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

April 1, 2020 updated by: Yale University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1233

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Public Health
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Centering Healthcare Institute
    • New York
      • New York, New York, United States, 10018
        • Clinical Directors Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Jeannette R. Ickovics, PhD, Yale University
  • Principal Investigator: Jonathan N. Tobin, PhD, Clinical Directors Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

February 29, 2008

First Submitted That Met QC Criteria

February 29, 2008

First Posted (Estimate)

March 5, 2008

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0408026962
  • R01MH074399 (U.S. NIH Grant/Contract)
  • R01MH074394 (U.S. NIH Grant/Contract)
  • DAHBR 9A-ASPC (Registry Identifier: Division of AIDS and Health and Behavior Research)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Usual care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe