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

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Yale University

Status and phase

Completed
Phase 3

Conditions

Sexually Transmitted Diseases
HIV Infections

Treatments

Behavioral: Usual care
Behavioral: CenteringPregnancyPlus
Behavioral: CenteringPregnancy

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00271960
R01MH061175 (U.S. NIH Grant/Contract)
0008011972

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,047 patients

Sex

Female

Ages

14 to 25 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,047 participants in 3 patient groups

Individual Care
Active Comparator group
Description:
Participants will receive usual care for their prenatal visits
Treatment:
Behavioral: Usual care
CenteringPregnancy
Active Comparator group
Description:
Participants will receive CenteringPregnancy(R) group prenatal care
Treatment:
Behavioral: CenteringPregnancy
CenteringPregnancyPlus
Experimental group
Description:
Participants will receive CenteringPregancy with an HIV/STD prevention component
Treatment:
Behavioral: CenteringPregnancyPlus
Behavioral: CenteringPregnancy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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