Trial Outcomes & Findings for Identification of Herpes Simplex Virus (HSV) Shedding in the Female Genital Tract of Pregnant and Nonpregnant Women by GeneXpert PCR, Routine PCR, and Culture (NCT NCT01878383)

Last Updated: 2020-09-09

Results Overview

Assessing the vaginal specimen collected via a swab of non-pregnant women presenting to their provider at the time of active HSV outbreak with standard HSV culture compared to the assay of new device called a GeneXpert. Percent of GeneXpert assessment in agreement with standard HSV culture, for subjects who were positive for HSV according to culture.

Recruitment status

COMPLETED

Target enrollment

12550 participants

Primary outcome timeframe

on day of enrollment

Results posted on

2020-09-09

Participant Flow

Participant milestones

Participant milestones
Measure	Non-pregnant Women/Active HSV Lesions Women presenting to local health department Genexpert assay	Pregnant Women/no Active HSV Lesions Women presenting in active labor will be tested for HSV utilizing the Genexpert assay
Overall Study STARTED	50	12500
Overall Study COMPLETED	50	11001
Overall Study NOT COMPLETED	0	1499

Reasons for withdrawal

Reasons for withdrawal
Measure	Non-pregnant Women/Active HSV Lesions Women presenting to local health department Genexpert assay	Pregnant Women/no Active HSV Lesions Women presenting in active labor will be tested for HSV utilizing the Genexpert assay
Overall Study Lost to Follow-up	0	1499

Baseline Characteristics

Age was not collected

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-pregnant Women/Active HSV Lesions n=50 Participants Women presenting to local health department Genexpert assay	Pregnant Women/no Active HSV Lesions n=12500 Participants Women presenting in active labor Genexpert assay	Total n=12550 Participants Total of all reporting groups
Sex: Female, Male Female	50 Participants n=50 Participants	12500 Participants n=12500 Participants	12550 Participants n=12550 Participants
Sex: Female, Male Male	0 Participants n=50 Participants	0 Participants n=12500 Participants	0 Participants n=12550 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=50 Participants • Baseline information not available for 2 subjects	1090 Participants n=12498 Participants • Baseline information not available for 2 subjects	1091 Participants n=12548 Participants • Baseline information not available for 2 subjects
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=50 Participants • Baseline information not available for 2 subjects	11124 Participants n=12498 Participants • Baseline information not available for 2 subjects	11173 Participants n=12548 Participants • Baseline information not available for 2 subjects
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=50 Participants • Baseline information not available for 2 subjects	284 Participants n=12498 Participants • Baseline information not available for 2 subjects	284 Participants n=12548 Participants • Baseline information not available for 2 subjects
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=50 Participants • Demographic information not available for 2 subjects.	39 Participants n=12498 Participants • Demographic information not available for 2 subjects.	39 Participants n=12548 Participants • Demographic information not available for 2 subjects.
Race (NIH/OMB) Asian	0 Participants n=50 Participants • Demographic information not available for 2 subjects.	335 Participants n=12498 Participants • Demographic information not available for 2 subjects.	335 Participants n=12548 Participants • Demographic information not available for 2 subjects.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=50 Participants • Demographic information not available for 2 subjects.	23 Participants n=12498 Participants • Demographic information not available for 2 subjects.	23 Participants n=12548 Participants • Demographic information not available for 2 subjects.
Race (NIH/OMB) Black or African American	43 Participants n=50 Participants • Demographic information not available for 2 subjects.	4631 Participants n=12498 Participants • Demographic information not available for 2 subjects.	4674 Participants n=12548 Participants • Demographic information not available for 2 subjects.
Race (NIH/OMB) White	7 Participants n=50 Participants • Demographic information not available for 2 subjects.	6859 Participants n=12498 Participants • Demographic information not available for 2 subjects.	6866 Participants n=12548 Participants • Demographic information not available for 2 subjects.
Race (NIH/OMB) More than one race	0 Participants n=50 Participants • Demographic information not available for 2 subjects.	225 Participants n=12498 Participants • Demographic information not available for 2 subjects.	225 Participants n=12548 Participants • Demographic information not available for 2 subjects.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=50 Participants • Demographic information not available for 2 subjects.	386 Participants n=12498 Participants • Demographic information not available for 2 subjects.	386 Participants n=12548 Participants • Demographic information not available for 2 subjects.

PRIMARY outcome

Timeframe: on day of enrollment

Outcome measures

Outcome measures
Measure	Non-pregnant Women/Active HSV Lesions n=50 Participants Women presenting to local health department Genexpert assay
Sensitivity of Detection of HSV DNA by GeneXpert PCR From Specimens Obtained From the Genital Tract of Non-pregnant Women in STI Clinics, as Compared With HSV Culture	100 Sensitivity (percent positive) Interval 90.8 to 100.0

PRIMARY outcome

Timeframe: DAY OF ENROLLMENT

Population: 12,500 pregnant women were enrolled into this study and were randomized (1:1) to either have their specimens stored or tested. The analysis population is the 6,658 subjects randomized to the test condition

Detection of HSV DNA by GeneXpert PCR compared to routine PCR detection by viral DNA. Percent of GeneXpert assessment in agreement with routine PCR detection, for subjects who are positive for HSV according to routine PCR.

Outcome measures

Outcome measures
Measure	Non-pregnant Women/Active HSV Lesions n=6658 Participants Women presenting to local health department Genexpert assay
Positive Percent Agreement of Detection of HSV DNA by GeneXpert PCR From Specimens Obtained From Genital Tract of Pregnant Women, as Compared With Routine PCR Detection of Viral DNA	80 Positive percent agreement Interval 73.7 to 86.3

PRIMARY outcome

Timeframe: DAY OF ENROLLMENT

Population: 12,500 pregnant women were enrolled into this study and were randomized (1:1) to either have the specimens stored or tested. The analysis population is the 6,658 subjects randomized to the test condition

Detection of HSV DNA by GeneXpert PCR compared to routine PCR detection by viral DNA. Percent of GeneXpert assessments in agreement with routine PCR detection, for subjects who were negative for HSV according to routine PCR.

Outcome measures

Outcome measures
Measure	Non-pregnant Women/Active HSV Lesions n=6658 Participants Women presenting to local health department Genexpert assay
Negative Percent Agreement of Detection of HSV DNA by GeneXpert PCR From Specimens Obtained From Genital Tract of Pregnant Women, as Compared With Routine PCR Detection of Viral DNA	99.2 Negative percent agreement Interval 99.0 to 99.5

Adverse Events

Non-pregnant Women/Active HSV Lesions

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pregnant Women/no Active HSV Lesions

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

David Kimberlin, MD

University of Alabama at Birmingham

Phone: 205.638.2530

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place