Completed

NCT Number: NCT03073421

Positive Pregnancy Program

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.

Completed

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Key information

Conditions

HIV Positive Pregnant Women

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

HIV positive pregnant women who took part in P3 program

Exclusion criteria

HIV negative
did not take part in P3 program

Treatment and study plan

Qualitative interview

Other

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 outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

A Qualitative Evaluation of the "Positive Pregnancy Program", an Inter-professional Multidisciplinary Program for the Care of HIV-positive Pregnant Women

Acronym: P3

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Mar 8, 2017
Registry last updated: Mar 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.