Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission

Perinatal Core Protocol

The purpose of this study is to collect and study clinical and laboratory information about a pregnant or new mother and her medical care that will increase our knowledge of the best care for HIV-infected pregnant women and their children.

The rate of transmission of HIV from mothers to their infants has gone down. Specific U.S. Public Health Service guidelines recommend that HIV-infected pregnant women be treated with anti-HIV therapies; but the effectiveness of treatment and safety for the mother and her infant have not been fully examined. This study will monitor the health of women and their infants while they receive anti-HIV therapy. Also, this study will provide information that may be used for future studies.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Pregnancy Complications, Infectious
• Intervention / Treatment: Behavioral: Adherence assessment

Detailed Description

The current low rate of vertical transmission of HIV in the U.S. limits the number and types of questions concerning transmission risk and pathogenesis that can be addressed by a single clinical trial. Specific U.S. Public Health Service guidelines recommend antiretroviral therapy (ART) during pregnancy to maximize health of women. However, data regarding the effectiveness and safety of and adherence to ART during pregnancy are limited. It is both appropriate and necessary for theInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) to recruit pregnant women into a non-interventional, analytic, epidemiologic study to methodically collect clinical and laboratory data from them and their infants. This way, the IMPAACT can achieve the aims of evaluating management of HIV-infected women during pregnancy and determining the safety and effectiveness of ART and other interventions intended to prevent vertical transmission and/or improve maternal health. In addition, longitudinally collected core protocol data and repository specimens will enable future substudies.

Participants receive no protocol specific treatment or other intervention as part of this study. The study involves the follow-up of HIV-infected women enrolled during pregnancy or at the time of delivery for 6 months postpartum and their infants for the first 6 months of life. There will be 8 study visits for enrolled participants and 6 study visits for infants. Data concerning ART use, adherence to medications, and review of symptoms relevant to side effects and toxicities are collected through administration of questionnaires at all maternal visits. Phlebotomy is conducted to obtain specimens for a repository and for required laboratory tests. During labor and delivery, maternal blood is obtained for lymphocyte subset and viral load assays and for repository storage. Collection of amniotic fluid at the time of cesarean section is encouraged. These collections are submitted to a central repository. Data for the core protocol are abstracted from the infant's medical record at the time of birth and at each postnatal visit.

