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

Human Immunodeficiency Virus Clinical Trial

— PACIFY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294499
• Other study ID #: 17IC3795
• Secondary ID: 221592
• Status: Completed
• Start date: May 31, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: May 2022
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Brighton and Sussex NHS Trist	Brighton
United Kingdom	Barts Health NHS Trust	London
United Kingdom	CENTRAL AND NORTH WEST London NHS Trsut	London
United Kingdom	Chelsea and Westminister NHS Trust	London
United Kingdom	Guys and St Thomas NHS Trust	London
United Kingdom	Homerton University Hospital Nhs Trust	London
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	Kings College NHS Trust	London
United Kingdom	Lewisham and Greenwich NHS Trust	London
United Kingdom	London Northwest Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Nyatsanza F, Gubbin J, Gubbin T, Seery P, Farrugia P, Croucher A, Gilleece Y, Rosenvinge M, Roedling S, Sarner L, Nayagam D, Stradling C, Namiba A, Fearnley N, Lyall H. Over a third of childbearing women with HIV would like to breastfeed: A UK survey of w — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge and Experiences of Breastfeeding Among Women Living With HIV	Participants were recruited by clinicians from 12 HIV clinics across England (South East, West Midlands and West Yorkshire) between June 2017 and June 2018. Participants were given the study patient information leaflet and consent form when they attended their regular pre- or postnatal outpatient appointment and, if they agreed to participate, they completed the anonymised questionnaire (Supplemental Appendix X) during the same visit. All the questionnaires were collated at Imperial College Healthcare NHS Trust.; In the data table, breastfeeding has been abbreviated to BF.	At their pre-or postnatal outpatient appointment, an average of one day
Primary	Views on Infant Feeding for Women Living With HIV	The PACIFY study (Positive Attitudes Concerning Infant Feeding) sought to explore the views, concerns and issues surrounding breastfeeding in women living with HIV (WLHs).; Questions within the questionnaire: If you did not have HIV, would you breastfeed your child?; Living with HIV, would you like to breastfeed your child?	At their pre-or postnatal outpatient appointment, an average of one day