Clinical trial · Observational
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 (REACH-UP): a Feasibility Study in Women Living With HIV
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| HIV Infections | — | UNRESOLVED | — |
| HPV Infection | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prevalence of HR HPV in WLWH aged 25-64 years in the UK
- timeFrame
- baseline
- description
- HPV DNA detected by PCR on vaginal self-taken swab
Secondary outcomes (7)
- measure
- Rates of enrolment
- timeFrame
- baseline
- description
- Proportion of eligible women on all the women attending the Clinic
- measure
- Response rate to questionnaires
- timeFrame
- 1 year
- description
- Proportion of questionnaires completed
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available