- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03073421
Positive Pregnancy Program (P3)
A Qualitative Evaluation of the "Positive Pregnancy Program", an Inter-professional Multidisciplinary Program for the Care of HIV-positive Pregnant Women
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HIV positive pregnant women who took part in P3 program
Exclusion Criteria:
- HIV negative
- did not take part in P3 program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: HIV positive pregnant women
HIV positive pregnant women who took part in the P3 program will take part in a 2-hour qualitative interview.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of satisfaction with P3 program during antenatal period
Time Frame: 36 weeks gestation
|
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.
|
36 weeks gestation
|
Post-partum degree of satisfaction with P3 program
Time Frame: 6 weeks post-partum
|
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.
|
6 weeks post-partum
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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