Trial Outcomes & Findings for Positive Attitudes Concerning Infant Feeding- a Questionnaire for Women Living With HIV (NCT NCT03294499)
NCT ID: NCT03294499
Last Updated: 2023-02-02
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
94 participants
Primary outcome timeframe
At their pre-or postnatal outpatient appointment, an average of one day
Results posted on
2023-02-02
Participant Flow
Patient were recruited from medical outpatient clinics across England The study period was May 2017 -May 2018
Participant milestones
| Measure |
Women Living With HIV
Women were in their third trimester or three months post-partum
|
|---|---|
|
Overall Study
STARTED
|
94
|
|
Overall Study
COMPLETED
|
94
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Positive Attitudes Concerning Infant Feeding- a Questionnaire for Women Living With HIV
Baseline characteristics by cohort
| Measure |
Women Living With HIV
n=94 Participants
The PACIFY was a descriptive questionnaire with no study arms Patients were recruited from 12 clinics in England.Participant were asked to complete a six paged questionnaire which would be analysed.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
94 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Immigration
Immigrants
|
70 Participants
n=5 Participants
|
|
Immigration
Non-immigrants
|
18 Participants
n=5 Participants
|
|
Immigration
No answer
|
6 Participants
n=5 Participants
|
|
Employment status
Employed
|
51 Participants
n=5 Participants
|
|
Employment status
Unemployed
|
43 Participants
n=5 Participants
|
|
Education status
Higher education
|
77 Participants
n=5 Participants
|
|
Education status
Secondary school
|
13 Participants
n=5 Participants
|
|
Education status
Primary school
|
3 Participants
n=5 Participants
|
|
Education status
No answer
|
1 Participants
n=5 Participants
|
|
HIV diagnosed
Before pregnancy
|
71 Participants
n=5 Participants
|
|
HIV diagnosed
During current pregnancy
|
23 Participants
n=5 Participants
|
|
HIV parameters
HIV viral load <50 copies/ml
|
86 Participants
n=5 Participants
|
|
HIV parameters
HIV viral load >50 copies/ml
|
1 Participants
n=5 Participants
|
|
HIV parameters
No answer
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At their pre-or postnatal outpatient appointment, an average of one dayParticipants 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.
Outcome measures
| Measure |
Women Living With HIV
n=94 Participants
The PACIFY was a descriptive questionnaire with no study arms Patients were recruited from 12 clinics in England.Participant were asked to complete a six paged questionnaire which would be analysed.
|
|---|---|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Have any friends, family or community members questioned you about your reasons for not BF? · Yes
|
58 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Have any friends, family or community members questioned you about your reasons for not BF? · No
|
25 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Have any friends, family or community members questioned you about your reasons for not BF? · Don't know
|
0 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Have any friends, family or community members questioned you about your reasons for not BF? · No answer
|
11 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Have you ever had to lie about your reasons for not BF? · Yes
|
62 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Have you ever had to lie about your reasons for not BF? · No
|
21 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Have you ever had to lie about your reasons for not BF? · Don't know
|
0 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Have you ever had to lie about your reasons for not BF? · No answer
|
11 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
If you did not have HIV, would you BF your child? · Yes
|
84 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
If you did not have HIV, would you BF your child? · No
|
2 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
If you did not have HIV, would you BF your child? · Don't know
|
8 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
If you did not have HIV, would you BF your child? · No answer
|
0 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Living with HIV, would you like to BF your child? · Yes
|
36 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Living with HIV, would you like to BF your child? · No
|
45 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Living with HIV, would you like to BF your child? · Don't know
|
6 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Living with HIV, would you like to BF your child? · No answer
|
7 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Do you think it's safe for women with detectable HIV in the blood to BF? · Yes
|
3 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Do you think it's safe for women with detectable HIV in the blood to BF? · No
|
63 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Do you think it's safe for women with detectable HIV in the blood to BF? · Don't know
|
22 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Do you think it's safe for women with detectable HIV in the blood to BF? · No answer
|
6 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Do you think it's safe for women on treatment with fully suppressed HIV to BF? · Yes
|
26 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Do you think it's safe for women on treatment with fully suppressed HIV to BF? · No
|
33 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Do you think it's safe for women on treatment with fully suppressed HIV to BF? · Don't know
|
31 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Do you think it's safe for women on treatment with fully suppressed HIV to BF? · No answer
|
4 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
If you were to BF, would you have monthly blood tests to check your viral load stays undetectable? · Yes
|
83 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
If you were to BF, would you have monthly blood tests to check your viral load stays undetectable? · No
|
10 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
If you were to BF, would you have monthly blood tests to check your viral load stays undetectable? · Don't know
|
0 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
If you were to BF, would you have monthly blood tests to check your viral load stays undetectable? · No answer
|
1 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
If you were to BF, would you be willing for your baby to have a monthly HIV blood test? · Yes
|
79 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
If you were to BF, would you be willing for your baby to have a monthly HIV blood test? · No
|
13 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
If you were to BF, would you be willing for your baby to have a monthly HIV blood test? · Don't know
|
0 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
If you were to BF, would you be willing for your baby to have a monthly HIV blood test? · No answer
|
2 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Do you have any concerns about BF while you are taking anti-HIV medicines? · Yes
|
47 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Do you have any concerns about BF while you are taking anti-HIV medicines? · No
|
44 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Do you have any concerns about BF while you are taking anti-HIV medicines? · Don't know
|
1 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Do you have any concerns about BF while you are taking anti-HIV medicines? · No answer
|
2 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Have you heard of 'exclusive BF' (giving the baby breast milk only and no other feeds or drinks)? · Yes
|
63 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Have you heard of 'exclusive BF' (giving the baby breast milk only and no other feeds or drinks)? · No
|
29 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Have you heard of 'exclusive BF' (giving the baby breast milk only and no other feeds or drinks)? · Don't know
|
0 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Have you heard of 'exclusive BF' (giving the baby breast milk only and no other feeds or drinks)? · No answer
|
2 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
If you were to BF, would you be happy to exclusively BF? · Yes
|
51 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
If you were to BF, would you be happy to exclusively BF? · No
|
41 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
If you were to BF, would you be happy to exclusively BF? · Don't know
|
0 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
If you were to BF, would you be happy to exclusively BF? · No answer
|
2 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Have any healthcare workers discussed BF with you? · Yes
|
84 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Have any healthcare workers discussed BF with you? · No
|
8 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Have any healthcare workers discussed BF with you? · Don't know
|
0 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Have any healthcare workers discussed BF with you? · No answer
|
2 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Would you like more information on the benefits and disadvantages of BF? · Yes
|
45 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Would you like more information on the benefits and disadvantages of BF? · No
|
48 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Would you like more information on the benefits and disadvantages of BF? · Don't know
|
0 Participants
|
|
Knowledge and Experiences of Breastfeeding Among Women Living With HIV
Would you like more information on the benefits and disadvantages of BF? · No answer
|
1 Participants
|
PRIMARY outcome
Timeframe: At their pre-or postnatal outpatient appointment, an average of one dayThe 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?
Outcome measures
| Measure |
Women Living With HIV
n=94 Participants
The PACIFY was a descriptive questionnaire with no study arms Patients were recruited from 12 clinics in England.Participant were asked to complete a six paged questionnaire which would be analysed.
|
|---|---|
|
Views on Infant Feeding for Women Living With HIV
would like to breastfeed if they were HIV negative
|
89 percentage of total participants
|
|
Views on Infant Feeding for Women Living With HIV
would like to breastfeed while living with HIV
|
38 percentage of total participants
|
Adverse Events
PACIFY Study
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place