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Effectiveness of Integrating Prenatal Care in Reducing HIV/STDs Among Young Pregnant Women
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), November 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00628771
  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 IV

MedlinePlus related topics: AIDS AIDS and Pregnancy Anxiety Prenatal Care Sexually Transmitted Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment
Official Title: Integrating Prenatal Care to Reduce HIV/STDs Among Teens: A Translational Study

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment: 1400
Study Start Date: January 2007
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Usual Care: Active Comparator
Participants will receive usual care for their prenatal visits.
Behavioral: Usual care
Usual care includes standard individual prenatal care and no prenatal group sessions.
CenteringPregnancy Plus: Experimental
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628771

Contacts
Contact: Jeannette R. Ickovics, PhD 203-785-6213 jeannette.ickovics@yale.edu
Contact: Maria Abraham, MD, MPH 212-382-0699 ext 224 cpp@cdnetwork.org

Locations
United States, Connecticut
Yale University Connecticut Women's Health Project Recruiting
New Haven, Connecticut, United States, 06510
Contact: Jeannette R. Ickovics, PhD     203-785-6213     jeannette.ickovics@yale.edu    
Principal Investigator: Jeannette R. Ickovics, PhD            
Centering Pregnancy and Parenting Association Recruiting
Cheshire, Connecticut, United States, 06410
Contact: Sharon S. Rising, CNM, FACNM     203-271-3632     rising@centeringpregnancy.org    
United States, New York
Clinical Directors Network Recruiting
New York, New York, United States, 10018
Contact: Jonathan N. Tobin, PhD     212-302-0699 ext 234     jntobin@CDNetwork.org    
Principal Investigator: Jonathan N. Tobin, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Jeannette R. Ickovics, PhD Yale University
Principal Investigator: Jonathan N. Tobin, PhD Clinical Directors Network
  More Information

Publications:
Holub CK, Kershaw TS, Ethier KA, Lewis JB, Milan S, Ickovics JR. Prenatal and parenting stress on adolescent maternal adjustment: identifying a high-risk subgroup. Matern Child Health J. 2007 Mar;11(2):153-9. Epub 2006 Oct 25.
Ickovics JR, Meade CS, Kershaw TS, Milan S, Lewis JB, Ethier KA. Urban teens: Trauma, posttraumatic growth, and emotional distress among female adolescents. J Consult Clin Psychol. 2006 Oct;74(5):841-50.
Ickovics JR, Milan S, Boland R, Schoenbaum E, Schuman P, Vlahov D; HIV Epidemiology Research Study (HERS) Group. Psychological resources protect health: 5-year survival and immune function among HIV-infected women from four US cities. AIDS. 2006 Sep 11;20(14):1851-60.
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.
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. Review.
Ethier KA, Kershaw TS, Lewis JB, Milan S, Niccolai LM, Ickovics JR. Self-esteem, emotional distress and sexual behavior among adolescent females: inter-relationships and temporal effects. J Adolesc Health. 2006 Mar;38(3):268-74.
Niccolai LM, Ickovics JR, Zeller K, Kershaw TS, Milan S, Lewis JB, Ethier KA. Knowledge of sex partner treatment for past bacterial STI and risk of current STI. Sex Transm Infect. 2005 Jun;81(3):271-5.
Niccolai LM, Kershaw TS, Lewis JB, Cicchetti DV, Ethier KA, Ickovics JR. Data collection for sexually transmitted disease diagnoses: a comparison of self-report, medical record reviews, and state health department reports. Ann Epidemiol. 2005 Mar;15(3):236-42.
Kershaw TS, Ickovics JR, Lewis JB, Niccolai LM, Milan S, Ethier KA. Sexual risk following a sexually transmitted disease diagnosis: the more things change the more they stay the same. J Behav Med. 2004 Oct;27(5):445-61.
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. Review.
Milan S, Lewis J, Ethier K, Kershaw T, Ickovics JR. The impact of physical maltreatment history on the adolescent mother-infant relationship: mediating and moderating effects during the transition to early parenthood. J Abnorm Child Psychol. 2004 Jun;32(3):249-61.
Wilson TE, Ickovics JR, Royce R, Fernandez MI, Lampe M, Koenig LJ. Prenatal care utilization and the implementation of prophylaxis to prevent perinatal HIV-1 transmission. Matern Child Health J. 2004 Mar;8(1):13-8.
Milan S, Ickovics JR, Kershaw T, Lewis J, Meade C, Ethier K. Prevalence, course, and predictors of emotional distress in pregnant and parenting adolescents. J Consult Clin Psychol. 2004 Apr;72(2):328-40.
Niccolai LM, Ethier KA, Kershaw TS, Lewis JB, Meade CS, Ickovics JR. New sex partner acquisition and sexually transmitted disease risk among adolescent females. J Adolesc Health. 2004 Mar;34(3):216-23.
Ickovics JR, Kershaw TS, Westdahl C, Rising SS, Klima C, Reynolds H, Magriples U. Group prenatal care and preterm birth weight: results from a matched cohort study at public clinics. Obstet Gynecol. 2003 Nov;102(5 Pt 1):1051-7.
Ickovics JR, Niccolai LM, Lewis JB, Kershaw TS, Ethier KA. High postpartum rates of sexually transmitted infections among teens: pregnancy as a window of opportunity for prevention. Sex Transm Infect. 2003 Dec;79(6):469-73.
Kershaw TS, Niccolai LM, Ickovics JR, Lewis JB, Meade CS, Ethier KA. Short and long-term impact of adolescent pregnancy on postpartum contraceptive use: implications for prevention of repeat pregnancy. J Adolesc Health. 2003 Nov;33(5):359-68.
Ethier KA, Kershaw T, Niccolai L, Lewis JB, Ickovics JR. Adolescent women underestimate their susceptibility to sexually transmitted infections. Sex Transm Infect. 2003 Oct;79(5):408-11.
Kershaw TS, Ethier KA, Niccolai LM, Lewis JB, Ickovics JR. Misperceived risk among female adolescents: social and psychological factors associated with sexual risk accuracy. Health Psychol. 2003 Sep;22(5):523-32.
Niccolai LM, Ethier KA, Kershaw TS, Lewis JB, Ickovics JR. Pregnant adolescents at risk: sexual behaviors and sexually transmitted disease prevalence. Am J Obstet Gynecol. 2003 Jan;188(1):63-70.
Ethier KA, Ickovics JR, Fernandez MI, Wilson TE, Royce RA, Koenig LJ; Perinatal Guidelines Evaluation Project Group. The Perinatal Guidelines Evaluation Project HIV and Pregnancy Study: overview and cohort description. Public Health Rep. 2002 Mar-Apr;117(2):137-47.
Walter EB, Royce RA, Fernández MI, DeHovitz J, Ickovics JR, Lampe MA; Perinatal Guidelines Evaluation Project group. New mothers' knowledge and attitudes about perinatal human immunodeficiency virus infection. Obstet Gynecol. 2001 Jan;97(1):70-6.
Ickovics JR, Ethier KA, Koenig LJ, Wilson TE, Walter EB, Fernandez MI. Infant birth weight among women with or at high risk for HIV infection: the impact of clinical, behavioral, psychosocial, and demographic factors. Health Psychol. 2000 Nov;19(6):515-23.
Ethier KA, Fox-Tierney R, Nicholas WC, Salisbury KM, Ickovics JR. Organizational predictors of prenatal HIV counseling and testing. Am J Public Health. 2000 Sep;90(9):1448-51.
Ickovics JR, Druley JA, Morrill AC, Grigorenko E, Rodin J. "A grief observed": the experience of HIV-related illness and death among women in a clinic-based sample in New Haven, Connecticut. J Consult Clin Psychol. 1998 Dec;66(6):958-66.
Ickovics JR, Druley JA, Grigorenko EL, Morrill AC, Beren SE, Rodin J. Long-term effects of HIV counseling and testing for women: behavioral and psychological consequences are limited at 18 months posttest. Health Psychol. 1998 Sep;17(5):395-402.
Ickovics JR, Yoshikawa H. Preventive interventions to reduce heterosexual HIV risk for women: current perspectives, future directions. AIDS. 1998;12 Suppl A:S197-208. Review. No abstract available.
Morrill AC, Ickovics JR, Golubchikov VV, Beren SE, Rodin J. Safer sex: social and psychological predictors of behavioral maintenance and change among heterosexual women. J Consult Clin Psychol. 1996 Aug;64(4):819-28.
Barone C, Ickovics JR, Ayers TS, Katz SM, Voyce CK, Weissberg RP. High-risk sexual behavior among young urban students. Fam Plann Perspect. 1996 Mar-Apr;28(2):69-74.
Jones DL, McPherson-Baker S, Lydston D, Camille J, Brondolo E, Tobin JN, Weiss SM. Efficacy of a group medication adherence intervention among HIV positive women: the SMART/EST Women's Project. AIDS Behav. 2007 Jan;11(1):79-86.
Segal-Isaacson CJ, Tobin JN, Weiss SM, Brondolo E, Vaughn A, Wang C, Camille J, Gousse Y, Ishii M, Jones D, Laperriere A, Lydston D, Schneiderman N, Ironson G. Improving dietary habits in disadvantaged women with HIV/AIDS: the SMART/EST women's project. AIDS Behav. 2006 Nov;10(6):659-70. Epub 2006 Jun 1.
Laperriere A, Ironson GH, Antoni MH, Pomm H, Jones D, Ishii M, Lydston D, Lawrence P, Grossman A, Brondolo E, Cassells A, Tobin JN, Schneiderman N, Weiss SM. Decreased depression up to one year following CBSM+ intervention in depressed women with AIDS: the smart/EST women's project. J Health Psychol. 2005 Mar;10(2):223-31.
Jones DL, Ishii M, LaPerriere A, Stanley H, Antoni M, Ironson G, Schneiderman N, Van Splunteren F, Cassells A, Alexander K, Gousse YP, Vaughn A, Brondolo E, Tobin JN, Weiss SM. Influencing medication adherence among women with AIDS. AIDS Care. 2003 Aug;15(4):463-74.
Lechner SC, Antoni MH, Lydston D, LaPerriere A, Ishii M, Devieux J, Stanley H, Ironson G, Schneiderman N, Brondolo E, Tobin JN, Weiss S. Cognitive-behavioral interventions improve quality of life in women with AIDS. J Psychosom Res. 2003 Mar;54(3):253-61.
Jones DL, Weiss SM, Malow R, Ishii M, Devieux J, Stanley H, Cassells A, Tobin JN, Brondolo E, LaPerriere A, Efantis-Potter J, O'Sullivan MJ, Schneiderman N. A brief sexual barrier intervention for women living with AIDS: acceptability, use, and ethnicity. J Urban Health. 2001 Dec;78(4):593-604.
Walker DS, Rising SS. Revolutionizing prenatal care: new evidence-based prenatal care delivery models. J N Y State Nurses Assoc. 2004 Fall-2005 Winter;35(2):18-21. Review.
Rising SS, Kennedy HP, Klima CS. Redesigning prenatal care through CenteringPregnancy. J Midwifery Womens Health. 2004 Sep-Oct;49(5):398-404.
Rising SS. Centering pregnancy. An interdisciplinary model of empowerment. J Nurse Midwifery. 1998 Jan-Feb;43(1):46-54.
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.
Ickovics JR. "Bundling" HIV prevention: integrating services to promote synergistic gain. Prev Med. 2008 Mar;46(3):222-5. Epub 2007 Sep 29. Review.
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.

Responsible Party: Yale University ( Jeannette Ickovics Professor, Yale School of Public Health; Director, Social and Behavioral Sciences Program )
Study ID Numbers: R01 MH074399, R01 MH074394, DAHBR 9A-ASPC
Study First Received: February 29, 2008
Last Updated: November 6, 2008
ClinicalTrials.gov Identifier: NCT00628771  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
HIV Prevention
Teen Pregnancy
Translational Research
Group Care
Prenatal Care
STD Prevention
Gonorrhea
Chlamydia
Adolescent Health
Community Health Centers
CenteringPregnancy Plus
HIV seronegativity

Study placed in the following topic categories:
Genital Diseases, Female
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Chlamydia Infections
Gonorrhea
Genital Diseases, Male
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 30, 2009