Clinical trial NCT03294499: Positive Attitudes Concerning Infant Feeding- a Questionnaire for Women Living With HIV
Official title: Positive Attitudes Concerning Infant Feeding- a Questionnaire for Women Living With HIV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Keywords: Human Immunodeficiency Virus
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV positive women who are three months post partum and third trimester

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.

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.

Primary outcomes:
measure: Knowledge and Experiences of Breastfeeding Among Women Living With HIV
timeFrame: At their pre-or postnatal outpatient appointment, an average of one day
measure: Views on Infant Feeding for Women Living With HIV
timeFrame: At their pre-or postnatal outpatient appointment, an average of one day
Secondary outcomes:
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Brighton and Sussex NHS Trist
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: CENTRAL AND NORTH WEST London NHS Trsut
city: London
country: United Kingdom
facility: Chelsea and Westminister NHS Trust
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Trust
city: London
country: United Kingdom
facility: Homerton University Hospital Nhs Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: Kings College NHS Trust
city: London
country: United Kingdom
facility: Lewisham and Greenwich NHS Trust
city: London
country: United Kingdom
facility: London Northwest Healthcare NHS Trust
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Hermione Lyall, MBChB
role: STUDY_CHAIR
References:
citation: 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.