• Study Type: Observational
• Enrollment (Actual): 3090

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00936-5067
    • University of Puerto Rico Pediatric HIV/AIDS (6601)
  • San Juan, Puerto Rico, 00936-7344
    • San Juan City Hosp. PR NICHD CRS (5031)
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Univ. of Alabama Birmingham NICHD CRS (5096)
    • Mobile, Alabama, United States, 36688
      • University Of South Alabama
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Phoenix Childrens Hospital
  • California
    • Long Beach, California, United States, 90801
      • Long Beach Memorial (Pediatric)
    • Long Beach, California, United States, 90806
      • Miller Children's Hospital Long Beach (5093)
    • Los Angeles, California, United States, 900951752
      • UCLA Med Ctr / Pediatric
    • Los Angeles, California, United States, 90033
      • Usc La Nichd Crs (5048)
    • Los Angeles, California, United States, 90095
      • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
    • Los Angeles, California, United States, 90033
      • Los Angeles County Medical Center/USC
    • San Diego, California, United States, 92103
      • Univ of California, San Diego (4601)
    • San Francisco, California, United States, 94117
      • Univ. of California San Francisco NICHD CRS (5091)
    • Torrance, California, United States, 90509
      • Harbor-UCLA Med Ctr (5045)
  • Colorado
    • Denver, Colorado, United States, 80218-1088
      • University of Colorado Denver NICHD CRS (5052)
  • Connecticut
    • Farmington, Connecticut, United States, 06030-3805
      • Connecticut Childrens Medical Center (Pediatric)
    • Farmington, Connecticut, United States, 06030-3805
      • University of Connecticut, Farmington
    • New Haven, Connecticut, United States, 06504
      • Yale Univ School of Med
  • District of Columbia
    • Washington, District of Columbia, United States, 20010-2970
      • Children's National Medical Center Washington DC NICHD CRS (5015)
    • Washington, District of Columbia, United States, 200102931
      • Washington Hospital Center NICHD CRS (5023)
    • Washington, District of Columbia, United States, 20060
      • Howard Univ Hosp (5044)
  • Florida
    • Fort Lauderdale, Florida, United States, 33311
      • North Broward Hosp District
    • Ft Lauderdal, Florida, United States, 33316
      • South Florida CDC Ft Lauderdale NICHD CRS (5055)
    • Jacksonville, Florida, United States, 32209
      • University of Florida Jacksonville (5051)
    • Miami, Florida, United States, 33136
      • University of Miami Pediatric/Perinatal HIV/AIDS (4201)
    • Miami, Florida, United States, 33136
      • Jackson Memorial Hosp
    • St Petersburg, Florida, United States, 33701
      • University of South Florida at Tampa (5018)
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Med College of Georgia
    • Columbus, Georgia, United States, 31901
      • The Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Cook County Hospital
    • Chicago, Illinois, United States, 60608
      • Mt Sinai Hosp Med Ctr / Dept of Pediatrics
    • Chicago, Illinois, United States, 60612
      • Rush University Cook County Hospital NICHD CRS (5083)
    • Chicago, Illinois, United States, 60608-1797
      • Womens & Childrens HIV Program
    • Chicago, Illinois, United States, 60612-7234
      • Univ of Illinois
    • Chicago, Illinois, United States, 60614
      • Chicago Childrens Memorial Hosp (Pediatric)
    • Chicago, Illinois, United States, 60637-1470
      • Univ of Chicago Children's Hosp (4001)
  • Louisiana
    • New Orleans, Louisiana, United States, 70112-2699
      • Tulane University New Orleans (5095)
    • New Orleans, Louisiana, United States, 70112-2699
      • Tulane-Lakeside Hospital
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Charity Hosp of New Orleans (7201)
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University NICHD CRS (5092)
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Baltimore NICHD CRS (5094)
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital of Boston NICHD CRS (5009)
    • Boston, Massachusetts, United States, 02118
      • Boston Med Ctr (Pediatric) (5011)
    • Boston, Massachusetts, United States, 02478
      • Brigham and Women's Hosp
    • Springfield, Massachusetts, United States, 01199
      • Baystate Med Ctr of Springfield
    • Worcester, Massachusetts, United States, 01605
      • WNE Maternal Pediatric Adolescent AIDS CRS (7301)
    • Worcester, Massachusetts, United States, 01655
      • Univ of Massachusetts Med School
  • Michigan
    • Detroit, Michigan, United States, 48201-1427
      • Hutzel Hospital (5089)
    • Detroit, Michigan, United States, 48201
      • Wayne State University Detroit Children's Hosp of Michigan (5041)
  • Missouri
    • St. Louis, Missouri, United States, 63108-2138
      • St. Louis Children's Hosp
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Univ of Med & Dentistry of New Jersey/Univ Hosp
    • Newark, New Jersey, United States, 07103-2714
      • Univ of Medicine & Dentistry of New Jersey / Univ Hosp (P2802)
    • Newark, New Jersey, United States, 07103
      • New Jersey Medical School (2802)
  • New York
    • Bronx, New York, United States, 19461
      • Montefiore Medical / AECOM
    • Bronx, New York, United States, 10451
      • Lincoln Medical & Mental Health Center
    • Bronx, New York, United States, 10461
      • Jacobi Med. Ctr. Bronx NICHD CRS (5013)
    • Bronx, New York, United States, 10457
      • Bronx-Lebanon Hospital IMPAACT (6901)
    • Brooklyn, New York, United States, 11203-2098
      • Children's Hospital at Downstate
    • New York, New York, United States, 10016
      • New York University NY (5012)
    • New York, New York, United States, 10032
      • Columbia IMPAACT CRS (4101)
    • New York, New York, United States, 10016
      • NYU/Bellevue Hospital
    • New York, New York, United States, 10029
      • Metropolitan Hosp Ctr (5003)
    • Rochester, New York, United States, 14642
      • Univ of Rochester Med Ctr
    • Stony Brook, New York, United States, 11776
      • State Univ of New York at Stony Brook (5040)
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical Univ
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Univ (Pediatric) (DUMC) (4701)
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102-1192
      • Hahnemann University Hospital (6706)
    • Philadelphia, Pennsylvania, United States, 19134
      • The Children's Hospital of Philadelphia (6701)
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Childrens Research Hosp, Memphis (6501)
    • Memphis, Tennessee, United States, 38105-2794
      • The Regional Med Ctr, Memphis (6502)
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Univ Med Ctr
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hosp / Baylor Univ (3801)
  • Washington
    • Seattle, Washington, United States, 98105
      • Harborview Medical Center NICHD CRS (5027)
    • Seattle, Washington, United States, 98105
      • University of Washington NICHD CRS (5029)
    • Seattle, Washington, United States, 98105-0371
      • Univ of Washington Children's Hospital Seattle (5017)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Primary care clinics

Description

Inclusion Criteria:

• HIV infected
• At least 14 weeks pregnant OR have delivered a liveborn or stillborn infant and are within 14 days of the delivery
• Currently receiving care at an IMPAACT or other participating site
• Have a parent or guardian willing to provide signed informed consent, if applicable
• Mentally capable of giving informed consent to have the infant and self followed at an IMPAACT site

Exclusion Criteria:

