An observational study in Human Immunodeficiency Virus, sponsored by Imperial College London. Completed at 10 sites in United Kingdom. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-02.
Sponsored by Imperial College London · Observational
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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.
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.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
This study's enrollment of 94 is below the median of 289 across 504 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
HIV positive women who are three months post partum and third trimester
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be asked to complete one off questionnaire.
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.
Time frame: 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?
Time frame: At their pre-or postnatal outpatient appointment, an average of one day
Patient were recruited from medical outpatient clinics across England The study period was May 2017 -May 2018
| Milestone | Women Living With HIV |
|---|---|
| Started | 94 |
| Completed | 94 |
| Not completed | 0 |
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.
| Participants | Women Living With HIV |
|---|---|
| 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 |
| If you did not have HIV, would you BF your child? — Yes | 84 |
| If you did not have HIV, would you BF your child? — No | 2 |
| If you did not have HIV, would you BF your child? — Don't know | 8 |
| If you did not have HIV, would you BF your child? — No answer | 0 |
| Living with HIV, would you like to BF your child? — Yes | 36 |
| Living with HIV, would you like to BF your child? — No | 45 |
| Living with HIV, would you like to BF your child? — Don't know | 6 |
| Living with HIV, would you like to BF your child? — No answer | 7 |
| Do you think it's safe for women with detectable HIV in the blood to BF? — Yes | 3 |
| Do you think it's safe for women with detectable HIV in the blood to BF? — No | 63 |
| Do you think it's safe for women with detectable HIV in the blood to BF? — Don't know | 22 |
| Do you think it's safe for women with detectable HIV in the blood to BF? — No answer | 6 |
| Do you think it's safe for women on treatment with fully suppressed HIV to BF? — Yes | 26 |
| Do you think it's safe for women on treatment with fully suppressed HIV to BF? — No | 33 |
| Do you think it's safe for women on treatment with fully suppressed HIV to BF? — Don't know | 31 |
| Do you think it's safe for women on treatment with fully suppressed HIV to BF? — No answer | 4 |
| If you were to BF, would you have monthly blood tests to check your viral load stays undetectable? — Yes | 83 |
| If you were to BF, would you have monthly blood tests to check your viral load stays undetectable? — No | 10 |
| If you were to BF, would you have monthly blood tests to check your viral load stays undetectable? — Don't know | 0 |
| If you were to BF, would you have monthly blood tests to check your viral load stays undetectable? — No answer | 1 |
| If you were to BF, would you be willing for your baby to have a monthly HIV blood test? — Yes | 79 |
| If you were to BF, would you be willing for your baby to have a monthly HIV blood test? — No | 13 |
| If you were to BF, would you be willing for your baby to have a monthly HIV blood test? — Don't know | 0 |
| If you were to BF, would you be willing for your baby to have a monthly HIV blood test? — No answer | 2 |
| Do you have any concerns about BF while you are taking anti-HIV medicines? — Yes | 47 |
| Do you have any concerns about BF while you are taking anti-HIV medicines? — No | 44 |
| Do you have any concerns about BF while you are taking anti-HIV medicines? — Don't know | 1 |
| Do you have any concerns about BF while you are taking anti-HIV medicines? — No answer | 2 |
| Have you heard of 'exclusive BF' (giving the baby breast milk only and no other feeds or drinks)? — Yes | 63 |
| Have you heard of 'exclusive BF' (giving the baby breast milk only and no other feeds or drinks)? — No | 29 |
| Have you heard of 'exclusive BF' (giving the baby breast milk only and no other feeds or drinks)? — Don't know | 0 |
| Have you heard of 'exclusive BF' (giving the baby breast milk only and no other feeds or drinks)? — No answer | 2 |
| If you were to BF, would you be happy to exclusively BF? — Yes | 51 |
| If you were to BF, would you be happy to exclusively BF? — No | 41 |
| If you were to BF, would you be happy to exclusively BF? — Don't know | 0 |
| If you were to BF, would you be happy to exclusively BF? — No answer | 2 |
| Have any healthcare workers discussed BF with you? — Yes | 84 |
| Have any healthcare workers discussed BF with you? — No | 8 |
| Have any healthcare workers discussed BF with you? — Don't know | 0 |
| Have any healthcare workers discussed BF with you? — No answer | 2 |
| Would you like more information on the benefits and disadvantages of BF? — Yes | 45 |
| Would you like more information on the benefits and disadvantages of BF? — No | 48 |
| Would you like more information on the benefits and disadvantages of BF? — Don't know | 0 |
| Would you like more information on the benefits and disadvantages of BF? — No answer | 1 |
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?
| percentage of total participants | Women Living With HIV |
|---|---|
| would like to breastfeed if they were HIV negative | 89 |
| would like to breastfeed while living with HIV | 38 |
Collected over Data was collected over a 12 month period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PACIFY Study | 0/94 (0%) | 0/94 (0%) | 0/94 (0%) |
94 participants were recruited from 12 clinics in England
| Age, Categorical(Participants) | Women Living With HIV |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 94 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Women Living With HIV |
|---|---|
| Female | 94 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Women Living With HIV |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 9 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 72 |
| White | 10 |
| More than one race | 3 |
| Unknown or Not Reported | 0 |
| Immigration(Participants) | Women Living With HIV |
|---|---|
| Immigrants | 70 |
| Non-immigrants | 18 |
| No answer | 6 |
| Employment status(Participants) | Women Living With HIV |
|---|---|
| Employed | 51 |
| Unemployed | 43 |
| Education status(Participants) | Women Living With HIV |
|---|---|
| Higher education | 77 |
| Secondary school | 13 |
| Primary school | 3 |
| No answer | 1 |
| HIV diagnosed(Participants) | Women Living With HIV |
|---|---|
| Before pregnancy | 71 |
| During current pregnancy | 23 |
| HIV parameters(Participants) | Women Living With HIV |
|---|---|
| HIV viral load <50 copies/ml | 86 |
| HIV viral load >50 copies/ml | 1 |
| No answer | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Results will be presented at a conference and published.
Ran from May 2017 to primary completion in May 2018, 12 months.
Results were first posted in Feb 2023, 4 years 8 months after primary completion.
Of 165 non-industry observational studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 83. This study's 12 months is below that.
Counting every sponsor, half of 177 studies reached it within 44 months; a quarter within 19 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →