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

Tracking Information
First Submitted Date ICMJE	February 29, 2008
First Posted Date ICMJE	March 5, 2008
Last Update Posted Date	July 27, 2016
Study Start Date ICMJE	June 2008
Actual Primary Completion Date	September 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 29, 2008)	Sexual behavior risk [ Time Frame: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum ]; Lab tested STDs [ Time Frame: Measured at 3rd trimester ]; Rapid repeat pregnancy [ Time Frame: Measured at Months 6 and 12 postpartum ]; Low birthweight [ Time Frame: Measured at delivery ]; Preterm labor [ Time Frame: Measured at delivery ]; Breastfeeding [ Time Frame: Measured at Months 6 and 12 postpartum ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00628771 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 29, 2008)	Maternal weight gain [ Time Frame: Measured at Months 6 and 12 postpartum ]; Prenatal care knowledge [ Time Frame: Measured at 2nd and 3rd trimesters ]; Pregnancy risk knowledge [ Time Frame: Measured at 2nd and 3rd trimesters ]; Perceived social conflict [ Time Frame: 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 ]; Depression [ Time Frame: 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 ]; Acculturation [ Time Frame: 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 ]; Treatment uptake, sustainability, fidelity, and cost-effectiveness [ Time Frame: Measured throughout the study ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effectiveness of Integrating Prenatal Care in Reducing HIV/STDs Among Young Pregnant Women
Official Title ICMJE	Integrating Prenatal Care to Reduce HIV/STDs Among Teens: A Translational Study
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.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Pregnancy; HIV Infections; Sexually Transmitted Diseases
Intervention ICMJE	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.; Behavioral: Usual care Usual care includes standard individual prenatal care and no prenatal group sessions.
Study Arms	Active Comparator: Usual Care Participants will receive usual care for their prenatal visits. Intervention: Behavioral: Usual care; Experimental: CenteringPregnancy Plus Participants will receive the CenteringPregnancy Plus treatment program, which includes an HIV/STD prevention component. Intervention: Behavioral: CenteringPregnancy Plus (CP+)
Publications *	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.; 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.; 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. "Bundling" HIV prevention: integrating services to promote synergistic gain. Prev Med. 2008 Mar;46(3):222-5. Epub 2007 Sep 29. Review.; 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.; 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.; 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.; 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.; 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.; 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.; 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.; Grilo, S., Earnshaw, V., Lewis, J., Stasko, E., Magriples, U., Tobin, J., & Ickovics, J. (2015). Food matters: Food insecurity among pregnant adolescents and infant birth outcomes. Journal of Applied Research on Children: Informing Policy for Children at Risk, 6, 4.; 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.; 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.; 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.; 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.; 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.; 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.; 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® plus group prenatal care. J Consult Clin Psychol. 2017 Jun;85(6):574-584. doi: 10.1037/ccp0000191. Epub 2017 Mar 13.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 20, 2014)	1233
Original Estimated Enrollment ICMJE; (submitted: February 29, 2008)	1400
Actual Study Completion Date	September 2012
Actual Primary Completion Date	September 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: Female
Ages	14 Years to 21 Years (Child, Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00628771
Other Study ID Numbers ICMJE	R01MH074399( U.S. NIH Grant/Contract ); R01MH074399 ( U.S. NIH Grant/Contract ); R01MH074394 ( U.S. NIH Grant/Contract ); DAHBR 9A-ASPC ( Other Grant/Funding Number: Office of AIDS Research )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Jeannette Ickovics, Yale University
Study Sponsor ICMJE	Yale University
Collaborators ICMJE	National Institute of Mental Health (NIMH)
Investigators ICMJE	Principal Investigator: Jeannette R. Ickovics, PhD Yale University Principal Investigator: Jonathan N. Tobin, PhD Clinical Directors Network
PRS Account	Yale University
Verification Date	July 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP