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Trial Outcomes & Findings for Screening for HPV and Cervical Cancer in Young Women With Perinatally Acquired HIV (NCT NCT04587050)

NCT ID: NCT04587050

Last Updated: 2024-12-10

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

57 participants

Primary outcome timeframe

1 year

Results posted on

2024-12-10

Participant Flow

Opportunistic recruitment

Participant milestones

Participant milestones
Measure
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
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
Overall Study
STARTED
54
3
Overall Study
COMPLETED
54
3
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort 1: Women Living With HIV Who Are Sexually Active
n=54 Participants
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
Cohort 2:Women Living With HIV Who Are Not Sexually Active
n=3 Participants
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
Total
n=57 Participants
Total of all reporting groups
Age, Customized
18-24 years
22 Participants
n=5 Participants
2 Participants
n=7 Participants
24 Participants
n=5 Participants
Age, Customized
25+ years
32 Participants
n=5 Participants
1 Participants
n=7 Participants
33 Participants
n=5 Participants
Sex: Female, Male
Female
54 Participants
n=5 Participants
3 Participants
n=7 Participants
57 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race/Ethnicity, Customized
White ethnicity
5 Participants
n=5 Participants
1 Participants
n=7 Participants
6 Participants
n=5 Participants
Race/Ethnicity, Customized
Black ethnicity
20 Participants
n=5 Participants
1 Participants
n=7 Participants
21 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
8 Participants
n=5 Participants
0 Participants
n=7 Participants
8 Participants
n=5 Participants
Race/Ethnicity, Customized
Not stated
21 Participants
n=5 Participants
1 Participants
n=7 Participants
22 Participants
n=5 Participants
Region of Enrollment
United Kingdom
54 participants
n=5 Participants
3 participants
n=7 Participants
57 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure
Cohort 1: Women Living With HIV Who Are Sexually Active
n=46 Participants
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
Cohort 2: Women Living With HIV Who Are Not Sexually Active
Women living with HIV who are not sexually active (no cervical sample taken)
Prevalence of Abnormal Cervical Cytology
12 Participants
—

SECONDARY outcome

Timeframe: 1 year

Population: Zero samples analysed in cohort 2 as no cervical sample taken as these participants were not sexually active (as per protocol)

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

Outcome measures

Outcome measures
Measure
Cohort 1: Women Living With HIV Who Are Sexually Active
n=46 Participants
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
Cohort 2: Women Living With HIV Who Are Not Sexually Active
Women living with HIV who are not sexually active (no cervical sample taken)
Prevalence of High Risk HPV by Subtype
HPV 16
2 Participants
—
Prevalence of High Risk HPV by Subtype
HPV 18/45
0 Participants
—
Prevalence of High Risk HPV by Subtype
Other high-risk HPV
12 Participants
—
Prevalence of High Risk HPV by Subtype
Negative
32 Participants
—

SECONDARY outcome

Timeframe: 1 year

Population: Zero samples analysed in cohort 2 as no cervical sample taken as these participants were not sexually active (as per protocol)

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+

Outcome measures

Outcome measures
Measure
Cohort 1: Women Living With HIV Who Are Sexually Active
n=46 Participants
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
Cohort 2: Women Living With HIV Who Are Not Sexually Active
Women living with HIV who are not sexually active (no cervical sample taken)
Prevalence of CIN2+
1 Participants
—

SECONDARY outcome

Timeframe: 1 year

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

Outcome measures

Outcome measures
Measure
Cohort 1: Women Living With HIV Who Are Sexually Active
n=53 Participants
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
Cohort 2: Women Living With HIV Who Are Not Sexually Active
n=3 Participants
Women living with HIV who are not sexually active (no cervical sample taken)
HPV Serology (16/18)
HPV 16 positive serology
44 Participants
1 Participants
HPV Serology (16/18)
HPV 18 positive serology
34 Participants
0 Participants

Adverse Events

Cohort 1:Women With HIV Sexually Active

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Cohort 2: Women With HIV Not Sexually Active

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Tamara Elliott

Imperial College london

Phone: 02075946230

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place