Trial Outcomes & Findings for Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV (NCT NCT01946139)
NCT ID: NCT01946139
Last Updated: 2023-11-07
Results Overview
Among patients who are HRA negative for HSIL, the number of participants who tested negative for HSIL on the APTIMA assay
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
276 participants
Primary outcome timeframe
at baseline
Results posted on
2023-11-07
Participant Flow
Participant milestones
| Measure |
Screening (HSIL Detection)
Patients undergo screening for the detection of high grade squamous intraepithelial lesions (HSIL) using anal cytology, human papillomavirus (HPV) hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 6, 12, 18, and 24 months.
comparison of screening methods: Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
276
|
|
Overall Study
COMPLETED
|
256
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Screening (HSIL Detection)
Patients undergo screening for the detection of high grade squamous intraepithelial lesions (HSIL) using anal cytology, human papillomavirus (HPV) hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 6, 12, 18, and 24 months.
comparison of screening methods: Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
ineligible
|
8
|
|
Overall Study
Specimens not available
|
4
|
Baseline Characteristics
Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV
Baseline characteristics by cohort
| Measure |
Screening (HSIL Detection)
n=256 Participants
Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 6, 12, 18, and 24 months.
comparison of screening methods: Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
251 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
256 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
199 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
168 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
256 participants
n=5 Participants
|
|
Anal HSIL at baseline
|
69 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at baselinePopulation: Participants who were negative for HSIL on the high resolution anoscopy at baseline and who had APTIMA assay results
Among patients who are HRA negative for HSIL, the number of participants who tested negative for HSIL on the APTIMA assay
Outcome measures
| Measure |
Screening (HSIL Detection)
n=175 Participants
Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 6, 12, 18, and 24 months.
comparison of screening methods: Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Specificity of Each Other Methods of HSIL Detection for APTIMA Assay
|
116 Participants
|
PRIMARY outcome
Timeframe: at baselineThe prevalence of HSIL will be estimated as the proportion of women who are HRA positive for HSIL at entry and its 95% confidence interval. Logistic regression analysis will be used to evaluate the association of potential risk factors with diagnosis of HSIL.
Outcome measures
| Measure |
Screening (HSIL Detection)
n=256 Participants
Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 6, 12, 18, and 24 months.
comparison of screening methods: Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Prevalence of HSIL
|
69 Participants
|
PRIMARY outcome
Timeframe: at baselinePopulation: Patients whose HRA results were positive and had APTIMA results at baseline
Among patients whose high resolution anoscopy (HRA) results were positive for HSIL and had APTIMA assays at baseline, the number whose APTIMA assay results were positive.
Outcome measures
| Measure |
Screening (HSIL Detection)
n=68 Participants
Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 6, 12, 18, and 24 months.
comparison of screening methods: Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Sensitivity of Each of the Methods of APTIMA Assay at Baseline
|
50 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Participants who did not have HSIL at baseline based on the high resolution anoscopy (HRA) results and who had follow-up HRA results
The Poisson rate and its 95% confidence interval will be estimated from the number of HSIL cases detected divided by the cumulative years of follow-up across these cases.
Outcome measures
| Measure |
Screening (HSIL Detection)
n=143 Participants
Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 6, 12, 18, and 24 months.
comparison of screening methods: Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Incidence of HSIL Among Women Who Were HRA Negative for HSIL at Study Entry
|
9.08 events per 100 person-years
Interval 6.09 to 13.55
|
SECONDARY outcome
Timeframe: at baselineAnal cancer screening is typically done using a high resolution anoscopy, a device which allows visualization of the anus. To determine if participants found anal screening acceptable, they were asked if they were at east with having a high resolution anoscopy. The results indicated the number of participants who felt at ease with having a high resolution anoscopy
Outcome measures
| Measure |
Screening (HSIL Detection)
n=256 Participants
Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 6, 12, 18, and 24 months.
comparison of screening methods: Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Acceptability of Anal Cancer Screening
|
137 Participants
|
Adverse Events
Screening (HSIL Detection)
Serious events: 4 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Screening (HSIL Detection)
n=256 participants at risk
Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 6, 12, 18, and 24 months.
comparison of screening methods: Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Cardiac disorders
Chest pain - Cardiac
|
0.39%
1/256 • 2 years
|
|
Infections and infestations
Bone infection
|
0.39%
1/256 • 2 years
|
|
Infections and infestations
Lung infection
|
0.39%
1/256 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.39%
1/256 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorder, other
|
0.39%
1/256 • 2 years
|
Other adverse events
| Measure |
Screening (HSIL Detection)
n=256 participants at risk
Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 6, 12, 18, and 24 months.
comparison of screening methods: Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
quality-of-life assessment: Ancillary studies
|
|---|---|
|
Eye disorders
Blurred vision
|
0.39%
1/256 • 2 years
|
|
Eye disorders
Eye disorders, other
|
0.39%
1/256 • 2 years
|
|
Eye disorders
Eye pain
|
0.39%
1/256 • 2 years
|
|
Gastrointestinal disorders
Anal hemorrhage
|
3.1%
8/256 • 2 years
|
|
Gastrointestinal disorders
Anal pain
|
2.0%
5/256 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
0.39%
1/256 • 2 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.39%
1/256 • 2 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications, other
|
0.39%
1/256 • 2 years
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy, puerperium and perinatal conditions, other
|
0.78%
2/256 • 2 years
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.39%
1/256 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.39%
1/256 • 2 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.39%
1/256 • 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures, other
|
0.39%
1/256 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place