NCT04587050: SHiP

Screening for HPV and Cervical Cancer in Young Women With Perinatally Acquired HIV

Completed Results posted Last updated 10 December 2024

What this trial tests

trial testing Human papillomavirus testing in HIV Infections in 57 participants. Completed in 30 June 2023.

Timeline

19 July 2021

Primary endpoint
30 June 2023

30 June 2023

Quick facts

Lead sponsor	Imperial College London
Status	Completed
Study type	OBSERVATIONAL
Enrollment	57
Start date	19 July 2021
Primary completion	30 June 2023
Estimated completion	30 June 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• Human papillomavirus testing
• Cervical cytology
• HPV serology

Conditions studied

• HIV Infections — all drugs for HIV Infections →
• Human Papillomavirus Infection — all drugs for Human Papillomavirus Infection →
• Cervical Cancer — all drugs for Cervical Cancer →

Sponsor

Imperial College London

Who can join

18 and older, female only, with HIV Infections or Human Papillomavirus Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Prevalence of Abnormal Cervical Cytology Primary · 1 year

Cervical sample taken in the clinic setting and sent to the laboratory for cytological examination. Prevalence of abnormal cytology is reported as the number of samples that had a non-normal cytology result (e.g. dyskaryotic cells) out of the total number tested

Group	Value	95% CI
Cohort 1: Women Living With HIV Who Are Sexually Active	12

Prevalence of High Risk HPV by Subtype Secondary · 1 year

Cervical sample taken in the clinic setting and tested for high-risk HPV on site using the Cepheid GeneXpert. Prevalence reported as the number of samples that were positive for any high-risk HPV out of all those tested

Group	Value	95% CI
Cohort 1:Women Living With HIV Who Are Sexually Active	2
Cohort 1:Women Living With HIV Who Are Sexually Active	0
Cohort 1:Women Living With HIV Who Are Sexually Active	12
Cohort 1:Women Living With HIV Who Are Sexually Active	32

Prevalence of CIN2+ Secondary · 1 year

Participants with abnormal cytology and/or tested positive for high-risk HPV were referred for colposcopy. Prevalence reported as the number of participants who were diagnosed with CIN2+

Group	Value	95% CI
Cohort 1:Women With HIV Sexually Active	1

HPV Serology (16/18) Secondary · 1 year

Number of participants testing positive for HPV 16 and 18 antibodies out of the those tested

HPV 16 positive serology

Group	Value	95% CI
Cohort 1: Women Living With HIV Who Are Not Sexually Active	44
Cohort 2: Women Living With HIV Who Are Not Sexually Active	1

HPV 18 positive serology

Group	Value	95% CI
Cohort 1: Women Living With HIV Who Are Not Sexually Active	34
Cohort 2: Women Living With HIV Who Are Not Sexually Active	0

Sponsor's own description

This is a cross-sectional, observational study of high-risk HPV status, cervical cytology and HPV vaccine uptake and response in young women with perinatally acquired HIV.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The effect of non-AIDS-defining cancers on people living with HIV.
   Chiao EY, Coghill A, Kizub D, Fink V, et al · · 2021 · cited 60× · PMID 34087151 · DOI 10.1016/s1470-2045(21)00137-6
2. High-risk human papillomavirus prevalence and serostatus in a cohort of cisgender women and people with a cervix living with perinatally acquired HIV.
   Henderson M, Lyons D, Beddows S, Cowen M, et al · · 2025 · cited 3× · PMID 39999769 · DOI 10.1111/hiv.70001
3. State-of-the-Science of human papillomavirus vaccination in women with human immunodeficiency Virus: Summary of a scientific workshop.
   Schuind AE, Rees H, Schiller J, Mugo N, et al · · 2023 · cited 3× · PMID 37576844 · DOI 10.1016/j.pmedr.2023.102331