Herpes SimplexNCT00194415
A Study of HSV Testing Among Pregnant Women
A study testing Safer-sex counseling and Type specific serologic HSV testing in people with Herpes Simplex and Pregnancy, run by University of Washington at 1 site in Canada.
Trial summary
The objective of the study is to evaluate the acceptance and effect of type- specific HSV serologic testing of pregnant women on sexual behavior at the end of pregnancy. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Herpes Simplex, Pregnancy
- What is being tested?
- Safer-sex counseling and Type specific serologic HSV testing
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2004to Nov 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 14 years of age or older
- Pregnant less than 28 weeks at time of enrollment
- No previous HSV serology within the past year
- able to comprehend english
Who cannot join
- History of genital herpes
- HIV seropositive
- Any contraindication for sexual activity during pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Children's & Women's Health Centre of British Columbia
Vancouver, British Columbia, V6H 3N1
About this study
Official title: A Randomized Clinical Trial of Antenatal vs Delayed (Post Partum) Testing for HSV Type-Specific Antibodies Among Pregnant Women.
The objective of the study is to evaluate the acceptance and effect of type- specific HSV serologic testing of pregnant women on sexual behavior at the end of pregnancy.
Read the detailed description
The study hypothesis is that women with antepartum testing who are identified as susceptible to HSV-1 or HSV-2 will have reduced unprotected coital activity and reduced unprotected oral-genital activity compared to those who did not receive antepartum testing. The objective of the study is to evaluate the acceptance, and effect of type-specific HSV serologic testing of pregnant women on sexual behavior at the end of pregnancy.
Upon enrollment, study participants will be randomized into either of two type-specific HSV serologic testing and counseling regimens:
- Group 1: Antepartum and postpartum testing. Subjects will be made aware of their antepartum testing results.
- Group 2: Antepartum blood draw and postpartum testing. Subjects' specimens will be tested at the same time.
Women in group 2 will receive information about herpes infection and how to decrease their chance of acquiring infection during pregnancy. Subjects will be asked to keep a diary of sexual activity and return to the clinic every 4 weeks until delivery.
- Conditions
- Herpes Simplex, Pregnancy
- Being tested
- Safer-sex counseling, Type specific serologic HSV testing
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safer-sex counselingBehavioural
Subjects will receive safer-sex counseling during pregnancy
Type specific serologic HSV testingProcedure or surgery
Subjects will be testing for HSV by Western Blot
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | HSV-2 antepartum testing Receives: Procedure: Type specific serologic HSV testing |
| 2 | Other | Subjects will receive safer-sex counseling during pregnancy Receives: Behavioral: Safer-sex counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The reduction of unprotected coital or oral-genital activity in women who are identified as being susceptible to HSV-1 or HSV-2.
Measured: From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
Secondary outcomes (3)
To determine HSV seroconversion rates in Group 1 versus Group 2
Measured: From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
To determine rates of neonatal HSV infection in Groups 1 & 2.
Measured: From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
To determine viral shedding characteristics in those mother-infant pairs where seroconversion occurs.
Measured: From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionNov 2006
- Study completionNov 2006
Why it stopped: An interim data analysis found no significant difference between testing groups.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes SimplexStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Deborah Money, MD, Principal investigator, University of British ColumbiaAnna Wald, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194415
- Sponsor's protocol ID
- 03-9950-E/A
- Other IDs
- P01AI030731
- Status last verified
- Dec 2007
- First submitted
- 12 Sep 2005
- Last updated
- 10 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Antenatal vs Delayed (Post Partum) Testing for HSV Type-Specific Antibodies Among Pregnant Women.
- ClinicalTrials.gov ID
- NCT00194415
- Acronym / sponsor ID
- 03-9950-E/A
- Conditions
- Herpes Simplex, Pregnancy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: An interim data analysis found no significant difference between testing groups.
- Enrolment
- 173 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the acceptance and effect of type- specific HSV serologic testing of pregnant women on sexual behavior at the end of pregnancy.
Detailed description
The study hypothesis is that women with antepartum testing who are identified as susceptible to HSV-1 or HSV-2 will have reduced unprotected coital activity and reduced unprotected oral-genital activity compared to those who did not receive antepartum testing. The objective of the study is to evaluate the acceptance, and effect of type-specific HSV serologic testing of pregnant women on sexual behavior at the end of pregnancy.
Upon enrollment, study participants will be randomized into either of two type-specific HSV serologic testing and counseling regimens:
- Group 1: Antepartum and postpartum testing. Subjects will be made aware of their antepartum testing results.
- Group 2: Antepartum blood draw and postpartum testing. Subjects' specimens will be tested at the same time.
Women in group 2 will receive information about herpes infection and how to decrease their chance of acquiring infection during pregnancy. Subjects will be asked to keep a diary of sexual activity and return to the clinic every 4 weeks until delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Type specific serologic HSV testingHSV-2 antepartum testing |
| 2 | Other | Behavioral: Safer-sex counselingSubjects will receive safer-sex counseling during pregnancy |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 14 years of age or older
- Pregnant less than 28 weeks at time of enrollment
- No previous HSV serology within the past year
- able to comprehend english
Key exclusion criteria (3 listed)
- History of genital herpes
- HIV seropositive
- Any contraindication for sexual activity during pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safer-sex counselingSubjects will receive safer-sex counseling during pregnancy | Behavioural | 2 |
| Type specific serologic HSV testingSubjects will be testing for HSV by Western Blot | Procedure or surgery | 1 |
Primary outcome
The reduction of unprotected coital or oral-genital activity in women who are identified as being susceptible to HSV-1 or HSV-2.
Time frame: From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
3 secondary outcomes
To determine HSV seroconversion rates in Group 1 versus Group 2
Time frame: From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
To determine rates of neonatal HSV infection in Groups 1 & 2.
Time frame: From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
To determine viral shedding characteristics in those mother-infant pairs where seroconversion occurs.
Time frame: From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
Results and safety
The study was stopped early (reason given: An interim data analysis found no significant difference between testing groups.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Money, MD principal investigator
University of British Columbia
Anna Wald, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safer-sex counseling and Type specific serologic HSV testing in people with Herpes Simplex and Pregnancy, run by University of Washington at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: An interim data analysis found no significant difference between testing groups.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The reduction of unprotected coital or oral-genital activity in women who are identified as being susceptible to HSV-1 or HSV-2. (time frame: From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2008.