Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291044
Status:
COMPLETED
Last Update Posted:
2010-11-19
First Post:
2006-02-09
Brief Title:
HSV Seroprevalence and Diagnosis of Genital Herpes in Pregnant Women
Sponsor:
Stony Brook University
Organization:
Stony Brook University
Study Overview
Official Title:
HSV Seroprevalence and Diagnosis of Genital Herpes in Pregnant Women
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Brief summary The current management guidelines recommended by ACOG rely on history as a screening method to determine pregnant women who are at risk for transmitting herpes to their newborn History fails completely in identifying the women most at risk of transmitting herpes to their newborn - the seronegative woman who acquires a primary infection from her partner during pregnancy Despite recent advances both pregnant women and newborns continue to be at risk of acquiring herpes infection Genital herpes infections are epidemic in the United States In the early 1990s 25 of women in the US were seropositive for the HSV-2 antibody These numbers are likely higher now The incidence of neonatal herpes in the US cannot be accurately estimated since it is not a reportable disease However in some areas of the US the incidence is 1 in 3200 live births which would translate to an incidence of approximately three infants a day in the US In other areas of the US the incidence is even higher approaching 1 in 1500 liveborns This protocol examines patient acceptance of HSV-1 and HSV-2 type specific serologic testing and assesses patient counseling tools In addition seroprevalence of HSV-2 in pregnant patients will be collected and evaluated
Detailed Description:
Detailed Description Despite recent advances both pregnant women and newborns continue to be at risk of acquiring herpes infection Genital herpes infections are epidemic in the United States In the early 1990s 25 of women in the US were seropositive for the HSV-2 antibody Fleming 1997 These numbers are likely higher now The incidence of neonatal herpes in the US cannot be accurately estimated since it is not a reportable disease However in some areas of the US the incidence is 1 in 3200 live births which would translate to an incidence of approximately three infants a day in the US Brown 2003 In other areas of the US the incidence is even higher approaching 1 in 1500 liveborns Whitley personal communication December 2002
The current management guidelines recommended by ACOG Guidelines for Perinatal Care 2002 rely on history as a screening method to determine pregnant women who are at risk for transmitting herpes to their newborn Based on data reported in NHANES III history is an unreliable method of determining those who are infected with genital herpes Fleming 1997 Most importantly history fails completely in identifying the women most at risk of transmitting herpes to their newborn - the seronegative woman who acquires a primary infection from her partner during pregnancy
Since at-risk women can now be accurately identified by new and more accurate type-specific serologic tests effective prevention strategies should be instituted to minimize risk of transmission to the neonate The first obligation is to diagnose who is at risk The highest risk is that of neonatal transmission from a mother experiencing a primary genital HSV-1 or HSV-2 infection in late pregnancy Studies indicate that approximately 13 of women seroconvert during pregnancy and among those who do the risk of neonatal transmission is as high as 30 - 50 Brown 1991 Conversely the rate of neonatal transmission from women with recurrent genital herpes infection is low 1 Brown 1991 1997 Smith 1998 Arvin 1986 Fonnest 1997 However since genital herpes is so common the total number of cases of neonatal herpes from women with recurrent disease remains high Fleming 1997 STD Guidelines 2002 Once a mother is identified as being infected with HSV-2 the health care providers - both pediatrician and obstetrician - can be alerted to the potential risk of neonatal herpes
Management of pregnant women with or without herpes infections should include steps designed to minimize the risk of herpes transmission to neonates This protocol examines patient acceptance of HSV-1 and HSV-2 type specific serologic testing and assesses patient counseling tools In addition seroprevalence of HSV-2 in pregnant patients will be collected and evaluated
STUDY DESIGN
This is a non-treatment study of acceptance rates of HSV-1 and HSV-2 type specific serologic testing by pregnant women and their partners This study will also evaluate Health Care Provider time spent in counseling effectiveness of counseling toolssessions and acceptance of antiviral suppression by pregnant women andor their partners In addition HSV-2 seroprevalence will be assessed This study will be conducted at a single center Obstetrics and Gynecology Office and is not designed to yield nationally representative estimates of HSV-2 seroprevalence rates
Pregnant women who present for their first prenatal visit will be invited to enroll A total of 300 patients will be enrolled
The clinician or staff will describe the study to the patient based on the provided description
If the patient is interested in participating in the study she will be given an informed consent to sign told that the blood test is to determine whether she is seropositive or seronegative for genital herpes HSV-2 and the virus that causes cold sores HSV-1 and given a demographic form to complete If the patient is willing to be tested for HSV-1 and HSV-2 she will continue with counseling and completion of questionnaires For those patients willing to be tested counseling and questionnaires will be completed during visit 1 and visit 2 For those patients who are unwilling to be tested counseling and questionnaires will be administered during this first visit
The investigator and office staff will monitor time spent in each counseling session and also provide assessment of effectiveness and satisfaction with counseling tools
STUDY ASSESSMENTS AND PROCEDURES
Screening and Assessments
Prior to inviting the patient to take part in the clinical trial each patients chart should be reviewed to be certain that the patient does not have a known history of genital herpes or prior knowledge of HSV-2 seropositivity
Prior to enrollment of patients in the study the investigator and appropriate study personnel will be provided with training on HSV serologic testing and provided with the counseling tools This will ensure that all patients receive standardized HSV counseling at the initial visit and during the follow-up visit when test results are discussed
It is important to note that ideally the same person on staff should administer the Counseling Scripts using verbiage consistent with the provided scripts This should be administered with care and concern in a private setting The counselor then should give the patient sufficient time to ask questions
Following is an outline of study assessments and procedures Visit 1
The clinician or staff will describe the study to the patient by the following script
This study involves your willingness to have a blood test to determine if you are infected with the virus that causes genital herpes or the virus that causes cold sores If you decide to participate in this study and decide to have the blood test or even if you decide NOT to have the blood test you will be asked to complete questionnaires and counseling sessions given by the office staff This will be a time commitment of about 1 hour and may include an additional 20 minute office visit next week
All patients willing to be a part of the study will sign an informed consent
Patients will complete a Demographics Questionnaire
Patients willing to be tested will
Sign informed consent for blood test
Have blood drawn for serological assessment via the FOCUS HerpeSelect 1 and 2 ELISA assay
Receive counseling
Complete Questionnaire on Understanding Counseling
Age race and infection history will be documented on the CRF based on information from the patients chart and the medical history sheet routinely used by the clinic completed by the patient
Be given brochure and one-page information sheet
Instruct the patient to read the entire brochure but to also focus on Page 4 the section related to pregnancy
Schedule visit in one week Visit 2
Patients unwilling to be tested will
Complete Questionnaire about Barriers to Testing
Receive counseling
After receipt of counseling the patient will be asked again if willing to be tested
If willing to be tested o Go to list of patients willing to be tested sign the informed consent for the blood test and draw the blood test without further counseling at this visit
If not willing to be tested
o Complete Understanding of Counseling and Survey on Satisfaction with Counseling
o Be given brochure and one-page information sheet
o Instruct the patient to read the entire brochure but to also focus on Page 4 the section related to pregnancy
o Repeat barriers questionnaire
o Schedule next visit continue with prenatal visits consistent with standard of care
At next visit ask again if willing to be tested if yes clinic staff will proceed with assessments and procedures under patients willing to be tested above except third bullet point Receive Counseling and sixth bullet point Complete questionnaire Understanding Counseling Offer the patient the brochure and information sheet again
If at any point during the study the patient changes her mind and becomes willing to be tested document the reason for this change in the CRF
Investigatorstaff will document time spent for counseling in the case report form
Follow Up Assessment
Visit 2
Patients willing to be tested will
Be given results of the HSV-1 and HSV-2 serologic test
Receive Counseling
1 Patients with negative HSV-2 serologic test If the woman is HSV-1 seronegative counsel her with the section of the Script For patients who are HSV-1 seronegative
Encourage the patient to discuss her test results and its meaning with her partner
Ask the following question answer will be documented in the case report form by YesNo response
Do you know if your partner is positive for HSV-1 or HSV-2 If NO to either HSV-1 and HSV-2 follow up as described below
Follow-up visit
During normally scheduled pre-natal visits up to week 28 ask the patient if her partner had been tested Document answer in the case report form
OR
