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

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

Sponsors

Lead sponsor: Imperial College London

Source Imperial College London
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.

Overall Status Unknown status
Start Date October 1, 2017
Completion Date January 1, 2018
Primary Completion Date January 1, 2018
Study Type Observational
Primary Outcome
Measure Time Frame
Questionnaire 6 months
Secondary Outcome
Measure Time Frame
PACIFY Questionnaire 6 months
Enrollment 100
Condition
Intervention

Intervention type: Other

Intervention name: Questionnaire

Description: Patients will be asked to complete one off questionnaire.

Eligibility

Sampling method: Non-Probability Sample

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.

Gender: Female

Gender based: Yes

Gender description: This is a questionnaire for HIV positive women who are in their third trimester and three months post partum

Minimum age: 18 Years

Maximum age: 60 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Hermione Lyall, MBChB Study Chair Imperial College Healthcare NHS Trust
Overall Contact

Last name: Farai Nyatsanza, MBChB

Phone: 02033126620

Email: [email protected]

Location
facility status contact
Brighton and Sussex NHS Trist | Brighton, United Kingdom Recruiting Yvonne Gilleece, MBChB [email protected]
Barts Health NHS Trust | London, United Kingdom Recruiting Liat Sarner [email protected]
CENTRAL AND NORTH WEST London NHS Trsut | London, United Kingdom Recruiting Sherie Roedling [email protected]
Chelsea and Westminister NHS Trust | London, United Kingdom Not yet recruiting Waheed Khan, MBChB [email protected] Waheed Khan, MBChB Principal Investigator
Guys and St Thomas NHS Trust | London, United Kingdom Recruiting Pippa Farrugia, MBChB 02071887188 [email protected] Pippa Farrugia, MBChB Principal Investigator
Homerton University Hospital Nhs Trust | London, United Kingdom Recruiting Adam Croucher [email protected]
Imperial College Healthcare NHS Trust | London, United Kingdom Recruiting Farai Nyatsanza, MBChB 02033126620 [email protected]
Kings College NHS Trust | London, United Kingdom Not yet recruiting Daya Nayagam, MBChB [email protected] Daya Nayagam, MBChB Principal Investigator
Lewisham and Greenwich NHS Trust | London, United Kingdom Not yet recruiting Judith Russell, MBChB [email protected] Judith Russell, MBChB Principal Investigator
London Northwest Healthcare NHS Trust | London, United Kingdom Not yet recruiting Siobhan Murphy [email protected]
Location Countries

United Kingdom

Verification Date

July 2017

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Acronym PACIFY
Patient Data No
Study Design Info

Observational model: Other

Time perspective: Prospective

Source: ClinicalTrials.gov