Effectiveness of Integrating Prenatal Care in Reducing HIV/STDs Among Young Pregnant Women
Condition: Pregnancy; HIV Infections; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effectiveness of CenteringPregnancy Plus, a group prenatal care
      treatment program with an HIV/sexually transmitted disease prevention component, in reducing
      health risk behaviors in pregnant teenagers seeking services at Community Health Centers in
      the New York metropolitan area.
    

Detailed description: 
      It is estimated that each year 1 out of 4 teenagers becomes infected with a sexually
      transmitted disease (STD), which may include chlamydia, herpes, human papillomavirus, or HIV.
      Teenagers are especially vulnerable to STD infections because of a lack of education about
      proper condom use and consequences of sexual risk behaviors, including pregnancy. In addition
      to the high prevalence of STD infection, teen pregnancy remains a health concern for young
      women, with 31% of young women in the United States becoming pregnant before the age of 20.
      Transmission of STDs from a pregnant woman to her baby is possible before, during, and after
      birth, making it particularly important to inform young pregnant women about STDs. A group
      prenatal care treatment program that incorporates HIV/STD prevention education, called
      CenteringPregnancy Plus (CP+), has shown success in reducing sexual risk behaviors in an
      academic setting, but its effectiveness at Community Health Centers (CHCs) serving women at
      high risk of these behaviors is unknown. This study will evaluate the effectiveness of CP+ in
      reducing transmission of STDs and rapid repeat pregnancies in pregnant teens seeking care at
      participating CHCs in the New York metropolitan area.

      This study will involve participants receiving prenatal care at 14 participating CHCs that
      predominantly serve black and Latina communities in the New York metropolitan area. The CHCs
      will be assigned randomly to deliver immediate CP+ or waitlist CP+ to women seeking care at
      the clinics.

      A subset of participants at CHCs assigned to hold CP+ treatment groups will first have an
      individual medical exam. Groups will then 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 complete handouts and self-assessments and engage in
      discussion with other group members. Discussions will be educational in nature and will focus
      on building prenatal, childbirth, and parenting skills. Additionally, sessions will include
      an HIV/STD risk reduction component, which will consist of interactive discussion, exercises,
      and skill-building activities targeted toward reducing HIV/STD risk behaviors. Participants
      at CHCs assigned to the waitlist condition will receive standard individual prenatal care and
      will not initially participate in group sessions. These CHCs will start offering CP+ after
      the end of the waitlist period.

      All participants will complete four 40-minute interviews, occurring when they are 14 weeks
      pregnant, during their 3rd trimester of pregnancy, and when their babies are 6 and 12 months
      old. During interviews, participants will listen to questions through headphones delivered on
      a handheld computer. The questions will concern participants' thoughts, feelings, health, and
      health care. During the final interview, participants will provide a urine sample for STD
      testing for chlamydia and gonorrhea and will be referred to treatment if necessary. The
      results of participants who test positive for either of these two STDs will be sent to the
      state STD Control Program. Information will also be collected from participants' medical
      charts on STD history, health history, and babies' health history. Outcome measures will
      include incidence of STD infection, rapid repeat pregnancy, degree of sexual risk behavior,
      and perinatal and psychosocial factors.
    

Intervention name(s): CenteringPregnancy Plus (CP+); Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The CenteringPregnancy model of group prenatal care involves skill-building in the areas of efficacy, risk assessment, negotiation, and prevention. CP+ integrates HIV prevention into prenatal care, builds on motivations for healthy pregnancy, and creates a sustainable model via reimbursement mechanisms for prenatal care. There will be ten 2-hour prenatal group sessions.; Usual care includes standard individual prenatal care and no prenatal group sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Prevention; Teen Pregnancy; Translational Research; Group Care; Prenatal Care; STD Prevention; Gonorrhea; Chlamydia; Adolescent Health; Community Health Centers; CenteringPregnancy Plus; HIV seronegativity