REACH UP
Research type
Research Study
Full title
Re-evaluation of Annual Cytology using HPV testing to Upgrade Prevention (REACH UP): a feasibility study in Women Living with HIV.
IRAS ID
259611
Contact name
Paola Cicconi
Contact email
Sponsor organisation
Univeristy of Oxford, Clinical Trials Reserach Governance
Duration of Study in the UK
1 years, 7 months, 29 days
Research 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. To collect robust evidence that would support changes to standard practice, we will need to conduct a large study. Before investing huge resources, we need to know if a study would be feasible. We will test the study on 70 WLWH aged 25-64, with no history of cervical abnormalities. They will be asked to complete an entry survey in which we will assess awareness of cervical cancer risk. They will undergo routine cervical smears (baseline and after 1 year) at the HIV clinic or GP practice. At baseline, after six months, and one year women will take their own vaginal swabs for the detection of HR-HPV; swabs can be sent back for testing via the post or given to the study team during the routine six-monthly HIV follow-up. An exit questionnaire will be undertaken to evaluate the acceptability of the study procedures.
Lay summary of study results: Sixty-seven of the 77 women enrolled between October2019 and March 2020 had demographic data availableand were included in analyses. The majority (86.5%)were black (African, Caribbean or British) and medianage was 47 years [interquartile range (IQR): 24–60].Their median CD4 count was 683 cells/µL (IQR: 527–910). The majority (95.4%) had HIV viral load < 50 cop-ies/mL (Table 1).Sixty-six baseline questionnaires were included in theanalysis; one questionnaire was not returned. All women except one had had at least one smear test in their life, and30 (45.5%) had at least one colposcopy. Median (IQR) ac-ceptability and perceived necessity of smear tests were 100(75– 100) and 100 (85– 100), respectively. More than half ofthe women (56.1%) reported no concerns about self-takenswabs; however, one-third reported fear of not doing itproperly or having inadequate results. Of note, 75.8% re-ported adherence to the annual cervical cancer screening,and only one reported doing smears at irregular intervals.
All women undertook the vaginal swab themselves;three (4.4%) did not perform the swab in the clinic andposted it subsequently (all the posted swabs reached thelaboratory). Three swabs did not reach the laboratory foranalysis, two leaked during shipment and could not beanalysed, and three produced indeterminate results. Ofthe 59 (88%) swabs analysed successfully, two (3.3%) werepositive for HPV18, two (3.3%) were positive for otherHR-HPV and for HPV16, and 15 (25.4%) were positive forother HR-HPV.Eighteen (27%) of the smear test results were notavailable from their NHS records, suggesting that a sig-nificant number of women self-administered the vagi-nal swab at the study visit but did not attend for theirannual smear test. Three sites did not offer the cervicalsmear routinely, and they recruited a total of 48 women.All 18 women with no smear test results were recruitedat these sites; this translates into 63% (30/48) of screen-ing uptake in women who were offered the test outsideof the HIV service. By contrast, the screening uptakewas 100% (19/19) in women recruited at the study siteswhere the smear was offered. No other differencesemerged between those with and without the cervical smear.
None of the 49 smear samples analysed as part of theNational Screening Programme was positive for HR- HPV.
However, HR-HPV was detected in 14/49 (30%) vaginal swab samples. In other words, only in 59.1% of the caseswas there concordance between the two tests (i.e both werenegative). In addition, five women with missing smearresults had positive HR-HPV on the self- administered swabs.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
19/LO/0842
Date of REC Opinion
16 Jul 2019
REC opinion
Further Information Favourable Opinion