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Positive Pregnancy Program (P3)

Primary Purpose

HIV Positive Pregnant Women

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Qualitative interview
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV Positive Pregnant Women

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV positive pregnant women who took part in P3 program

Exclusion Criteria:

  • HIV negative
  • did not take part in P3 program

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    HIV positive pregnant women

    Arm Description

    HIV positive pregnant women who took part in the P3 program will take part in a 2-hour qualitative interview.

    Outcomes

    Primary Outcome Measures

    Degree of satisfaction with P3 program during antenatal period
    A qualitative 2 hour interview will be conducted with HIV positive pregnant women taking part in the P3 program. The first interview will be timed to occur late in the third trimester, at approximately 36 weeks gestation. This interview will allow an evaluation of women's experiences during antenatal care. The second interview will occur in the post partum period, and will be timed to coincide with the post partum visit at six weeks after birth. This interview will allow an evaluation of women's experiences in the hospital, during labour and delivery, and on the post partum floor.
    Post-partum degree of satisfaction with P3 program
    The second interview will occur in the post partum period, and will be timed to coincide with the post partum visit at six weeks after birth. This interview will allow an evaluation of women's experiences in the hospital, during labour and delivery, and on the post partum floor.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 22, 2017
    Last Updated
    March 2, 2017
    Sponsor
    Unity Health Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03073421
    Brief Title
    Positive Pregnancy Program
    Acronym
    P3
    Official Title
    A Qualitative Evaluation of the "Positive Pregnancy Program", an Inter-professional Multidisciplinary Program for the Care of HIV-positive Pregnant Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 29, 2012 (Actual)
    Primary Completion Date
    September 1, 2016 (Actual)
    Study Completion Date
    September 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Unity Health Toronto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The Positive Pregnancy Program is an innovative, unique, interprofessional model of care for HIV-positive pregnant women. This program has been in place at St. Michael's Hospital for five years. This study is important because it will allow for a critical evaluation of the Program, and to identify strengths and weaknesses. This will in turn provide the opportunity to improve delivery of care for HIV positive women.
    Detailed Description
    The aim of the P3 program is to provide supportive and comprehensive care from a variety of perspectives, including medical, social, and psychological. The premises on which the program are built include: a commitment to the respect, confidentiality, dignity and medical care of clients; health promotion; normalizing the care of HIV-positive pregnant women; knowledge translation; and the intentions to build a model of care that is transferable to other clinicians and to other conditions. During antenatal visits, pregnant women are seen by a multidisciplinary team of professionals including an Obstetrician, Midwife, Prenatal Nurse and Social Worker. Different rooms are used for routine antenatal care maneuvers and for consultation and counseling. The Midwife attends the births of the women in the program, and does home post partum care visits. Care is provided that is patient- and family-centered. Partners are invited to attend as many visits as the couple wishes. Because of this team approach, significantly more time is spent with each woman than would occur at a routine prenatal visit. The patient population at the St. Michael's clinic is largely made up of immigrant women. Many of these women are refugees, and have fled conflict zones or wars to come to Canada. More than 50% have lived in Canada for less than five years. Many of these women are marginalized, and may not access care elsewhere. They have many issues beyond HIV, and some of the social determinants of health that we observe during their time in the program include issues surrounding housing, finance, immigration, legal issues, social support, co-morbid conditions and substance use. Since the launch of the program, there has been a rapid increase in the number of women attending each year. The program has also attracted significant attention, both from within the medical and health care communities and beyond. This study seeks to determine if women cared for in the Positive Pregnancy Program will have a high degree of satisfaction with this model of care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Positive Pregnant Women

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HIV positive pregnant women
    Arm Type
    Other
    Arm Description
    HIV positive pregnant women who took part in the P3 program will take part in a 2-hour qualitative interview.
    Intervention Type
    Other
    Intervention Name(s)
    Qualitative interview
    Intervention Description
    This interview will be 2 hours in length and will be conducted with a Peer Research Assistant (PRA). The PRAs will be women living with HIV.
    Primary Outcome Measure Information:
    Title
    Degree of satisfaction with P3 program during antenatal period
    Description
    A qualitative 2 hour interview will be conducted with HIV positive pregnant women taking part in the P3 program. The first interview will be timed to occur late in the third trimester, at approximately 36 weeks gestation. This interview will allow an evaluation of women's experiences during antenatal care. The second interview will occur in the post partum period, and will be timed to coincide with the post partum visit at six weeks after birth. This interview will allow an evaluation of women's experiences in the hospital, during labour and delivery, and on the post partum floor.
    Time Frame
    36 weeks gestation
    Title
    Post-partum degree of satisfaction with P3 program
    Description
    The second interview will occur in the post partum period, and will be timed to coincide with the post partum visit at six weeks after birth. This interview will allow an evaluation of women's experiences in the hospital, during labour and delivery, and on the post partum floor.
    Time Frame
    6 weeks post-partum

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Pregnant women
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: HIV positive pregnant women who took part in P3 program Exclusion Criteria: HIV negative did not take part in P3 program
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark Yudin, MD
    Organizational Affiliation
    Unity Health Toronto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Positive Pregnancy Program

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