NCT03294499: PACIFY

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

Completed Results posted Last updated 2 February 2023

What this trial tests

trial testing Questionnaire in Human Immunodeficiency Virus in 94 participants. Completed in 31 May 2018.

Timeline

31 May 2017

Primary endpoint
31 May 2018

31 May 2018

Quick facts

Lead sponsor	Imperial College London
Status	Completed
Study type	OBSERVATIONAL
Enrollment	94
Start date	31 May 2017
Primary completion	31 May 2018
Estimated completion	31 May 2018
Sites	10 locations across United Kingdom

Drugs / interventions tested

• Questionnaire

Conditions studied

• Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →

Sponsor

Imperial College London

Who can join

Adults 18 to 60, female only, with Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Knowledge and Experiences of Breastfeeding Among Women Living With HIV Primary · 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.

Have any friends, family or community members questioned you about your reasons for not BF?

Group	Value	95% CI
Women Living With HIV	58
Women Living With HIV	25
Women Living With HIV	0
Women Living With HIV	11

Have you ever had to lie about your reasons for not BF?

Group	Value	95% CI
Women Living With HIV	62
Women Living With HIV	21
Women Living With HIV	0
Women Living With HIV	11

If you did not have HIV, would you BF your child?

Group	Value	95% CI
Women Living With HIV	84
Women Living With HIV	2
Women Living With HIV	8
Women Living With HIV	0

Living with HIV, would you like to BF your child?

Group	Value	95% CI
Women Living With HIV	36
Women Living With HIV	45
Women Living With HIV	6
Women Living With HIV	7

Do you think it's safe for women with detectable HIV in the blood to BF?

Group	Value	95% CI
Women Living With HIV	3
Women Living With HIV	63
Women Living With HIV	22
Women Living With HIV	6

Do you think it's safe for women on treatment with fully suppressed HIV to BF?

Group	Value	95% CI
Women Living With HIV	26
Women Living With HIV	33
Women Living With HIV	31
Women Living With HIV	4

If you were to BF, would you have monthly blood tests to check your viral load stays undetectable?

Group	Value	95% CI
Women Living With HIV	83
Women Living With HIV	10
Women Living With HIV	0
Women Living With HIV	1

If you were to BF, would you be willing for your baby to have a monthly HIV blood test?

Group	Value	95% CI
Women Living With HIV	79
Women Living With HIV	13
Women Living With HIV	0
Women Living With HIV	2

Views on Infant Feeding for Women Living With HIV Primary · 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?

would like to breastfeed if they were HIV negative

Group	Value	95% CI
Women Living With HIV	89

would like to breastfeed while living with HIV

Group	Value	95% CI
Women Living With HIV	38

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.