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

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT00628771

Collaborator

National Institute of Mental Health (NIMH) (NIH)

1,233

Enrollment

Locations

Arms

Duration (Months)

411

Patients Per Site

8.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy HIV Infections Sexually Transmitted Diseases	Behavioral: CenteringPregnancy Plus (CP+) Behavioral: Usual care	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1233 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Integrating Prenatal Care to Reduce HIV/STDs Among Teens: A Translational Study

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Usual Care Participants will receive usual care for their prenatal visits.	Behavioral: Usual care Usual care includes standard individual prenatal care and no prenatal group sessions.
Experimental: CenteringPregnancy Plus Participants will receive the CenteringPregnancy Plus treatment program, which includes an HIV/STD prevention component.	Behavioral: CenteringPregnancy Plus (CP+) 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.

Arm

Intervention/Treatment

Active Comparator: Usual Care

Participants will receive usual care for their prenatal visits.

Behavioral: Usual care

Usual care includes standard individual prenatal care and no prenatal group sessions.

Experimental: CenteringPregnancy Plus

Participants will receive the CenteringPregnancy Plus treatment program, which includes an HIV/STD prevention component.

Behavioral: CenteringPregnancy Plus (CP+)

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.

Outcome Measures

Primary Outcome Measures

Sexual behavior risk [Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum]
Lab tested STDs [Measured at 3rd trimester]
Rapid repeat pregnancy [Measured at Months 6 and 12 postpartum]
Low birthweight [Measured at delivery]
Preterm labor [Measured at delivery]
Breastfeeding [Measured at Months 6 and 12 postpartum]

Secondary Outcome Measures

Maternal weight gain [Measured at Months 6 and 12 postpartum]
Prenatal care knowledge [Measured at 2nd and 3rd trimesters]
Pregnancy risk knowledge [Measured at 2nd and 3rd trimesters]
Perceived social conflict [Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum]
Social support [Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum]
Depression [Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum]
Generalized anxiety disorder [Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum]
Acculturation [Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum]
Substance use [Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum]
Treatment uptake, sustainability, fidelity, and cost-effectiveness [Measured throughout the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 21 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University School of PUblic Health	New Haven	Connecticut	United States	06510
2	Centering Healthcare Institute	Boston	Massachusetts	United States	02111
3	Clinical Directors Network	New York	New York	United States	10018