NCT03073421

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
Last Updated

March 8, 2017

Status Verified

March 1, 2017

Enrollment Period

4.2 years

First QC Date

February 22, 2017

Last Update Submit

March 2, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    36 weeks gestation

  • 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.

    6 weeks post-partum

Study Arms (1)

HIV positive pregnant women

OTHER

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

Other: Qualitative interview

Interventions

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.

HIV positive pregnant women

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • HIV positive pregnant women who took part in P3 program

You may not qualify if:

  • HIV negative
  • did not take part in P3 program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Mark Yudin, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2017

First Posted

March 8, 2017

Study Start

June 29, 2012

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 8, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share