PregnancyPhase 4NCT00628771
Effectiveness of Integrating Prenatal Care in Reducing HIV/STDs Among Young Pregnant Women
A Phase 4 study testing CenteringPregnancy Plus (CP+) in people with Pregnancy and HIV Infections, run by Yale University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 21 years, women only
- Conditions the study is for
- Pregnancy, HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- CenteringPregnancy Plus (CP+)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,233 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2008to Sep 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 21 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnant
- Able to attend group treatment sessions conducted in English or Spanish
Who cannot join
- Positive HIV infection
- Severe medical problem requiring individualized assessment and tracking as high-risk pregnancy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Centering Healthcare Institute
Boston, Massachusetts, 02111
Yale University School of PUblic Health
New Haven, Connecticut, 06510
Clinical Directors Network
New York, New York, 10018
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy, HIV Infections, Sexually Transmitted Diseases
- Being tested
- CenteringPregnancy Plus (CP+), Usual care
- Keywords
- HIV Prevention, Teen Pregnancy, Translational Research, Group Care, Prenatal Care, STD Prevention, Gonorrhea, Chlamydia, Adolescent Health, Community Health Centers, CenteringPregnancy Plus, HIV seronegativity
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases, Gonorrhea, Chlamydia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenteringPregnancy Plus (CP+)Behavioural
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 careBehavioural
Usual care includes standard individual prenatal care and no prenatal group sessions.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Participants will receive usual care for their prenatal visits. Receives: Behavioral: Usual care |
| CenteringPregnancy Plus | Experimental | Participants will receive the CenteringPregnancy Plus treatment program, which includes an HIV/STD prevention component. Receives: Behavioral: CenteringPregnancy Plus (CP+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual behavior risk
Measured: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Lab tested STDs
Measured: Measured at 3rd trimester
Rapid repeat pregnancy
Measured: Measured at Months 6 and 12 postpartum
Low birthweight
Measured: Measured at delivery
Preterm labor
Measured: Measured at delivery
Breastfeeding
Measured: Measured at Months 6 and 12 postpartum
Secondary outcomes (10)
Maternal weight gain
Measured: Measured at Months 6 and 12 postpartum
Prenatal care knowledge
Measured: Measured at 2nd and 3rd trimesters
Pregnancy risk knowledge
Measured: Measured at 2nd and 3rd trimesters
Perceived social conflict
Measured: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Social support
Measured: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Depression
Measured: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Generalized anxiety disorder
Measured: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Acculturation
Measured: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Substance use
Measured: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum
Treatment uptake, sustainability, fidelity, and cost-effectiveness
Measured: Measured throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jeannette R. Ickovics, PhD, Principal investigator, Yale UniversityJonathan N. Tobin, PhD, Principal investigator, Clinical Directors Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628771
- Sponsor's protocol ID
- 0408026962
- Other IDs
- R01MH074399, R01MH074394, DAHBR 9A-ASPC
- Status last verified
- Apr 2020
- First submitted
- 29 Feb 2008
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1111/j.1552-6909.2006.00040.x.
PubMed 16620257Meade 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. doi: 10.1016/j.socscimed.2004.06.015.
PubMed 15571886Rising SS, Kennedy HP, Klima CS. Redesigning prenatal care through CenteringPregnancy. J Midwifery Womens Health. 2004 Sep-Oct;49(5):398-404. doi: 10.1016/j.jmwh.2004.04.018.
PubMed 15351329Rising SS. Centering pregnancy. An interdisciplinary model of empowerment. J Nurse Midwifery. 1998 Jan-Feb;43(1):46-54. doi: 10.1016/s0091-2182(97)00117-1.
PubMed 9489291Ickovics JR. "Bundling" HIV prevention: integrating services to promote synergistic gain. Prev Med. 2008 Mar;46(3):222-5. doi: 10.1016/j.ypmed.2007.09.006. Epub 2007 Sep 29.
PubMed 17964637Cunningham 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.
PubMed 27485493Udo 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.
PubMed 27310354Martinez 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.
PubMed 27338951Ickovics 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.
PubMed 26691105Reid 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.
PubMed 27038321Cunningham 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.
PubMed 26165914Earnshaw 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.
PubMed 26542382Grilo SA, Earnshaw VA, Lewis JB, Stasko EC, Magriples U, Tobin J, Ickovics JR. Food Matters: Food Insecurity among Pregnant Adolescents and Infant Birth Outcomes. J Appl Res Child. 2015;6(2):4. No abstract available.
PubMed 35441055Novick 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.
PubMed 26340483Magriples 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.
PubMed 26164694
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Prenatal Care to Reduce HIV/STDs Among Teens: A Translational Study
- ClinicalTrials.gov ID
- NCT00628771
- Acronym / sponsor ID
- 0408026962
- Conditions
- Pregnancy, HIV Infections, Sexually Transmitted Diseases
- Keywords
- HIV Prevention, Teen Pregnancy, Translational Research, Group Care, Prenatal Care, STD Prevention, Gonorrhea, Chlamydia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,233 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual careParticipants will receive usual care for their prenatal visits. |
| CenteringPregnancy Plus | Experimental | Behavioral: CenteringPregnancy Plus (CP+)Participants will receive the CenteringPregnancy Plus treatment program, which includes an HIV/STD prevention component. |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pregnant
- Able to attend group treatment sessions conducted in English or Spanish
Key exclusion criteria (2 listed)
- Positive HIV infection
- Severe medical problem requiring individualized assessment and tracking as high-risk pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CenteringPregnancy Plus |
| Usual careUsual care includes standard individual prenatal care and no prenatal group sessions. | Behavioural | Usual Care |
Primary outcome
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
10 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Background: PubMed 16620257Massey 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. doi: 10.1111/j.1552-6909.2006.00040.x.
- Background: PubMed 15571886Meade 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. doi: 10.1016/j.socscimed.2004.06.015.
- Background: PubMed 15351329Rising SS, Kennedy HP, Klima CS. Redesigning prenatal care through CenteringPregnancy. J Midwifery Womens Health. 2004 Sep-Oct;49(5):398-404. doi: 10.1016/j.jmwh.2004.04.018.
- Background: PubMed 9489291Rising SS. Centering pregnancy. An interdisciplinary model of empowerment. J Nurse Midwifery. 1998 Jan-Feb;43(1):46-54. doi: 10.1016/s0091-2182(97)00117-1.
- Background: PubMed 17964637Ickovics JR. "Bundling" HIV prevention: integrating services to promote synergistic gain. Prev Med. 2008 Mar;46(3):222-5. doi: 10.1016/j.ypmed.2007.09.006. Epub 2007 Sep 29.
- Results publication: PubMed 27485493Cunningham 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.
- Results publication: PubMed 27310354Udo 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.
- Results publication: PubMed 27338951Martinez 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.
- Results publication: PubMed 26691105Ickovics 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.
- Results publication: PubMed 27038321Reid 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.
- Results publication: PubMed 26165914Cunningham 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.
- Results publication: PubMed 26542382Earnshaw 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeannette R. Ickovics, PhD principal investigator
Yale University
Jonathan N. Tobin, PhD principal investigator
Clinical Directors Network
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CenteringPregnancy Plus (CP+) in people with Pregnancy and HIV Infections, run by Yale University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual behavior risk (time frame: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00628771, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.