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Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention in Women Living With HIV (REACH UP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155294
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Collaborator:
British HIV Association (BHIVA)
Information provided by (Responsible Party):
University of Oxford

Brief 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. 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.

Condition or disease
Cervical Cancer HPV Infection HIV Infections

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.

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention (REACH UP): a Feasibility Study in Women Living With HIV
Actual Study Start Date : October 28, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Rates of enrolment [ Time Frame: baseline ]
    Proportion of eligible women on all the women attending the Clinic

  2. Response rate to questionnaires [ Time Frame: 1 year ]
    Proportion of questionnaires completed

  3. Feasibility of self-sampling [ Time Frame: 1 year ]
    Proportion of HR-HPV self-sample tests returned

  4. Participants retention rate [ Time Frame: 1 year ]
    Proportion of patients who complete the study procedures

  5. 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

  6. 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

  7. 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


Biospecimen Retention:   Samples With DNA
Mucosal cells obtained by a vaginal swabs will be stored in Microbiology lab before analysis. Specimens will be destroyed after the study analysis if performed according to local regulation.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   gender at birth
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155294


Contacts
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Contact: Paola Cicconi +4401865611413 ext 11413 paola.cicconi@ndm.ox.ac.uk
Contact: Lucy Dorrell lucy.dorrell@ndm.ox.ac.uk

Locations
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United Kingdom
Oxford University Hospital NHS Foundation Trust Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Paola Cicconi    +4401865611413 ext +4401865611413    paola.cicconi@ndm.ox.ac.uk   
Contact: Lucy Dorrell       lucy.dorrell@ndm.ox.ac.uk   
Principal Investigator: Paola Cicconi         
Royal Free Hospital Nhs Foundation Trust Recruiting
London, United Kingdom, NW3 2QG
Contact: Fiona Burns       f.burns@ucl.uk   
Principal Investigator: Fiona Burns         
GUY's AND ST THOMAS' NHS FOUNDATION TRUSTS Not yet recruiting
London, United Kingdom, SE1 9RT
Contact: Julie Fox       julie.fox@kcl.ac.uk   
Principal Investigator: Julie Fox         
ROYAL BERKSHIRE NHS FOUNDATION TRUST, Upton Hospital, Albert Street Not yet recruiting
Slough, United Kingdom, SL1 2BJ
Contact: Nisha Pal       Nisha.Pal@berkshire.nhs.uk   
Principal Investigator: Nisha Pal         
Sponsors and Collaborators
University of Oxford
British HIV Association (BHIVA)
Investigators
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Principal Investigator: Paola Cicconi University of Oxford
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT04155294    
Other Study ID Numbers: IRAS Reference 259611
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
HPV infection
Women
HIV Infection
Cervical cancer
Screening
Additional relevant MeSH terms:
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Infection
Communicable Diseases
HIV Infections
Papillomavirus Infections
Uterine Cervical Neoplasms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
DNA Virus Infections
Tumor Virus Infections