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

Primary Purpose

Pregnancy, HIV Infections, Sexually Transmitted Diseases

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CenteringPregnancy Plus (CP+)
Usual care
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring HIV Prevention, Teen Pregnancy, Translational Research, Group Care, Prenatal Care, STD Prevention, Gonorrhea, Chlamydia, Adolescent Health, Community Health Centers, CenteringPregnancy Plus, HIV seronegativity

Eligibility Criteria

14 Years - 21 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

  • Yale University School of PUblic Health
  • Centering Healthcare Institute
  • Clinical Directors Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care

CenteringPregnancy Plus

Arm Description

Participants will receive usual care for their prenatal visits.

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

Outcomes

Primary Outcome Measures

Sexual behavior risk
Lab tested STDs
Rapid repeat pregnancy
Low birthweight
Preterm labor
Breastfeeding

Secondary Outcome Measures

Maternal weight gain
Prenatal care knowledge
Pregnancy risk knowledge
Perceived social conflict
Social support
Depression
Generalized anxiety disorder
Acculturation
Substance use
Treatment uptake, sustainability, fidelity, and cost-effectiveness

Full Information

First Posted
February 29, 2008
Last Updated
April 1, 2020
Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00628771
Brief Title
Effectiveness of Integrating Prenatal Care in Reducing HIV/STDs Among Young Pregnant Women
Official Title
Integrating Prenatal Care to Reduce HIV/STDs Among Teens: A Translational Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, HIV Infections, Sexually Transmitted Diseases
Keywords
HIV Prevention, Teen Pregnancy, Translational Research, Group Care, Prenatal Care, STD Prevention, Gonorrhea, Chlamydia, Adolescent Health, Community Health Centers, CenteringPregnancy Plus, HIV seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1233 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants will receive usual care for their prenatal visits.
Arm Title
CenteringPregnancy Plus
Arm Type
Experimental
Arm Description
Participants will receive the CenteringPregnancy Plus treatment program, which includes an HIV/STD prevention component.
Intervention Type
Behavioral
Intervention Name(s)
CenteringPregnancy Plus (CP+)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Usual care includes standard individual prenatal care and no prenatal group sessions.
Primary Outcome Measure Information:
Title
Sexual behavior risk
Time Frame
Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Title
Lab tested STDs
Time Frame
Measured at 3rd trimester
Title
Rapid repeat pregnancy
Time Frame
Measured at Months 6 and 12 postpartum
Title
Low birthweight
Time Frame
Measured at delivery
Title
Preterm labor
Time Frame
Measured at delivery
Title
Breastfeeding
Time Frame
Measured at Months 6 and 12 postpartum
Secondary Outcome Measure Information:
Title
Maternal weight gain
Time Frame
Measured at Months 6 and 12 postpartum
Title
Prenatal care knowledge
Time Frame
Measured at 2nd and 3rd trimesters
Title
Pregnancy risk knowledge
Time Frame
Measured at 2nd and 3rd trimesters
Title
Perceived social conflict
Time Frame
Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Title
Social support
Time Frame
Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Title
Depression
Time Frame
Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Title
Generalized anxiety disorder
Time Frame
Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Title
Acculturation
Time Frame
Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Title
Substance use
Time Frame
Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Title
Treatment uptake, sustainability, fidelity, and cost-effectiveness
Time Frame
Measured throughout the study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannette R. Ickovics, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan N. Tobin, PhD
Organizational Affiliation
Clinical Directors Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of PUblic Health
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Centering Healthcare Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Clinical Directors Network
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16620257
Citation
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.
Results Reference
background
PubMed Identifier
15571886
Citation
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.
Results Reference
background
PubMed Identifier
15351329
Citation
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.
Results Reference
background
PubMed Identifier
9489291
Citation
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Results Reference
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PubMed Identifier
17964637
Citation
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.
Results Reference
background
PubMed Identifier
27485493
Citation
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.
Results Reference
result
PubMed Identifier
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Citation
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.
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PubMed Identifier
27338951
Citation
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Citation
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Results Reference
derived

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

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