Effectiveness of Integrating Prenatal Care in Reducing HIV/STDs Among Young Pregnant Women
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|ClinicalTrials.gov Identifier: NCT00628771|
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : July 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy HIV Infections Sexually Transmitted Diseases||Behavioral: CenteringPregnancy Plus (CP+) Behavioral: Usual care||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||1233 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Integrating Prenatal Care to Reduce HIV/STDs Among Teens: A Translational Study|
|Study Start Date :||June 2008|
|Primary Completion Date :||September 2012|
|Study Completion Date :||September 2012|
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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628771
|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|
|Principal Investigator:||Jeannette R. Ickovics, PhD||Yale University|
|Principal Investigator:||Jonathan N. Tobin, PhD||Clinical Directors Network|