<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/NCT03255941</url>
  </required_header>
  <id_info>
    <org_study_id>4798-CHS-ERC-17</org_study_id>
    <nct_id>NCT03255941</nct_id>
  </id_info>
  <brief_title>Clinical Study of Depo Provera Comparing Lay Health Workers and Clinically-trained Health Workers</brief_title>
  <official_title>'A Randomized Controlled Trial of Safety and Effectiveness of Depo Provera Intramuscular and Subcutaneous Administration Comparing Lay Lady Health Workers With Clinically-trained Family Welfare Workers in Pakistan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>FHI 360</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jhpiego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>United States Agency for International Development (USAID)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Population Welfare Department, Government of Sindh, Pakistan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>FHI 360</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized controlled trial comparing lay Lady Health Workers (Lay Health Workers)&#xD;
      with Family Welfare Workers (Clinically- trained Health Workers) on quantitative measures of&#xD;
      safety and effectiveness of Depo Provera and Sayana Press provision in a clinic setting. This&#xD;
      comparative trial will test the non-inferiority hypothesis that Lady Health Workers are just&#xD;
      as competent as clinically-trained Family Welfare Workers in screening and counseling&#xD;
      first-time injectable users. These first time users will also be randomly assigned to receive&#xD;
      intramuscular or subcutaneous injections of DMPA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      FHI 360 and Jhpiego in collaboration with USAID, Aga Khan University (AKU) and the Government&#xD;
      of Sindh province propose a randomized controlled trial (RCT) to provide evidence that could&#xD;
      change current policies in Pakistan that forbid initiation of DMPA by Lady Health Workers&#xD;
      (LHWs). Positive findings on the safety and effectiveness of LHW-initiation of DMPA may also&#xD;
      prompt the WHO to consider modifying the recommendation for targeted M&amp;E for lay health&#xD;
      worker provision of intramuscular injectable contraceptives. The trial will compare the&#xD;
      screening and counseling of (LHWs)-the main lay health worker cadre--with that of Family&#xD;
      Welfare Workers (FWWs) who are clinically-trained. The Government of Sindh province also&#xD;
      expressed interest in introducing Pfizer's subcutaneous form of Depo Provera, Sayana Press®&#xD;
      (SP) in Pakistan, which could simplify administration of injectable contraceptives. As such,&#xD;
      an SP arm will be included in the trial, which will be facilitated by relevant training of&#xD;
      LHWs and FWWs by Jhpiego and stocks provided by a special USAID procurement, since the&#xD;
      registration process for SP in Pakistan is ongoing. A successful RCT demonstrating the&#xD;
      non-inferiority of LHWs vis á vis FWWs on first-dose initiation of Depo Provera IM (DMPA IM)&#xD;
      and (SP) would facilitate efforts to expand CBA2I in Pakistan, and in turn improve access to&#xD;
      family planning services for a potentially large number of underserved women.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 19, 2018</start_date>
  <completion_date type="Actual">July 23, 2018</completion_date>
  <primary_completion_date type="Actual">July 15, 2018</primary_completion_date>
  <phase>Early Phase 1</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>
    <intervention_model_description>Women who are new users of injectable contraception will be randomly assigned to receive services from an LHW or an FWW and will be randomly assigned to receive either intramuscular DMPA or the subcutaneous formulation, Sayana Press.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants That Were Appropriately Screened for Contraceptive Use</measure>
    <time_frame>3 months from randomization</time_frame>
    <description>Number of participants that were appropriately screened for injectable contraceptive use in both rural and urban settings in Pakistan.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants That Were Appropriately Counseled for DMPA Use.</measure>
    <time_frame>3 months from randomization</time_frame>
    <description>Number of participants that were appropriately counseled by both types of providers in both urban and rural settings.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider</measure>
    <time_frame>3 months from randomization</time_frame>
    <description>DMPA clients served by both types of providers in both urban and rural settings will report whether or not they were satisfied with the DMPA method provided to them.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Clients Who Report Satisfaction With Provider Services</measure>
    <time_frame>3 months from randomization</time_frame>
    <description>Clients who received intramuscular or subcutaneous DMPA injections will report whether or not they were satisfied with the services provided to them by their provider.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">460</enrollment>
  <condition>Contraception</condition>
  <arm_group>
    <arm_group_label>Clinic Provider - Urban</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Urban Clinic Provider providing DMPA or Sayana Press</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lay Provider - Urban</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Urban Lay Provider providing DMPA or Sayana Press</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinic Provider- Rural</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rural Clinic Provider providing DMPA or Sayana Press</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lay Provider- Rural</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rural Lay Provider providing DMPA or Sayana Press</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DMPA</intervention_name>
    <description>The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.</description>
    <arm_group_label>Clinic Provider - Urban</arm_group_label>
