NCT00271960

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,047

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 4, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

7.7 years

First QC Date

December 30, 2005

Last Update Submit

April 1, 2020

Conditions

Sexually Transmitted DiseasesHIV Infections

Keywords

PregnancyBirth WeightGestational AgePreterm DeliveryHIV Seronegativity

Outcome Measures

Primary Outcomes (4)

  • Sexually transmitted disease

    Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum

  • Rapid repeat pregnancy

    Measured at Month 12 postpartum

  • Sexual risk behavior

    Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum

  • Perinatal outcomes (e.g., birth weight, gestational age)

    Measured at Months 6 and 12 postpartum

Secondary Outcomes (1)

  • Psychosocial factors (e.g., depression, stress, social support)

    Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum

Study Arms (3)

Individual Care

ACTIVE COMPARATOR

Participants will receive usual care for their prenatal visits

Behavioral: Usual care

CenteringPregnancy

ACTIVE COMPARATOR

Participants will receive CenteringPregnancy(R) group prenatal care

Behavioral: CenteringPregnancy

CenteringPregnancyPlus

EXPERIMENTAL

Participants will receive CenteringPregancy with an HIV/STD prevention component

Behavioral: CenteringPregnancyBehavioral: CenteringPregnancyPlus

Interventions

CenteringPregnancyBEHAVIORAL

Following the initial intake into obstetric care in the usual manner, participants will be invited to join with 8 to 12 other women/couples/teens with similar due dates, meeting together regularly during their pregnancy.

CenteringPregnancyCenteringPregnancyPlus
CenteringPregnancyPlusBEHAVIORAL

CenteringPregnancyPlus is a modified program that integrated HIV/STD prevention components with the group prenatal care model. Participants will learn skill-building in the areas of efficacy, risk assessment, negotiation skills and prevention.

CenteringPregnancyPlus
Usual careBEHAVIORAL

Participants will receive usual prenatal care.

Individual Care

Eligibility Criteria

Age14 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Any severe medical problems requiring individualized assessment and tracking as a "high-risk pregnancy" (e.g., active substance use, mental illness, HIV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale New Haven Hospital, Women's Center

New Haven, Connecticut, 06520, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30350, United States

Location

Related Publications (16)

  • Ickovics JR. "Bundling" HIV prevention: integrating services to promote synergistic gain. Prev Med. 2008 Mar;46(3):222-5. doi: 10.1016/j.ypmed.2007.09.006. Epub 2007 Sep 29.

    PMID: 17964637BACKGROUND

  • Massey Z, Rising SS, Ickovics J. CenteringPregnancy group prenatal care: Promoting relationship-centered care. J Obstet Gynecol Neonatal Nurs. 2006 Mar-Apr;35(2):286-94. doi: 10.1111/j.1552-6909.2006.00040.x.

    PMID: 16620257BACKGROUND

  • Kershaw TS, Magriples U, Westdahl C, Rising SS, Ickovics J. Pregnancy as a window of opportunity for HIV prevention: effects of an HIV intervention delivered within prenatal care. Am J Public Health. 2009 Nov;99(11):2079-86. doi: 10.2105/AJPH.2008.154476. Epub 2009 Sep 17.

    PMID: 19762662RESULT

  • Ickovics JR, Kershaw TS, Westdahl C, Magriples U, Massey Z, Reynolds H, Rising SS. Group prenatal care and perinatal outcomes: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):330-9. doi: 10.1097/01.AOG.0000275284.24298.23.

    PMID: 17666608RESULT

  • Ickovics JR, Reed E, Magriples U, Westdahl C, Schindler Rising S, Kershaw TS. Effects of group prenatal care on psychosocial risk in pregnancy: results from a randomised controlled trial. Psychol Health. 2011 Feb;26(2):235-50. doi: 10.1080/08870446.2011.531577.

    PMID: 21318932RESULT

  • Gould Rothberg BE, Magriples U, Kershaw TS, Rising SS, Ickovics JR. Gestational weight gain and subsequent postpartum weight loss among young, low-income, ethnic minority women. Am J Obstet Gynecol. 2011 Jan;204(1):52.e1-11. doi: 10.1016/j.ajog.2010.08.028. Epub 2010 Oct 25.

    PMID: 20974459RESULT

  • Magriples U, Boynton MH, Kershaw TS, Duffany KO, Rising SS, Ickovics JR. Blood pressure changes during pregnancy: impact of race, body mass index, and weight gain. Am J Perinatol. 2013 May;30(5):415-24. doi: 10.1055/s-0032-1326987. Epub 2012 Oct 11.

    PMID: 23059493RESULT

  • Magriples U, Kershaw TS, Rising SS, Westdahl C, Ickovics JR. The effects of obesity and weight gain in young women on obstetric outcomes. Am J Perinatol. 2009 May;26(5):365-71. doi: 10.1055/s-0028-1110088. Epub 2008 Dec 11.

    PMID: 19085680RESULT

  • Agrawal A, Ickovics J, Lewis JB, Magriples U, Kershaw TS. Postpartum intimate partner violence and health risks among young mothers in the United States: a prospective study. Matern Child Health J. 2014 Oct;18(8):1985-92. doi: 10.1007/s10995-014-1444-9.

    PMID: 24562504RESULT

  • Cole-Lewis HJ, Kershaw TS, Earnshaw VA, Yonkers KA, Lin H, Ickovics JR. Pregnancy-specific stress, preterm birth, and gestational age among high-risk young women. Health Psychol. 2014 Sep;33(9):1033-45. doi: 10.1037/a0034586. Epub 2014 Jan 20.

    PMID: 24447189RESULT

  • Novick G, Reid AE, Lewis J, Kershaw TS, Rising SS, Ickovics JR. Group prenatal care: model fidelity and outcomes. Am J Obstet Gynecol. 2013 Aug;209(2):112.e1-6. doi: 10.1016/j.ajog.2013.03.026. Epub 2013 Mar 21.

    PMID: 23524175RESULT

  • Magriples U, Kershaw TS, Rising SS, Massey Z, Ickovics JR. Prenatal health care beyond the obstetrics service: utilization and predictors of unscheduled care. Am J Obstet Gynecol. 2008 Jan;198(1):75.e1-7. doi: 10.1016/j.ajog.2007.05.040.

    PMID: 18166312RESULT

  • Kershaw TS, Lewis J, Westdahl C, Wang YF, Rising SS, Massey Z, Ickovics J. Using clinical classification trees to identify individuals at risk of STDs during pregnancy. Perspect Sex Reprod Health. 2007 Sep;39(3):141-8. doi: 10.1363/3914107.

    PMID: 17845525RESULT

  • Westdahl C, Milan S, Magriples U, Kershaw TS, Rising SS, Ickovics JR. Social support and social conflict as predictors of prenatal depression. Obstet Gynecol. 2007 Jul;110(1):134-40. doi: 10.1097/01.AOG.0000265352.61822.1b.

    PMID: 17601908RESULT

  • Kershaw TS, Milan S, Westdahl C, Lewis J, Rising SS, Fletcher R, Ickovics J. Avoidance, anxiety, and sex: the influence of romantic attachment on HIV-risk among pregnant women. AIDS Behav. 2007 Mar;11(2):299-311. doi: 10.1007/s10461-006-9153-z.

    PMID: 16865541RESULT

  • Kershaw TS, Arnold A, Lewis JB, Magriples U, Ickovics JR. The skinny on sexual risk: the effects of BMI on STI incidence and risk. AIDS Behav. 2011 Oct;15(7):1527-38. doi: 10.1007/s10461-010-9842-5.

    PMID: 20976536DERIVED

MeSH Terms

Conditions

Sexually Transmitted DiseasesHIV InfectionsBirth WeightPremature Birth

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBody WeightSigns and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • Jeannette R. Ickovics, PhD

    Yale University School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2005

First Posted

January 4, 2006

Study Start

April 1, 2001

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 3, 2020

Record last verified: 2020-04

Locations

US(2)