Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women
Condition: Sexually Transmitted Diseases; HIV Infections
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): CenteringPregnancy; CenteringPregnancyPlus; Usual care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; Participants will receive usual prenatal care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnancy; Birth Weight; Gestational Age; Preterm Delivery; HIV Seronegativity