Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention in Women Living With HIV
Condition: Cervical Cancer; HPV Infection; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Papillomavirus Infections; Uterine Cervical Neoplasms
Study type: Observational

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.
    

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.
    

Observational model: Cohort
Time perspective: Prospective
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.
      
Biospecimen description: 
      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.
    
Keywords: HPV infection; Women; HIV Infection; Cervical cancer; Screening