PACIFY: Positive Attitudes Concerning Infant Feeding- a Questionnaire for Women Living With HIV
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Questionnaire [6 months]
A six paged questionnaire assessing the attitudes towards breastfeeding amongst HIV positive women, who are either pregnant(third trimester) and 3 months post postpartum.The questionnaire will ask questions around their views ,route of acquisition of HIV and attitudes towards breastfeeding with HIV.
Secondary Outcome Measures
- PACIFY Questionnaire [6 months]
The questionnaire will have questions that will assess understanding of current infant feeding guidance in the United Kingdom and compliance to guidance for HIV positive women. It will also assess whether HIV positive mothers would be willing and able to comply with special monitoring and guidance whilst breastfeeding as per British HIV Association guidelines.Questionnaires will then be collected and data collated once we have 100 questionnaires completed.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 18 years
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Able to give written informed consent
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Post-natal and antenatal HIV positive women
Exclusion Criteria:
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Age <18 years
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Patients who are unable to consent.
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Women with HIV who have not been pregnant.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brighton and Sussex NHS Trist | Brighton | United Kingdom | ||
| 2 | Barts Health NHS Trust | London | United Kingdom | ||
| 3 | CENTRAL AND NORTH WEST London NHS Trsut | London | United Kingdom | ||
| 4 | Chelsea and Westminister NHS Trust | London | United Kingdom | ||
| 5 | Guys and St Thomas NHS Trust | London | United Kingdom | ||
| 6 | Homerton University Hospital Nhs Trust | London | United Kingdom | ||
| 7 | Imperial College Healthcare NHS Trust | London | United Kingdom | ||
| 8 | Kings College NHS Trust | London | United Kingdom | ||
| 9 | Lewisham and Greenwich NHS Trust | London | United Kingdom | ||
| 10 | London Northwest Healthcare NHS Trust | London | United Kingdom |
Sponsors and Collaborators
- Imperial College London
Investigators
- Study Chair: Hermione Lyall, MBChB, Imperial College Healthcare NHS Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 221592