<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/NCT03022370</url>
  </required_header>
  <id_info>
    <org_study_id>BFC043/15</org_study_id>
    <nct_id>NCT03022370</nct_id>
  </id_info>
  <brief_title>Stepping Stones and Creating Futures Intervention Trial</brief_title>
  <official_title>Stepping Stones and Creating Futures Intervention Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of KwaZulu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>London School of Hygiene and Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department for International Development, United Kingdom</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates whether the behavioural/structural interventions of Stepping Stones and&#xD;
      Creating Futures can reduce the incidence of intimate partner violence in urban informal&#xD;
      settlements amongst young people. Half the participants will receive the interventions, while&#xD;
      the other half will be in a control wait-list, only receiving the intervention after final&#xD;
      data collection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">October 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Any Past Year Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)</measure>
    <time_frame>24 months post baseline</time_frame>
    <description>Physical intimate partner violence is assessed using five items based on the WHO VAW scale. A positive response to any item leads to a person being classified as perpetrating (men) and experiencing (women) in the past year. With 0=none, 1=yes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Any Past Year Sexual Intimate Partner Violence Perpetration (Men) and Experience (Women)</measure>
    <time_frame>24 months post baseline</time_frame>
    <description>Sexual intimate partner violence is assessed using three items based on the WHO VAW scale. A positive response to any item leads to a person being classified as perpetrating (men) and experiencing (women) in the past year. With 0=none, 1=yes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Past Year Severe Sexual and/or Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)</measure>
    <time_frame>24 months post baseline</time_frame>
    <description>Severe sexual and/or physical intimate partner violence perpetration (men) and experience (women) is assessed using 8 items. Past year severe sexual and/or physical IPV is assessed as positive if a person responds to two (or more) items as once, or one item as few (or more), essentially creating a more than once categorization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Controlling Behaviours</measure>
    <time_frame>24 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. A mean score is calculated with higher scores indicating more controlling (bad). Range: 0-24</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Earnings in Past Month</measure>
    <time_frame>24 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, with no upper limit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gender Attitudes</measure>
    <time_frame>24 months post baseline</time_frame>
    <description>Modified gender equitable men's scale (GEMS) assess participant's gender attitudes. A mean score is calculated with higher scores indicative of more gender inequitable attitudes (range: 0-60)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive Symptomology</measure>
    <time_frame>24 months post baseline</time_frame>
    <description>Past week depressive symptomology is assessed by the Centre for Epidemiological Studies Depression (CESD) scale, with the full twenty items (range 0-60). A mean score is calculated, with higher scores indicating more depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Suicidal Ideation</measure>
    <time_frame>24 months post baseline</time_frame>
    <description>Past four week suicidal ideation was assessed using a single item question. Responses are either 0=no, or 1=yes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life Circumstances</measure>
    <time_frame>24 months post baseline</time_frame>
    <description>Four items modified from the Satisfaction with Life Scale (SWLS) by Denier et al. (1985), with items on a five point Likert Scale (range 0-20) higher scores indicative of greater life satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Problem Alcohol Use</measure>
    <time_frame>24 months post baseline</time_frame>
    <description>Problem drinking in the past year is assessed using the AUDIT (alcohol use disorders identification test) scale. With a range of 0-40, and recoded with scores of 8 or more classifing a participant as having potentially problematic alcohol use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of People Quarreling With Partner About Alcohol Use</measure>
    <time_frame>24 months post baseline</time_frame>
    <description>A single item binary response question asks whether participants have argued about alcohol with their sexual partner in the past year (0=no; 1=yes). Only asked to those who reported alcohol use in the past year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Last Sexual Partner of Participant is the Main Partner</measure>
    <time_frame>24 months post baseline</time_frame>
    <description>A single item assess who the participant last had sex with, with possible responses being: &quot;main partner&quot;, &quot;casual partner&quot;, &quot;once-off sex partner&quot; or &quot;ex-partner&quot;. As per the protocol, we recategorised this into either &quot;1=main partner&quot; or &quot;0=other&quot;. Positive change is towards main partner. And the reported number (proportion) is those reporting Main partner.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transactional Sex Past Year</measure>
    <time_frame>24 months post baseline</time_frame>
    <description>Five item scale asks about transactional sex with casual or once-off sexual partners in the past year based on the scale developed and tested by Dunkle et al (2004). Each item has a no/yes response. A response of yes to any is classified as having engaged in transactional sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shame About Lack of Work</measure>
    <time_frame>24 months post baseline</time_frame>
    <description>Four items assess participants' feelings of shame about not enough work, based on a scale developed for use in the IMAGES study, with . Mean score calculated, with higher scores indicative of more shame (range: 4-16)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress About Lack of Work</measure>
    <time_frame>24 months post baseline</time_frame>
    <description>Four items assess participants' feelings of stress about not enough work, based on a scale developed for the IMAGES study. Mean score calculated, with higher scores indicating more stress (range: 4-20)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Individual's Ability to Mobilise Money in an Emergency</measure>
    <time_frame>24 months post baseline</time_frame>
    <description>A single item asks participants how hard it would be to mobilise R200 (~US$15) in an emergency. Those responding it would be &quot;very difficult, or somewhat difficult&quot; are classified as finding it hard (=1). Those responding &quot;fairly easy or easy&quot; are classified as not finding it hard (=0). Reported number (proportion) is of those finding it hard to mobilise money in an emergency. A positive change is towards a lower proportion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stolen Because of Hunger in Past Month</measure>
    <time_frame>24 months post baseline</time_frame>
    <description>Single item question asks about stealing because of lack of food or money in the past month with responses &quot;never&quot;, &quot;once&quot;, &quot;every week&quot; or &quot;every day&quot;. Responses are recoded, as per protocol, into &quot;0=never&quot; and &quot;1=once or more&quot;. The number/proportion of those stealing in the past month is reported. A lower proportion is a positive change.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1351</enrollment>
  <condition>IPV</condition>
  <condition>Sexual Violence</condition>
  <arm_group>
    <arm_group_label>Stepping Stones and Creating Futures</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive the Stepping Stones and Creating Futures intervention, comprising of 21 participatory/inter-active sessions, delivered by a trained facilitators. Each session last approximately 3 hours. Sessions are delivered twice a week. Sessions are primarily single sex, with 20 participants per group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants receive no intervention until after final data collection occurs, at which point they will be offered Stepping Stones and Creating Futures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stepping Stones and Creating Futures</intervention_name>
    <description>Stepping Stones consists of 10 sessions. It seeks to strengthen relationships and to transform views on gender and in the process impact on exposure to, or participation in, gender-based violence and HIV risk. These cover gender and peer influences our actions; sex and love; conception and contraception; STIs and HIV; safer sex and condoms; GBV; motivations for behaviour (including influences of alcohol and poverty); and communication skills.&#xD;
Creating Futures is a facilitated group intervention of eleven sessions. It seeks to strengthen livelihoods. The key sessions include: setting medium term livelihood goals, the need for assets and coping with crises; social resources for livelihoods (trust and community participation); getting and keeping jobs; and savings and spending.</description>
    <arm_group_label>Stepping Stones and Creating Futures</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normally resident in informal settlement cluster&#xD;
&#xD;
          -  Not formally employed&#xD;
&#xD;
          -  Able to communicate in main study languages (English, isiZulu, iXhosa)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18&#xD;
&#xD;
          -  Mental deficit (learning difficulty, mental illness or substance abuse)&#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>
  <overall_official>
    <last_name>Andrew Gibbs, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gender and Health Research Unit, South African Medical Research Council (SAMRC); Health Economics and HIV/AIDS Research Division (HEARD), University of KwaZulu Natal</affiliation>
  </overall_official>
  <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, Washington L, Willan S, Ntini N, Khumalo T, Mbatha N, Sikweyiya Y, Shai N, Chirwa E, Strauss M, Ferrari G, Jewkes R. The Stepping Stones and Creating Futures intervention to prevent intimate partner violence and HIV-risk behaviours in Durban, South Africa: study protocol for a cluster randomized control trial, and baseline characteristics. BMC Public Health. 2017 Apr 20;17(1):336. doi: 10.1186/s12889-017-4223-x.</citation>
    <PMID>28427380</PMID>
  </reference>
  <reference>
    <citation>Gibbs A, Dunkle K, Washington L, Willan S, Shai N, Jewkes R. Childhood traumas as a risk factor for HIV-risk behaviours amongst young women and men living in urban informal settlements in South Africa: A cross-sectional study. PLoS One. 2018 Apr 6;13(4):e0195369. doi: 10.1371/journal.pone.0195369. eCollection 2018.</citation>
    <PMID>29624612</PMID>
  </reference>
  <reference>
    <citation>Gibbs A, Dunkle K, Jewkes R. Emotional and economic intimate partner violence as key drivers of depression and suicidal ideation: A cross-sectional study among young women in informal settlements in South Africa. PLoS One. 2018 Apr 16;13(4):e0194885. doi: 10.1371/journal.pone.0194885. eCollection 2018.</citation>
    <PMID>29659595</PMID>
  </reference>
  <reference>
    <citation>Gibbs A, Washington L, Abdelatif N, Chirwa E, Willan S, Shai N, Sikweyiya Y, Mkhwanazi S, Ntini N, Jewkes R. Stepping Stones and Creating Futures Intervention to Prevent Intimate Partner Violence Among Young People: Cluster Randomized Controlled Trial. J Adolesc Health. 2020 Mar;66(3):323-335. doi: 10.1016/j.jadohealth.2019.10.004. Epub 2019 Nov 26.</citation>
    <PMID>31784410</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <results_first_submitted>March 11, 2020</results_first_submitted>
  <results_first_submitted_qc>May 25, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 4, 2020</results_first_posted>
  <last_update_submitted>May 25, 2020</last_update_submitted>
  <last_update_submitted_qc>May 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical Research Council, South Africa</investigator_affiliation>
    <investigator_full_name>Andrew Gibbs</investigator_full_name>
    <investigator_title>Principal Investigator, Senior Specialist Scientist</investigator_title>
  </responsible_party>
  <keyword>informal settlements</keyword>
  <keyword>poverty</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT03022370/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT03022370/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 7, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT03022370/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Stepping Stones and Creating Futures</title>
          <description>Participants receive the Stepping Stones and Creating Futures intervention, comprising of 21 participatory/inter-active sessions, delivered by a trained facilitators. Each session last approximately 3 hours. Sessions are delivered twice a week. Sessions are primarily single sex, with 20 participants per group.</description>
        </group>
        <group group_id="P2">
          <title>Wait-list Control</title>
          <description>Participants receive no intervention until after final data collection occurs, at which point they will be offered Stepping Stones and Creating Futures.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="677"/>
                <participants group_id="P2" count="674"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="497"/>
                <participants group_id="P2" count="553"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="180"/>
                <participants group_id="P2" count="121"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="174"/>
                <participants group_id="P2" count="109"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Women - Intervention</title>
          <description>Women who received the Stepping Stones and Creating Futures intervention</description>
        </group>
        <group group_id="B2">
          <title>Men - Intervention</title>
          <description>Men who received the intervention</description>
        </group>
        <group group_id="B3">
          <title>Women - Control</title>
          <description>Women in the wait list control</description>
        </group>
        <group group_id="B4">
          <title>Men - Control</title>
          <description>Men in the wait list control</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="339"/>
            <count group_id="B2" value="338"/>
            <count group_id="B3" value="338"/>
            <count group_id="B4" value="336"/>
            <count group_id="B5" value="1351"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="339"/>
                    <count group_id="B2" value="338"/>
                    <count group_id="B3" value="338"/>
                    <count group_id="B4" value="336"/>
                    <count group_id="B5" value="1351"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="339"/>
                    <measurement group_id="B2" value="338"/>
                    <measurement group_id="B3" value="338"/>
                    <measurement group_id="B4" value="336"/>
                    <measurement group_id="B5" value="1351"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" 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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="339"/>
                    <count group_id="B2" value="338"/>
                    <count group_id="B3" value="338"/>
                    <count group_id="B4" value="336"/>
                    <count group_id="B5" value="1351"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="339"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="338"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="677"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="338"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="336"/>
                    <measurement group_id="B5" value="674"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>South Africa</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="339"/>
                    <count group_id="B2" value="338"/>
                    <count group_id="B3" value="338"/>
                    <count group_id="B4" value="336"/>
                    <count group_id="B5" value="1351"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="339"/>
                    <measurement group_id="B2" value="338"/>
                    <measurement group_id="B3" value="338"/>
                    <measurement group_id="B4" value="336"/>
                    <measurement group_id="B5" value="1351"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Any Past Year Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)</title>
        <description>Physical intimate partner violence is assessed using five items based on the WHO VAW scale. A positive response to any item leads to a person being classified as perpetrating (men) and experiencing (women) in the past year. With 0=none, 1=yes.</description>
        <time_frame>24 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women - Intervention</title>
            <description>Women who received the Stepping Stones and Creating Futures intervention</description>
