A Study of HSV Testing Among Pregnant Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Clinical Trial of Antenatal vs Delayed (Post Partum) Testing for HSV Type-Specific Antibodies Among Pregnant Women.

Conditions
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Herpes Simplex, Pregnancy

Intervention / Treatment
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* Behavioral: Safer-sex counseling
* Procedure: Type specific serologic HSV testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: History of genital herpes HIV seropositive Any contraindication for sexual activity during pregnancy

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>HSV-2 antepartum testing | Procedure: Type specific serologic HSV testing<br>* Subjects will be testing for HSV by Western Blot<br>|
| Other: 2<br>Subjects will receive safer-sex counseling during pregnancy | Behavioral: Safer-sex counseling<br>* Subjects will receive safer-sex counseling during pregnancy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The reduction of unprotected coital or oral-genital activity in women who are identified as being susceptible to HSV-1 or HSV-2. |  | From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine HSV seroconversion rates in Group 1 versus Group 2 |  | 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. |  | 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. |  | From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery |