Positive Attitudes Concerning Infant Feeding- a Questionnaire for Women Living With HIV
Conditions: Human Immunodeficiency Virus
Sponsor: Imperial College London

1 
 
 
 
The PACIFY Study 
 
 
 
 
Positive Attitudes Concerning Infant Feeding- a questionnaire for women living with HIV. 
 
 
 
 
Version 2.0 
 
 
 
 
MAIN SPONSOR: Imperial College London/Imperial College Healthcare NHS Trust  
FUNDERS: None 
STUDY COORDINATION CENTRE: Imperial College NHS Healthcare Trust, St Mary’s Hospital 
NCT number 03294499 
Date of document :23rd of January 2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study Management Group 
 
Chief Investigator: Dr Hermione Lyall 
Imperial College NHS Trust 
St Mary’s Hospital 
Praed Street 
London 
W2 1NY 
Tel: 02033136965 
Email: hermoine.lyall@imperial.nhs.uk 
 
Co-investigators:  
 
Dr Farai Nyatsanza 
Imperial College NHS Trust 
St Mary’s Hospital 
Praed Street 
London 
W2 1NY 
Tel: 0203 312 6972 
Fax: 0203 312 6123 
Email: farai.nyatsanza@imperial.nhs.uk 
 
 
 
Dr Jessica Gubbin 
Imperial College NHS Trust 
St Mary’s Hospital 
Praed Street 
London 
W2 1NY 
Tel: 07825410023 
Email: jessica.gubbin@gmail.com 
 
Thomas Gubbin 
Imperial College London 
South Kensington Campus  
London  
SW7 2AZ 
Tel: 07956220980 
Email: thomas.gubbin14@imperial.ac.uk 
 
 
 
Study Management: Chief Investigator Dr Hermione Lyall 
 
 
 
For general queries, supply of study documentation, and collection of data, please contact: 
 
Principal Investigator: Farai Nyatsanza 
Address: Imperial College Healthcare NHS Trust, Jefferiss Wing, Praed Street, W21NY 
Tel: 07846807243  
E-mail: farai.nyatsanza@imperial.nhs.uk 

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Clinical Queries 
 
Clinical queries should be directed to individual participant’s clinician who will direct the 
query to the appropriate person. 
 
 
Sponsor 
 
Imperial College London/Imperial College Healthcare NHS Trust (delete as applicable) is the 
main research Sponsor for this study.  For further information regarding the sponsorship 
conditions, please contact the Head of Regulatory Compliance at: 
 
 
 
Joint Research Compliance Office 
Imperial College London & Imperial College Healthcare NHS Trust 
2nd Floor Medical School Building 
St Mary’s Hospital 
Praed Street 
London 
W2 1NY 
Tel: 020759 41862 
 
 
 
 
 
This protocol describes the PACIFY study and provides information about procedures for entering 
participants.  Every care was taken in its drafting, but corrections or amendments may be necessary. 
These will be circulated to investigators in the study.  Problems relating to this study should be 
referred, in the first instance, to the Chief Investigator.  
 
This study will adhere to the principles outlined in the NHS Research Governance Framework for 
Health and Social Care (2nd edition). It will be conducted in compliance with the protocol, the Data 
Protection Act and other regulatory requirements as appropriate.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
1. 
INTRODUCTION                                                                                               5 
 
 
1.1 BACKGROUND 
6 
2.  STUDY OBJECTIVES 
7 
3.  STUDY DESIGN 
8 
3.1 STUDY OUTCOME MEASURES 
8 
4. 
PARTICIPANT ENTRY 
 
4.1 PRE-REGISTRATION EVALUATIONS 
9 
4.2 INCLUSION CRITERIA 
9 
4.3 EXCLUSION CRITERIA 
9 
4.4 WITHDRAWAL CRITERIA 
9 
5. 
ADVERSE EVENTS 
 
5.1 DEFINITIONS 
9 
5.3 REPORTING PROCEDURES 
10 
6. 
ASSESSMENT AND FOLLOW-UP 
10 
7. 
STATISTICS AND DATA ANALYSIS 
10 
8. 
REGULATORY ISSUES 
 