          </group>
          <group group_id="O2">
            <title>Men - Intervention</title>
            <description>Men who received the intervention</description>
          </group>
          <group group_id="O3">
            <title>Women - Control</title>
            <description>Women in the wait list control</description>
          </group>
          <group group_id="O4">
            <title>Men - Control</title>
            <description>Men in the wait list control</description>
          </group>
        </group_list>
        <measure>
          <title>Any Past Year Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)</title>
          <description>Physical intimate partner violence is assessed using five items based on the WHO VAW scale. A positive response to any item leads to a person being classified as perpetrating (men) and experiencing (women) in the past year. With 0=none, 1=yes.</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="260"/>
                <count group_id="O2" value="237"/>
                <count group_id="O3" value="285"/>
                <count group_id="O4" value="268"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134"/>
                    <measurement group_id="O2" value="86"/>
                    <measurement group_id="O3" value="155"/>
                    <measurement group_id="O4" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.686</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>1.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.032</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.51</ci_lower_limit>
            <ci_upper_limit>0.97</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Any Past Year Sexual Intimate Partner Violence Perpetration (Men) and Experience (Women)</title>
        <description>Sexual intimate partner violence is assessed using three items based on the WHO VAW scale. A positive response to any item leads to a person being classified as perpetrating (men) and experiencing (women) in the past year. With 0=none, 1=yes.</description>
        <time_frame>24 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women - Intervention</title>
            <description>Women who received the Stepping Stones and Creating Futures intervention</description>
          </group>
          <group group_id="O2">
            <title>Men - Intervention</title>
            <description>Men who received the intervention</description>
          </group>
          <group group_id="O3">
            <title>Women - Control</title>
            <description>Women in the wait list control</description>
          </group>
          <group group_id="O4">
            <title>Men - Control</title>
            <description>Men in the wait list control</description>
          </group>
        </group_list>
        <measure>
          <title>Any Past Year Sexual Intimate Partner Violence Perpetration (Men) and Experience (Women)</title>
          <description>Sexual intimate partner violence is assessed using three items based on the WHO VAW scale. A positive response to any item leads to a person being classified as perpetrating (men) and experiencing (women) in the past year. With 0=none, 1=yes.</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="260"/>
                <count group_id="O2" value="237"/>
                <count group_id="O3" value="285"/>
                <count group_id="O4" value="268"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                    <measurement group_id="O2" value="52"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.555</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>1.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.072</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.54</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Past Year Severe Sexual and/or Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)</title>
        <description>Severe sexual and/or physical intimate partner violence perpetration (men) and experience (women) is assessed using 8 items. Past year severe sexual and/or physical IPV is assessed as positive if a person responds to two (or more) items as once, or one item as few (or more), essentially creating a more than once categorization.</description>
        <time_frame>24 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women - Intervention</title>
            <description>Women who received the Stepping Stones and Creating Futures intervention</description>
          </group>
          <group group_id="O2">
            <title>Men - Intervention</title>
            <description>Men who received the intervention</description>
          </group>
          <group group_id="O3">
            <title>Women - Control</title>
            <description>Women in the wait list control</description>
          </group>
          <group group_id="O4">
            <title>Men - Control</title>
            <description>Men in the wait list control</description>
          </group>
        </group_list>
        <measure>
          <title>Past Year Severe Sexual and/or Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)</title>
          <description>Severe sexual and/or physical intimate partner violence perpetration (men) and experience (women) is assessed using 8 items. Past year severe sexual and/or physical IPV is assessed as positive if a person responds to two (or more) items as once, or one item as few (or more), essentially creating a more than once categorization.</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="260"/>
                <count group_id="O2" value="237"/>
                <count group_id="O3" value="285"/>
                <count group_id="O4" value="268"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151"/>
                    <measurement group_id="O2" value="99"/>
                    <measurement group_id="O3" value="171"/>
                    <measurement group_id="O4" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.672</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>1.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.019</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.52</ci_lower_limit>
            <ci_upper_limit>0.94</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Controlling Behaviours</title>
        <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. A mean score is calculated with higher scores indicating more controlling (bad). Range: 0-24</description>
        <time_frame>24 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women - Intervention</title>
            <description>Women who received the Stepping Stones and Creating Futures intervention</description>
          </group>
          <group group_id="O2">
            <title>Men - Intervention</title>
            <description>Men who received the intervention</description>
          </group>
          <group group_id="O3">
            <title>Women - Control</title>
            <description>Women in the wait list control</description>
          </group>
          <group group_id="O4">
            <title>Men - Control</title>
            <description>Men in the wait list control</description>
          </group>
        </group_list>
        <measure>
          <title>Controlling Behaviours</title>
          <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. A mean score is calculated with higher scores indicating more controlling (bad). Range: 0-24</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="260"/>
                <count group_id="O2" value="237"/>
                <count group_id="O3" value="285"/>
                <count group_id="O4" value="268"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.75" lower_limit="9.17" upper_limit="10.32"/>
                    <measurement group_id="O2" value="9.96" lower_limit="9.36" upper_limit="10.56"/>
                    <measurement group_id="O3" value="9.70" lower_limit="9.12" upper_limit="10.22"/>
                    <measurement group_id="O4" value="9.96" lower_limit="9.44" upper_limit="10.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.984</p_value>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>-0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.88</ci_lower_limit>
            <ci_upper_limit>0.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.839</p_value>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>0.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.51</ci_lower_limit>
            <ci_upper_limit>0.63</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Earnings in Past Month</title>
        <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, with no upper limit.</description>
        <time_frame>24 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women - Intervention</title>
            <description>Women who received the Stepping Stones and Creating Futures intervention</description>
