Cervical Cancer, HIV Infections, Human Papillomavirus Infection
Conditions
Keywords
Cervical screening, HPV vaccination
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.
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.
Interventions
DIAGNOSTIC_TESTHuman papillomavirus testing
HPV test from cervical sample using Cepheid GeneXpert HPV
DIAGNOSTIC_TESTCervical cytology
Cervical cytology
DIAGNOSTIC_TESTHPV serology
HPV type specific serology (16/18) using ELISA from serum samples
Sponsors
Public Health England
Imperial College London
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Cohort 1: * Perinatally acquired HIV aged 18+ * Sexually active * Able to give informed consent Inclusion Criteria - Cohort 2: * Perinatally acquired HIV aged 18+ * Able to give informed consent
Exclusion criteria
- Cohort 1: * Pregnancy * Not sexually active * Previous total abdominal hysterectomy * Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Abnormal Cervical Cytology | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of High Risk HPV by Subtype | 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 |
| Prevalence of CIN2+ | 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+ |
| HPV Serology (16/18) | 1 year | Number of participants testing positive for HPV 16 and 18 antibodies out of the those tested |
Countries
United Kingdom
Participant flow
Pre-assignment details
Opportunistic recruitment
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Women Living With HIV Who Are Sexually Active Women with perinatally acquired HIV aged 18 or over who are sexually active
Human papillomavirus testing: HPV test from cervical sample using Cepheid GeneXpert HPV
Cervical cytology: Cervical cytology
HPV serology: HPV type specific serology (16/18) using ELISA from serum samples | 54 |
| Cohort 2:Women Living With HIV Who Are Not Sexually Active Women with perinatally acquired HIV aged 18 or over who are not sexually active
HPV serology: HPV type specific serology (16/18) using ELISA from serum samples | 3 |
| Total | 57 |
Baseline characteristics
| Characteristic | Total | Cohort 1: Women Living With HIV Who Are Sexually Active | Cohort 2:Women Living With HIV Who Are Not Sexually Active |
|---|---|---|---|
| Age, Customized 18-24 years | 24 Participants | 22 Participants | 2 Participants |
| Age, Customized 25+ years | 33 Participants | 32 Participants | 1 Participants |
| Race/Ethnicity, Customized Black ethnicity | 21 Participants | 20 Participants | 1 Participants |
| Race/Ethnicity, Customized Not stated | 22 Participants | 21 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 8 Participants | 8 Participants | 0 Participants |
| Race/Ethnicity, Customized White ethnicity | 6 Participants | 5 Participants | 1 Participants |
| Region of Enrollment United Kingdom | 57 participants | 54 participants | 3 participants |
| Sex: Female, Male Female | 57 Participants | 54 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 3 |
| other Total, other adverse events | 0 / 54 | 0 / 3 |
| serious Total, serious adverse events | 0 / 54 | 0 / 3 |
Outcome results
Primary
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
Time frame: 1 year
Population: Zero women analysed in cohort 2 as these women were not sexually active and so cervical sample was not taken as per the protocol
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Women Living With HIV Who Are Sexually Active | Prevalence of Abnormal Cervical Cytology | 12 Participants |
Secondary
HPV Serology (16/18)
Number of participants testing positive for HPV 16 and 18 antibodies out of the those tested
Time frame: 1 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Women Living With HIV Who Are Sexually Active | HPV Serology (16/18) | HPV 16 positive serology | 44 Participants |
| Cohort 1: Women Living With HIV Who Are Sexually Active | HPV Serology (16/18) | HPV 18 positive serology | 34 Participants |
| Cohort 2: Women Living With HIV Who Are Not Sexually Active | HPV Serology (16/18) | HPV 16 positive serology | 1 Participants |
| Cohort 2: Women Living With HIV Who Are Not Sexually Active | HPV Serology (16/18) | HPV 18 positive serology | 0 Participants |
Secondary
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+
Time frame: 1 year
Population: Zero samples analysed in cohort 2 as no cervical sample taken as these participants were not sexually active (as per protocol)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Women Living With HIV Who Are Sexually Active | Prevalence of CIN2+ | 1 Participants |
Secondary
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
Time frame: 1 year
Population: Zero samples analysed in cohort 2 as no cervical sample taken as these participants were not sexually active (as per protocol)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Women Living With HIV Who Are Sexually Active | Prevalence of High Risk HPV by Subtype | HPV 16 | 2 Participants |
| Cohort 1: Women Living With HIV Who Are Sexually Active | Prevalence of High Risk HPV by Subtype | HPV 18/45 | 0 Participants |
| Cohort 1: Women Living With HIV Who Are Sexually Active | Prevalence of High Risk HPV by Subtype | Other high-risk HPV | 12 Participants |
| Cohort 1: Women Living With HIV Who Are Sexually Active | Prevalence of High Risk HPV by Subtype | Negative | 32 Participants |