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NCT Number: NCT04155294

Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention 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.

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Key information

Conditions

Cervical Cancer Blood-Borne Infections Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HIV Infections HPV Infection Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

25 year–64 year

Sex eligibility

Female

Study type

Observational

Primary location

Oxford University Hospital NHS Foundation Trust, Oxford, Oxfordshire, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • British HIV Association (BHIVA)

Registry information

Official study title

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

Acronym: REACH-UP

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 7, 2019
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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