          </group>
          <group group_id="O2">
            <title>Men - Intervention</title>
            <description>Men who received the intervention</description>
          </group>
          <group group_id="O3">
            <title>Women - Control</title>
            <description>Women in the wait list control</description>
          </group>
          <group group_id="O4">
            <title>Men - Control</title>
            <description>Men in the wait list control</description>
          </group>
        </group_list>
        <measure>
          <title>Earnings in Past Month</title>
          <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, with no upper limit.</description>
          <units>Rands</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="260"/>
                <count group_id="O2" value="237"/>
                <count group_id="O3" value="285"/>
                <count group_id="O4" value="268"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="565" lower_limit="443" upper_limit="688"/>
                    <measurement group_id="O2" value="988" lower_limit="798" upper_limit="1177"/>
                    <measurement group_id="O3" value="385" lower_limit="268" upper_limit="503"/>
                    <measurement group_id="O4" value="817" lower_limit="594" upper_limit="1038"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Tobit</method>
            <method_desc>Log + 1 performed on data</method_desc>
            <param_type>Slope</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.43</ci_lower_limit>
            <ci_upper_limit>1.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.521</p_value>
            <method>Tobit</method>
            <method_desc>Log plus 1 to transform data</method_desc>
            <param_type>Slope</param_type>
            <param_value>0.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.42</ci_lower_limit>
            <ci_upper_limit>0.83</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Gender Attitudes</title>
        <description>Modified gender equitable men's scale (GEMS) assess participant's gender attitudes. A mean score is calculated with higher scores indicative of more gender inequitable attitudes (range: 0-60)</description>
        <time_frame>24 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women - Intervention</title>
            <description>Women who received the Stepping Stones and Creating Futures intervention</description>
          </group>
          <group group_id="O2">
            <title>Men - Intervention</title>
            <description>Men who received the intervention</description>
          </group>
          <group group_id="O3">
            <title>Women - Control</title>
            <description>Women in the wait list control</description>
          </group>
          <group group_id="O4">
            <title>Men - Control</title>
            <description>Men in the wait list control</description>
          </group>
        </group_list>
        <measure>
          <title>Gender Attitudes</title>
          <description>Modified gender equitable men's scale (GEMS) assess participant's gender attitudes. A mean score is calculated with higher scores indicative of more gender inequitable attitudes (range: 0-60)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="260"/>
                <count group_id="O2" value="237"/>
                <count group_id="O3" value="285"/>
                <count group_id="O4" value="268"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.98" lower_limit="20.78" upper_limit="23.18"/>
                    <measurement group_id="O2" value="24.99" lower_limit="23.58" upper_limit="26.39"/>
                    <measurement group_id="O3" value="21.65" lower_limit="20.74" upper_limit="22.72"/>
                    <measurement group_id="O4" value="25.15" lower_limit="23.93" upper_limit="26.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.718</p_value>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>0.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.09</ci_lower_limit>
            <ci_upper_limit>1.58</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.712</p_value>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>-0.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.87</ci_lower_limit>
            <ci_upper_limit>1.28</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depressive Symptomology</title>
        <description>Past week depressive symptomology is assessed by the Centre for Epidemiological Studies Depression (CESD) scale, with the full twenty items (range 0-60). A mean score is calculated, with higher scores indicating more depression.</description>
        <time_frame>24 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women - Intervention</title>
            <description>Women who received the Stepping Stones and Creating Futures intervention</description>
          </group>
          <group group_id="O2">
            <title>Men - Intervention</title>
            <description>Men who received the intervention</description>
          </group>
          <group group_id="O3">
            <title>Women - Control</title>
            <description>Women in the wait list control</description>
          </group>
          <group group_id="O4">
            <title>Men - Control</title>
            <description>Men in the wait list control</description>
          </group>
        </group_list>
        <measure>
          <title>Depressive Symptomology</title>
          <description>Past week depressive symptomology is assessed by the Centre for Epidemiological Studies Depression (CESD) scale, with the full twenty items (range 0-60). A mean score is calculated, with higher scores indicating more depression.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="260"/>
                <count group_id="O2" value="237"/>
                <count group_id="O3" value="285"/>
                <count group_id="O4" value="268"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.95" lower_limit="20.70" upper_limit="23.20"/>
                    <measurement group_id="O2" value="19.26" lower_limit="18.06" upper_limit="20.47"/>
                    <measurement group_id="O3" value="23.11" lower_limit="21.86" upper_limit="24.36"/>
                    <measurement group_id="O4" value="20.35" lower_limit="19.26" upper_limit="20.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.067</p_value>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>-1.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.14</ci_lower_limit>
            <ci_upper_limit>0.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.398</p_value>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>-0.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.48</ci_lower_limit>
            <ci_upper_limit>0.99</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Suicidal Ideation</title>
        <description>Past four week suicidal ideation was assessed using a single item question. Responses are either 0=no, or 1=yes.</description>
        <time_frame>24 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women - Intervention</title>
            <description>Women who received the Stepping Stones and Creating Futures intervention</description>
          </group>
          <group group_id="O2">
            <title>Men - Intervention</title>
            <description>Men who received the intervention</description>
          </group>
          <group group_id="O3">
            <title>Women - Control</title>
            <description>Women in the wait list control</description>
          </group>
          <group group_id="O4">
            <title>Men - Control</title>
            <description>Men in the wait list control</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Suicidal Ideation</title>
          <description>Past four week suicidal ideation was assessed using a single item question. Responses are either 0=no, or 1=yes.</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="260"/>
                <count group_id="O2" value="237"/>
                <count group_id="O3" value="285"/>
                <count group_id="O4" value="268"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="49"/>
                    <measurement group_id="O3" value="72"/>
                    <measurement group_id="O4" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.228</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>1.97</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.558</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>1.41</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Life Circumstances</title>
        <description>Four items modified from the Satisfaction with Life Scale (SWLS) by Denier et al. (1985), with items on a five point Likert Scale (range 0-20) higher scores indicative of greater life satisfaction.</description>
