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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeannette Ickovics, Yale University
ClinicalTrials.gov Identifier:
NCT00628771
First received: February 29, 2008
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Pregnancy
HIV Infections
Sexually Transmitted Diseases
Behavioral: CenteringPregnancy Plus (CP+)
Behavioral: Usual care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Integrating Prenatal Care to Reduce HIV/STDs Among Teens: A Translational Study

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Sexual behavior risk [ Time Frame: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum ] [ Designated as safety issue: No ]
  • Lab tested STDs [ Time Frame: Measured at 3rd trimester ] [ Designated as safety issue: No ]
  • Rapid repeat pregnancy [ Time Frame: Measured at Months 6 and 12 postpartum ] [ Designated as safety issue: No ]
  • Low birthweight [ Time Frame: Measured at delivery ] [ Designated as safety issue: No ]
  • Preterm labor [ Time Frame: Measured at delivery ] [ Designated as safety issue: No ]
  • Breastfeeding [ Time Frame: Measured at Months 6 and 12 postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maternal weight gain [ Time Frame: Measured at Months 6 and 12 postpartum ] [ Designated as safety issue: No ]
  • Prenatal care knowledge [ Time Frame: Measured at 2nd and 3rd trimesters ] [ Designated as safety issue: No ]
  • Pregnancy risk knowledge [ Time Frame: Measured at 2nd and 3rd trimesters ] [ Designated as safety issue: No ]
  • Perceived social conflict [ Time Frame: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum ] [ Designated as safety issue: No ]
  • Social support [ Time Frame: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum ] [ Designated as safety issue: No ]
  • Generalized anxiety disorder [ Time Frame: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum ] [ Designated as safety issue: No ]
  • Acculturation [ Time Frame: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum ] [ Designated as safety issue: No ]
  • Substance use [ Time Frame: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum ] [ Designated as safety issue: No ]
  • Treatment uptake, sustainability, fidelity, and cost-effectiveness [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]

Enrollment: 1233
Study Start Date: August 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628771

Locations
United States, Connecticut
Yale University School of PUblic Health
New Haven, Connecticut, United States, 06510
United States, Massachusetts
Centering Healthcare Institute
Boston, Massachusetts, United States, 02111
United States, New York
Clinical Directors Network
New York, New York, United States, 10018
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Jeannette R. Ickovics, PhD Yale University
Principal Investigator: Jonathan N. Tobin, PhD Clinical Directors Network
  More Information

Publications:

Responsible Party: Jeannette Ickovics, Professor, Yale University
ClinicalTrials.gov Identifier: NCT00628771     History of Changes
Other Study ID Numbers: R01 MH074399, R01MH074399, R01 MH074394, DAHBR 9A-ASPC
Study First Received: February 29, 2008
Last Updated: February 4, 2014
Health Authority: United States: Federal Government

Keywords provided by Yale University:
HIV Prevention
Teen Pregnancy
Translational Research
Group Care
Prenatal Care
STD Prevention
Gonorrhea
Chlamydia
Adolescent Health
Community Health Centers
CenteringPregnancy Plus
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 26, 2014