immune system) increases the risk of persistent HPV infection and of cancer in those who are infected, consider safer for all WLWH to go straight to annual smear testing. Most WLWH in the UK are now receiving treatment which protects their immune system - this suggests that less WLWH could be HPV infected. The identification of a group of WLWH who could benefit from less frequent screening could improve quality of life, and allow the NHS to reduce unnecessary tests and costs. A large study is needed to collect robust evidence that would support changes to standard practice. Before investing huge resources, the investigators need to know if a study would be feasible, conducting a pilot study on 70 WLWH aged 25-64, regularly attending clinics for HIV care. Participants will be asked to complete an entry survey and they will undergo routine cervical smears (baseline and after 1 year). At baseline, after six months, and one year women will take their own vaginal swabs for the detection of HR-HPV. An exit questionnaire will be undertaken at the last visit.
Read the detailed description
This pilot study will enrol 70 WLWH aged 25-64, with no history of cervical abnormalities attending 4 HIV clinics in the UK. Participants will be asked to complete an entry survey in which behavioural information, gynaecological and sexual history, will be collected, with the aim of characterising the study population for the risk factors of HPV infection. Women's attitude towards the current cervical screening and their view on a change to HPV testing will also be assessed. Participants' relevant clinical data will be collected form their medical notes. Women will be instructed to perform a self-taken vaginal swab for the detection of HR HPV while in clinic, and they will be reminded of the annual cervical smear (which can be offered in clinic or performed at their GP practice as per local policy). After six months, women will be asked to take another vaginal swab; this can be offered in clinic, during the regular HIV follow up, or can be sent via the post. Another sample for HR-HPV testing will be collected one year later, at the next routine HIV appointment. The annual smear test will be due and this will be offered in clinic or done at the GP practice, according to local policies. After this visit, an exit questionnaire will be undertaken to evaluate the acceptability of the study procedures.
- Conditions
- Cervical Cancer, HPV Infection, HIV Infections
- Keywords
- HPV infection, Women, HIV Infection, Cervical cancer, Screening
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections, HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of HR HPV in WLWH aged 25-64 years in the UK
HPV DNA detected by PCR on vaginal self-taken swab
Measured: baseline
Secondary outcomes (7)
Rates of enrolment
Proportion of eligible women on all the women attending the Clinic
Measured: baseline
Response rate to questionnaires
Proportion of questionnaires completed
Measured: 1 year
Feasibility of self-sampling
Proportion of HR-HPV self-sample tests returned
Measured: 1 year
Participants retention rate
Proportion of patients who complete the study procedures
Measured: 1 year
Acceptability of study procedures including self-taken vaginal swabs
questionnaire containing closed and opened questions and visual scale from 0 to 100, higher score indicate a better outcome
Measured: 1 year
Awareness of cervical cancer risk
questionnaire containing closed and opened questions and visual scale from 0 to 100, where higher scores indicate a better outcome
Measured: baseline
Compliance to standard screening procedures
questionnaire containing closed and opened questions and visual scale from 0 to 100, where higher scores indicate a better outcome
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start28 Oct 2019
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- British HIV Association (BHIVA)
- Responsible party
- Sponsor
- Investigators
- Paola Cicconi, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155294
- Sponsor's protocol ID
- IRAS Reference 259611
- Acronym
- REACH-UP
- Status last verified
- May 2022
- First submitted
- 18 Oct 2019
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention (REACH-UP): a Feasibility Study in Women Living With HIV
- ClinicalTrials.gov ID
- NCT04155294
- Acronym / sponsor ID
- REACH-UP / IRAS Reference 259611
- Conditions
- Cervical Cancer, HPV Infection, HIV Infections
- Keywords
- HPV infection, Women, HIV Infection, Cervical cancer, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- British HIV Association (BHIVA)
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current British HIV Association (BHIVA) guidelines recommend annual cervical screening (with a cervical smear) for women living with HIV (WLWH). NHS guidelines for women in England will, however, change soon. Women will initially be tested for human papilloma virus (HPV), a virus which causes virtually all cervical cancer. Only those who are infected with HPV will then undergo the smear testing. The BHIVA guidelines, however, taking the view that HIV infection (and its ability to weaken the immune system) increases the risk of persistent HPV infection and of cancer in those who are infected, consider safer for all WLWH to go straight to annual smear testing. Most WLWH in the UK are now receiving treatment which protects their immune system - this suggests that less WLWH could be HPV infected. The identification of a group of WLWH who could benefit from less frequent screening could improve quality of life, and allow the NHS to reduce unnecessary tests and costs. A large study is needed to collect robust evidence that would support changes to standard practice. Before investing huge resources, the investigators need to know if a study would be feasible, conducting a pilot study on 70 WLWH aged 25-64, regularly attending clinics for HIV care. Participants will be asked to complete an entry survey and they will undergo routine cervical smears (baseline and after 1 year). At baseline, after six months, and one year women will take their own vaginal swabs for the detection of HR-HPV. An exit questionnaire will be undertaken at the last visit.
Detailed description
This pilot study will enrol 70 WLWH aged 25-64, with no history of cervical abnormalities attending 4 HIV clinics in the UK. Participants will be asked to complete an entry survey in which behavioural information, gynaecological and sexual history, will be collected, with the aim of characterising the study population for the risk factors of HPV infection. Women's attitude towards the current cervical screening and their view on a change to HPV testing will also be assessed. Participants' relevant clinical data will be collected form their medical notes. Women will be instructed to perform a self-taken vaginal swab for the detection of HR HPV while in clinic, and they will be reminded of the annual cervical smear (which can be offered in clinic or performed at their GP practice as per local policy). After six months, women will be asked to take another vaginal swab; this can be offered in clinic, during the regular HIV follow up, or can be sent via the post. Another sample for HR-HPV testing will be collected one year later, at the next routine HIV appointment. The annual smear test will be due and this will be offered in clinic or done at the GP practice, according to local policies. After this visit, an exit questionnaire will be undertaken to evaluate the acceptability of the study procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women aged 25-64 years living with HIV for at least 6 months with annual cervical smear due, in accordance with national guidelines. The majority of HIV women >25 years in 2019 will not have been vaccinated against HPV.
Key inclusion criteria (6 listed)
- Women aged 25-64
- HIV diagnosis ≥ 6 months
- No previous diagnosis of CIN 2/3 and/or treatment for cervical dysplasia
- Last smear test done ≥1 year before baseline
- Able to speak and understand English
Key exclusion criteria (3 listed)
- Suspected or known invasive cervical malignancy
- Currently pregnant or breast-feeding
- Any other condition, which, in the opinion of the Investigator, would make participation in the study unsafe or interfere with interpretation of the study outcomes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of HR HPV in WLWH aged 25-64 years in the UK
Time frame: baseline
HPV DNA detected by PCR on vaginal self-taken swab
7 secondary outcomes
Rates of enrolment
Time frame: baseline
Response rate to questionnaires
Time frame: 1 year
Feasibility of self-sampling
Time frame: 1 year
Participants retention rate
Time frame: 1 year
Acceptability of study procedures including self-taken vaginal swabs
Time frame: 1 year
Awareness of cervical cancer risk
Time frame: baseline
Compliance to standard screening procedures
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola Cicconi principal investigator
University of Oxford
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and HPV Infection, run by University of Oxford at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of HR HPV in WLWH aged 25-64 years in the UK (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.