<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/NCT01667276</url>
  </required_header>
  <id_info>
    <org_study_id>10196</org_study_id>
    <nct_id>NCT01667276</nct_id>
  </id_info>
  <brief_title>Acceptability of Depo-subQ in Uniject</brief_title>
  <official_title>Acceptability of Depo-subQ in Uniject</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>FHI 360</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Agency for International Development (USAID)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>PATH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>FHI 360</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational study to assess the experience of current depot medroxyprogesterone&#xD;
      acetate (DMPA) intramuscular (IM) clients and providers when they try Depo-subQ in Uniject&#xD;
      and offer recommendations for the introduction of this method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational study to assess the experience of current depot medroxyprogesterone&#xD;
      acetate (DMPA) intramuscular (IM) clients and providers when they try Depo-subQ in Uniject&#xD;
      and offer recommendations for the introduction of this method.&#xD;
&#xD;
      A total of 560 participants will be enrolled in the study in the following groups:&#xD;
&#xD;
      360 participants (120 in Uganda and 240 in Senegal) who are current DMPA IM clients who seek&#xD;
      re-injection of DMPA from either community health workers (CHWs) or clinic-based providers;&#xD;
      and are 18-40 years of age; received their most recent DMPA injection no more than 13 weeks&#xD;
      prior to enrollment in the study [16].&#xD;
&#xD;
      Up to 100 participants (50 in Uganda and 50 in Senegal) current DMPA IM clients who meet the&#xD;
      inclusion/exclusion criteria but do not want to receive the injection with Depo-subQ in&#xD;
      Uniject and are willing to complete a short questionnaire&#xD;
&#xD;
      80 CHWs (40 in Uganda and 40 in Senegal) and 20 clinic-based providers (from Senegal only)&#xD;
      who are trained to give Depo-subQ in Uniject as part of this study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure the acceptability of Depo-subQ in Uniject among DMPA IM family planning clients;</measure>
    <time_frame>1 year</time_frame>
    <description>percent of participants who declare they would select Depo-subQ in Uniject for their next injection if this drug product was available at three months with a 95% confidence interval per country</description>
  </primary_outcome>
  <primary_outcome>
    <measure>2) Measure the acceptability of Depo-subQ in Uniject among family planning providers (both clinic-based and CHWs);</measure>
    <time_frame>1 year</time_frame>
    <description>key themes will be identified from interview transcripts to summarize family planning providers' (clinic-based and CHWs) acceptability of Depo-subQ in Uniject and preference for administering Depo-subQ in Uniject relative to the typical DMPA intramuscular injection by county</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess family planning providers' (clinic-based and CHWs) training materials.</measure>
    <time_frame>1 year</time_frame>
    <description>descriptive analyses (e.g., frequencies and means) of responses for quantitative questions and summaries providers' qualitative responses to open-ended questions from the post-training evaluation for each country</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>1) To qualitatively compare acceptability of Depo-subQ in Uniject among the two types of family planning providers-clinic-based and CHWs (Senegal only)</measure>
    <time_frame>1 year</time_frame>
    <description>frequencies and summary statistics of acceptability data among family planning clients by asking participants to compare their experiences receiving Depo-subQ in Uniject to their experiences receiving the typical DMPA intramuscular injection by country</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2) To assess the safety of participants who receive Depo-subQ in Uniject during the study</measure>
    <time_frame>1 year</time_frame>
    <description>frequencies of reported adverse events by country</description>
  </secondary_outcome>
  <enrollment type="Actual">476</enrollment>
  <condition>Contraception</condition>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 560 participants will be enrolled in the study in the following groups:&#xD;
&#xD;
          -  360 participants (120 in Uganda and 240 in Senegal) who are current DMPA IM clients&#xD;
             who seek re-injection of DMPA from either CHWs or clinic-based providers; and are&#xD;
             18-40 years of age; received their most recent DMPA injection no more than 13 weeks&#xD;
             prior to enrollment in the study [16].&#xD;
&#xD;
          -  Up to 100 participants (50 in Uganda and 50 in Senegal) current DMPA IM clients who&#xD;
             meet the inclusion/exclusion criteria but do not want to receive the injection with&#xD;
             Depo-subQ in Uniject and are willing to complete a short questionnaire&#xD;
&#xD;
          -  80 CHWs (40 in Uganda and 40 in Senegal) and 20 clinic-based providers (from Senegal&#xD;
             only) who are trained to give Depo-subQ in Uniject as part of this study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-40&#xD;
&#xD;
          -  In general good health (the participant verbally reports she feels well)&#xD;
&#xD;
          -  Using DMPA continuously for at least six months prior to enrollment in the study&#xD;
             (i.e., had at least two previous injections)&#xD;
&#xD;
          -  Received their most recent DMPA injection no more than 13 weeks prior to enrollment in&#xD;
             the study at the study clinic or from a family planning provider involved in the study&#xD;
             (Senegal only)&#xD;
&#xD;
          -  Received their most recent DMPA injection no more than 13 weeks prior to enrollment in&#xD;
             the study from a family planning provider involved in the study (Uganda only)&#xD;
&#xD;
          -  Desires to be re-injected with DMPA&#xD;
&#xD;
          -  Willing to sign an informed consent document&#xD;
&#xD;
          -  Willing to provide contact information and be interviewed three months after&#xD;
             enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Holly Burke, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>FHI 360</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anthony Mbonye, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ministry of Health, Uganda</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bpcar M Daff, MD, PhD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division de la Sante de la Reproduction</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ministry of Health Clinics</name>
      <address>
        <city>All Cities Where There Is A Clinic</city>
        <country>Senegal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ministry of Health Clinics, Uganda</name>
      <address>
        <city>All Cities Where There Is A Clinic</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Senegal</country>
    <country>Uganda</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>July 16, 2013</last_update_submitted>
  <last_update_submitted_qc>July 16, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AE adverse event</keyword>
  <keyword>AIDS acquired immunodeficiency syndrome</keyword>
  <keyword>ALT (SGPT) alanine aminotransferase</keyword>
  <keyword>ART antiretroviral therapy</keyword>
  <keyword>AST (SGOT) aspartate aminotransferase</keyword>
  <keyword>DCF data collection forms</keyword>
  <keyword>DMC Data Monitoring Committee</keyword>
  <keyword>FDA (U.S.) Food and Drug Administration</keyword>
  <keyword>GCP Good Clinical Practice guidelines</keyword>
  <keyword>HB sAg Hepatitis B surface antigen</keyword>
  <keyword>ICH International Conference of Harmonisation</keyword>
  <keyword>IND Investigational New Drug Application</keyword>
  <keyword>IRB Institutional Review Board</keyword>
  <keyword>IU international units</keyword>
  <keyword>mg milligram(s)</keyword>
  <keyword>mm3 cubic millimeter(s)</keyword>
  <keyword>PCR polymerase chain reaction</keyword>
  <keyword>SAE serious adverse event</keyword>
  <keyword>µg microgram</keyword>
  <keyword>ULN upper limit of the normal range</keyword>
  <keyword>WB Western Blot</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01667276
org study id: 10196
nct id: NCT01667276
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This is an observational study to assess the experience of current depot medroxyprogesterone
      acetate (DMPA) intramuscular (IM) clients and providers when they try Depo-subQ in Uniject
      and offer recommendations for the introduction of this method.
This is an observational study to assess the experience of current depot medroxyprogesterone
      acetate (DMPA) intramuscular (IM) clients and providers when they try Depo-subQ in Uniject
      and offer recommendations for the introduction of this method.

