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

Completed

• Conditions: Human Immunodeficiency Virus

• Registration Number: NCT03294499
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-31
• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-09-22
• Study First Posted: 2017-09-27
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Results First Submitted: 2021-02-15
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-05
• Last Update Submitted: 2022-05-05
• Results First Posted: 2023-02-02
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 94

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Views on Infant Feeding for Women Living With HIV	At their pre-or postnatal outpatient appointment, an average of one day	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: 1. If you did not have HIV, would you breastfeed your child?; 2. Living with HIV, would you like to breastfeed your child?
Knowledge and Experiences of Breastfeeding Among Women Living With HIV	At their pre-or postnatal outpatient appointment, an average of one day	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.

Trial Locations

Locations (10)

Barts Health NHS Trust; 🇬🇧 London, United Kingdom

Guys and St Thomas NHS Trust; 🇬🇧 London, United Kingdom

CENTRAL AND NORTH WEST London NHS Trsut; 🇬🇧 London, United Kingdom

Brighton and Sussex NHS Trist; 🇬🇧 Brighton, United Kingdom

Kings College NHS Trust; 🇬🇧 London, United Kingdom

Chelsea and Westminister NHS Trust; 🇬🇧 London, United Kingdom

Homerton University Hospital Nhs Trust; 🇬🇧 London, United Kingdom

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom

London Northwest Healthcare NHS Trust; 🇬🇧 London, United Kingdom

Lewisham and Greenwich NHS Trust; 🇬🇧 London, United Kingdom