        <time_frame>24 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women - Intervention</title>
            <description>Women who received the Stepping Stones and Creating Futures intervention</description>
          </group>
          <group group_id="O2">
            <title>Men - Intervention</title>
            <description>Men who received the intervention</description>
          </group>
          <group group_id="O3">
            <title>Women - Control</title>
            <description>Women in the wait list control</description>
          </group>
          <group group_id="O4">
            <title>Men - Control</title>
            <description>Men in the wait list control</description>
          </group>
        </group_list>
        <measure>
          <title>Life Circumstances</title>
          <description>Four items modified from the Satisfaction with Life Scale (SWLS) by Denier et al. (1985), with items on a five point Likert Scale (range 0-20) higher scores indicative of greater life satisfaction.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="260"/>
                <count group_id="O2" value="237"/>
                <count group_id="O3" value="285"/>
                <count group_id="O4" value="268"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.28" lower_limit="9.82" upper_limit="10.75"/>
                    <measurement group_id="O2" value="10.59" lower_limit="10.13" upper_limit="11.06"/>
                    <measurement group_id="O3" value="9.88" lower_limit="9.47" upper_limit="10.29"/>
                    <measurement group_id="O4" value="10.03" lower_limit="9.62" upper_limit="10.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.679</p_value>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.52</ci_lower_limit>
            <ci_upper_limit>0.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.08</p_value>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>0.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.07</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Problem Alcohol Use</title>
        <description>Problem drinking in the past year is assessed using the AUDIT (alcohol use disorders identification test) scale. With a range of 0-40, and recoded with scores of 8 or more classifing a participant as having potentially problematic alcohol use.</description>
        <time_frame>24 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women - Intervention</title>
            <description>Women who received the Stepping Stones and Creating Futures intervention</description>
          </group>
          <group group_id="O2">
            <title>Men - Intervention</title>
            <description>Men who received the intervention</description>
          </group>
          <group group_id="O3">
            <title>Women - Control</title>
            <description>Women in the wait list control</description>
          </group>
          <group group_id="O4">
            <title>Men - Control</title>
            <description>Men in the wait list control</description>
          </group>
        </group_list>
        <measure>
          <title>Problem Alcohol Use</title>
          <description>Problem drinking in the past year is assessed using the AUDIT (alcohol use disorders identification test) scale. With a range of 0-40, and recoded with scores of 8 or more classifing a participant as having potentially problematic alcohol use.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="260"/>
                <count group_id="O2" value="237"/>
                <count group_id="O3" value="285"/>
                <count group_id="O4" value="268"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.27" lower_limit="3.49" upper_limit="5.06"/>
                    <measurement group_id="O2" value="6.81" lower_limit="5.86" upper_limit="7.75"/>
                    <measurement group_id="O3" value="4.62" lower_limit="3.80" upper_limit="5.45"/>
                    <measurement group_id="O4" value="7.97" lower_limit="6.94" upper_limit="8.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.810</p_value>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>-0.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.21</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.041</p_value>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>-1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.01</ci_lower_limit>
            <ci_upper_limit>-0.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of People Quarreling With Partner About Alcohol Use</title>
        <description>A single item binary response question asks whether participants have argued about alcohol with their sexual partner in the past year (0=no; 1=yes). Only asked to those who reported alcohol use in the past year.</description>
        <time_frame>24 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women - Intervention</title>
            <description>Women who received the Stepping Stones and Creating Futures intervention</description>
          </group>
          <group group_id="O2">
            <title>Men - Intervention</title>
            <description>Men who received the intervention</description>
          </group>
          <group group_id="O3">
            <title>Women - Control</title>
            <description>Women in the wait list control</description>
          </group>
          <group group_id="O4">
            <title>Men - Control</title>
            <description>Men in the wait list control</description>
          </group>
        </group_list>
        <measure>
          <title>Number of People Quarreling With Partner About Alcohol Use</title>
          <description>A single item binary response question asks whether participants have argued about alcohol with their sexual partner in the past year (0=no; 1=yes). Only asked to those who reported alcohol use in the past year.</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="129"/>
                <count group_id="O2" value="160"/>
                <count group_id="O3" value="138"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="54"/>
                    <measurement group_id="O3" value="47"/>
                    <measurement group_id="O4" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.635</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>1.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.256</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.41</ci_lower_limit>
            <ci_upper_limit>1.27</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Last Sexual Partner of Participant is the Main Partner</title>
        <description>A single item assess who the participant last had sex with, with possible responses being: &quot;main partner&quot;, &quot;casual partner&quot;, &quot;once-off sex partner&quot; or &quot;ex-partner&quot;. As per the protocol, we recategorised this into either &quot;1=main partner&quot; or &quot;0=other&quot;. Positive change is towards main partner. And the reported number (proportion) is those reporting Main partner.</description>
        <time_frame>24 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women - Intervention</title>
            <description>Women who received the Stepping Stones and Creating Futures intervention</description>
          </group>
          <group group_id="O2">
            <title>Men - Intervention</title>
            <description>Men who received the intervention</description>
          </group>
          <group group_id="O3">
            <title>Women - Control</title>
            <description>Women in the wait list control</description>
          </group>
          <group group_id="O4">
            <title>Men - Control</title>
            <description>Men in the wait list control</description>
          </group>
        </group_list>
        <measure>
          <title>Last Sexual Partner of Participant is the Main Partner</title>
          <description>A single item assess who the participant last had sex with, with possible responses being: &quot;main partner&quot;, &quot;casual partner&quot;, &quot;once-off sex partner&quot; or &quot;ex-partner&quot;. As per the protocol, we recategorised this into either &quot;1=main partner&quot; or &quot;0=other&quot;. Positive change is towards main partner. And the reported number (proportion) is those reporting Main partner.</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="236"/>
                <count group_id="O2" value="220"/>
                <count group_id="O3" value="243"/>
                <count group_id="O4" value="258"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185"/>
                    <measurement group_id="O2" value="138"/>
                    <measurement group_id="O3" value="182"/>
                    <measurement group_id="O4" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.526</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>1.84</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.931</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>1.56</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Transactional Sex Past Year</title>
        <description>Five item scale asks about transactional sex with casual or once-off sexual partners in the past year based on the scale developed and tested by Dunkle et al (2004). Each item has a no/yes response. A response of yes to any is classified as having engaged in transactional sex.</description>
        <time_frame>24 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women - Intervention</title>
            <description>Women who received the Stepping Stones and Creating Futures intervention</description>
          </group>
          <group group_id="O2">
            <title>Men - Intervention</title>
            <description>Men who received the intervention</description>
          </group>
          <group group_id="O3">
            <title>Women - Control</title>
            <description>Women in the wait list control</description>
          </group>
          <group group_id="O4">
            <title>Men - Control</title>
            <description>Men in the wait list control</description>
          </group>
        </group_list>
        <measure>
          <title>Transactional Sex Past Year</title>
          <description>Five item scale asks about transactional sex with casual or once-off sexual partners in the past year based on the scale developed and tested by Dunkle et al (2004). Each item has a no/yes response. A response of yes to any is classified as having engaged in transactional sex.</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="236"/>
                <count group_id="O2" value="220"/>
                <count group_id="O3" value="243"/>
                <count group_id="O4" value="258"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111"/>
                    <measurement group_id="O2" value="138"/>
                    <measurement group_id="O3" value="118"/>
                    <measurement group_id="O4" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.691</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.63</ci_lower_limit>
            <ci_upper_limit>1.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.692</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>1.40</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Shame About Lack of Work</title>
        <description>Four items assess participants' feelings of shame about not enough work, based on a scale developed for use in the IMAGES study, with . Mean score calculated, with higher scores indicative of more shame (range: 4-16)</description>
        <time_frame>24 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women - Intervention</title>
            <description>Women who received the Stepping Stones and Creating Futures intervention</description>
          </group>
          <group group_id="O2">
            <title>Men - Intervention</title>
            <description>Men who received the intervention</description>
          </group>
          <group group_id="O3">
            <title>Women - Control</title>
            <description>Women in the wait list control</description>
          </group>
          <group group_id="O4">
            <title>Men - Control</title>
            <description>Men in the wait list control</description>
          </group>
        </group_list>
        <measure>
          <title>Shame About Lack of Work</title>
          <description>Four items assess participants' feelings of shame about not enough work, based on a scale developed for use in the IMAGES study, with . Mean score calculated, with higher scores indicative of more shame (range: 4-16)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="260"/>
                <count group_id="O2" value="237"/>
                <count group_id="O3" value="285"/>
                <count group_id="O4" value="268"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" lower_limit="9.9" upper_limit="10.6"/>
                    <measurement group_id="O2" value="10.7" lower_limit="10.4" upper_limit="11.1"/>
                    <measurement group_id="O3" value="10.7" lower_limit="10.4" upper_limit="10.9"/>
                    <measurement group_id="O4" value="10.9" lower_limit="10.6" upper_limit="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.137</p_value>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>-0.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.72</ci_lower_limit>
            <ci_upper_limit>0.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.721</p_value>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>-0.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.58</ci_lower_limit>
            <ci_upper_limit>0.40</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stress About Lack of Work</title>
        <description>Four items assess participants' feelings of stress about not enough work, based on a scale developed for the IMAGES study. Mean score calculated, with higher scores indicating more stress (range: 4-20)</description>
        <time_frame>24 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women - Intervention</title>
            <description>Women who received the Stepping Stones and Creating Futures intervention</description>
          </group>
          <group group_id="O2">
            <title>Men - Intervention</title>
            <description>Men who received the intervention</description>
          </group>
          <group group_id="O3">
            <title>Women - Control</title>
            <description>Women in the wait list control</description>
          </group>
          <group group_id="O4">
            <title>Men - Control</title>
            <description>Men in the wait list control</description>
          </group>
        </group_list>
        <measure>
          <title>Stress About Lack of Work</title>
          <description>Four items assess participants' feelings of stress about not enough work, based on a scale developed for the IMAGES study. Mean score calculated, with higher scores indicating more stress (range: 4-20)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="260"/>
                <count group_id="O2" value="237"/>
                <count group_id="O3" value="285"/>
                <count group_id="O4" value="268"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="11.6" upper_limit="12.3"/>
                    <measurement group_id="O2" value="11.8" lower_limit="11.5" upper_limit="12.2"/>
                    <measurement group_id="O3" value="12.1" lower_limit="11.8" upper_limit="12.5"/>
                    <measurement group_id="O4" value="12.0" lower_limit="11.7" upper_limit="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.332</p_value>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>-0.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.70</ci_lower_limit>
            <ci_upper_limit>0.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.468</p_value>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>-0.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.71</ci_lower_limit>
            <ci_upper_limit>0.32</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Individual's Ability to Mobilise Money in an Emergency</title>
        <description>A single item asks participants how hard it would be to mobilise R200 (~US$15) in an emergency. Those responding it would be &quot;very difficult, or somewhat difficult&quot; are classified as finding it hard (=1). Those responding &quot;fairly easy or easy&quot; are classified as not finding it hard (=0). Reported number (proportion) is of those finding it hard to mobilise money in an emergency. A positive change is towards a lower proportion.</description>
        <time_frame>24 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women - Intervention</title>
            <description>Women who received the Stepping Stones and Creating Futures intervention</description>
          </group>
          <group group_id="O2">
            <title>Men - Intervention</title>
            <description>Men who received the intervention</description>
          </group>
          <group group_id="O3">
            <title>Women - Control</title>
            <description>Women in the wait list control</description>
          </group>
          <group group_id="O4">
            <title>Men - Control</title>
            <description>Men in the wait list control</description>
          </group>
        </group_list>
        <measure>
          <title>Individual's Ability to Mobilise Money in an Emergency</title>
          <description>A single item asks participants how hard it would be to mobilise R200 (~US$15) in an emergency. Those responding it would be &quot;very difficult, or somewhat difficult&quot; are classified as finding it hard (=1). Those responding &quot;fairly easy or easy&quot; are classified as not finding it hard (=0). Reported number (proportion) is of those finding it hard to mobilise money in an emergency. A positive change is towards a lower proportion.</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="260"/>
                <count group_id="O2" value="237"/>
                <count group_id="O3" value="285"/>
                <count group_id="O4" value="268"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="37"/>
                    <measurement group_id="O3" value="30"/>
                    <measurement group_id="O4" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.174</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>1.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.129</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>2.50</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stolen Because of Hunger in Past Month</title>
        <description>Single item question asks about stealing because of lack of food or money in the past month with responses &quot;never&quot;, &quot;once&quot;, &quot;every week&quot; or &quot;every day&quot;. Responses are recoded, as per protocol, into &quot;0=never&quot; and &quot;1=once or more&quot;. The number/proportion of those stealing in the past month is reported. A lower proportion is a positive change.</description>
        <time_frame>24 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Women - Intervention</title>
            <description>Women who received the Stepping Stones and Creating Futures intervention</description>
          </group>
          <group group_id="O2">
            <title>Men - Intervention</title>
            <description>Men who received the intervention</description>
          </group>
          <group group_id="O3">
            <title>Women - Control</title>
            <description>Women in the wait list control</description>
          </group>
          <group group_id="O4">
            <title>Men - Control</title>
            <description>Men in the wait list control</description>
          </group>
        </group_list>
        <measure>
          <title>Stolen Because of Hunger in Past Month</title>
          <description>Single item question asks about stealing because of lack of food or money in the past month with responses &quot;never&quot;, &quot;once&quot;, &quot;every week&quot; or &quot;every day&quot;. Responses are recoded, as per protocol, into &quot;0=never&quot; and &quot;1=once or more&quot;. The number/proportion of those stealing in the past month is reported. A lower proportion is a positive change.</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="260"/>
                <count group_id="O2" value="237"/>
                <count group_id="O3" value="285"/>
                <count group_id="O4" value="268"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                    <measurement group_id="O2" value="91"/>
                    <measurement group_id="O3" value="84"/>
                    <measurement group_id="O4" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.174</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>1.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.836</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>1.43</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 months of follow up</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Women - Intervention</title>
          <description>Women who received the Stepping Stones and Creating Futures intervention</description>
        </group>
        <group group_id="E2">
          <title>Men - Intervention</title>
          <description>Men who received the intervention</description>
        </group>
        <group group_id="E3">
          <title>Women - Control</title>
          <description>Women in the wait list control</description>
        </group>
        <group group_id="E4">
          <title>Men - Control</title>
          <description>Men in the wait list control</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="339"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="338"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="338"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="336"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="339"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="338"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="338"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="336"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Violence experience</sub_title>
                <description>Participants experienced violence other men</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="339"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="338"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="338"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="336"/>
              </event>
              <event>
                <sub_title>Hospitalisation</sub_title>
                <description>We did not collect detailed information on causes of hospitalisation</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="339"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="338"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="338"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="336"/>
              </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="339"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="338"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="338"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="336"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr Andrew Gibbs</name_or_title>
      <organization>SAMRC</organization>
      <phone>+27(0)312034899</phone>
      <email>andrew.gibbs@mrc.ac.za</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/NCT03022370
org study id: BFC043/15
nct id: NCT03022370
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This study evaluates whether the behavioural/structural interventions of Stepping Stones and
      Creating Futures can reduce the incidence of intimate partner violence in urban informal
      settlements amongst young people. Half the participants will receive the interventions, while
      the other half will be in a control wait-list, only receiving the intervention after final
      data collection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Any Past Year Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)
time frame: 24 months post baseline
description: Physical intimate partner violence is assessed using five items based on the WHO VAW scale. A positive response to any item leads to a person being classified as perpetrating (men) and experiencing (women) in the past year. With 0=none, 1=yes.
measure: Any Past Year Sexual Intimate Partner Violence Perpetration (Men) and Experience (Women)
time frame: 24 months post baseline
description: Sexual intimate partner violence is assessed using three items based on the WHO VAW scale. A positive response to any item leads to a person being classified as perpetrating (men) and experiencing (women) in the past year. With 0=none, 1=yes.
measure: Past Year Severe Sexual and/or Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)
time frame: 24 months post baseline
description: Severe sexual and/or physical intimate partner violence perpetration (men) and experience (women) is assessed using 8 items. Past year severe sexual and/or physical IPV is assessed as positive if a person responds to two (or more) items as once, or one item as few (or more), essentially creating a more than once categorization.
measure: Controlling Behaviours
time frame: 24 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. A mean score is calculated with higher scores indicating more controlling (bad). Range: 0-24
measure: Earnings in Past Month
time frame: 24 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, with no upper limit.
measure: Gender Attitudes
time frame: 24 months post baseline
description: Modified gender equitable men's scale (GEMS) assess participant's gender attitudes. A mean score is calculated with higher scores indicative of more gender inequitable attitudes (range: 0-60)
measure: Depressive Symptomology
time frame: 24 months post baseline
description: Past week depressive symptomology is assessed by the Centre for Epidemiological Studies Depression (CESD) scale, with the full twenty items (range 0-60). A mean score is calculated, with higher scores indicating more depression.
measure: Number of Participants Reporting Suicidal Ideation
time frame: 24 months post baseline
description: Past four week suicidal ideation was assessed using a single item question. Responses are either 0=no, or 1=yes.
measure: Life Circumstances
time frame: 24 months post baseline
description: Four items modified from the Satisfaction with Life Scale (SWLS) by Denier et al. (1985), with items on a five point Likert Scale (range 0-20) higher scores indicative of greater life satisfaction.
