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| Name | Class |
|---|---|
| Public Health England | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Women with HIV sexually active | Women with perinatally acquired HIV aged 18 or over who are sexually active |
| |
| Cohort 2: Women with HIV not sexually active | Women with perinatally acquired HIV aged 18 or over who are not sexually active |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human papillomavirus testing | Diagnostic Test | HPV test from cervical sample using Cepheid GeneXpert HPV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Prevalence of CIN2+ |
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Inclusion Criteria - Cohort 1:
Inclusion Criteria - Cohort 2:
Exclusion Criteria - Cohort 1:
Exclusion Criteria - Cohort 2:
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Women living with perinatally acquired HIV aged 18 years or older
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| Name | Affiliation | Role |
|---|---|---|
| Tamara Elliott | Imperial College London | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | United Kingdom |
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Opportunistic recruitment
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 using ELISA from serum samples |
| FG001 | 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 using ELISA from serum samples |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Zero women analysed in cohort 2 as these women were not sexually active and so cervical sample was not taken as per the protocol | Posted | Count of Participants | Participants | 1 year |
|
6 months
No intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1:Women With HIV 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 using ELISA from serum samples |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Tamara Elliott | Imperial College london | 02075946230 | te04@ic.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2019 | Jun 19, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D030361 | Papillomavirus Infections |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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Serum blood samples
| Cervical cytology | Diagnostic Test | Cervical cytology |
|
| HPV serology | Diagnostic Test | HPV type specific serology (16/18) using ELISA from serum samples |
|
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+ |
| 1 year |
| HPV Serology (16/18) | Number of participants testing positive for HPV 16 and 18 antibodies out of the those tested | 1 year |
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Cohort 2: Women Living With HIV Who Are Not Sexually Active | Women living with HIV who are not sexually active (no cervical sample taken) |
|
|
| 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 | Zero samples analysed in cohort 2 as no cervical sample taken as these participants were not sexually active (as per protocol) | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 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+ | Zero samples analysed in cohort 2 as no cervical sample taken as these participants were not sexually active (as per protocol) | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | HPV Serology (16/18) | Number of participants testing positive for HPV 16 and 18 antibodies out of the those tested | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Cohort 2: Women With HIV Not Sexually Active | Women with perinatally acquired HIV aged 18 or over who are not sexually active HPV serology: HPV type specific serology using ELISA from serum samples | 0 | 3 | 0 | 3 | 0 | 3 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D004266 | DNA Virus Infections |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| Negative |
|