HIV InfectionsSHiPNCT04587050
Screening for HPV and Cervical Cancer in Young Women With Perinatally Acquired HIV
An observational study of HIV Infections and Human Papillomavirus Infection, run by Imperial College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infections, Human Papillomavirus Infection, Cervical Cancer
- What is being tested?
- Human papillomavirus testing, Cervical cytology and HPV serology
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jul 2021to 30 Jun 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women living with perinatally acquired HIV aged 18 years or older
Who may be able to join
- Perinatally acquired HIV aged 18+
- Sexually active
- Able to give informed consent
- Perinatally acquired HIV aged 18+
- Able to give informed consent
Who cannot join
- Pregnancy
- Not sexually active
- Previous total abdominal hysterectomy
- Unable to give informed consent
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for Human Papillomavirus and Cervical Cancer in Young Women With Perinatally Acquired HIV
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.
Read the detailed description
This is an observational study of cervical cytology assessment, high risk human papilloma virus (hr-HPV) status, and HPV antibody titres amongst adult women living with perinatally acquired HIV infection (PaHIV). Eligible consenting participants will have two samples taken; firstly, a cervical sample tested for cytology and Hr-HPV with the Cepheid GeneXpert HPV; secondly serum will be assessed for hr-HPV serology. All women with PaHIV, vaccinated and unvaccinated for HPV, over the age of 18 years will be eligible and will be recruited into one of two cohorts: (1) sexually active women: full study, cervical and blood sampling or (2) non-sexually active women, blood sampling only (total n=80). Follow up for abnormal smear results or hr-HPV positivity will be arranged through colposcopy.
- Being tested
- Human papillomavirus testing, Cervical cytology, HPV serology
- Keywords
- Cervical screening, HPV vaccination
- Medical subject headings
- HIV Infections, Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human papillomavirus testingDiagnostic test
HPV test from cervical sample using Cepheid GeneXpert HPV
Cervical cytologyDiagnostic test
Cervical cytology
HPV serologyDiagnostic test
HPV type specific serology (16/18) using ELISA from serum samples
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Women with HIV sexually active | Women with perinatally acquired HIV aged 18 or over who are sexually active Receives: Diagnostic Test: Human papillomavirus testing; Diagnostic Test: Cervical cytology; Diagnostic Test: HPV serology | |
| Cohort 2: Women with HIV not sexually active | Women with perinatally acquired HIV aged 18 or over who are not sexually active Receives: Diagnostic Test: HPV serology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Abnormal Cervical Cytology
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
Measured: 1 year
Secondary outcomes (3)
Prevalence of High Risk HPV by Subtype
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
Measured: 1 year
Prevalence of CIN2+
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+
Measured: 1 year
HPV Serology (16/18)
Number of participants testing positive for HPV 16 and 18 antibodies out of the those tested
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start19 Jul 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health England
- Responsible party
- Sponsor
- Investigators
- Tamara Elliott, Study chair, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587050
- Sponsor's protocol ID
- 19SM5242
- Acronym
- SHiP
- Status last verified
- Dec 2024
- First submitted
- 7 Oct 2020
- Last updated
- 10 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Human Papillomavirus and Cervical Cancer in Young Women With Perinatally Acquired HIV
- ClinicalTrials.gov ID
- NCT04587050
- Acronym / sponsor ID
- SHiP / 19SM5242
- Keywords
- Cervical screening, HPV vaccination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Public Health England
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 10 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an observational study of cervical cytology assessment, high risk human papilloma virus (hr-HPV) status, and HPV antibody titres amongst adult women living with perinatally acquired HIV infection (PaHIV). Eligible consenting participants will have two samples taken; firstly, a cervical sample tested for cytology and Hr-HPV with the Cepheid GeneXpert HPV; secondly serum will be assessed for hr-HPV serology. All women with PaHIV, vaccinated and unvaccinated for HPV, over the age of 18 years will be eligible and will be recruited into one of two cohorts: (1) sexually active women: full study, cervical and blood sampling or (2) non-sexually active women, blood sampling only (total n=80). Follow up for abnormal smear results or hr-HPV positivity will be arranged through colposcopy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Women with HIV sexually active | – | Diagnostic Test: Human papillomavirus testing, Diagnostic Test: Cervical cytology, Diagnostic Test: HPV serologyWomen with perinatally acquired HIV aged 18 or over who are sexually active |
| Cohort 2: Women with HIV not sexually active | – | Diagnostic Test: HPV serologyWomen with perinatally acquired HIV aged 18 or over who are not sexually active |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women living with perinatally acquired HIV aged 18 years or older
Key inclusion criteria (5 listed)
- Perinatally acquired HIV aged 18+
- Sexually active
- Able to give informed consent
- Perinatally acquired HIV aged 18+
- Able to give informed consent
Key exclusion criteria (5 listed)
- Pregnancy
- Not sexually active
- Previous total abdominal hysterectomy
- Unable to give informed consent
- Unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human papillomavirus testingHPV test from cervical sample using Cepheid GeneXpert HPV | Diagnostic test | Cohort 1: Women with HIV sexually active |
| Cervical cytologyCervical cytology | Diagnostic test | Cohort 1: Women with HIV sexually active |
| HPV serologyHPV type specific serology (16/18) using ELISA from serum samples | Diagnostic test | Cohort 1: Women with HIV sexually active, Cohort 2: Women with HIV not sexually active |
Primary outcome
Prevalence of Abnormal Cervical Cytology
Time frame: 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
3 secondary outcomes
Prevalence of High Risk HPV by Subtype
Time frame: 1 year
Prevalence of CIN2+
Time frame: 1 year
HPV Serology (16/18)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Elliott study chair
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Human Papillomavirus Infection, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Abnormal Cervical Cytology (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.