    <arm_group_label>Clinic Provider- Rural</arm_group_label>
    <arm_group_label>Lay Provider - Urban</arm_group_label>
    <arm_group_label>Lay Provider- Rural</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sayana Press</intervention_name>
    <description>The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press</description>
    <arm_group_label>Clinic Provider - Urban</arm_group_label>
    <arm_group_label>Clinic Provider- Rural</arm_group_label>
    <arm_group_label>Lay Provider - Urban</arm_group_label>
    <arm_group_label>Lay Provider- Rural</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who voluntarily accept DMPA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women unable to provide informed consent&#xD;
&#xD;
          -  Women with contraindications to DMPA&#xD;
&#xD;
          -  Women who are pregnant&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Gender at birth</gender_description>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dawn S Chin-Quee, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>FHI 360</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aga Khan University</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <results_first_submitted>June 27, 2019</results_first_submitted>
  <results_first_submitted_qc>March 18, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 13, 2021</results_first_posted>
  <last_update_submitted>March 18, 2021</last_update_submitted>
  <last_update_submitted_qc>March 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>FWW (Family Welfare Worker)</keyword>
  <keyword>LHW (Lady Health Worker)</keyword>
  <keyword>DMPA (Depot medroxyprogesterone acetate or Depo Provera)</keyword>
  <keyword>DMPA IM (Depo Provera intramuscular injection)</keyword>
  <keyword>SP (Sayana Press subcutaneous injection)</keyword>
  <keyword>Contraception</keyword>
  <keyword>CBA2I (Community-based access to injectables)</keyword>
  <keyword>Sayana (Sayana Press)</keyword>
  <keyword>JHPIEGO (Johns Hopkins Program for International Education in Gynaecology and Obstetrics)</keyword>
  <keyword>Sayana</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 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03255941/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>August 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03255941/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>461 participants were assessed for eligibility and 460 were randomized to a provider.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Clinic Provider - Urban</title>
          <description>Family Welfare Workers that are clinically trained providers in the urban setting of Karachi</description>
        </group>
        <group group_id="P2">
          <title>Lay Provider - Urban</title>
          <description>Lady Health Workers that are not clinically trained in the urban setting of Karachi</description>
        </group>
        <group group_id="P3">
          <title>Clinic Provider - Rural</title>
          <description>Famly Welfare Workers that are clinically trained providers in the rural setting of Thatta</description>
        </group>
        <group group_id="P4">
          <title>Lay Provider - Rural</title>
          <description>Lady Health Workers that are not clinically trained providers in the rural setting of Thatta</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="177"/>
                <participants group_id="P2" count="178"/>
                <participants group_id="P3" count="53"/>
                <participants group_id="P4" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Deemed Eligible to Receive DMPA</title>
              <participants_list>
                <participants group_id="P1" count="140"/>
                <participants group_id="P2" count="134"/>
                <participants group_id="P3" count="48"/>
                <participants group_id="P4" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="139"/>
                <participants group_id="P2" count="132"/>
                <participants group_id="P3" count="48"/>
                <participants group_id="P4" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="46"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Not eligible or refused injection</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="44"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not complete exit interview</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Clinic Provider Urban</title>
          <description>Clinic provider providing DMPA or Sayana Press&#xD;
The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA or Sayana Press.</description>
        </group>
        <group group_id="B2">
          <title>Lay Provider Urban</title>
          <description>Lay Provider providing DMPA or Sayana Press&#xD;
The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA or Sayana Press.</description>
        </group>
        <group group_id="B3">
          <title>Clinic Provider Rural</title>
          <description>Clinic provider providing DMPA or Sayana Press&#xD;
The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA or Sayana Press.</description>
        </group>
        <group group_id="B4">
          <title>Lay Provider Rural</title>
          <description>Clinic provider providing DMPA or Sayana Press&#xD;
The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA or Sayana Press.</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="177"/>
            <count group_id="B2" value="178"/>
            <count group_id="B3" value="53"/>
            <count group_id="B4" value="52"/>
            <count group_id="B5" value="460"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="177"/>
                    <count group_id="B2" value="178"/>
                    <count group_id="B3" value="53"/>
                    <count group_id="B4" value="52"/>
                    <count group_id="B5" value="460"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.0" spread="5.4"/>
                    <measurement group_id="B2" value="27.1" spread="6.0"/>
                    <measurement group_id="B3" value="30.1" spread="30.1"/>
                    <measurement group_id="B4" value="29.7" spread="5.2"/>