• Intend to end the pregnancy
• Unable to come for a study visit within 14 days after delivery (if known to be HIV infected prior to delivery) OR within 28 days after delivery (if found to be HIV infected at the time of labor and delivery or within 14 days after delivery)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Pregnant, HIV-infected women	Behavioral: Adherence assessment; Adherence will be assessed using questionnaires at all study visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maternal and infant response to prescribed interventions	Throughout study
Immune and viral parameters of participants taking prescribed interventions	Throughout study

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrences of genotypic and phenotypic resistance in HIV-infected mothers	Throughout study
Clinical, immunological, and virological responses in HIV-infected women	Throughout study
Mother-to-child transmission rates of resistance mutations	Throughout study
Adherence to ART among HIV-infected pregnant women during pregnancy and postpartum	Throughout study

Collaborators and Investigators

• Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Study Chair: Ruth Tuomala, MD, Director of Obstetrics and Gynecology, Brigham and Women's Hospital; Study Chair: Gwen Scott, MD, Pediatric Infectious Diseases, University of Miami School of Medicine

Publications and helpful links

General Publications

• Ciambrone D, Loewenthal HG, Bazerman LB, Zorilla C, Urbina B, Mitty JA. Adherence among women with HIV infection in Puerto Rico: the potential use of modified directly observed therapy (MDOT) among pregnant and postpartum women. Women Health. 2006;44(4):61-77. doi: 10.1300/j013v44n04_04.
• Kingston MA, Letham CJ, McQuillan O. Adherence to antiretroviral therapy in pregnancy. Int J STD AIDS. 2007 Nov;18(11):787-9. doi: 10.1258/095646207782212216.
• Bardeguez AD, Lindsey JC, Shannon M, Tuomala RE, Cohn SE, Smith E, Stek A, Buschur S, Cotter A, Bettica L, Read JS; PACTG 1025 Protocol Team. Adherence to antiretrovirals among US women during and after pregnancy. J Acquir Immune Defic Syndr. 2008 Aug 1;48(4):408-17. doi: 10.1097/QAI.0b013e31817bbe80.
• Momplaisir F, Hussein M, Kacanek D, Brady K, Agwu A, Scott G, Tuomala R, Bennett D. Perinatal Depressive Symptoms, Human Immunodeficiency Virus (HIV) Suppression, and the Underlying Role of Antiretroviral Therapy Adherence: A Longitudinal Mediation Analysis in the IMPAACT P1025 Cohort. Clin Infect Dis. 2021 Oct 20;73(8):1379-1387. doi: 10.1093/cid/ciab416.
• Jao J, Kacanek D, Williams PL, Geffner ME, Livingston EG, Sperling RS, Patel K, Bardeguez AD, Burchett SK, Chakhtoura N, Scott GB, Van Dyke RB, Abrams EJ; Pediatric HIV/AIDS Cohort Study and the International Maternal Pediatric Adolescent AIDS Clinical Trials P1025 Protocol; Pediatric HIV/AIDS Cohort Study and the International Maternal Pediatric Adolescent AIDS Clinical Trials P1025 Protocol. Birth Weight and Preterm Delivery Outcomes of Perinatally vs Nonperinatally Human Immunodeficiency Virus-Infected Pregnant Women in the United States: Results From the PHACS SMARTT Study and IMPAACT P1025 Protocol. Clin Infect Dis. 2017 Sep 15;65(6):982-989. doi: 10.1093/cid/cix488.
• Scott GB, Brogly SB, Muenz D, Stek AM, Read JS; International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1025 Study Team. Missed Opportunities for Prevention of Mother-to-Child Transmission of Human Immunodeficiency Virus. Obstet Gynecol. 2017 Apr;129(4):621-628. doi: 10.1097/AOG.0000000000001929.
• Livingston EG, Huo Y, Patel K, Tuomala RE, Scott GB, Stek A; P1025 Team of the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Group. Complications and Route of Delivery in a Large Cohort Study of HIV-1-Infected Women-IMPAACT P1025. J Acquir Immune Defic Syndr. 2016 Sep 1;73(1):74-82. doi: 10.1097/QAI.0000000000001021.
• Katz IT, Leister E, Kacanek D, Hughes MD, Bardeguez A, Livingston E, Stek A, Shapiro DE, Tuomala R. Factors associated with lack of viral suppression at delivery among highly active antiretroviral therapy-naive women with HIV: a cohort study. Ann Intern Med. 2015 Jan 20;162(2):90-9. doi: 10.7326/M13-2005.

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: December 13, 2001
• First Submitted That Met QC Criteria: December 13, 2001
• First Posted (Estimate): December 14, 2001

Study Record Updates

• Last Update Posted (Estimate): October 10, 2014
• Last Update Submitted That Met QC Criteria: October 8, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Disease Transmission, Vertical; Treatment Experienced; Women's Health; Preventive Medicine
• Additional Relevant MeSH Terms: Infections; Pregnancy Complications; Pregnancy Complications, Infectious
• Other Study ID Numbers: PACTG P1025; U01AI068632 (U.S. NIH Grant/Contract)