Effectiveness of Integrating Prenatal Care in Reducing HIV/STDs Among Young Pregnant Women

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Yale University

Status and phase

Completed
Phase 4

Conditions

Sexually Transmitted Diseases
HIV Infections
Pregnancy

Treatments

Behavioral: Usual care
Behavioral: CenteringPregnancy Plus (CP+)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00628771
R01MH074394 (U.S. NIH Grant/Contract)
DAHBR 9A-ASPC (Other Grant/Funding Number)
0408026962
R01MH074399 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,233 patients

Sex

Female

Ages

14 to 21 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pregnant
  • Able to attend group treatment sessions conducted in English or Spanish

Exclusion criteria

  • Positive HIV infection
  • Severe medical problem requiring individualized assessment and tracking as high-risk pregnancy

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,233 participants in 2 patient groups

Usual Care
Active Comparator group
Description:
Participants will receive usual care for their prenatal visits.
Treatment:
Behavioral: Usual care
CenteringPregnancy Plus
Experimental group
Description:
Participants will receive the CenteringPregnancy Plus treatment program, which includes an HIV/STD prevention component.
Treatment:
Behavioral: CenteringPregnancy Plus (CP+)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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