2 Patients with positive HSV-2 serologic test If the woman is HSV-1 seronegative counsel her with the section of the Script For patients who are HSV-1 seronegative
Encourage the patient to discuss her test results and its meaning with her partner
o Give the patient the brochure Taking Charge of your Life and instruct the patient to read the entire brochure but to also focus on the section related to pregnancy
Ask the following questions answer will be documented in the case report form by YesNo response
Are you willing to take medicine to treat your herpes during your pregnancy
Do you know if your partner is positive for HSV-1 or HSV-2 If NO to either HSV-1 or HSV-2 follow up as described below
Follow-up visit
During normally scheduled prenatal visits up to week 28 ask the patient if her partner had been tested Document answer in the case report form
Complete Understanding Counseling Questionnaire appropriate questionnaire for seronegative or seropositive patients respectively and Survey of Satisfaction with Counseling
Investigatorcounseling staff will
Document time spent for counseling and for ordering HSV-1 and HSV-2 blood tests for each patient in the case report form Upon completion of study complete Satisfaction with Counseling Tools Questionnaire
HEALTH OUTCOMES
At the first visit a self administered questionnaire regarding barriers to testing will be given to each eligible patient refusing to be tested After counseling this questionnaire will be repeated for those patients who still refuse testing All patients will be counseled and will be given two self administered questionnaires One questionnaire will assess the patients understanding of the counseling and the other will assess the patients satisfaction with the counseling session At the second visit those patients who were tested will receive their test results and will be counseled on their status positive or negative These patients will receive two self administered questionnaires One questionnaire will assess the patients understanding of counseling specific to their status and the other will assess the patients satisfaction with the counseling session A separate self administered questionnaire will be given to the investigator andor appropriate office personnel to assess their satisfaction with the counseling tools and sessions
DATA ANALYSIS AND STATISTICAL CONSIDERATIONS
Hypotheses
This is a non-treatment study in pregnant women to assess the acceptances of HSV serologic testing and their understanding and satisfaction with counseling tools
Interim Analysis
An interim analysis is not planned
Primary Analysis
The percentage of pregnant patients who accept HSV-1 and HSV-2 type specific testing
Secondary Analyzes
The mean SD percent and frequencies n of questions answered correctly by all subjects in the Understanding Counseling questionnaire
The mean SD percent and frequencies n of questions answered correctly by seronegative subjects in the Understanding Counseling questionnaire
The frequencies n and mean SD percent of questions answered correctly by seropositive subjects in the Understanding Counseling questionnaire
The frequencies n and mean SD scores for each item in the Satisfaction with Counseling for the patient scale
The frequencies n and mean SD scores for each item in the Satisfaction with Counseling Tools for the counselor scale
The percentage of partners of pregnant women who were tested
The percentage of pregnant women who are HSV-2 positive who would accept antiviral suppressive therapy during pregnancy
The frequencies n and mean SD scores for each reasonitem in the Reason For Choosing Not To Be Tested scale
The mean SD total time in minutes spent by the investigator and clinic staff in obtaining the both the HSV-2 type specific serologic test and counseling
The current management guidelines recommended by ACOG Guidelines for Perinatal Care 2002 rely on history as a screening method to determine pregnant women who are at risk for transmitting herpes to their newborn Based on data reported in NHANES III history is an unreliable method of determining those who are infected with genital herpes Fleming 1997 Most importantly history fails completely in identifying the women most at risk of transmitting herpes to their newborn - the seronegative woman who acquires a primary infection from her partner during pregnancy
Since at-risk women can now be accurately identified by new and more accurate type-specific serologic tests effective prevention strategies should be instituted to minimize risk of transmission to the neonate The first obligation is to diagnose who is at risk The highest risk is that of neonatal transmission from a mother experiencing a primary genital HSV-1 or HSV-2 infection in late pregnancy Studies indicate that approximately 13 of women seroconvert during pregnancy and among those who do the risk of neonatal transmission is as high as 30 - 50 Brown 1991 Conversely the rate of neonatal transmission from women with recurrent genital herpes infection is low 1 Brown 1991 1997 Smith 1998 Arvin 1986 Fonnest 1997 However since genital herpes is so common the total number of cases of neonatal herpes from women with recurrent disease remains high Fleming 1997 STD Guidelines 2002 Once a mother is identified as being infected with HSV-2 the health care providers - both pediatrician and obstetrician - can be alerted to the potential risk of neonatal herpes
Management of pregnant women with or without herpes infections should include steps designed to minimize the risk of herpes transmission to neonates This protocol examines patient acceptance of HSV-1 and HSV-2 type specific serologic testing and assesses patient counseling tools In addition seroprevalence of HSV-2 in pregnant patients will be collected and evaluated
STUDY DESIGN
This is a non-treatment study of acceptance rates of HSV-1 and HSV-2 type specific serologic testing by pregnant women and their partners This study will also evaluate Health Care Provider time spent in counseling effectiveness of counseling toolssessions and acceptance of antiviral suppression by pregnant women andor their partners In addition HSV-2 seroprevalence will be assessed This study will be conducted at a single center Obstetrics and Gynecology Office and is not designed to yield nationally representative estimates of HSV-2 seroprevalence rates
Pregnant women who present for their first prenatal visit will be invited to enroll A total of 300 patients will be enrolled
The clinician or staff will describe the study to the patient based on the provided description
If the patient is interested in participating in the study she will be given an informed consent to sign told that the blood test is to determine whether she is seropositive or seronegative for genital herpes HSV-2 and the virus that causes cold sores HSV-1 and given a demographic form to complete If the patient is willing to be tested for HSV-1 and HSV-2 she will continue with counseling and completion of questionnaires For those patients willing to be tested counseling and questionnaires will be completed during visit 1 and visit 2 For those patients who are unwilling to be tested counseling and questionnaires will be administered during this first visit
The investigator and office staff will monitor time spent in each counseling session and also provide assessment of effectiveness and satisfaction with counseling tools
STUDY ASSESSMENTS AND PROCEDURES
Screening and Assessments
Prior to inviting the patient to take part in the clinical trial each patients chart should be reviewed to be certain that the patient does not have a known history of genital herpes or prior knowledge of HSV-2 seropositivity
Prior to enrollment of patients in the study the investigator and appropriate study personnel will be provided with training on HSV serologic testing and provided with the counseling tools This will ensure that all patients receive standardized HSV counseling at the initial visit and during the follow-up visit when test results are discussed
It is important to note that ideally the same person on staff should administer the Counseling Scripts using verbiage consistent with the provided scripts This should be administered with care and concern in a private setting The counselor then should give the patient sufficient time to ask questions
Following is an outline of study assessments and procedures Visit 1
The clinician or staff will describe the study to the patient by the following script
This study involves your willingness to have a blood test to determine if you are infected with the virus that causes genital herpes or the virus that causes cold sores If you decide to participate in this study and decide to have the blood test or even if you decide NOT to have the blood test you will be asked to complete questionnaires and counseling sessions given by the office staff This will be a time commitment of about 1 hour and may include an additional 20 minute office visit next week
All patients willing to be a part of the study will sign an informed consent
Patients will complete a Demographics Questionnaire
Patients willing to be tested will
Sign informed consent for blood test
Have blood drawn for serological assessment via the FOCUS HerpeSelect 1 and 2 ELISA assay
Receive counseling
Complete Questionnaire on Understanding Counseling
Age race and infection history will be documented on the CRF based on information from the patients chart and the medical history sheet routinely used by the clinic completed by the patient
Be given brochure and one-page information sheet
Instruct the patient to read the entire brochure but to also focus on Page 4 the section related to pregnancy
Schedule visit in one week Visit 2
Patients unwilling to be tested will
Complete Questionnaire about Barriers to Testing
Receive counseling
After receipt of counseling the patient will be asked again if willing to be tested
If willing to be tested o Go to list of patients willing to be tested sign the informed consent for the blood test and draw the blood test without further counseling at this visit
If not willing to be tested
o Complete Understanding of Counseling and Survey on Satisfaction with Counseling
o Be given brochure and one-page information sheet
o Instruct the patient to read the entire brochure but to also focus on Page 4 the section related to pregnancy
o Repeat barriers questionnaire
