<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03294499</url>
  </required_header>
  <id_info>
    <org_study_id>17IC3795</org_study_id>
    <secondary_id>221592</secondary_id>
    <nct_id>NCT03294499</nct_id>
  </id_info>
  <brief_title>Positive Attitudes Concerning Infant Feeding- a Questionnaire for Women Living With HIV</brief_title>
  <acronym>PACIFY</acronym>
  <official_title>Positive Attitudes Concerning Infant Feeding- a Questionnaire for Women Living With HIV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The PACIFY Study is a questionnaire for antenatal(third trimester) and postnatal(three months&#xD;
      post delivery) Human Immunodeficiency Virus (HIV) positive women attending clinics in London&#xD;
      and Brighton. The current World Health Organisation guidance advises HIV positive women, who&#xD;
      are adhering to antiretroviral therapy (ART), to exclusively breastfeed for the first 6&#xD;
      months of the infant's life and continue supplemental breastfeeding for up to 2 years.&#xD;
&#xD;
      This is conflicts with the current British HIV Association guidelines which advise exclusive&#xD;
      formula feeding. The reason for this difference is the relative safety of formula feeding in&#xD;
      the United Kingdom(UK)against the low but persisting risk of HIV infection through&#xD;
      breast-feeding. The aim of the PACIFY study is to explore attitudes towards breastfeeding&#xD;
      amongst HIV positive women, who are either pregnant or post-partum. The study will also&#xD;
      assess the understanding of current infant feeding guidance by these women and assess their&#xD;
      current or recent infant feeding practice. It will also look at whether HIV positive mothers&#xD;
      would be willing and able to comply with special monitoring and guidance whilst breastfeeding&#xD;
      if the guidelines were to change. The study aims to analyse 100 questionnaires completed over&#xD;
      a 3-6 month period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All eligible female patients (currently or recently pregnant) attending routine HIV-related&#xD;
      appointments will be invited to participate and a participant information sheet will be&#xD;
      given. Those who have consented to join the study will be given a short questionnaire to&#xD;
      complete and return during that attendance. The questionnaire takes about 15 minutes to&#xD;
      complete. The option of returning the questionnaire by post will be available but not&#xD;
      encouraged.&#xD;
&#xD;
      During the collection period, women with HIV attending either antenatal (third trimester) or&#xD;
      postnatal (within three months of delivery) care will be eligible to participate, but they&#xD;
      will only be asked once, either before or after delivery.&#xD;
&#xD;
      Ideally equivalent numbers of pre and postnatal participants will be enrolled. Participants&#xD;
      given a questionnaire and have a centre and unique study number. Maternal cluster of&#xD;
      differentiation 4 (CD4) count and HIV Viral load nearest to time of questionnaire completion&#xD;
      will be recorded if patient consents.&#xD;
&#xD;
      Participants will be able to place their completed paper questionnaires in a sealed envelope&#xD;
      in a box in the clinic.Participants will be informed that their questionnaire responses will&#xD;
      not be seen by clinical staff (unless participants request staff support in completion of the&#xD;
      questionnaire) or recorded in their clinical notes. In the clinics the study log will be the&#xD;
      only document linking study number with hospital identification (ID)number and soundex.&#xD;
      Completed questionnaires will be stored securely in local sites prior to transfer to St&#xD;
      Mary's Hospital (by the study team). The study log will be maintained securely along with the&#xD;
      delegation log by the site lead investigator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 31, 2017</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge and Experiences of Breastfeeding Among Women Living With HIV</measure>
    <time_frame>At their pre-or postnatal outpatient appointment, an average of one day</time_frame>
    <description>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.&#xD;
In the data table, breastfeeding has been abbreviated to BF.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Views on Infant Feeding for Women Living With HIV</measure>
    <time_frame>At their pre-or postnatal outpatient appointment, an average of one day</time_frame>
    <description>The PACIFY study (Positive Attitudes Concerning Infant Feeding) sought to explore the views, concerns and issues surrounding breastfeeding in women living with HIV (WLHs).&#xD;
Questions within the questionnaire:&#xD;
If you did not have HIV, would you breastfeed your child?&#xD;
Living with HIV, would you like to breastfeed your child?</description>
  </primary_outcome>
  <enrollment type="Actual">94</enrollment>
  <condition>Human Immunodeficiency Virus</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Patients will be asked to complete one off questionnaire.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        HIV positive women who are three months post partum and third trimester&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Able to give written informed consent&#xD;
&#xD;
          -  Post-natal and antenatal HIV positive women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Patients who are unable to consent.&#xD;
&#xD;
          -  Women with HIV who have not been pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>This is a questionnaire for HIV positive women who are in their third trimester and three months post partum</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hermione Lyall, MBChB</last_name>
    <role>Study Chair</role>
    <affiliation>Imperial College Healthcare NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brighton and Sussex NHS Trist</name>
      <address>
        <city>Brighton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barts Health NHS Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CENTRAL AND NORTH WEST London NHS Trsut</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chelsea and Westminister NHS Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guys and St Thomas NHS Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Homerton University Hospital Nhs Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imperial College Healthcare NHS Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kings College NHS Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lewisham and Greenwich NHS Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Northwest Healthcare NHS Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Nyatsanza F, Gubbin J, Gubbin T, Seery P, Farrugia P, Croucher A, Gilleece Y, Rosenvinge M, Roedling S, Sarner L, Nayagam D, Stradling C, Namiba A, Fearnley N, Lyall H. Over a third of childbearing women with HIV would like to breastfeed: A UK survey of women living with HIV. Int J STD AIDS. 2021 Aug;32(9):856-860. doi: 10.1177/0956462421999951. Epub 2021 Feb 25.</citation>
    <PMID>33629917</PMID>
  </results_reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <results_first_submitted>February 15, 2021</results_first_submitted>
  <results_first_submitted_qc>May 5, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 2, 2023</results_first_posted>
  <last_update_submitted>May 5, 2022</last_update_submitted>
  <last_update_submitted_qc>May 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Human Immunodeficiency Virus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Results will be presented at a conference and published.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 23, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03294499/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patient were recruited from medical outpatient clinics across England The study period was May 2017 -May 2018</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Women Living With HIV</title>
          <description>Women were in their third trimester or three months post-partum</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="94"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="94"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>94 participants were recruited from 12 clinics in England</population>
      <group_list>
        <group group_id="B1">
          <title>Women Living With HIV</title>