                    <measurement group_id="B5" value="28.14" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Only females as participants who accepted intramuscular or subcutaneous DMPA.</description>
          <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="177"/>
                    <count group_id="B2" value="178"/>
                    <count group_id="B3" value="53"/>
                    <count group_id="B4" value="52"/>
                    <count group_id="B5" value="460"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="177"/>
                    <measurement group_id="B2" value="178"/>
                    <measurement group_id="B3" value="53"/>
                    <measurement group_id="B4" value="52"/>
                    <measurement group_id="B5" value="460"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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>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>
          <description>There were 2 regions in Pakistan: Karachi which is urban and Thatta which is rural.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Pakistan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="177"/>
                    <count group_id="B2" value="178"/>
                    <count group_id="B3" value="53"/>
                    <count group_id="B4" value="52"/>
                    <count group_id="B5" value="460"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="177"/>
                    <measurement group_id="B2" value="178"/>
                    <measurement group_id="B3" value="53"/>
                    <measurement group_id="B4" value="52"/>
                    <measurement group_id="B5" value="460"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants That Were Appropriately Screened for Contraceptive Use</title>
        <description>Number of participants that were appropriately screened for injectable contraceptive use in both rural and urban settings in Pakistan.</description>
        <time_frame>3 months from randomization</time_frame>
        <population>Clients of lay providers or clinic providers who are screened appropriately for injectable contraceptive use</population>
        <group_list>
          <group group_id="O1">
            <title>Clinic Provider - Urban</title>
            <description>Urban Clinic Provider providing DMPA or Sayana Press&#xD;
The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA or Sayana Press.</description>
          </group>
          <group group_id="O2">
            <title>Lay Provider - Urban</title>
            <description>Urban Lay Provider providing DMPA or Sayana Press&#xD;
The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press or DMPA</description>
          </group>
          <group group_id="O3">
            <title>Clinic Provider - Rural</title>
            <description>Rural Clinic Provider providing DMPA or Sayana Press&#xD;
The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press or DMPA</description>
          </group>
          <group group_id="O4">
            <title>Lay Provider - Rural</title>
            <description>Rural Lay Provider providing DMPA or Sayana Press&#xD;
The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press or DMPA</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Were Appropriately Screened for Contraceptive Use</title>
          <description>Number of participants that were appropriately screened for injectable contraceptive use in both rural and urban settings in Pakistan.</description>
          <population>Clients of lay providers or clinic providers who are screened appropriately for injectable contraceptive use</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="176"/>
                <count group_id="O2" value="176"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Screening appropriate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="155"/>
                    <measurement group_id="O2" value="136"/>
                    <measurement group_id="O3" value="49"/>
                    <measurement group_id="O4" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Screening not appropriate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="40"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants That Were Appropriately Counseled for DMPA Use.</title>
        <description>Number of participants that were appropriately counseled by both types of providers in both urban and rural settings.</description>
        <time_frame>3 months from randomization</time_frame>
        <population>Clients of lay and clinic providers who receive appropriate counseling for Injectable contraceptive use.</population>
        <group_list>
          <group group_id="O1">
            <title>Clinic Providers - Urban</title>
            <description>Appropriateness of counseling by Urban Clinic providers.</description>
          </group>
          <group group_id="O2">
            <title>Lay Provider - Urban</title>
            <description>Appropriateness of counseling by Urban Lay providers.</description>
          </group>
          <group group_id="O3">
            <title>Clinic Provider - Rural</title>
            <description>Appropriateness of counseling by Rural Clinical Providers</description>
          </group>
          <group group_id="O4">
            <title>Lay Provider - Rural</title>
            <description>Appropriateness of counseling by Rural Lay Providers</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Were Appropriately Counseled for DMPA Use.</title>
          <description>Number of participants that were appropriately counseled by both types of providers in both urban and rural settings.</description>
          <population>Clients of lay and clinic providers who receive appropriate counseling for Injectable contraceptive use.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="178"/>
                <count group_id="O3" value="53"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Counseling appropriate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Counseling not appropriate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="160"/>
                    <measurement group_id="O2" value="154"/>
                    <measurement group_id="O3" value="29"/>