8.1 ETHICS APPROVAL 
11 
8.2 CONSENT 
11 
8.3 CONFIDENTIALITY 
11 
8.4 INDEMNITY 
11 
8.5 SPONSOR 
11 
8.6 FUNDING 
11 
8.7 AUDITS AND INSPECTIONS 
11 
9. 
STUDY MANAGEMENT 
11 
11. 
PUBLICATION POLICY 
12 
12. 
REFERENCES 
12 
EXAMPLE APPENDICES 
 
APPENDIX 1. 
PATIENT INFORMATION LEAFLET 
14 
APPENDIX 2. 
QUESTIONNAIRE CONSENT FORM 
16 
APPENDIX 3. 
DELEGATION LOG 
17 
 
 
 

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STUDY SUMMARY 
 
TITLE Positive Attitudes Concerning Infant Feeding (PACIFY) – a questionnaire for 
women living with HIV. 
DESIGN Questionnaires will be completed by eligible volunteers from London HIV 
Pregnancy research group and analysed. Maternal CD4 and viral load 
nearest to time of questionnaire will be recorded. 
AIMS To explore attitudes towards breastfeeding amongst HIV positive women, 
who are either pregnant or post-partum. 
OUTCOME MEASURES Assessment of attitudes towards breastfeeding amongst HIV positive women, 
who are either pregnant (third trimester) or post-partum (three months post-
delivery). 
POPULATION HIV positive women in the third trimester or up to 3 months post-partum. 
ELIGIBILITY Age >18 years; able to give written consent; post-natal and antenatal HIV 
positive women. 
DURATION 6 months. 
 
1. 
INTRODUCTION  
 
1.1 
INTRODUCTION 
Every year in the UK, over 1,000 children are born to women who are positive for Human 
Immunodeficiency Virus (HIV). Current UK guidelines advise complete avoidance of 
breastfeeding for all HIV-infected women to reduce rates of mother to child transmission 
(MCT)(4). However, the World Health Organisation (WHO) now recommends breastfeeding in 
resource-poor areas due to increasing evidence that the risk of MCT from breastfeeding is 
outweighed by the increased morbidity and mortality of non-breastfed infants in these 
settings (16). The British HIV Association (BHIVA) guidelines are due to be reviewed in 2017 
and the relevance of the WHO guidelines to women on antiretroviral treatment (ART) in 
resource-rich settings will be reconsidered (4). However, there is very little information about 
the views about breastfeeding amongst women living with HIV in the UK. The PACIFY study 
(Positive Attitudes Concerning Infant Feeding) is an observational study that will explore 
these views, concerns and issues surrounding breastfeeding with HIV. We will recruit around 
100 HIV-positive women who are pregnant or have recently given birth from several 
healthcare trusts around London. We will administer self-completed questionnaires to 
participants at antenatal and postnatal clinics and perform descriptive statistical analysis on 
the data collected. We aim to gain a greater depth of knowledge about the attitudes towards 
breastfeeding amongst HIV-positive women that will provide an important, and currently 
missing, factor to the debate about HIV and infant feeding in resource-rich settings. 
 
 
1.2 
BACKGROUND 
In the UK, 1.5 per 1,000 pregnant women are infected with HIV, amounting to 1,018 women 
testing positive for HIV during routine antenatal screening in 2014 (1). This has resulted in 
11,000 children being born to HIV-infected mothers between 2006 and 2014(1, 2). The primary 
concern for women with HIV infection in pregnancy is mother to child transmission (MCT) of 
HIV, the rate of which has been shown to be 30-40% without any interventions. Current UK 

6 
 
practice has achieved a reduction in this rate to below 0.5 %(3), through a combination of 
maternal antiretroviral therapy, elective Caesarean section and avoidance of 
breastfeeding(4). 
However, world-wide, encouragement of breastfeeding is accepted as vital public health 
strategy due to its numerous benefits to the infant, both in the short-term and long-term, as 
well as the reduction breast and ovarian cancers in the mother (5, 6). Breastfeeding results in 
significant reductions in morbidity, hospital admissions and mortality of infants from many 
conditions including gastroenteritis, respiratory infections, otitis media and atopic diseases (7, 
8) . Though these reductions are pronounced in low resource settings with high rates of infant 
mortality, they also occur  in more economically developed countries(7, 8), with correlations 
being found between prevalence of breastfeeding and reductions in infant admissions due to 
these causes at a Primary Care and Secondary Care level in the UK(9). Similarly, the long-
term risk of hypertension, type 2 diabetes mellitus and obesity is significantly lower in people 
who were breastfed in infancy (10, 11, 12, 13). The evidence in support of the benefits of 
breastfeeding led to the WHO recommendation for infants born to mothers not infected with 
HIV to be exclusively breastfed for the first 6 months of life, with supplemental breastfeeding 
for up to 2 years and beyond(14, 15). 
However, the traditional advice for HIV-positive mothers has been to exclusively formula 
feed infants from birth in settings where this is acceptable, feasible, affordable, sustainable 
and safe (AFASS), in order to remove the risk of MCT (16,18) .  Meta-analysis of 9 randomised 
control trials in Africa, carried out in the era before use of ART during breastfeeding, showed 
the cumulative risk of MCT from breastfeeding was 9.3% at 18 months, accounting for 
overall 42% of the cases of MCT (17). In similar settings, complete avoidance of breastfeeding 
eliminates the risk of MCT through breastfeeding, but the 2-year mortality rate is not 
significantly different. However results on HIV-free survival have been shown to be varied 
with studies showing either a decrease or increase in the breast feeding arm (18, 19, 20). In 
randomised controlled trials (RCTs) and cohort studies, where women in resource poor 
settings have breastfed on ART, MCT rates have been reduced to 3% or less (21, 22, 23). 
Studies have also shown suppressed levels of HIV RNA in breast milk, although cells that 
may contain integrated virus are still present (24). RCTs assessing these outcomes in HIV-
positive mothers are not possible in resource-rich settings due to formula feeding that meets 
AFASS criteria. In view of this most resource rich settings still advocate exclusive formula 
feeding. 
The evidence of increased mortality in formula fed infants born to mothers with HIV, in 
resource-poor settings, as well as improved availability of ART and its efficacy of reducing 
MCT through breastfeeding, has led to a gradual shift in the WHO guidelines towards 
encouraging breastfeeding in HIV-positive mothers in countries where ART is available and 
infant mortality rates are high. The current WHO guidance advises women in this setting, 
who are adhering to ART, to exclusively breastfeed for the first 6 months of the infant’s life 
and continue supplemental breastfeeding for at least 12 months, and even up to 2 years or 
beyond (25). Recent changes in WHO guidelines also suggest lifelong ART from diagnosis of 
chronic HIV infection irrespective of CD4 count or clinical status and in line with this, women 
receiving lifelong ART should have no restrictions in the duration of breastfeeding (25, 26, 27) . 
They suggest that this guidance may be relevant to resource-rich countries, depending on 
the causes and rates of infant mortality, as well as the culture and practices of the population 
(25). In such settings, adherence to ART is good and the provision of intensive support and 
monitoring of HIV-positive women and their child during breastfeeding is possible. 
Although, to date BHIVA guidelines advise all mothers known to be HIV-positive to 
exclusively formula feed from birth, regardless of ART(4), if a mother decides to breastfeed, 
when fully supressed on ART, it is no longer considered a child safeguarding issue. There is 
also BHIVA guidance in place to support women who decide to breastfeed: maternal ART 
should be monitored and continued until at least 1 week after breastfeeding ceases; 
breastfeeding should be exclusive, other than during the weaning period; and breastfeeding 
should ideally end by 6 months after birth. The rationale for this advice is that engagement 
with healthcare services during breastfeeding will be increased, and the rate of MCT during 

7 
 
breastfeeding is significantly reduced by adherence to ART and increased by mixed 
feeding(21, 22, 23, 4, 28).  
Several issues may arise from the current BHIVA recommendation for HIV positive women 
to avoid breastfeeding. Confusion amongst mothers with HIV stemming from the 
contradiction between the WHO and BHIVA guidelines, can cause mistrust in the medical 
professionals and a reduced uptake in the guidelines.  In addition to this, there are a variety 
of social and cultural pressures for women to breastfeed which can cause difficulties for HIV-
positive women who are advised not to breastfeed. These pressures may cause personal 
distress and difficult questions about their reasons for not breastfeeding, and may result in 
occasional breastfeeding against medical advice in certain circumstances. In addition to this, 
there are many practical or financial reasons why women may choose to breastfeed their 
infant against the recommendations, either on an occasional basis or as a primary means of 
infant feeding. One unifying issue with these situations, in a setting where breastfeeding in 
HIV positive mothers is frowned upon by the medical profession, is breastfeeding without the 
extra support and precautions recommended by the WHO and BHIVA and potential 
disengagement from healthcare services(4, 25). This may occur without the knowledge of the 
medical profession due to shame or fear of judgement. Breastfeeding in this situation would 
have an increased risk of MCT as well as delayed diagnosis of HIV infection in the infant if 
transmission occurred.  
There has been very little research into these issues, or the prevalence of unreported 
breastfeeding in HIV-positive mothers in the UK. There has also been limited exploration into 
the views of women with HIV about breastfeeding; the cultural and social pressures they 
may be experiencing to breastfeed; and their understanding of the current 
recommendations. With the changing evidence from African countries, and the increasing 
recognition that fully suppressed HIV significantly reduces all types of transmission, it is time 
to better understand the views of women with HIV about infant feeding. 
 
 
 
2.  STUDY OBJECTIVES 
 
Primary aim: 
 
To explore attitudes towards breastfeeding amongst HIV positive women, who are 
either pregnant or post-partum. 
 
Secondary objectives: 
 
To assess the understanding of current infant feeding guidance amongst HIV positive 
women. 
 
To assess reported non-compliance to current infant feeding guidance for HIV 
positive women. 
 
To assess whether HIV positive mothers would be willing and able to comply with 
special monitoring and guidance whilst breastfeeding. 
 
To assess the link between maternal views on breast feeding and their current CD4 
and viral load measurements. 
 
 
3.  STUDY DESIGN 
 
Setting: 
HIV (antenatal and postnatal) clinics in and around London participating in the “London HIV 
Pregnancy Research Group”. 
 
 

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Study Design and Methods: 
All female patients attending who are eligible to join the study will be invited to participate 
and a participant information sheet will be given. For those eligible women, who have 
consented to join the study, they will then be given a short participant questionnaire to 
complete. 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. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Material/Sample storage 
None required. 
 
Peer and regulatory review 
The study was deemed to require regulatory approval from NHS Research Ethics 
Committees.  This approval will be obtained before the study commences. The study has 
been reviewed and approved by an HIV women’s user group. The study has been peer 
reviewed and approved by the Research Review Committee of the HIV Team at Imperial 
College. 
 
Assessment and management of risk 
Participants will be informed that they are free to withdraw from the study at any time, 
without giving a reason, and without prejudicing their medical care.  
The study comprises a structured questionnaire that contains sensitive questions. 
Participants will be informed that they are not obliged to answer any questions they find 
difficult. A space in clinic will be offered to participants who wish to complete the 
questionnaire in private. We will strongly encourage all participants to complete the 
questionnaire on site at their clinical centre to avoid any inadvertent disclosure of HIV status 
 
Eligible participant given patient 
information sheet 
Consent obtained to enrol into 
study. This will be stored in 
notes. 
 
Questionnaire will have a centre 
and unique study number. This 
will then be given to participant to 
complete, anonymously. 
Questionnaire collected and sent 
to St Mary’s Hospital (London) for 
analysis 
Study design 
Source of HIV infection, Maternal 
CD4 and viral load nearest to 
time of questionnaire recorded on 
questionnaire. 

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3.1 
STUDY OUTCOME MEASURES 
 
Primary outcome measure:  
Assessment of attitudes towards breastfeeding amongst HIV positive women, who are either 
pregnant (third trimester) or post-partum (three months post-delivery). 
 
4. 
PARTICIPANT ENTRY  
 
4.1 
PRE-REGISTRATION EVALUATIONS  
Patients should meet criteria below. No other pre-registration evaluations required. 
 
4.2 
INCLUSION CRITERIA 
Age > 18 years  
Able to give written informed consent 
Post-natal and antenatal HIV positive women 
 
4.3 
EXCLUSION CRITERIA 
 
Age <18 years 
Patients who are unable to consent. 
Women with HIV who have not been pregnant. 
 
 
4.4 
WITHDRAWAL CRITERIA 
Participants will be required to fill in questionnaire after consenting. Questionnaires will not 
have any identifiable information; therefore participants cannot withdraw once questionnaire 
has been completed. 
 
 
5. 
ADVERSE EVENTS 
 
5.1 
DEFINITIONS   
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study subject.   
 
Serious Adverse Event (SAE): any untoward and unexpected medical occurrence or effect 
that: 
 
Results in death 
 
Is life-threatening – refers to an event in which the subject was at risk of death 
at the time of the event; it does not refer to an event which hypothetically might 
have caused death if it were more severe 
 
 
Requires 
hospitalisation, 
or 
prolongation 
of 
existing 
inpatients’ 
hospitalisation 
 
Results in persistent or significant disability or incapacity 
 
Is a congenital anomaly or birth defect 
 
Medical judgement should be exercised in deciding whether an AE is serious in other 
situations.  Important AEs that are not immediately life-threatening or do not result in death 
or hospitalisation but may jeopardise the subject or may require intervention to prevent one 
of the other outcomes listed in the definition above, should also be considered serious. 
 

10 
 
5.3 
REPORTING PROCEDURES 
All adverse events should be reported.  Depending on the nature of the event the reporting 
procedures below should be followed.  Any questions concerning adverse event reporting 
should be directed to the Chief Investigator in the first instance.   
 
5.3.1 Non serious AEs 
All such events, whether expected or not, should be recorded.   
 
5.3.2 Serious AEs 
An SAE form should be completed and faxed to the Chief Investigator within 24 hours.  
However, relapse, death and hospitalisations for elective treatment of a pre-existing 
condition do not need reporting as SAEs. 
 
All SAEs should be reported to the Imperial College HIV research Ethics Committee where 
in the opinion of the Chief Investigator, the event was: 
 
‘related’, ie resulted from the administration of any of the research procedures; 
and 
 
‘unexpected’, ie an event that is not listed in the protocol as an expected 
occurrence 
 
Reports of related and unexpected SAEs should be submitted within 15 days of the Chief 
Investigator becoming aware of the event, using the NRES SAE form for non-IMP studies.  
The Chief Investigator must also notify the Sponsor of all SAEs. 
 
Local investigators should report any SAEs as required by their Local Research Ethics 
Committee, Sponsor and/or Research & Development Office. 
 
Contact details for reporting SAEs 
Attention:Dr Hermoine Lyall 
Please send SAE forms to: Imperial College Healthcare Trust St Mary’s Hospital, 
Paediatric Services, London, W2 1NY 
Telephone: 0203 3126965 
 
6. 
ASSESSMENT AND FOLLOW-UP  
 
They will be no follow up once questionnaires are completed by participants. 
 
7. 
STATISTICS AND DATA ANALYSIS 
 
Analysis plan 
Data will be collected via the questionnaire from around 100 HIV positive participants over a 
3 -6 month period. The questionnaires will then be analysed using descriptive statistical 
methods. 
 
Data Handling and management 
Participants will complete paper questionnaires.  The questionnaires themselves will contain 
a study / site number only, with no identifying information. The patient’s name and clinic 
number will not be recorded on the questionnaire. 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 

11 
 
hospital 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. Maternal CD4 
and viral load nearest to time of questionnaire will be recorded on the questionnaire and sent 
with the questionnaire to St Mary’s Hospital (London) with for analysis. 
 
Data and all appropriate documentation will be stored for a minimum of 10 years after the 
completion of the study, including the follow-up period.   
 
 
8. 
REGULATORY ISSUES 
 
8.1 
ETHICS APPROVAL 
The Chief Investigator has obtained approval from the Imperial College Healthcare NHS 
trust HIV Research Ethics Committee.  The study must be submitted for Site Specific 
Assessment (SSA) at each participating NHS Trust.  The Chief Investigator will require a 
copy of the Trust R&D approval letter before accepting participants into the study.  The study 
will be conducted in accordance with the recommendations for physicians involved in 
research on human subjects adopted by the 18th World Medical Assembly, Helsinki 1964 
and later revisions. 
 
8.2 
CONSENT  
Consent to enter the study must be sought from each participant only after a full explanation 
has been given, an information leaflet offered and time allowed for consideration.  Signed 
participant consent should be obtained.  The right of the participant to refuse to participate 
without giving reasons must be respected.  After the participant has entered the study the 
clinician remains free to give alternative treatment to that specified in the protocol at any 
stage if he/she feels it is in the participant’s best interest, but the reasons for doing so should 
be recorded.  In these cases the participants remain within the study for the purposes of 
follow-up and data analysis.  All participants are free to withdraw at any time from the 
protocol treatment without giving reasons and without prejudicing further treatment. 
 
8.3 
CONFIDENTIALITY 
The Chief Investigator will preserve the confidentiality of participants taking part in the study 
and is registered under the Data Protection Act. 
 
8.4 
INDEMNITY 
Imperial College London holds negligent harm and non-negligent harm insurance policies 
which apply to this study/ Imperial College Healthcare NHS Trust holds standard NHS 
Hospital Indemnity and insurance cover with NHS Litigation Authority for NHS Trusts in 
England, which apply to this study (delete as applicable) 
 
8.5 
SPONSOR 
Imperial College London/Imperial College Healthcare NHS Trust (delete as applicable) will 
act as the main Sponsor for this study.  Delegated responsibilities will be assigned to the 
NHS trusts taking part in this study.   
 
8.6 
FUNDING 
Funding applications are currently in progress. 
  
8.7 
AUDITS  
The study may be subject to inspection and audit by Imperial College London under their 
remit as sponsor and other regulatory bodies to ensure adherence to GCP and the NHS 
Research Governance Framework for Health and Social Care (2nd edition).  

12 
 
 
 
9. 
STUDY MANAGEMENT 
 
The day-to-day management of the study will be co-ordinated through Dr Hermione Lyall.   
 
 
 
 
10. 
PUBLICATION POLICY 
 
This study will be presented at international conferences and be published in an international 
journal. 
 
11. 
REFERENCES 
 
1. 
Aghaizu, A. et al. HIV in the United Kingdom: 2014 Report About Public Health 
England. (2014). 
2. 
Birrell, P. et al. HIV in the UK – Situation Report 2015 Incidence, prevalence and 
prevention. (2015). 
3. 
Townsend, C. L. et al. Earlier initiation of ART and further decline in mother-to-child 
HIV transmission rates, 2000–2011. AIDS 28, 1049–1057 (2014). 
4. 
de Ruiter, A. et al. British HIV Association guidelines for the management of HIV 
infection in pregnant women 2012 (2014 interim review). HIV Med. 15, 1–77 (2014). 
5. 
DH (2009a) Parents’ views on the maternity journey and early parenthood: what 
expectant and new parents have told us about their experiences of maternity and early years 
care, The Futures Company. Gateway ref. 15469. 
6. 
WCRF/AICR (2009) Policy and Action for Cancer Prevention: Food, Nutrition, and 
Physical Activity: a Global Perspective, Washington DC, AICR 
7. 
Horta, B. L. & Victora, C. G. Short-term effects of breastfeeding- a systematic review 
8. 
Ip, S. et al. Breastfeeding and maternal and infant health outcomes in developed 
countries. Evid. Rep. Technol. Assess. (Full. Rep). 1–186 (2007). 
9. 
DH (2013a) Infant feeding profiles 2002/03 to 2010/11. Accessed 08/11/2016 
(https://www.gov.uk/government/.../Infant_Feeding_Profile_Excel_tool_v2.0.xls) 
10. 
Horta, B. L. & Victora, C. G. Long-term effects of breastfeeding- a systematic review 
11. 
Martin, R. M. Breastfeeding in Infancy and Blood Pressure in Later Life: Systematic 
Review and Meta-Analysis. Am. J. Epidemiol. 161, 15–26 (2005). 
12. 
American Academy of Paediatrics (2012) Policy Statement: Breastfeeding and the 
Use of Human Milk, Pediatrics 2012, Vol. 129 (3); e827-e841 
13. 
Arenz, S., Rückerl, R., Koletzko, B. & von Kries, R. Breast-feeding and childhood 
obesity--a systematic review. Int. J. Obes. Relat. Metab. Disord. 28, 1247–56 (2004). 
14. 
Kramer, M. S. & Kakuma, R. Optimal duration of exclusive breastfeeding (Review) 
Optimal duration of exclusive breastfeeding (Review) Optimal duration of exclusive 
breastfeeding. Cochrane Database Syst. Rev. Art (2012). 
doi:10.1002/14651858.CD003517.pub2 
15. 
WHO website: Exclusive breastfeeding. Accessed 08/11/2016 
(http://www.who.int/nutrition/topics/exclusive_breastfeeding/en/) 
16. 
WHO, UNICEF, UNAIDS & UNFPA. Guidelines on HIV and Infant Feeding: 
Principles and recommendations for infant feeding in the context of HIV and summary of 
evidence. World Health Organization. Geneva (2010). 
17. 
Breastfeeding and HIV International Transmission Study Group, D. J. S. et al. Late 
postnatal transmission of HIV-1 in breast-fed children: an individual patient data meta-
analysis. J. Infect. Dis. 189, 2154–66 (2004). 