measure: Problem Alcohol Use
time frame: 24 months post baseline
description: Problem drinking in the past year is assessed using the AUDIT (alcohol use disorders identification test) scale. With a range of 0-40, and recoded with scores of 8 or more classifing a participant as having potentially problematic alcohol use.
measure: Number of People Quarreling With Partner About Alcohol Use
time frame: 24 months post baseline
description: A single item binary response question asks whether participants have argued about alcohol with their sexual partner in the past year (0=no; 1=yes). Only asked to those who reported alcohol use in the past year.
measure: Last Sexual Partner of Participant is the Main Partner
time frame: 24 months post baseline
description: A single item assess who the participant last had sex with, with possible responses being: "main partner", "casual partner", "once-off sex partner" or "ex-partner". As per the protocol, we recategorised this into either "1=main partner" or "0=other". Positive change is towards main partner. And the reported number (proportion) is those reporting Main partner.
measure: Transactional Sex Past Year
time frame: 24 months post baseline
description: Five item scale asks about transactional sex with casual or once-off sexual partners in the past year based on the scale developed and tested by Dunkle et al (2004). Each item has a no/yes response. A response of yes to any is classified as having engaged in transactional sex.
measure: Shame About Lack of Work
time frame: 24 months post baseline
description: Four items assess participants' feelings of shame about not enough work, based on a scale developed for use in the IMAGES study, with . Mean score calculated, with higher scores indicative of more shame (range: 4-16)
measure: Stress About Lack of Work
time frame: 24 months post baseline
description: Four items assess participants' feelings of stress about not enough work, based on a scale developed for the IMAGES study. Mean score calculated, with higher scores indicating more stress (range: 4-20)
measure: Individual's Ability to Mobilise Money in an Emergency
time frame: 24 months post baseline
description: A single item asks participants how hard it would be to mobilise R200 (~US$15) in an emergency. Those responding it would be "very difficult, or somewhat difficult" are classified as finding it hard (=1). Those responding "fairly easy or easy" are classified as not finding it hard (=0). Reported number (proportion) is of those finding it hard to mobilise money in an emergency. A positive change is towards a lower proportion.
measure: Stolen Because of Hunger in Past Month
time frame: 24 months post baseline
description: Single item question asks about stealing because of lack of food or money in the past month with responses "never", "once", "every week" or "every day". Responses are recoded, as per protocol, into "0=never" and "1=once or more". The number/proportion of those stealing in the past month is reported. A lower proportion is a positive change.
arm group label: Stepping Stones and Creating Futures
arm group type: Experimental
description: Participants receive the Stepping Stones and Creating Futures intervention, comprising of 21 participatory/inter-active sessions, delivered by a trained facilitators. Each session last approximately 3 hours. Sessions are delivered twice a week. Sessions are primarily single sex, with 20 participants per group.
arm group label: Wait-list control
arm group type: No Intervention
description: Participants receive no intervention until after final data collection occurs, at which point they will be offered Stepping Stones and Creating Futures.
intervention type: Behavioral
intervention name: Stepping Stones and Creating Futures
description: Stepping Stones consists of 10 sessions. It seeks to strengthen relationships and to transform views on gender and in the process impact on exposure to, or participation in, gender-based violence and HIV risk. These cover gender and peer influences our actions; sex and love; conception and contraception; STIs and HIV; safer sex and condoms; GBV; motivations for behaviour (including influences of alcohol and poverty); and communication skills.
Creating Futures is a facilitated group intervention of eleven sessions. It seeks to strengthen livelihoods. The key sessions include: setting medium term livelihood goals, the need for assets and coping with crises; social resources for livelihoods (trust and community participation); getting and keeping jobs; and savings and spending.
arm group label: Stepping Stones and Creating Futures
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew Gibbs, PhD
role: Principal Investigator
affiliation: Gender and Health Research Unit, South African Medical Research Council (SAMRC); Health Economics and HIV/AIDS Research Division (HEARD), University of KwaZulu Natal
facility: 
country: South Africa
citation: Gibbs A, Washington L, Willan S, Ntini N, Khumalo T, Mbatha N, Sikweyiya Y, Shai N, Chirwa E, Strauss M, Ferrari G, Jewkes R. The Stepping Stones and Creating Futures intervention to prevent intimate partner violence and HIV-risk behaviours in Durban, South Africa: study protocol for a cluster randomized control trial, and baseline characteristics. BMC Public Health. 2017 Apr 20;17(1):336. doi: 10.1186/s12889-017-4223-x.
PMID: 28427380
citation: Gibbs A, Dunkle K, Washington L, Willan S, Shai N, Jewkes R. Childhood traumas as a risk factor for HIV-risk behaviours amongst young women and men living in urban informal settlements in South Africa: A cross-sectional study. PLoS One. 2018 Apr 6;13(4):e0195369. doi: 10.1371/journal.pone.0195369. eCollection 2018.
PMID: 29624612
citation: Gibbs A, Dunkle K, Jewkes R. Emotional and economic intimate partner violence as key drivers of depression and suicidal ideation: A cross-sectional study among young women in informal settlements in South Africa. PLoS One. 2018 Apr 16;13(4):e0194885. doi: 10.1371/journal.pone.0194885. eCollection 2018.
PMID: 29659595
citation: Gibbs A, Washington L, Abdelatif N, Chirwa E, Willan S, Shai N, Sikweyiya Y, Mkhwanazi S, Ntini N, Jewkes R. Stepping Stones and Creating Futures Intervention to Prevent Intimate Partner Violence Among Young People: Cluster Randomized Controlled Trial. J Adolesc Health. 2020 Mar;66(3):323-335. doi: 10.1016/j.jadohealth.2019.10.004. Epub 2019 Nov 26.
PMID: 31784410
responsible party type: Principal Investigator
investigator affiliation: Medical Research Council, South Africa
investigator full name: Andrew Gibbs
investigator title: Principal Investigator, Senior Specialist Scientist
sharing ipd: No
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