- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04155294
Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention in Women Living With HIV (REACH-UP)
May 17, 2022 updated by: University of Oxford
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
71
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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High Wycombe, United Kingdom
- Buckinghamshire Healthcare NHS Trust
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London, United Kingdom, NW3 2QG
- Royal Free Hospital NHS Foundation Trust
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London, United Kingdom, SE1 9RT
- GUY's AND ST THOMAS' NHS FOUNDATION TRUSTS
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Milton Keynes, United Kingdom
- Milton Keynes University NHS Foundation Trust
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Slough, United Kingdom, SL1 2BJ
- ROYAL BERKSHIRE NHS FOUNDATION TRUST, Upton Hospital, Albert Street
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Oxfordshire
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Oxford, Oxfordshire, United Kingdom, OX3 9DU
- Oxford University Hospital NHS Foundation Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
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.
Description
INCLUSION CRITERIA
- 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
EXCLUSION CRITERIA
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rates of enrolment
Time Frame: baseline
|
Proportion of eligible women on all the women attending the Clinic
|
baseline
|
Response rate to questionnaires
Time Frame: 1 year
|
Proportion of questionnaires completed
|
1 year
|
Feasibility of self-sampling
Time Frame: 1 year
|
Proportion of HR-HPV self-sample tests returned
|
1 year
|
Participants retention rate
Time Frame: 1 year
|
Proportion of patients who complete the study procedures
|
1 year
|
Acceptability of study procedures including self-taken vaginal swabs
Time Frame: 1 year
|
questionnaire containing closed and opened questions and visual scale from 0 to 100, higher score indicate a better outcome
|
1 year
|
Awareness of cervical cancer risk
Time Frame: baseline
|
questionnaire containing closed and opened questions and visual scale from 0 to 100, where higher scores indicate a better outcome
|
baseline
|
Compliance to standard screening procedures
Time Frame: baseline
|
questionnaire containing closed and opened questions and visual scale from 0 to 100, where higher scores indicate a better outcome
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Paola Cicconi, University of Oxford
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 28, 2019
Primary Completion (Actual)
October 31, 2021
Study Completion (Actual)
October 31, 2021
Study Registration Dates
First Submitted
October 18, 2019
First Submitted That Met QC Criteria
November 4, 2019
First Posted (Actual)
November 7, 2019
Study Record Updates
Last Update Posted (Actual)
May 24, 2022
Last Update Submitted That Met QC Criteria
May 17, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Disease Attributes
- DNA Virus Infections
- Tumor Virus Infections
- HIV Infections
- Uterine Cervical Neoplasms
- Infections
- Communicable Diseases
- Papillomavirus Infections
Other Study ID Numbers
- IRAS Reference 259611
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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