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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628771
• Other study ID #: 0408026962
• Secondary ID: R01MH074399R01MH
• Status: Completed
• Phase: Phase 4
• Start date: June 2008
• Est. completion date: September 2012

Study information

• Verified date: April 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1233
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Pregnancy
• Sexually Transmitted Diseases

Intervention

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.
• Usual care
Usual care includes standard individual prenatal care and no prenatal group sessions.

Locations

Country	Name	City	State
United States	Centering Healthcare Institute	Boston	Massachusetts
United States	Yale University School of PUblic Health	New Haven	Connecticut
United States	Clinical Directors Network	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. — View 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. — View Citation

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 — View Citation

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 — View Citation

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 F — View Citation

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

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 Cent — View Citation

Ickovics JR. "Bundling" HIV prevention: integrating services to promote synergistic gain. Prev Med. 2008 Mar;46(3):222-5. Epub 2007 Sep 29. Review. — View Citation

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 — View Citation

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. — View 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. Review. — View 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. Review. — View Citation

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( — View Citation

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. — View Citation

Rising SS, Kennedy HP, Klima CS. Redesigning prenatal care through CenteringPregnancy. J Midwifery Womens Health. 2004 Sep-Oct;49(5):398-404. — View Citation

Rising SS. Centering pregnancy. An interdisciplinary model of empowerment. J Nurse Midwifery. 1998 Jan-Feb;43(1):46-54. — View Citation

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. — View Citation

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):68 — View 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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual behavior risk		Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Primary	Lab tested STDs		Measured at 3rd trimester
Primary	Rapid repeat pregnancy		Measured at Months 6 and 12 postpartum
Primary	Low birthweight		Measured at delivery
Primary	Preterm labor		Measured at delivery
Primary	Breastfeeding		Measured at Months 6 and 12 postpartum
Secondary	Maternal weight gain		Measured at Months 6 and 12 postpartum
Secondary	Prenatal care knowledge		Measured at 2nd and 3rd trimesters
Secondary	Pregnancy risk knowledge		Measured at 2nd and 3rd trimesters
Secondary	Perceived social conflict		Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Secondary	Social support		Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Secondary	Depression		Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Secondary	Generalized anxiety disorder		Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Secondary	Acculturation		Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Secondary	Substance use		Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Secondary	Treatment uptake, sustainability, fidelity, and cost-effectiveness		Measured throughout the study

External Links

•   Study Website