                    <measurement group_id="O4" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider</title>
        <description>DMPA clients served by both types of providers in both urban and rural settings will report whether or not they were satisfied with the DMPA method provided to them.</description>
        <time_frame>3 months from randomization</time_frame>
        <population>Clients of lay and clinic providers reports of satisfaction with the DMPA method received.</population>
        <group_list>
          <group group_id="O1">
            <title>DMPA - IM Urban</title>
            <description>Provider providing DMPA- Intra muscular&#xD;
Proportion of clients highly satisfied with their DMPA Method</description>
          </group>
          <group group_id="O2">
            <title>DMPA - SC - Urban</title>
            <description>Provider providing DMPA - sub cutaneous&#xD;
Prop[portion of clients highly satisfied with the DMPA method provided to them</description>
          </group>
          <group group_id="O3">
            <title>DMPA-IM Rural</title>
            <description>Provider providing DMPA- Intra muscular&#xD;
Proportion of clients highly satisfied with their DMPA Method</description>
          </group>
          <group group_id="O4">
            <title>DMPA-SC- Rural</title>
            <description>Provider providing DMPA - sub cutaneous&#xD;
Prop[portion of clients highly satisfied with the DMPA method provided to them</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider</title>
          <description>DMPA clients served by both types of providers in both urban and rural settings will report whether or not they were satisfied with the DMPA method provided to them.</description>
          <population>Clients of lay and clinic providers reports of satisfaction with the DMPA method received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
                <count group_id="O2" value="139"/>
                <count group_id="O3" value="45"/>
                <count group_id="O4" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107"/>
                    <measurement group_id="O2" value="108"/>
                    <measurement group_id="O3" value="41"/>
                    <measurement group_id="O4" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Clients Who Report Satisfaction With Provider Services</title>
        <description>Clients who received intramuscular or subcutaneous DMPA injections will report whether or not they were satisfied with the services provided to them by their provider.</description>
        <time_frame>3 months from randomization</time_frame>
        <population>Clients of lay and clinic providers who report satisfaction with DMPA services provided by their provider.</population>
        <group_list>
          <group group_id="O1">
            <title>Clinic Provider - Urban</title>
            <description>Urban Clinic provider providing DMPA services</description>
          </group>
          <group group_id="O2">
            <title>Lay Provider- Urban</title>
            <description>Urban Lay provider providing DMPA services</description>
          </group>
          <group group_id="O3">
            <title>Clinic Provider - Rural</title>
            <description>Rural Clinic provider providing DMPA services</description>
          </group>
          <group group_id="O4">
            <title>Lay Provider - Rural</title>
            <description>Lay rural provider providing DMPA services</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Clients Who Report Satisfaction With Provider Services</title>
          <description>Clients who received intramuscular or subcutaneous DMPA injections will report whether or not they were satisfied with the services provided to them by their provider.</description>
          <population>Clients of lay and clinic providers who report satisfaction with DMPA services provided by their provider.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125"/>
                    <measurement group_id="O2" value="112"/>
                    <measurement group_id="O3" value="42"/>
                    <measurement group_id="O4" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>This study was cross-sectional; no adverse events data were collected.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Lay Provider &amp; DMPA</title>
          <description>Lay provider providing DMPA&#xD;
DMPA: The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.</description>
        </group>
        <group group_id="E2">
          <title>Lay Provider &amp; Sayana Press</title>
          <description>Lay Provider providing Sayana Press&#xD;
Sayana Press: The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press</description>
        </group>
        <group group_id="E3">
          <title>Clinic Provider &amp; DMPA</title>
          <description>Clinic provider providing DMPA&#xD;
DMPA: The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.</description>
        </group>
        <group group_id="E4">
          <title>Clinic Provider and Sayana Press</title>
          <description>Clinic provider providing Sayana Press&#xD;
Sayana Press: The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </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>Mario Chen</name_or_title>
      <organization>FHI 360</organization>
      <phone>919 544 7040 ext 11399</phone>
      <email>mchen@fhi360.org</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/NCT03255941
org study id: 4798-CHS-ERC-17
nct id: NCT03255941
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized controlled trial comparing lay Lady Health Workers (Lay Health Workers)
      with Family Welfare Workers (Clinically- trained Health Workers) on quantitative measures of
      safety and effectiveness of Depo Provera and Sayana Press provision in a clinic setting. This
      comparative trial will test the non-inferiority hypothesis that Lady Health Workers are just
      as competent as clinically-trained Family Welfare Workers in screening and counseling
      first-time injectable users. These first time users will also be randomly assigned to receive
      intramuscular or subcutaneous injections of DMPA.
