- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- HIV positive pregnant women who took part in P3 program
Exclusion Criteria:
- HIV negative
- did not take part in P3 program
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Degree of satisfaction with P3 program during antenatal period
Lasso di tempo: 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
|
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Post-partum degree of satisfaction with P3 program
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Sindromi da deficit immunologico
- Malattie del sistema immunitario
- Infezioni da HIV
- Sieropositività HIV
Altri numeri di identificazione dello studio
- 12-124
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .