<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/NCT03019601</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00048133</org_study_id>
    <secondary_id>UM1AI069530</secondary_id>
    <nct_id>NCT03019601</nct_id>
  </id_info>
  <brief_title>Enhancing Uptake of Family Planning Services by HIV-Infected Women Attending the PMTCT Program</brief_title>
  <official_title>Enhancing Uptake of Family Planning Services by HIV Infected Women Attending the Postpartum Component of the PMTCT Program in Mulago National Referral Hospital, Kampala, Uganda Utilizing HIV-Infected Peers as Family Planning Champions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MU-JHU CARE</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A specific organized program utilizing peers in the PMTCT clinic who provide family planning&#xD;
      information and support to HIV infected mothers was compared to providing standard family&#xD;
      planning messages currently used in the clinic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A planned group education structural intervention utilizing peers in the PMTCT clinic who&#xD;
      provide family planning information and support to HIV infected mothers was compared to the&#xD;
      standard of care which consisted of providing standard family planning messages to women&#xD;
      attending the PMTCT Clinic. The study had two phases.&#xD;
&#xD;
      The Formative Phase consisted of six focus group discussions and six in depth interviews.&#xD;
&#xD;
      In the Implementation Phase, patient attendance and family planning uptake summaries for&#xD;
      during implementation were monitored and summarized daily. Weekly average summaries were&#xD;
      considered as time points.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>proportion of mothers who took up Family Planning</measure>
    <time_frame>weekly for one year</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3300</enrollment>
  <condition>Contraception</condition>
  <arm_group>
    <arm_group_label>Group education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non pregnant HIV+ mothers were exposed to a structured educational intervention on family planning facilitated by Peer Champions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group Education</intervention_name>
    <description>Structured group education on family planning facilitated by Peer Champions</description>
    <arm_group_label>Group education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  This being a program based intervention, all HIV positive mothers who utilize the&#xD;
             PMTCT and post natal clinic during the study period will be enrolled.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Mudiope, MBChB, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>MU-JHU CARE</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>PMTCT</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03019601
org study id: NA_00048133
secondary id: UM1AI069530
nct id: NCT03019601
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
A specific organized program utilizing peers in the PMTCT clinic who provide family planning
      information and support to HIV infected mothers was compared to providing standard family
      planning messages currently used in the clinic.
A planned group education structural intervention utilizing peers in the PMTCT clinic who
      provide family planning information and support to HIV infected mothers was compared to the
      standard of care which consisted of providing standard family planning messages to women
      attending the PMTCT Clinic. The study had two phases.

      The Formative Phase consisted of six focus group discussions and six in depth interviews.

      In the Implementation Phase, patient attendance and family planning uptake summaries for
      during implementation were monitored and summarized daily. Weekly average summaries were
      considered as time points.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: proportion of mothers who took up Family Planning
time frame: weekly for one year
arm group label: Group education
arm group type: Experimental
description: Non pregnant HIV+ mothers were exposed to a structured educational intervention on family planning facilitated by Peer Champions.
intervention type: Behavioral
intervention name: Group Education
description: Structured group education on family planning facilitated by Peer Champions
arm group label: Group education
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Peter Mudiope, MBChB, MSc
role: Principal Investigator
affiliation: MU-JHU CARE
responsible party type: Sponsor
sharing ipd: No