NCT04587050

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

July 19, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 10, 2024

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

1.9 years

First QC Date

October 7, 2020

Results QC Date

July 18, 2024

Last Update Submit

December 2, 2024

Conditions

HIV InfectionsHuman Papillomavirus InfectionCervical Cancer

Keywords

Cervical screeningHPV vaccination

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (3)

  • Prevalence of High Risk HPV by Subtype

    1 year

  • Prevalence of CIN2+

    1 year

  • HPV Serology (16/18)

    1 year

Study Arms (2)

Cohort 1: Women with HIV sexually active

Women with perinatally acquired HIV aged 18 or over who are sexually active

Diagnostic Test: Human papillomavirus testingDiagnostic Test: Cervical cytologyDiagnostic 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

Diagnostic Test: HPV serology

Interventions

Human papillomavirus testingDIAGNOSTIC_TEST

HPV test from cervical sample using Cepheid GeneXpert HPV

Cohort 1: Women with HIV sexually active
Cervical cytologyDIAGNOSTIC_TEST

Cervical cytology

Cohort 1: Women with HIV sexually active
HPV serologyDIAGNOSTIC_TEST

HPV type specific serology (16/18) using ELISA from serum samples

Cohort 1: Women with HIV sexually activeCohort 2: Women with HIV not sexually active

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women living with perinatally acquired HIV aged 18 years or older

You may qualify if:

  • Perinatally acquired HIV aged 18+
  • Sexually active
  • Able to give informed consent
  • Perinatally acquired HIV aged 18+
  • Able to give informed consent

You may not qualify if:

  • Pregnancy
  • Not sexually active
  • Previous total abdominal hysterectomy
  • Unable to give informed consent
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum blood samples

MeSH Terms

Conditions

HIV InfectionsPapillomavirus InfectionsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDNA Virus InfectionsTumor Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Results Point of Contact

Title
Dr Tamara Elliott
Organization
Imperial College london
te04@ic.ac.uk
02075946230

Study Officials

  • Tamara Elliott

    Imperial College London

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 14, 2020

Study Start

July 19, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

December 10, 2024

Results First Posted

December 10, 2024

Record last verified: 2024-12

Locations

GB(1)