13 
 
18. 
Nduati, R. et al. Effect of Breastfeeding and Formula Feeding on Transmission of 
HIV-1. JAMA 283, 1167 (2000). 
19. 
Thior, I. et al. Breastfeeding Plus Infant Zidovudine Prophylaxis for 6 Months vs 
Formula Feeding Plus Infant Zidovudine for 1 Month to Reduce Mother-to-Child HIV 
Transmission in Botswana. JAMA 296, 794 (2006). 
20. 
Kafulafula, G. et al. Frequency of Gastroenteritis and Gastroenteritis-Associated 
Mortality With Early Weaning in HIV-1-Uninfected Children Born to HIV-Infected Women in 
Malawi. JAIDS J. Acquir. Immune Defic. Syndr. 53, 6–13 (2010). 
21. 
Triple antiretroviral compared with zidovudine and single-dose nevirapine prophylaxis 
during pregnancy and breastfeeding for prevention of mother-to-child transmission of HIV-1 
(Kesho Bora study): a randomised controlled trial. Lancet Infect. Dis. 11, 171–180 (2011). 
22. 
Shapiro, R. L. et al. Antiretroviral Regimens in Pregnancy and Breast-Feeding in 
Botswana. N. Engl. J. Med. 362, 2282–2294 (2010). 
23. 
Chasela, C. S. et al. Maternal or Infant Antiretroviral Drugs to Reduce HIV-1 
Transmission. N. Engl. J. Med. 362, 2271–2281 (2010). 
24. 
Valea, D. et al. CD4+ T cells spontaneously producing human immunodeficiency 
virus type I in breast milk from women with or without antiretroviral drugs. Retrovirology 8, 34 
(2011). 
25. 
WHO. Guideline: updates on HIV and infant feeding: duration of breastfeeding, and 
support from health services to improve feeding practices among mothers living with HIV. 59 
(2016). 
26. 
WHO. Guideline on when to start atiretroviral therapy and on pre-exposure 
prophylaxis for HIV. (2015). 
27. 
Group, T. I. S. S. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV 
Infection. N. Engl. J. Med. 373, 795–807 (2015). 
28. 
Coutsoudis, A. et al. Method of feeding and transmission of HIV-1 from mothers to 
children by 15 months of age: prospective cohort study from Durban, South Africa. AIDS 15, 
379–87 (2001). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

14 
 
 
 
 
 
 
Appendix 1. Patient Information Leaflet 
 
 
 
 
 
 
 
 
Patient Information Leaflet 
Study Title: Positive Attitudes Concerning Infant Feeding (PACIFY) 
study 
Ethics Ref:  
Date and Version No 1.0 
1. 
Invitation 
You are invited to take part in a research study which will involve you answering a 
questionnaire on what you think about breastfeeding for women with HIV. The information 
we obtain from this study will help us to understand HIV positive women’s views on 
breastfeeding in resource rich settings. 
2. 
What is the purpose of this study? 
We want to understand more about the views of HIV positive women on breastfeeding, by 
asking women with HIV who are either pregnant (in the third trimester) or have recently 
given birth (within the last 3 months) to complete a questionnaire. This information may help 
us to shape national guidelines for other women with HIV in future. 
3. 
Why have I been chosen? 
You have been invited to take part because you are attending the clinic today and are either 
pregnant or have recently given birth. Taking part in this study will not alter in any way the 
care and treatment that your medical team are recommending for you. 
4. 
Do I have to take part? 
No. Taking part in this study is completely voluntary which means it is entirely up to you to 
decide whether or not to take part. Your decision will not affect your medical care or 
treatment in any way. If you decide to take part you will be given this information sheet to 
keep and be asked to sign a consent form to confirm that you understand what is involved 
when taking part in this study. If you change your mind, you can, withdraw at any time, or if 
you decide not to take part, this will not affect the quality of care you receive. 
5. 
What would happen to me if I take part? 
We will ask you to complete a 10 minute anonymous questionnaire.  Once you have 
completed the questionnaire we will ask you to place it in the envelope and box provided. If 
you agree, we would also like to ask your local team to fill in your latest CD4 and viral load 
results on the questionnaire. 
6. 
What would happen to questionnaires after? 
The questionnaires will then be reviewed and analysed by the research staff. 
7. 
What are the possible disadvantages and risks? 
The risks involved in this research are very few and no personal identifiable information will 
be collected with the questionnaire. We will not include your information your name or 
address. The information that you give will be stored with a code (a number) not your name, 
on a secure computer system, which will only be accessible by the few individuals who are 
working closely on this research project that are specifically named in this study. 

