NCT00628771

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,233

participants targeted

Target at P75+ for phase_4 pregnancy

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_4 pregnancy

Geographic Reach
1 country

3 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

First Submitted

Initial submission to the registry

February 29, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

4.3 years

First QC Date

February 29, 2008

Last Update Submit

April 1, 2020

Conditions

PregnancyHIV InfectionsSexually Transmitted Diseases

Keywords

HIV PreventionTeen PregnancyTranslational ResearchGroup CarePrenatal CareSTD PreventionGonorrheaChlamydiaAdolescent HealthCommunity Health CentersCenteringPregnancy PlusHIV seronegativity

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Participants will receive usual care for their prenatal visits.

Behavioral: Usual care

CenteringPregnancy Plus

EXPERIMENTAL

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

Behavioral: CenteringPregnancy Plus (CP+)

Interventions

CenteringPregnancy Plus (CP+)BEHAVIORAL

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.

CenteringPregnancy Plus
Usual careBEHAVIORAL

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

Usual Care

Eligibility Criteria

Age14 Years - 21 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Yale University School of PUblic Health

New Haven, Connecticut, 06510, United States

Location

Centering Healthcare Institute

Boston, Massachusetts, 02111, United States

Location

Clinical Directors Network

New York, New York, 10018, United States

Location

Related Publications (23)

  • 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

  • Meade CS, Ickovics JR. Systematic review of sexual risk among pregnant and mothering teens in the USA: pregnancy as an opportunity for integrated prevention of STD and repeat pregnancy. Soc Sci Med. 2005 Feb;60(4):661-78. doi: 10.1016/j.socscimed.2004.06.015.

    PMID: 15571886BACKGROUND

  • Rising SS, Kennedy HP, Klima CS. Redesigning prenatal care through CenteringPregnancy. J Midwifery Womens Health. 2004 Sep-Oct;49(5):398-404. doi: 10.1016/j.jmwh.2004.04.018.

    PMID: 15351329BACKGROUND

  • Rising SS. Centering pregnancy. An interdisciplinary model of empowerment. J Nurse Midwifery. 1998 Jan-Feb;43(1):46-54. doi: 10.1016/s0091-2182(97)00117-1.

    PMID: 9489291BACKGROUND

  • 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

  • Cunningham SD, Grilo S, Lewis JB, Novick G, Rising SS, Tobin JN, Ickovics JR. Group Prenatal Care Attendance: Determinants and Relationship with Care Satisfaction. Matern Child Health J. 2017 Apr;21(4):770-776. doi: 10.1007/s10995-016-2161-3.

    PMID: 27485493RESULT

  • Udo IE, Lewis Lmft JB, Tobin JN, Ickovics JR. Intimate Partner Victimization and Health Risk Behaviors Among Pregnant Adolescents. Am J Public Health. 2016 Aug;106(8):1457-9. doi: 10.2105/AJPH.2016.303202. Epub 2016 Jun 16.

    PMID: 27310354RESULT

  • Martinez I, Kershaw TS, Lewis JB, Stasko EC, Tobin JN, Ickovics JR. Between Synergy and Travesty: A Sexual Risk Syndemic Among Pregnant Latina Immigrant and Non-immigrant Adolescents. AIDS Behav. 2017 Mar;21(3):858-869. doi: 10.1007/s10461-016-1461-3.

    PMID: 27338951RESULT

  • Ickovics JR, Earnshaw V, Lewis JB, Kershaw TS, Magriples U, Stasko E, Rising SS, Cassells A, Cunningham S, Bernstein P, Tobin JN. Cluster Randomized Controlled Trial of Group Prenatal Care: Perinatal Outcomes Among Adolescents in New York City Health Centers. Am J Public Health. 2016 Feb;106(2):359-65. doi: 10.2105/AJPH.2015.302960. Epub 2015 Dec 21.

    PMID: 26691105RESULT

  • Reid AE, Rosenthal L, Earnshaw VA, Lewis TT, Lewis JB, Stasko EC, Tobin JN, Ickovics JR. Discrimination and excessive weight gain during pregnancy among Black and Latina young women. Soc Sci Med. 2016 May;156:134-41. doi: 10.1016/j.socscimed.2016.03.012. Epub 2016 Mar 14.

    PMID: 27038321RESULT

  • Cunningham SD, Smith A, Kershaw T, Lewis JB, Cassells A, Tobin JN, Ickovics JR. Prenatal Depressive Symptoms and Postpartum Sexual Risk Among Young Urban Women of Color. J Pediatr Adolesc Gynecol. 2016 Feb;29(1):11-7. doi: 10.1016/j.jpag.2015.04.011. Epub 2015 May 9.

    PMID: 26165914RESULT

  • Earnshaw VA, Rosenthal L, Cunningham SD, Kershaw T, Lewis J, Rising SS, Stasko E, Tobin J, Ickovics JR. Exploring Group Composition among Young, Urban Women of Color in Prenatal Care: Implications for Satisfaction, Engagement, and Group Attendance. Womens Health Issues. 2016 Jan-Feb;26(1):110-5. doi: 10.1016/j.whi.2015.09.011. Epub 2015 Nov 3.