          <description>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.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="94"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Descriptive Questionnaire</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Immigration</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Immigrants</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-immigrants</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No answer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Employment status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Employed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unemployed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Higher education</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Secondary school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Primary school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No answer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HIV diagnosed</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Before pregnancy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>During current pregnancy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HIV parameters</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>HIV viral load &lt;50 copies/ml</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>HIV viral load &gt;50 copies/ml</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No answer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Knowledge and Experiences of Breastfeeding Among Women Living With HIV</title>
        <description>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.&#xD;
In the data table, breastfeeding has been abbreviated to BF.</description>
        <time_frame>At their pre-or postnatal outpatient appointment, an average of one day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women Living With HIV</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Knowledge and Experiences of Breastfeeding Among Women Living With HIV</title>
          <description>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.&#xD;
In the data table, breastfeeding has been abbreviated to BF.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Have any friends, family or community members questioned you about your reasons for not BF?</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Don't know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Have you ever had to lie about your reasons for not BF?</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Don't know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>If you did not have HIV, would you BF your child?</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Don't know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Living with HIV, would you like to BF your child?</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Don't know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you think it's safe for women with detectable HIV in the blood to BF?</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Don't know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you think it's safe for women on treatment with fully suppressed HIV to BF?</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Don't know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>If you were to BF, would you have monthly blood tests to check your viral load stays undetectable?</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Don't know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>If you were to BF, would you be willing for your baby to have a monthly HIV blood test?</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Don't know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you have any concerns about BF while you are taking anti-HIV medicines?</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Don't know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Have you heard of 'exclusive BF' (giving the baby breast milk only and no other feeds or drinks)?</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Don't know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>If you were to BF, would you be happy to exclusively BF?</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Don't know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Have any healthcare workers discussed BF with you?</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Don't know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Would you like more information on the benefits and disadvantages of BF?</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Don't know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Views on Infant Feeding for Women Living With HIV</title>
        <description>The PACIFY study (Positive Attitudes Concerning Infant Feeding) sought to explore the views, concerns and issues surrounding breastfeeding in women living with HIV (WLHs).&#xD;
Questions within the questionnaire:&#xD;
If you did not have HIV, would you breastfeed your child?&#xD;
Living with HIV, would you like to breastfeed your child?</description>
        <time_frame>At their pre-or postnatal outpatient appointment, an average of one day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women Living With HIV</title>
            <description>The PACIFY was a descriptive questionnaire with no study arms</description>
          </group>
        </group_list>
        <measure>
          <title>Views on Infant Feeding for Women Living With HIV</title>
          <description>The PACIFY study (Positive Attitudes Concerning Infant Feeding) sought to explore the views, concerns and issues surrounding breastfeeding in women living with HIV (WLHs).&#xD;
Questions within the questionnaire:&#xD;
If you did not have HIV, would you breastfeed your child?&#xD;
Living with HIV, would you like to breastfeed your child?</description>
          <units>percentage of total participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>would like to breastfeed if they were HIV negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>would like to breastfeed while living with HIV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data was collected over a 12 month period</time_frame>
      <group_list>
        <group group_id="E1">
          <title>PACIFY Study</title>
          <description>They were no adverse events reported</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>We sampled a small number of participants and we were unable to ascertain how many participants refused to respond to questionnaire</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr Farai Nyatsanza</name_or_title>
      <organization>Imperial College Healthcare NHS Trust</organization>
      <email>farai.nyatsanza@nhs.net</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03294499
org study id: 17IC3795
secondary id: 221592
nct id: NCT03294499
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Other
time perspective: Prospective
measure: Knowledge and Experiences of Breastfeeding Among Women Living With HIV
time frame: At their pre-or postnatal outpatient appointment, an average of one day
description: 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.
measure: Views on Infant Feeding for Women Living With HIV
time frame: At their pre-or postnatal outpatient appointment, an average of one day
description: 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:
If you did not have HIV, would you breastfeed your child?
Living with HIV, would you like to breastfeed your child?
intervention type: Other
intervention name: Questionnaire
description: Patients will be asked to complete one off questionnaire.
study pop: 
sampling method: Non-Probability Sample
criteria: 
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
last name: Hermione Lyall, MBChB
role: Study Chair
affiliation: Imperial College Healthcare NHS Trust
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
citation: Nyatsanza F, Gubbin J, Gubbin T, Seery P, Farrugia P, Croucher A, Gilleece Y, Rosenvinge M, Roedling S, Sarner L, Nayagam D, Stradling C, Namiba A, Fearnley N, Lyall H. Over a third of childbearing women with HIV would like to breastfeed: A UK survey of women living with HIV. Int J STD AIDS. 2021 Aug;32(9):856-860. doi: 10.1177/0956462421999951. Epub 2021 Feb 25.
PMID: 33629917
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Immunologic Deficiency Syndromes
sharing ipd: No
ipd description: Results will be presented at a conference and published.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: We sampled a small number of participants and we were unable to ascertain how many participants refused to respond to questionnaire
point of contact: 