15 
 
8. 
What are the possible benefits? 
This research will improve our understanding of HIV positive women’s views on 
breastfeeding. This information may help us to shape national guidelines in future. 
9. 
What happens when the research study stops? 
We aim to feed back our findings to HIV user groups and to the scientific community. 
10. 
What will happen if I don’t want to carry on? 
You are free to withdraw from with this research at any time, without giving a reason and 
without any effect on your future care or treatment 
11. 
What if something goes wrong? 
Imperial College Healthcare NHS Trust has arrangements in place to provide for harm 
arising from participation in the study for which the Imperial College Healthcare NHS Trust 
Joint Research Compliance Office, 2nd Floor Medical School Building, St Mary’s Hospital 
Praed Street, London, W2 1NY is the Research Sponsor. 
12. 
Would my taking part in this study be kept confidential?  
Confidentiality and keeping your records securely are very important parts of this research. 
You will be allocated a unique study number that will be used for the questionnaire.   All the 
information necessary for the research will be used through your unique research number.  
The researchers using this information are aware of the importance of security and 
confidentiality. 
13. 
What will happen to the results of the research study? 
The results of this research study may be presented at medical, scientific, and user group 
meetings or in publications.  You will not be personally identified in any presentations or 
publications, but if you agree, we may use anonymised quotes from what you have written 
down on your response. These can be very powerful at getting messages across to the 
scientific community. 
14. 
 Who is organising and funding the research? 
The research is supported by Imperial College NHS Trust. 
15. 
Who has reviewed the study? 
This research study has been peer reviewed by the research committee of the HIV team at 
Imperial College. It has also been reviewed by appropriate ethical committees in accordance 
with local and national regulations. 
 
16. 
Complaints procedure 
If you wish to complain about any aspect of the way in which you have been approached or 
treated during the course of this study, you should contact the Joint Research Office of 
Imperial College and Imperial College Healthcare NHS Trust 
 
18. 
Contact for further information 
If you would like more information, or if you have any problems, concerns or questions about 
the study, please contact the doctor looking after you, or the Imperial College Healthcare 
NHS Trust Joint Research Compliance Office, 2nd Floor Medical School Building, St Mary’s 
Hospital, Praed Street, London, W2 1NY and Imperial College Healthcare NHS Trust or Dr 
Hermione Lyall, Imperial College Healthcare NHS Trust, St Mary’s Hospital, Paediatric 
Services, London, W21NY. 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 2. Questionnaire consent form 
 
 
 
 
 
 
 
 
 
Questionnaire consent form 
Title of project: The PACIFY Study 
Positive Attitudes Concerning Infant Feeding 
 
Researcher: Dr Hermione Lyall 
 
 
Please initial all boxes 
 
I confirm that I have read and understood the information sheet dated ________ for the 
above study. I have had the opportunity to consider the information, ask questions and 
have had these answered satisfactorily. 
 
I understand that my participation is voluntary and that I am free to withdraw at any time 
without giving any reason, without my medical care or legal rights being affected.  
 
I agree that the anonymous information that I provide can be used for the purposes of this 
research. 
 
I agree to have my viral load and CD4 count recorded anonymously for the study 
 
 
I agree to take part in the above study.  
 
__________________________  
 __________________  
______________________ 
 
Name of participant  
 
 Date  
 
 
Signature 
 
__________________________  
 __________________  
______________________ 
 
Name of person taking consent  
 Date  
 
 
Signature 
 
 
 

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Appendix 3. Delegation log