<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/NCT03257176</url>
  </required_header>
  <id_info>
    <org_study_id>HSS/0789/011</org_study_id>
    <nct_id>NCT03257176</nct_id>
  </id_info>
  <brief_title>Stepping Stones and Creating Futures Intervention Pilot</brief_title>
  <official_title>Stepping Stones and Creating Futures Intervention Pilot</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of KwaZulu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Research Council, South Africa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Project Empower</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of KwaZulu</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>
      This is a shortened interrupted time series pilot evaluation over a twelve month period to&#xD;
      evaluate whether the combined Stepping Stones and Creating Futures intervention can reduce&#xD;
      men's perpetration of IPV and women's experience of IPV, strengthen livelihoods and reduce&#xD;
      gender inequality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2, 2012</start_date>
  <completion_date type="Actual">July 30, 2013</completion_date>
  <primary_completion_date type="Actual">July 30, 2013</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Past three month physical IPV perpetration (men) and experience (women)</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>Physical intimate partner violence is assessed using five items based on the WHO VAW scale, asking about perpetration (men) and experience (women) of these five behaviourally specific actions in the past three months. A positive response to any of the five items leads to a person being classified as perpetrating (men) and experiencing (women) physical IPV in the past three months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Past three month sexual IPV perpetration (men) and experience (women)</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>Sexual intimate partner violence is assessed using three items based on the WHO VAW scale for sexual IPV. Questions are asked for the past three month perpetration (men) and experience (women). A positive response to any item leads to a person being classified as perpetrating (men) and experiencing (women) in the past three months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Earnings in past month</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>A single item question asks &quot;Considering all the money you earned from jobs or selling things (excluding grants), how much did you earn last month?&quot; Responses are in Rands and a continuous scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Work stress</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>4 items ask about work stress because of a lack of work. Responses are on a likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feelings about work shame</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>4 items ask about shame because of type and lack of work. Responses are on a likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gender attitudes</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>Modified gender equitable men's scale assess participant's gender attitudes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Controlling behaviours</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>Controlling behaviours are assessed using a modified Sexual Relationship Power (SRP) scale. Men's control of female sexual partner's and women's experience of controlling behaviours from a male partner.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Condom use at last sex</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>Single item asking about condom use at last sex</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hunger in the past month</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>Single item assesses hunger in the past month</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">232</enrollment>
  <condition>Physical Violence</condition>
  <condition>Sexual Violence</condition>
  <condition>Livelihoods</condition>
  <arm_group>
    <arm_group_label>Stepping Stones and Creating Futures</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive the 21 session intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stepping Stones and Creating Futures</intervention_name>
    <description>21 session intervention, comprising of 10 Stepping Stones sessions focused on gender, relationships and communication. 11 Creating Futures sessions focused on livelihoods.</description>
    <arm_group_label>Stepping Stones and Creating Futures</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18&#xD;
&#xD;
          -  Mentally competent&#xD;
&#xD;
          -  Able to communicate in English, Zulu, or Xhosa&#xD;
&#xD;
          -  Normally resident in the informal settlement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Over 30&#xD;
&#xD;
          -  Unable to do informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gender and Health Research Unit, South African Medical Research Council</name>
      <address>
        <city>Durban</city>
        <state>KwaZulu-Natal</state>
        <zip>4001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <reference>
    <citation>Gibbs A, Willan S, Jama-Shai N, Washington L, Jewkes R. 'Eh! I felt I was sabotaged!': facilitators' understandings of success in a participatory HIV and IPV prevention intervention in urban South Africa. Health Educ Res. 2015 Dec;30(6):985-95. doi: 10.1093/her/cyv059.</citation>
    <PMID>26590246</PMID>
  </reference>
  <results_reference>
    <citation>Jewkes R, Gibbs A, Jama-Shai N, Willan S, Misselhorn A, Mushinga M, Washington L, Mbatha N, Skiweyiya Y. Stepping Stones and Creating Futures intervention: shortened interrupted time series evaluation of a behavioural and structural health promotion and violence prevention intervention for young people in informal settlements in Durban, South Africa. BMC Public Health. 2014 Dec 29;14:1325. doi: 10.1186/1471-2458-14-1325.</citation>
    <PMID>25544716</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03257176
org study id: HSS/0789/011
nct id: NCT03257176
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a shortened interrupted time series pilot evaluation over a twelve month period to
      evaluate whether the combined Stepping Stones and Creating Futures intervention can reduce
      men's perpetration of IPV and women's experience of IPV, strengthen livelihoods and reduce
      gender inequality.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Past three month physical IPV perpetration (men) and experience (women)
time frame: 12 months post baseline
description: Physical intimate partner violence is assessed using five items based on the WHO VAW scale, asking about perpetration (men) and experience (women) of these five behaviourally specific actions in the past three months. A positive response to any of the five items leads to a person being classified as perpetrating (men) and experiencing (women) physical IPV in the past three months.
measure: Past three month sexual IPV perpetration (men) and experience (women)
time frame: 12 months post baseline
description: Sexual intimate partner violence is assessed using three items based on the WHO VAW scale for sexual IPV. Questions are asked for the past three month perpetration (men) and experience (women). A positive response to any item leads to a person being classified as perpetrating (men) and experiencing (women) in the past three months.
measure: Earnings in past month
time frame: 12 months post baseline
description: A single item question asks "Considering all the money you earned from jobs or selling things (excluding grants), how much did you earn last month?" Responses are in Rands and a continuous scale.
measure: Work stress
time frame: 12 months post baseline
description: 4 items ask about work stress because of a lack of work. Responses are on a likert scale.
measure: Feelings about work shame
time frame: 12 months post baseline
description: 4 items ask about shame because of type and lack of work. Responses are on a likert scale.
measure: Gender attitudes
time frame: 12 months post baseline
description: Modified gender equitable men's scale assess participant's gender attitudes.
measure: Controlling behaviours
time frame: 12 months post baseline
description: Controlling behaviours are assessed using a modified Sexual Relationship Power (SRP) scale. Men's control of female sexual partner's and women's experience of controlling behaviours from a male partner.
measure: Condom use at last sex
time frame: 12 months post baseline
description: Single item asking about condom use at last sex
measure: Hunger in the past month
time frame: 12 months post baseline
description: Single item assesses hunger in the past month
arm group label: Stepping Stones and Creating Futures
arm group type: Experimental
description: Receive the 21 session intervention
intervention type: Behavioral
intervention name: Stepping Stones and Creating Futures
description: 21 session intervention, comprising of 10 Stepping Stones sessions focused on gender, relationships and communication. 11 Creating Futures sessions focused on livelihoods.
arm group label: Stepping Stones and Creating Futures
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: South Africa
citation: Gibbs A, Willan S, Jama-Shai N, Washington L, Jewkes R. 'Eh! I felt I was sabotaged!': facilitators' understandings of success in a participatory HIV and IPV prevention intervention in urban South Africa. Health Educ Res. 2015 Dec;30(6):985-95. doi: 10.1093/her/cyv059.
PMID: 26590246
citation: Jewkes R, Gibbs A, Jama-Shai N, Willan S, Misselhorn A, Mushinga M, Washington L, Mbatha N, Skiweyiya Y. Stepping Stones and Creating Futures intervention: shortened interrupted time series evaluation of a behavioural and structural health promotion and violence prevention intervention for young people in informal settlements in Durban, South Africa. BMC Public Health. 2014 Dec 29;14:1325. doi: 10.1186/1471-2458-14-1325.
PMID: 25544716
responsible party type: Sponsor