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Performance of Nucleic Acid Amplification Tests for the Detection of NG and CT (pNAAT)

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ClinicalTrials.gov Identifier: NCT02870101
Recruitment Status : Completed
First Posted : August 17, 2016
Results First Posted : April 26, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Neisseria Gonorrhoeae Infection
Chlamydia Trachomatis Infection
Sexually Transmitted Infections
Interventions Diagnostic Test: Nucleic acid amplification test 1 for NG and CT
Diagnostic Test: Nucleic acid amplification test 2 for NG and CT
Diagnostic Test: Nucleic acid amplification test 3 for NG and CT
Enrollment 2767
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention
Hide Arm/Group Description Performance of three nucleic acid amplification tests (NAATs) to detect Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) from swabs collected from the pharynx and rectum. Assays include: nucleic acid amplification test 1 for NG and CT; nucleic acid amplification test 2 for NG and CT; and, nucleic acid amplification test 3 for NG and CT.
Period Title: Overall Study
Started 2767
Completed 2598
Not Completed 169
Arm/Group Title Intervention
Hide Arm/Group Description Performance of three nucleic acid amplification tests (NAATs) to detect Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) from swabs collected from the pharynx and rectum. Assays include: nucleic acid amplification test 1 for NG and CT; nucleic acid amplification test 2 for NG and CT; and, nucleic acid amplification test 3 for NG and CT.
Overall Number of Baseline Participants 2598
Hide Baseline Analysis Population Description
Participants who completed the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2598 participants
<=18 years
25
   1.0%
Between 18 and 65 years
2542
  97.8%
>=65 years
31
   1.2%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 2598 participants
30
(25 to 41)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Gender Number Analyzed 2598 participants
Man
2010
  77.4%
Woman
532
  20.5%
Transman
3
   0.1%
Transwoman
42
   1.6%
Genderqueer
8
   0.3%
Decline to answer
3
   0.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2598 participants
Female
539
  20.7%
Male
2059
  79.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2598 participants
Hispanic or Latino
772
  29.7%
Not Hispanic or Latino
1814
  69.8%
Unknown or Not Reported
12
   0.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2598 participants
American Indian or Alaska Native
15
   0.6%
Asian
84
   3.2%
Native Hawaiian or Other Pacific Islander
4
   0.2%
Black or African American
935
  36.0%
White
1285
  49.5%
More than one race
71
   2.7%
Unknown or Not Reported
204
   7.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2598 participants
2598
1.Primary Outcome
Title Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Hide Description NAAT 1 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 2 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Time Frame One day
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.
Arm/Group Title Intervention
Hide Arm/Group Description:
Performance of nucleic acid amplification test 1 to detect Neisseria gonorrhoeae from swabs collected from the pharynx.
Overall Number of Participants Analyzed 2590
Measure Type: Count of Participants
Unit of Measure: Participants
Index Test Negative; ASIS Negative
2340
  90.3%
Index Test Negative; ASIS Positive
9
   0.3%
Index Test Negative; ASIS Indeterminate
2
   0.1%
Index Test Negative; ASIS Invalid
1
   0.0%
Index Test Positive; ASIS Negative
28
   1.1%
Index Test Positive; ASIS Positive
195
   7.5%
Index Test Positive; ASIS Indeterminate
1
   0.0%
Index Test Positive; ASIS Invalid
1
   0.0%
Index Test No Result; ASIS Negative
11
   0.4%
Index Test No Result; ASIS Positive
0
   0.0%
Index Test No Result; ASIS Indeterminate
0
   0.0%
Index Test No Result; ASIS Invalid
2
   0.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)
Method of Estimation Estimation Parameter PPA
Estimated Value 94.7
Confidence Interval (2-Sided) 95%
90.7 to 97.0
Estimation Comments PPA estimated with two-sided 95% score confidence interval.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)
Method of Estimation Estimation Parameter NPA
Estimated Value 98.8
Confidence Interval (2-Sided) 95%
98.2 to 99.1
Estimation Comments NPA estimated with two-sided 95% score confidence interval.
2.Primary Outcome
Title Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Hide Description NAAT 1 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 2 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Time Frame One day
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from this outcome.
Arm/Group Title Intervention
Hide Arm/Group Description:
Performance of nucleic acid amplification test 1 to detect Neisseria gonorrhoeae from swabs collected from the rectum.
Overall Number of Participants Analyzed 2585
Measure Type: Count of Participants
Unit of Measure: Participants
Index Test Negative; ASIS Negative
2323
  89.9%
Index Test Negative; ASIS Positive
17
   0.7%
Index Test Negative; ASIS Indeterminate
1
   0.0%
Index Test Negative; ASIS Invalid
2
   0.1%
Index Test Positive; ASIS Negative
8
   0.3%
Index Test Positive; ASIS Positive
187
   7.2%
Index Test Positive; ASIS Indeterminate
1
   0.0%
Index Test Positive; ASIS Invalid
0
   0.0%
Index Test No Result; ASIS Negative
40
   1.5%
Index Test No Result; ASIS Positive
1
   0.0%
Index Test No Result; ASIS Indeterminate
0
   0.0%
Index Test No Result; ASIS Invalid
5
   0.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)
Method of Estimation Estimation Parameter PPA
Estimated Value 91.2
Confidence Interval (2-Sided) 95%
86.5 to 94.4
Estimation Comments PPA estimated with two-sided 95% score confidence interval.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)
Method of Estimation Estimation Parameter NPA
Estimated Value 99.6
Confidence Interval (2-Sided) 95%
99.3 to 99.8
Estimation Comments NPA estimated with two-sided 95% score confidence interval.
3.Primary Outcome
Title Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Hide Description NAAT 2 index test results include negative, positive, equivocal, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid
Time Frame One day
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.
Arm/Group Title Intervention
Hide Arm/Group Description:
Performance of nucleic acid amplification test 2 to detect Neisseria gonorrhoeae from swabs collected from the pharynx.
Overall Number of Participants Analyzed 2590
Measure Type: Count of Participants
Unit of Measure: Participants
Index Test Negative; ASIS Negative
2351
  90.8%
Index Test Negative; ASIS Positive
8
   0.3%
Index Test Negative; ASIS Indeterminate
2
   0.1%
Index Test Negative; ASIS Invalid
2
   0.1%
Index Test Positive; ASIS Negative
25
   1.0%
Index Test Positive; ASIS Positive
195
   7.5%
Index Test Positive; ASIS Indeterminate
1
   0.0%
Index Test Positive; ASIS Invalid
0
   0.0%
Index Test Equivocal; ASIS Negative
3
   0.1%
Index Test Equivocal; ASIS Positive
0
   0.0%
Index Test Equivocal; ASIS Indeterminate
0
   0.0%
Index Test Equivocal; ASIS Invalid
0
   0.0%
Index Test No Result; ASIS Negative
0
   0.0%
Index Test No Result; ASIS Positive
1
   0.0%
Index Test No Result; ASIS Indeterminate
0
   0.0%
Index Test No Result; ASIS Invalid
2
   0.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)
Method of Estimation Estimation Parameter PPA
Estimated Value 95.1
Confidence Interval (2-Sided) 95%
91.3 to 97.3
Estimation Comments PPA estimated with two-sided 95% score confidence interval.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)
Method of Estimation Estimation Parameter NPA
Estimated Value 98.8
Confidence Interval (2-Sided) 95%
98.3 to 99.2
Estimation Comments NPA estimated with two-sided 95% score confidence interval.
4.Primary Outcome
Title Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Hide Description NAAT 2 index test results include negative, positive, equivocal, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Time Frame One day
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from this outcome.
Arm/Group Title Intervention
Hide Arm/Group Description:
Performance of nucleic acid amplification test 2 to detect Neisseria gonorrhoeae from swabs collected from the rectum.
