Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women

Study Overview
=================
Brief Summary
-----------------
This study will determine the effectiveness of two group prenatal care programs as compared to individual prenatal care in reducing the risk for HIV, STDs and adverse perinatal outcomes in young women during and after pregnancy.

Detailed Description
-----------------
Millions of young adults become infected with sexually transmitted diseases (STDs) each year. Young adults are particularly vulnerable to STD infection because most are not educated about STDs and use condoms improperly or inconsistently. Transmission of STDs from a pregnant woman to her baby can occur before, during, or after birth. It is, therefore, particularly important to educate young pregnant women about STDs. Group prenatal care may be a beneficial way to assist young women. It would allow increased contact with care providers, integrate the complex needs of pregnant women, and provide support services. This study will determine the effectiveness of two group prenatal care programs as compared to individual prenatal care in reducing the risk for HIV and other STDs in young women during and after pregnancy. Participants in this unblinded study will be randomly assigned to one of three groups: standard individual prenatal care; standard CenteringPregnancy group prenatal care; or CenteringPregnancy Plus (CP+) group prenatal care. All participants assigned to either CenteringPregnancy or CP+ will have an initial individual medical exam. Groups will be formed based on participants' estimated delivery months, and will be led by a trained independent practitioner. There will be ten 2-hour group sessions between Weeks 16 and 40 of pregnancy. At each session, participants will first weigh themselves and take their blood pressure to chart their own progress. Individual prenatal assessments lasting approximately 30 minutes will be conducted by the practitioner. Participants will then have time to fill out handouts and self-assessments and engage in discussion with other group members. Discussions will focus on education and building prenatal, childbirth, and parenting skills. The CP+ sessions will include an HIV/STD risk reduction component in addition to all the elements of the standard CenteringPregnancy program. This additional feature will consist of interactive discussion, exercises, and skill-building activities targeted towards reducing HIV/STD risk behaviors. Participants assigned to receive standard individual prenatal care will not participate in group sessions, but will receive standard prenatal care. Outcome measures will include incidence of STD infection, rapid repeat pregnancy, degree of sexual risk behavior, perinatal and psychosocial factors.

Official Title
-----------------
Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women

Conditions
-----------------
Sexually Transmitted Diseases, HIV Infections

Intervention / Treatment
-----------------
* Behavioral: CenteringPregnancy
* Behavioral: CenteringPregnancyPlus
* Behavioral: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant and currently at less than 24 weeks gestation English- or Spanish-speaking Willing to be randomly assigned to either group or individual prenatal care Exclusion Criteria: Any severe medical problems requiring individualized assessment and tracking as a high-risk pregnancy (e.g., active substance use, mental illness, HIV)

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Individual Care<br>Participants will receive usual care for their prenatal visits | Behavioral: Usual care<br>* Participants will receive usual prenatal care.<br>|
| Active Comparator: CenteringPregnancy<br>Participants will receive CenteringPregnancy(R) group prenatal care | Behavioral: CenteringPregnancy<br>* Following the initial intake into obstetric care in the usual manner, participants will be invited to join with 8 to 12 other women/couples/teens with similar due dates, meeting together regularly during their pregnancy.<br>|
| Experimental: CenteringPregnancyPlus<br>Participants will receive CenteringPregancy with an HIV/STD prevention component | Behavioral: CenteringPregnancy<br>* Following the initial intake into obstetric care in the usual manner, participants will be invited to join with 8 to 12 other women/couples/teens with similar due dates, meeting together regularly during their pregnancy.<br>Behavioral: CenteringPregnancyPlus<br>* CenteringPregnancyPlus is a modified program that integrated HIV/STD prevention components with the group prenatal care model. Participants will learn skill-building in the areas of efficacy, risk assessment, negotiation skills and prevention.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexually transmitted disease |  | Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum | 
| Rapid repeat pregnancy |  | Measured at Month 12 postpartum | 
| Sexual risk behavior |  | Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum | 
| Perinatal outcomes (e.g., birth weight, gestational age) |  | Measured at Months 6 and 12 postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial factors (e.g., depression, stress, social support) |  | Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Birth Weight, Gestational Age, Preterm Delivery, HIV Seronegativity