Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00291044 |
| Other study ID # |
VAL R116 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
February 9, 2006 |
| Last updated |
November 18, 2010 |
| Start date |
September 2005 |
| Est. completion date |
September 2009 |
Study information
| Verified date |
November 2010 |
| Source |
Stony Brook University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Observational
|
Clinical Trial 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 1990's, 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 3,200 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 1,500 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.
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 1990's, 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 3,200 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 1,500 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 1.3% 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 tools/sessions, and
acceptance of antiviral suppression by pregnant women and/or 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 patient's 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 patient's 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.
- Investigator/staff 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 Yes/No
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
Yes/No 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,
Investigator/counseling 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
patient's understanding of the counseling and the other will assess the patient's
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 patient's understanding of counseling (specific to their
status), and the other will assess the patient's satisfaction with the counseling session. A
separate self administered questionnaire will be given to the investigator and/or
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 reason/item 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