Overall Number of Participants Analyzed 2585
Measure Type: Count of Participants
Unit of Measure: Participants
Index Test Negative; ASIS Negative
2359
  91.3%
Index Test Negative; ASIS Positive
5
   0.2%
Index Test Negative; ASIS Indeterminate
0
   0.0%
Index Test Negative; ASIS Invalid
3
   0.1%
Index Test Positive; ASIS Negative
13
   0.5%
Index Test Positive; ASIS Positive
192
   7.4%
Index Test Positive; ASIS Indeterminate
2
   0.1%
Index Test Positive; ASIS Invalid
0
   0.0%
Index Test Equivocal; ASIS Negative
3
   0.1%
Index Test Equivocal; ASIS Positive
2
   0.1%
Index Test Equivocal; ASIS Indeterminate
0
   0.0%
Index Test Equivocal; ASIS Invalid
0
   0.0%
Index Test No Result; ASIS Negative
1
   0.0%
Index Test No Result; ASIS Positive
0
   0.0%
Index Test No Result; ASIS Indeterminate
0
   0.0%
Index Test No Result; ASIS Invalid
5
   0.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)
Method of Estimation Estimation Parameter PPA
Estimated Value 96.5
Confidence Interval (2-Sided) 95%
92.9 to 98.3
Estimation Comments PPA estimated with two-sided 95% score confidence interval.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)
Method of Estimation Estimation Parameter NPA
Estimated Value 99.2
Confidence Interval (2-Sided) 95%
98.8 to 99.5
Estimation Comments NPA estimated with two-sided 95% score confidence interval.
5.Primary Outcome
Title Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Hide Description NAAT 3 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 2 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Time Frame One day
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.
Arm/Group Title Intervention
Hide Arm/Group Description:
Performance of nucleic acid amplification test 3 to detect Neisseria gonorrhoeae from swabs collected from the pharynx.
Overall Number of Participants Analyzed 2590
Measure Type: Count of Participants
Unit of Measure: Participants
Index Test Negative; ASIS Negative
2356
  91.0%
Index Test Negative; ASIS Positive
28
   1.1%
Index Test Negative; ASIS Indeterminate
4
   0.2%
Index Test Negative; ASIS Invalid
1
   0.0%
Index Test Positive; ASIS Negative
11
   0.4%
Index Test Positive; ASIS Positive
179
   6.9%
Index Test Positive; ASIS Indeterminate
0
   0.0%
Index Test Positive; ASIS Invalid
1
   0.0%
Index Test No Result; ASIS Negative
6
   0.2%
Index Test No Result; ASIS Positive
2
   0.1%
Index Test No Result; ASIS Indeterminate
0
   0.0%
Index Test No Result; ASIS Invalid
2
   0.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)
Method of Estimation Estimation Parameter PPA
Estimated Value 84.8
Confidence Interval (2-Sided) 95%
79.4 to 89.0
Estimation Comments PPA estimated with two-sided 95% score confidence interval.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)
Method of Estimation Estimation Parameter NPA
Estimated Value 99.5
Confidence Interval (2-Sided) 95%
99.2 to 99.7
Estimation Comments NPA estimated with two-sided 95% score confidence interval.
6.Primary Outcome
Title Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Hide Description NAAT 3 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 2 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Time Frame One day
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from this outcome.
Arm/Group Title Intervention
Hide Arm/Group Description:
Performance of nucleic acid amplification test 3 to detect Neisseria gonorrhoeae from swabs collected from the rectum.
Overall Number of Participants Analyzed 2585
Measure Type: Count of Participants
Unit of Measure: Participants
Index Test Negative; ASIS Negative
2312
  89.4%
Index Test Negative; ASIS Positive
23
   0.9%
Index Test Negative; ASIS Indeterminate
1
   0.0%
Index Test Negative; ASIS Invalid
1
   0.0%
Index Test Positive; ASIS Negative
8
   0.3%
Index Test Positive; ASIS Positive
181
   7.0%
Index Test Positive; ASIS Indeterminate
2
   0.1%
Index Test Positive; ASIS Invalid
0
   0.0%
Index Test No Result; ASIS Negative
51
   2.0%
Index Test No Result; ASIS Positive
1
   0.0%
Index Test No Result; ASIS Indeterminate
0
   0.0%
Index Test No Result; ASIS Invalid
5
   0.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)
Method of Estimation Estimation Parameter PPA
Estimated Value 88.3
Confidence Interval (2-Sided) 95%
83.2 to 92.0
Estimation Comments PPA estimated with two-sided 95% score confidence interval.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)
Method of Estimation Estimation Parameter NPA
Estimated Value 99.6
Confidence Interval (2-Sided) 95%
99.2 to 99.8
Estimation Comments NPA estimated with two-sided 95% score confidence interval.