o Schedule next visit continue with prenatal visits consistent with standard of care
At next visit ask again if willing to be tested if yes clinic staff will proceed with assessments and procedures under patients willing to be tested above except third bullet point Receive Counseling and sixth bullet point Complete questionnaire Understanding Counseling Offer the patient the brochure and information sheet again
If at any point during the study the patient changes her mind and becomes willing to be tested document the reason for this change in the CRF
Investigatorstaff will document time spent for counseling in the case report form
Follow Up Assessment
Visit 2
Patients willing to be tested will
Be given results of the HSV-1 and HSV-2 serologic test
Receive Counseling
1 Patients with negative HSV-2 serologic test If the woman is HSV-1 seronegative counsel her with the section of the Script For patients who are HSV-1 seronegative
Encourage the patient to discuss her test results and its meaning with her partner
Ask the following question answer will be documented in the case report form by YesNo response
Do you know if your partner is positive for HSV-1 or HSV-2 If NO to either HSV-1 and HSV-2 follow up as described below
Follow-up visit
During normally scheduled pre-natal visits up to week 28 ask the patient if her partner had been tested Document answer in the case report form
OR
2 Patients with positive HSV-2 serologic test If the woman is HSV-1 seronegative counsel her with the section of the Script For patients who are HSV-1 seronegative
Encourage the patient to discuss her test results and its meaning with her partner
o Give the patient the brochure Taking Charge of your Life and instruct the patient to read the entire brochure but to also focus on the section related to pregnancy
Ask the following questions answer will be documented in the case report form by YesNo response
Are you willing to take medicine to treat your herpes during your pregnancy
Do you know if your partner is positive for HSV-1 or HSV-2 If NO to either HSV-1 or HSV-2 follow up as described below
Follow-up visit
During normally scheduled prenatal visits up to week 28 ask the patient if her partner had been tested Document answer in the case report form
Complete Understanding Counseling Questionnaire appropriate questionnaire for seronegative or seropositive patients respectively and Survey of Satisfaction with Counseling
Investigatorcounseling staff will
Document time spent for counseling and for ordering HSV-1 and HSV-2 blood tests for each patient in the case report form Upon completion of study complete Satisfaction with Counseling Tools Questionnaire
HEALTH OUTCOMES
At the first visit a self administered questionnaire regarding barriers to testing will be given to each eligible patient refusing to be tested After counseling this questionnaire will be repeated for those patients who still refuse testing All patients will be counseled and will be given two self administered questionnaires One questionnaire will assess the patients understanding of the counseling and the other will assess the patients satisfaction with the counseling session At the second visit those patients who were tested will receive their test results and will be counseled on their status positive or negative These patients will receive two self administered questionnaires One questionnaire will assess the patients understanding of counseling specific to their status and the other will assess the patients satisfaction with the counseling session A separate self administered questionnaire will be given to the investigator andor appropriate office personnel to assess their satisfaction with the counseling tools and sessions
DATA ANALYSIS AND STATISTICAL CONSIDERATIONS
Hypotheses
This is a non-treatment study in pregnant women to assess the acceptances of HSV serologic testing and their understanding and satisfaction with counseling tools
Interim Analysis
An interim analysis is not planned
Primary Analysis
The percentage of pregnant patients who accept HSV-1 and HSV-2 type specific testing
Secondary Analyzes
The mean SD percent and frequencies n of questions answered correctly by all subjects in the Understanding Counseling questionnaire
The mean SD percent and frequencies n of questions answered correctly by seronegative subjects in the Understanding Counseling questionnaire
The frequencies n and mean SD percent of questions answered correctly by seropositive subjects in the Understanding Counseling questionnaire
The frequencies n and mean SD scores for each item in the Satisfaction with Counseling for the patient scale
The frequencies n and mean SD scores for each item in the Satisfaction with Counseling Tools for the counselor scale
The percentage of partners of pregnant women who were tested
The percentage of pregnant women who are HSV-2 positive who would accept antiviral suppressive therapy during pregnancy
The frequencies n and mean SD scores for each reasonitem in the Reason For Choosing Not To Be Tested scale
The mean SD total time in minutes spent by the investigator and clinic staff in obtaining the both the HSV-2 type specific serologic test and counseling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None