HIV Infections Clinical Trial
Official title:
Integrating Prenatal Care to Reduce HIV/STDs Among Teens: A Translational Study
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.
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.
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