Positive Pregnancy Program (P3)
Primary Purpose
HIV Positive Pregnant Women
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Qualitative interview
Sponsored by
About this trial
This is an interventional health services research trial for HIV Positive Pregnant Women
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
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
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
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Positive Pregnancy Program
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