    PMID: 26542382RESULT

  • Grilo SA, Earnshaw VA, Lewis JB, Stasko EC, Magriples U, Tobin J, Ickovics JR. Food Matters: Food Insecurity among Pregnant Adolescents and Infant Birth Outcomes. J Appl Res Child. 2015;6(2):4. No abstract available.

    PMID: 35441055RESULT

  • Novick G, Womack JA, Lewis J, Stasko EC, Rising SS, Sadler LS, Cunningham SC, Tobin JN, Ickovics JR. Perceptions of Barriers and Facilitators During Implementation of a Complex Model of Group Prenatal Care in Six Urban Sites. Res Nurs Health. 2015 Dec;38(6):462-74. doi: 10.1002/nur.21681. Epub 2015 Sep 4.

    PMID: 26340483RESULT

  • Magriples U, Boynton MH, Kershaw TS, Lewis J, Rising SS, Tobin JN, Epel E, Ickovics JR. The impact of group prenatal care on pregnancy and postpartum weight trajectories. Am J Obstet Gynecol. 2015 Nov;213(5):688.e1-9. doi: 10.1016/j.ajog.2015.06.066. Epub 2015 Jul 9.

    PMID: 26164694RESULT

  • Carrion BV, Earnshaw VA, Kershaw T, Lewis JB, Stasko EC, Tobin JN, Ickovics JR. Housing instability and birth weight among young urban mothers. J Urban Health. 2015 Feb;92(1):1-9. doi: 10.1007/s11524-014-9913-4.

    PMID: 25344356RESULT

  • Rosenthal L, Earnshaw VA, Lewis TT, Reid AE, Lewis JB, Stasko EC, Tobin JN, Ickovics JR. Changes in experiences with discrimination across pregnancy and postpartum: age differences and consequences for mental health. Am J Public Health. 2015 Apr;105(4):686-93. doi: 10.2105/AJPH.2014.301906. Epub 2014 Jun 12.

    PMID: 24922166RESULT

  • Rosenthal L, Earnshaw VA, Lewis JB, Lewis TT, Reid AE, Stasko EC, Tobin JN, Ickovics JR. Discrimination and sexual risk among young urban pregnant women of color. Health Psychol. 2014 Jan;33(1):3-10. doi: 10.1037/a0032502.

    PMID: 24417689RESULT

  • Earnshaw VA, Rosenthal L, Lewis JB, Stasko EC, Tobin JN, Lewis TT, Reid AE, Ickovics JR. Maternal experiences with everyday discrimination and infant birth weight: a test of mediators and moderators among young, urban women of color. Ann Behav Med. 2013 Feb;45(1):13-23. doi: 10.1007/s12160-012-9404-3.

    PMID: 22927016RESULT

  • Simons HR, Thorpe LE, Jones HE, Lewis JB, Tobin JN, Ickovics JR. Perinatal Depressive Symptom Trajectories Among Adolescent Women in New York City. J Adolesc Health. 2020 Jul;67(1):84-92. doi: 10.1016/j.jadohealth.2019.12.017. Epub 2020 Apr 5.

    PMID: 32268996DERIVED

  • Thomas JL, Lewis JB, Martinez I, Cunningham SD, Siddique M, Tobin JN, Ickovics JR. Associations between intimate partner violence profiles and mental health among low-income, urban pregnant adolescents. BMC Pregnancy Childbirth. 2019 Apr 26;19(1):120. doi: 10.1186/s12884-019-2256-0.

    PMID: 31023259DERIVED

  • Martinez I, Kershaw TS, Keene D, Perez-Escamilla R, Lewis JB, Tobin JN, Ickovics JR. Acculturation and Syndemic Risk: Longitudinal Evaluation of Risk Factors Among Pregnant Latina Adolescents in New York City. Ann Behav Med. 2018 Jan 5;52(1):42-52. doi: 10.1007/s12160-017-9924-y.

    PMID: 28707175DERIVED

  • Felder JN, Epel E, Lewis JB, Cunningham SD, Tobin JN, Rising SS, Thomas M, Ickovics JR. Depressive symptoms and gestational length among pregnant adolescents: Cluster randomized control trial of CenteringPregnancy(R) plus group prenatal care. J Consult Clin Psychol. 2017 Jun;85(6):574-584. doi: 10.1037/ccp0000191. Epub 2017 Mar 13.

    PMID: 28287802DERIVED

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted DiseasesGonorrheaChlamydia Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, BacterialChlamydiaceae Infections

Study Officials

  • Jeannette R. Ickovics, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Jonathan N. Tobin, PhD

    Clinical Directors Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2008

First Posted

March 5, 2008

Study Start

June 1, 2008

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

April 3, 2020

Record last verified: 2020-04

Locations

US(3)