      A total of 560 participants will be enrolled in the study in the following groups:

      360 participants (120 in Uganda and 240 in Senegal) who are current DMPA IM clients who seek
      re-injection of DMPA from either community health workers (CHWs) or clinic-based providers;
      and are 18-40 years of age; received their most recent DMPA injection no more than 13 weeks
      prior to enrollment in the study [16].

      Up to 100 participants (50 in Uganda and 50 in Senegal) current DMPA IM clients who meet the
      inclusion/exclusion criteria but do not want to receive the injection with Depo-subQ in
      Uniject and are willing to complete a short questionnaire

      80 CHWs (40 in Uganda and 40 in Senegal) and 20 clinic-based providers (from Senegal only)
      who are trained to give Depo-subQ in Uniject as part of this study
time perspective: Prospective
measure: Measure the acceptability of Depo-subQ in Uniject among DMPA IM family planning clients;
time frame: 1 year
description: percent of participants who declare they would select Depo-subQ in Uniject for their next injection if this drug product was available at three months with a 95% confidence interval per country
measure: 2) Measure the acceptability of Depo-subQ in Uniject among family planning providers (both clinic-based and CHWs);
time frame: 1 year
description: key themes will be identified from interview transcripts to summarize family planning providers' (clinic-based and CHWs) acceptability of Depo-subQ in Uniject and preference for administering Depo-subQ in Uniject relative to the typical DMPA intramuscular injection by county
measure: Assess family planning providers' (clinic-based and CHWs) training materials.
time frame: 1 year
description: descriptive analyses (e.g., frequencies and means) of responses for quantitative questions and summaries providers' qualitative responses to open-ended questions from the post-training evaluation for each country
measure: 1) To qualitatively compare acceptability of Depo-subQ in Uniject among the two types of family planning providers-clinic-based and CHWs (Senegal only)
time frame: 1 year
description: frequencies and summary statistics of acceptability data among family planning clients by asking participants to compare their experiences receiving Depo-subQ in Uniject to their experiences receiving the typical DMPA intramuscular injection by country
measure: 2) To assess the safety of participants who receive Depo-subQ in Uniject during the study
time frame: 1 year
description: frequencies of reported adverse events by country
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Holly Burke, PhD, MPH
role: Principal Investigator
affiliation: FHI 360
last name: Anthony Mbonye, MD, PhD
role: Principal Investigator
affiliation: Ministry of Health, Uganda
last name: Bpcar M Daff, MD, PhD, MSc
role: Principal Investigator
affiliation: Division de la Sante de la Reproduction
facility: 
facility: 
country: Senegal
country: Uganda
responsible party type: Sponsor