Human Immunodeficiency VirusPACIFYNCT03294499

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

An observational study of Human Immunodeficiency Virus, run by Imperial College London at 10 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Human Immunodeficiency Virus
What is being tested?: Questionnaire
How many people: 94 participants
Where: 10 sitesUnited Kingdom
Study dates: 31 May 2017to 31 May 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Women only
Healthy volunteers accepted
Adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United Kingdom10 sites

Brighton and Sussex NHS Trist
Brighton
Barts Health NHS Trust
London
CENTRAL AND NORTH WEST London NHS Trsut
London
Chelsea and Westminister NHS Trust
London
Guys and St Thomas NHS Trust
London
Homerton University Hospital Nhs Trust
London
Imperial College Healthcare NHS Trust
London
Kings College NHS Trust
London
Lewisham and Greenwich NHS Trust
London
London Northwest Healthcare NHS Trust
London

Other trials in United Kingdom

About this study

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.

Read the 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
Being tested: Questionnaire
Keywords: Human Immunodeficiency Virus
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QuestionnaireOther
Patients will be asked to complete one off questionnaire.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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?
Measured: At their pre-or postnatal outpatient appointment, an average of one day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 201731 May 2018

First posted27 Sep 2017
Study start31 May 2017
Primary completion31 May 2018
Study completion31 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
More trials run by Imperial College LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03294499
Sponsor's protocol ID: 17IC3795
Other IDs: 221592
Acronym: PACIFY
Status last verified: May 2022
First submitted: 1 Aug 2017
Last updated: 2 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Results will be presented at a conference and published.

Publications

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.
PubMed 33629917

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Positive Attitudes Concerning Infant Feeding- a Questionnaire for Women Living With HIV
ClinicalTrials.gov ID: NCT03294499
Acronym / sponsor ID: PACIFY / 17IC3795
Conditions: Human Immunodeficiency Virus
Keywords: Human Immunodeficiency Virus
Study type: Observational
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Imperial College LondonUniversity, hospital or other
Study start: 31 May 2017 (actual)
Primary completion: 31 May 2018 (actual)
Study completion: 31 May 2018 (actual)
First posted: 27 Sep 2017 (actual)
Results: Posted 2 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult
Study population: HIV positive women who are three months post partum and third trimester

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QuestionnairePatients will be asked to complete one off questionnaire.	Other	–

Primary outcome

Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Time frame: 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.
Views on Infant Feeding for Women Living With HIV
Time frame: 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?

Results and safety

Results posted to the registry on 2 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Women Living With HIV	94	94

Primary outcome: Knowledge and Experiences of Breastfeeding Among Women Living With HIV

Time frame: At their pre-or postnatal outpatient appointment, an average of one day. Count of participants. Unit: Participants

Measure	Women Living With HIV n = 94
Have any friends, family or community members questioned you about your reasons for not BF?: Yes	58
Have any friends, family or community members questioned you about your reasons for not BF?: No	25
Have any friends, family or community members questioned you about your reasons for not BF?: Don't know	0
Have any friends, family or community members questioned you about your reasons for not BF?: No answer	11
Have you ever had to lie about your reasons for not BF?: Yes	62
Have you ever had to lie about your reasons for not BF?: No	21
Have you ever had to lie about your reasons for not BF?: Don't know	0
Have you ever had to lie about your reasons for not BF?: No answer	11

Primary outcome: Views on Infant Feeding for Women Living With HIV

Time frame: At their pre-or postnatal outpatient appointment, an average of one day. Number. Unit: percentage of total participants

Measure	Women Living With HIV n = 94
would like to breastfeed if they were HIV negative	89
would like to breastfeed while living with HIV	38

Adverse events

Time frame: Data was collected over a 12 month period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PACIFY Study	0 of 94 (0%)	0 of 94 (0%)	0 of 94

Limitations and caveats (from the sponsor): We sampled a small number of participants and we were unable to ascertain how many participants refused to respond to questionnaire

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33629917Nyatsanza 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.
Individual participant dataSharing planned: No. Results will be presented at a conference and published.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hermione Lyall, MBChB study chair

Imperial College Healthcare NHS Trust

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Human Immunodeficiency Virus, run by Imperial College London at 10 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge and Experiences of Breastfeeding Among Women Living With HIV (time frame: At their pre-or postnatal outpatient appointment, an average of one day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03294499, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.