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

NCT03294499 | Completed Results

• 2 other identifiers: 17IC3795221592
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 10

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.

Conditions

Human Immunodeficiency Virus

Keywords

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (2)

• 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

• 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: 1. If you did not have HIV, would you breastfeed your child? 2. Living with HIV, would you like to breastfeed your child?

  At their pre-or postnatal outpatient appointment, an average of one day

Interventions

Questionnaire OTHER

Patients will be asked to complete one off questionnaire.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: This is a questionnaire for HIV positive women who are in their third trimester and three months post partum
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

HIV positive women who are three months post partum and third trimester

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (10)

Brighton and Sussex NHS Trist

Brighton, United Kingdom

Location

Barts Health NHS Trust

London, United Kingdom

Location

CENTRAL AND NORTH WEST London NHS Trsut

London, United Kingdom

Location

Chelsea and Westminister NHS Trust

London, United Kingdom

Location

Guys and St Thomas NHS Trust

London, United Kingdom

Location

Homerton University Hospital Nhs Trust

London, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

Kings College NHS Trust

London, United Kingdom

Location

Lewisham and Greenwich NHS Trust

London, United Kingdom

Location

London Northwest Healthcare NHS Trust

London, United Kingdom

Location

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

  PMID: 33629917 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Limitations and Caveats

We sampled a small number of participants and we were unable to ascertain how many participants refused to respond to questionnaire

Results Point of Contact

• Title: Dr Farai Nyatsanza
• Organization: Imperial College Healthcare NHS Trust

farai.nyatsanza@nhs.net

n/a

Study Officials

• Hermione Lyall, MBChB

  Imperial College Healthcare NHS Trust

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: September 27, 2017
• Study Start: May 31, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: February 2, 2023
• Results First Posted: February 2, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (10)