7.Primary Outcome
Title Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Hide Description NAAT 1 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 2 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Time Frame One day
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.
Arm/Group Title Intervention
Hide Arm/Group Description:
Performance of nucleic acid amplification test 1 to detect Chlamydia trachomatis from swabs collected from the pharynx.
Overall Number of Participants Analyzed 2590
Measure Type: Count of Participants
Unit of Measure: Participants
Index Test Negative; ASIS Negative
2518
  97.2%
Index Test Negative; ASIS Positive
2
   0.1%
Index Test Negative; ASIS Indeterminate
0
   0.0%
Index Test Negative; ASIS Invalid
2
   0.1%
Index Test Positive; ASIS Negative
6
   0.2%
Index Test Positive; ASIS Positive
47
   1.8%
Index Test Positive; ASIS Indeterminate
2
   0.1%
Index Test Positive; ASIS Invalid
0
   0.0%
Index Test No Result; ASIS Negative
11
   0.4%
Index Test No Result; ASIS Positive
0
   0.0%
Index Test No Result; ASIS Indeterminate
0
   0.0%
Index Test No Result; ASIS Invalid
2
   0.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)
Method of Estimation Estimation Parameter PPA
Estimated Value 95.9
Confidence Interval (2-Sided) 95%
86.3 to 98.9
Estimation Comments PPA estimated with two-sided 95% score confidence interval.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)
Method of Estimation Estimation Parameter NPA
Estimated Value 99.7
Confidence Interval (2-Sided) 95%
99.4 to 99.8
Estimation Comments NPA estimated with two-sided 95% score confidence interval.
8.Primary Outcome
Title Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Hide Description NAAT 1 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 2 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Time Frame One day
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from this outcome.
Arm/Group Title Intervention
Hide Arm/Group Description:
Performance of nucleic acid amplification test 1 to detect Chlamydia trachomatis from swabs collected from the rectum.
Overall Number of Participants Analyzed 2585
Measure Type: Count of Participants
Unit of Measure: Participants
Index Test Negative; ASIS Negative
2292
  88.7%
Index Test Negative; ASIS Positive
28
   1.1%
Index Test Negative; ASIS Indeterminate
4
   0.2%
Index Test Negative; ASIS Invalid
2
   0.1%
Index Test Positive; ASIS Negative
15
   0.6%
Index Test Positive; ASIS Positive
197
   7.6%
Index Test Positive; ASIS Indeterminate
1
   0.0%
Index Test Positive; ASIS Invalid
0
   0.0%
Index Test No Result; ASIS Negative
40
   1.5%
Index Test No Result; ASIS Positive
1
   0.0%
Index Test No Result; ASIS Indeterminate
0
   0.0%
Index Test No Result; ASIS Invalid
5
   0.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)
Method of Estimation Estimation Parameter PPA
Estimated Value 86.0
Confidence Interval (2-Sided) 95%
80.9 to 89.9
Estimation Comments PPA estimated with two-sided 95% score confidence interval.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated Negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)
Method of Estimation Estimation Parameter NPA
Estimated Value 99.3
Confidence Interval (2-Sided) 95%
98.9 to 99.6
Estimation Comments NPA estimated with two-sided 95% score confidence interval.
9.Primary Outcome
Title Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Hide Description NAAT 2 index test results include negative, positive, equivocal, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Time Frame One day
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.
Arm/Group Title Intervention
Hide Arm/Group Description:
Performance of nucleic acid amplification test 2 to detect Chlamydia trachomatis from swabs collected from the pharynx.
Overall Number of Participants Analyzed 2590
Measure Type: Count of Participants
Unit of Measure: Participants
Index Test Negative; ASIS Negative
2526
  97.5%
Index Test Negative; ASIS Positive
6
   0.2%
Index Test Negative; ASIS Indeterminate
0
   0.0%
Index Test Negative; ASIS Invalid
2
   0.1%
Index Test Positive; ASIS Negative
8
   0.3%
Index Test Positive; ASIS Positive
45
   1.7%
Index Test Positive; ASIS Indeterminate
0
   0.0%
Index Test Positive; ASIS Invalid
0
   0.0%
Index Test Equivocal; ASIS Negative
0
   0.0%
Index Test Equivocal; ASIS Positive
0
   0.0%
Index Test Equivocal; ASIS Indeterminate
0
   0.0%
Index Test Equivocal; ASIS Invalid
0
   0.0%
Index Test No Result; ASIS Negative
1
   0.0%
Index Test No Result; ASIS Positive
0
   0.0%
Index Test No Result; ASIS Indeterminate
0
   0.0%
Index Test No Result; ASIS Invalid
2
   0.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)
Method of Estimation Estimation Parameter PPA
Estimated Value 88.2
Confidence Interval (2-Sided) 95%
76.6 to 94.5
Estimation Comments PPA estimated with two-sided 95% score confidence interval.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)
Method of Estimation Estimation Parameter NPA
Estimated Value 99.7
Confidence Interval (2-Sided) 95%
99.4 to 99.8
Estimation Comments NPA estimated with two-sided 95% score confidence interval.
10.Primary Outcome
Title Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Hide Description NAAT 2 index test results include negative, positive, equivocal, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Time Frame One day
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from analysis.
Arm/Group Title Intervention
Hide Arm/Group Description:
Performance of nucleic acid amplification test 2 to detect Chlamydia trachomatis from swabs collected from the rectum.
Overall Number of Participants Analyzed 2585
Measure Type: Count of Participants
Unit of Measure: Participants
Index Test Negative; ASIS Negative
2322
  89.8%
Index Test Negative; ASIS Positive
18
   0.7%
Index Test Negative; ASIS Indeterminate
2
   0.1%
Index Test Negative; ASIS Invalid
3
   0.1%
Index Test Positive; ASIS Negative
25
   1.0%
Index Test Positive; ASIS Positive
197
   7.6%
Index Test Positive; ASIS Indeterminate
0
   0.0%
Index Test Positive; ASIS Invalid
0
   0.0%
Index Test Equivocal; ASIS Negative
5
   0.2%
Index Test Equivocal; ASIS Positive
5
   0.2%
Index Test Equivocal; ASIS Indeterminate
2
   0.1%
Index Test Equivocal; ASIS Invalid
0
   0.0%
Index Test No Result; ASIS Negative
1
   0.0%
Index Test No Result; ASIS Positive
0
   0.0%
Index Test No Result; ASIS Indeterminate
0
   0.0%
Index Test No Result; ASIS Invalid
5
   0.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)
Method of Estimation Estimation Parameter PPA
Estimated Value 88.7
Confidence Interval (2-Sided) 95%
83.9 to 92.3
Estimation Comments PPA estimated with two-sided 95% score confidence interval.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)
Method of Estimation Estimation Parameter NPA
Estimated Value 98.7
Confidence Interval (2-Sided) 95%
98.2 to 99.1
Estimation Comments NPA estimated with two-sided 95% score confidence interval.
11.Primary Outcome
Title Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Hide Description NAAT 3 index test results include negative, positive, equivocal, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 2 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Time Frame One day
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.
Arm/Group Title Intervention
Hide Arm/Group Description:
Performance of nucleic acid amplification test 3 to detect Chlamydia trachomatis from swabs collected from the pharynx.
Overall Number of Participants Analyzed 2590
Measure Type: Count of Participants
Unit of Measure: Participants
Index Test Negative; ASIS Negative
2522
  97.4%
Index Test Negative; ASIS Positive
8
   0.3%
Index Test Negative; ASIS Indeterminate
0
   0.0%
Index Test Negative; ASIS Invalid
2
   0.1%
Index Test Positive; ASIS Negative
4
   0.2%
Index Test Positive; ASIS Positive
42
   1.6%
Index Test Positive; ASIS Indeterminate
1
   0.0%
Index Test Positive; ASIS Invalid
0
   0.0%
Index Test Equivocal; ASIS Negative
1
   0.0%
Index Test Equivocal; ASIS Positive
0
   0.0%
Index Test Equivocal; ASIS Indeterminate
0
   0.0%
Index Test Equivocal; ASIS Invalid
0
   0.0%
Index Test No Result; ASIS Negative
7
   0.3%
Index Test No Result; ASIS Positive
1
   0.0%
Index Test No Result; ASIS Indeterminate
0
   0.0%
Index Test No Result; ASIS Invalid
2
   0.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)
Method of Estimation Estimation Parameter PPA
Estimated Value 84.0
Confidence Interval (2-Sided) 95%
71.5 to 91.7
Estimation Comments PPA estimated with two-sided 95% score confidence interval.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)
Method of Estimation Estimation Parameter NPA
Estimated Value 99.8
Confidence Interval (2-Sided) 95%
99.5 to 99.9
Estimation Comments NPA estimated with two-sided 95% score confidence interval.
12.Primary Outcome
Title Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Hide Description NAAT 3 index test results include negative, positive, equivocal, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 2 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.
Time Frame One day
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from this outcome.
Arm/Group Title Intervention
Hide Arm/Group Description:
Performance of nucleic acid amplification test 3 to detect Chlamydia trachomatis from swabs collected from the rectum.
Overall Number of Participants Analyzed 2585
Measure Type: Count of Participants
Unit of Measure: Participants
Index Test Negative; ASIS Negative
2277
  88.1%
Index Test Negative; ASIS Positive
34
   1.3%
Index Test Negative; ASIS Indeterminate
5
   0.2%
Index Test Negative; ASIS Invalid
1
   0.0%
Index Test Positive; ASIS Negative
19
   0.7%
Index Test Positive; ASIS Positive
190
   7.4%
Index Test Positive; ASIS Indeterminate
2
   0.1%
Index Test Positive; ASIS Invalid
0
   0.0%
Index Test Equivocal; ASIS Negative
0
   0.0%
Index Test Equivocal; ASIS Positive
0
   0.0%
Index Test Equivocal; ASIS Indeterminate
0
   0.0%
Index Test Equivocal; ASIS Invalid
0
   0.0%
Index Test No Result; ASIS Negative
49
   1.9%
Index Test No Result; ASIS Positive
2
   0.1%
Index Test No Result; ASIS Indeterminate
1
   0.0%
Index Test No Result; ASIS Invalid
5
   0.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)
Method of Estimation Estimation Parameter PPA
Estimated Value 83.0
Confidence Interval (2-Sided) 95%
77.6 to 87.3
Estimation Comments PPA estimated with two-sided 95% score confidence interval.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)
Method of Estimation Estimation Parameter NPA
Estimated Value 99.1
Confidence Interval (2-Sided) 95%
98.6 to 99.4
Estimation Comments NPA estimated with two-sided 95% score confidence interval.
Time Frame One day
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention
Hide Arm/Group Description Performance of three nucleic acid amplification tests (NAATs) to detect Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) from swabs collected from the pharynx and rectum. Assays include: nucleic acid amplification test 1 for NG and CT; nucleic acid amplification test 2 for NG and CT; and, nucleic acid amplification test 3 for NG and CT.
All-Cause Mortality
Intervention
Affected / at Risk (%)
Total   0/2598 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention
Affected / at Risk (%)
Total   0/2598 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention
Affected / at Risk (%)
Total   0/2598 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Following completion of the study, the Investigator may publish the results of this research under the oversight of the Antibiotic Resistance Leadership Group (ARLG) Publication Committee. All public presentations by participating Investigators, participating institutions, SDMC, and ARLG, that use ARLG data and are intended to represent the ARLG, or are supported by the ARLG, will be reviewed by the ARLG Publication Committee per the ARLG Publication Committee Charter.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffrey D. Klausner, MD, MPH
Organization: UCLA David Geffen School of Medicine and Fielding School of Public Health
Phone: 310-557-2273
EMail: JDKlausner@mednet.ucla.edu
Publications:
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02870101     History of Changes
Other Study ID Numbers: Pro00073558
5UM1AI104681 ( U.S. NIH Grant/Contract )
First Submitted: August 12, 2016
First Posted: August 17, 2016
Results First Submitted: April 4, 2019
Results First Posted: April 26, 2019
Last Update Posted: May 15, 2019