Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention in Women Living With HIV
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.
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.
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.