FHI 360 and Jhpiego in collaboration with USAID, Aga Khan University (AKU) and the Government
      of Sindh province propose a randomized controlled trial (RCT) to provide evidence that could
      change current policies in Pakistan that forbid initiation of DMPA by Lady Health Workers
      (LHWs). Positive findings on the safety and effectiveness of LHW-initiation of DMPA may also
      prompt the WHO to consider modifying the recommendation for targeted M&E for lay health
      worker provision of intramuscular injectable contraceptives. The trial will compare the
      screening and counseling of (LHWs)-the main lay health worker cadre--with that of Family
      Welfare Workers (FWWs) who are clinically-trained. The Government of Sindh province also
      expressed interest in introducing Pfizer's subcutaneous form of Depo Provera, Sayana Press®
      (SP) in Pakistan, which could simplify administration of injectable contraceptives. As such,
      an SP arm will be included in the trial, which will be facilitated by relevant training of
      LHWs and FWWs by Jhpiego and stocks provided by a special USAID procurement, since the
      registration process for SP in Pakistan is ongoing. A successful RCT demonstrating the
      non-inferiority of LHWs vis á vis FWWs on first-dose initiation of Depo Provera IM (DMPA IM)
      and (SP) would facilitate efforts to expand CBA2I in Pakistan, and in turn improve access to
      family planning services for a potentially large number of underserved women.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Women who are new users of injectable contraception will be randomly assigned to receive services from an LHW or an FWW and will be randomly assigned to receive either intramuscular DMPA or the subcutaneous formulation, Sayana Press.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of Participants That Were Appropriately Screened for Contraceptive Use
time frame: 3 months from randomization
description: Number of participants that were appropriately screened for injectable contraceptive use in both rural and urban settings in Pakistan.
measure: Number of Participants That Were Appropriately Counseled for DMPA Use.
time frame: 3 months from randomization
description: Number of participants that were appropriately counseled by both types of providers in both urban and rural settings.
measure: Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider
time frame: 3 months from randomization
description: DMPA clients served by both types of providers in both urban and rural settings will report whether or not they were satisfied with the DMPA method provided to them.
measure: Proportion of Clients Who Report Satisfaction With Provider Services
time frame: 3 months from randomization
description: Clients who received intramuscular or subcutaneous DMPA injections will report whether or not they were satisfied with the services provided to them by their provider.
arm group label: Clinic Provider - Urban
arm group type: Active Comparator
description: Urban Clinic Provider providing DMPA or Sayana Press
arm group label: Lay Provider - Urban
arm group type: Active Comparator
description: Urban Lay Provider providing DMPA or Sayana Press
arm group label: Clinic Provider- Rural
arm group type: Active Comparator
description: Rural Clinic Provider providing DMPA or Sayana Press
arm group label: Lay Provider- Rural
arm group type: Active Comparator
description: Rural Lay Provider providing DMPA or Sayana Press
intervention type: Drug
intervention name: DMPA
description: The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.
arm group label: Clinic Provider - Urban
arm group label: Clinic Provider- Rural
arm group label: Lay Provider - Urban
arm group label: Lay Provider- Rural
intervention type: Drug
intervention name: Sayana Press
description: The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press
arm group label: Clinic Provider - Urban
arm group label: Clinic Provider- Rural
arm group label: Lay Provider - Urban
arm group label: Lay Provider- Rural
criteria: 
gender: Female
gender based: Yes
gender description: Gender at birth
minimum age: 15 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dawn S Chin-Quee, PhD, MPH
role: Principal Investigator
affiliation: FHI 360
facility: 
country: Pakistan
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 