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Trial record 9 of 51852 for:    questionnaire

Positive Attitudes Concerning Infant Feeding- a Questionnaire for Women Living With HIV (PACIFY)

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ClinicalTrials.gov Identifier: NCT03294499
Recruitment Status : Unknown
Verified July 2017 by Imperial College London.
Recruitment status was:  Recruiting
First Posted : September 27, 2017
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

The PACIFY Study is a questionnaire for antenatal(third trimester) and postnatal(three months post delivery) Human Immunodeficiency Virus (HIV) positive women attending clinics in London and Brighton. The current World Health Organisation guidance advises HIV positive women, who are adhering to antiretroviral therapy (ART), to exclusively breastfeed for the first 6 months of the infant's life and continue supplemental breastfeeding for up to 2 years.

This is conflicts with the current British HIV Association guidelines which advise exclusive formula feeding. The reason for this difference is the relative safety of formula feeding in the United Kingdom(UK)against the low but persisting risk of HIV infection through breast-feeding. The aim of the PACIFY study is to explore attitudes towards breastfeeding amongst HIV positive women, who are either pregnant or post-partum. The study will also assess the understanding of current infant feeding guidance by these women and assess their current or recent infant feeding practice. It will also look at whether HIV positive mothers would be willing and able to comply with special monitoring and guidance whilst breastfeeding if the guidelines were to change. The study aims to analyse 100 questionnaires completed over a 3-6 month period.


Condition or disease Intervention/treatment
Human Immunodeficiency Virus Other: Questionnaire

Detailed Description:

All eligible female patients (currently or recently pregnant) attending routine HIV-related appointments will be invited to participate and a participant information sheet will be given. Those who have consented to join the study will be given a short questionnaire to complete and return during that attendance. The questionnaire takes about 15 minutes to complete. The option of returning the questionnaire by post will be available but not encouraged.

During the collection period, women with HIV attending either antenatal (third trimester) or postnatal (within three months of delivery) care will be eligible to participate, but they will only be asked once, either before or after delivery.

Ideally equivalent numbers of pre and postnatal participants will be enrolled. Participants given a questionnaire and have a centre and unique study number. Maternal cluster of differentiation 4 (CD4) count and HIV Viral load nearest to time of questionnaire completion will be recorded if patient consents.

Participants will be able to place their completed paper questionnaires in a sealed envelope in a box in the clinic.Participants will be informed that their questionnaire responses will not be seen by clinical staff (unless participants request staff support in completion of the questionnaire) or recorded in their clinical notes. In the clinics the study log will be the only document linking study number with hospital identification (ID)number and soundex. Completed questionnaires will be stored securely in local sites prior to transfer to St Mary's Hospital (by the study team). The study log will be maintained securely along with the delegation log by the site lead investigator.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Positive Attitudes Concerning Infant Feeding- a Questionnaire for Women Living With HIV
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : January 1, 2018
Estimated Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


Intervention Details:
  • Other: Questionnaire
    Patients will be asked to complete one off questionnaire.


Primary Outcome Measures :
  1. Questionnaire [ Time Frame: 6 months ]
    A six paged questionnaire assessing the attitudes towards breastfeeding amongst HIV positive women, who are either pregnant(third trimester) and 3 months post postpartum.The questionnaire will ask questions around their views ,route of acquisition of HIV and attitudes towards breastfeeding with HIV.


Secondary Outcome Measures :
  1. PACIFY Questionnaire [ Time Frame: 6 months ]

    The questionnaire will have questions that will assess understanding of current infant feeding guidance in the United Kingdom and compliance to guidance for HIV positive women.

    It will also assess whether HIV positive mothers would be willing and able to comply with special monitoring and guidance whilst breastfeeding as per British HIV Association guidelines.Questionnaires will then be collected and data collated once we have 100 questionnaires completed.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This is a questionnaire for HIV positive women who are in their third trimester and three months post partum
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
HIV positive women who are three months post partum and third trimester
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Able to give written informed consent
  • Post-natal and antenatal HIV positive women

Exclusion Criteria:

  • Age <18 years
  • Patients who are unable to consent.
  • Women with HIV who have not been pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294499


Contacts
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Contact: Farai Nyatsanza, MBChB 02033126620 farai.nyatsanza@nhs.net
Contact: Hermione Lyall, MBChB 02033126965 hermione.lyall@imperial.nhs.uk

Locations
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United Kingdom
Brighton and Sussex NHS Trist Recruiting
Brighton, United Kingdom
Contact: Yvonne Gilleece, MBChB       yvonne.gilleece@bsuh.nhs.uk   
Barts Health NHS Trust Recruiting
London, United Kingdom
Contact: Liat Sarner       liat.sarner@bartshealth.nhs.uk   
CENTRAL AND NORTH WEST London NHS Trsut Recruiting
London, United Kingdom
Contact: Sherie Roedling       sherie.roedling@nhs.net   
Chelsea and Westminister NHS Trust Not yet recruiting
London, United Kingdom
Contact: Waheed Khan, MBChB       Waheed.Khan@chelwest.nhs.uk   
Principal Investigator: Waheed Khan, MBChB         
Guys and St Thomas NHS Trust Recruiting
London, United Kingdom
Contact: Pippa Farrugia, MBChB    02071887188    pippa.farrugia@gstt.nhs.uk   
Principal Investigator: Pippa Farrugia, MBChB         
Homerton University Hospital Nhs Trust Recruiting
London, United Kingdom
Contact: Adam Croucher       adam.croucher@homerton.nhs.uk   
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom
Contact: Farai Nyatsanza, MBChB    02033126620    farai.nyatsanza@nhs.net   
Kings College NHS Trust Not yet recruiting
London, United Kingdom
Contact: Daya Nayagam, MBChB       dnayagam@nhs.net   
Principal Investigator: Daya Nayagam, MBChB         
Lewisham and Greenwich NHS Trust Not yet recruiting
London, United Kingdom
Contact: Judith Russell, MBChB       judith.russell@nhs.net   
Principal Investigator: Judith Russell, MBChB         
London Northwest Healthcare NHS Trust Not yet recruiting
London, United Kingdom
Contact: Siobhan Murphy       s.murphy13@nhs.net   
Sponsors and Collaborators
Imperial College London
Investigators
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Study Chair: Hermione Lyall, MBChB Imperial College Healthcare NHS Trust

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03294499     History of Changes
Other Study ID Numbers: 221592
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Results will be presented at a conference and published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases