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

NCT ID: NCT03294499

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 94 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-31
• Study Completion Date: 2018-05-31

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.

Conditions

Human Immunodeficiency Virus

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Questionnaire

Patients will be asked to complete one off questionnaire.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hermione Lyall, MBChB

Role: STUDY_CHAIR

Imperial College Healthcare NHS Trust

Locations

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, , United Kingdom

Countries

United Kingdom

References

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 women living with HIV. Int J STD AIDS. 2021 Aug;32(9):856-860. doi: 10.1177/0956462421999951. Epub 2021 Feb 25.

Reference Type: RESULT

PMID: 33629917 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

221592

Identifier Type: OTHER

Identifier Source: secondary_id

17IC3795

Identifier Type: -

Identifier Source: org_study_id