<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/NCT03248050</url>
  </required_header>
  <id_info>
    <org_study_id>011-17</org_study_id>
    <nct_id>NCT03248050</nct_id>
  </id_info>
  <brief_title>Evaluating an Intervention to Increase Use of Call Centre Support for Self-managed Medical Abortion</brief_title>
  <official_title>Evaluating an Intervention to Increase Use of Call Centre Support for Self-managed Medical Abortion, and the Effectiveness of Call Centre Support for Correct Use of Medical Abortion: A Cluster Randomised-controlled Trial With Nested Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marie Stopes International</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marie Stopes International</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>
      Self-management of medical abortion (MA) pills purchased from pharmacies is considered to be&#xD;
      one of the reasons behind falling morbidity and mortality from unsafe abortion in recent&#xD;
      years. While pharmacy workers commonly sell MA medications over the counter, they have&#xD;
      inadequate knowledge about how women should take the medications and their potential&#xD;
      complications, and do not offer adequate information and counselling to women buying the&#xD;
      drugs. This study aims to evaluate if a pharmacy-based intervention to promote use of a&#xD;
      support hotline (Marie Stopes Zambia (MSZ) call centre) among MA purchasers can increase use&#xD;
      of the call centre, and to assess whether correct MA use and acceptability of self-&#xD;
      administered MA is higher among MA users who contact the call centre than those who&#xD;
      self-administer MA without call centre support.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Self-management of medical abortion (MA) pills purchased from pharmacies is considered to be&#xD;
      one of the reasons behind falling morbidity and mortality from unsafe abortion in recent&#xD;
      years. While pharmacy workers commonly sell MA medications over the counter, they have&#xD;
      inadequate knowledge about how women should take the medications and their potential&#xD;
      complications, and do not offer adequate information and counselling to women buying the&#xD;
      drugs.&#xD;
&#xD;
      This study aims to evaluate if a pharmacy-based intervention to promote use of a support&#xD;
      hotline (Marie Stopes Zambia (MSZ) call centre) among MA purchasers can increase use of the&#xD;
      call centre, and to assess whether correct MA use and acceptability of self- administered MA&#xD;
      is higher among MA users who contact the call centre than those who self-administer MA&#xD;
      without call centre support.&#xD;
&#xD;
      The objectives of the study are:&#xD;
&#xD;
        1. To evaluate whether a pharmacy-based intervention to promote the MSZ call centre&#xD;
           increases contact with the call centre among women purchasing the combination regimen or&#xD;
           misoprostol alone from pharmacies for MA.&#xD;
&#xD;
        2. To evaluate whether a pharmacy-based intervention to promote the MSZ call centre can&#xD;
           increase the proportion of pharmacy workers encouraging mystery clients purchasing the&#xD;
           combination regimen or misoprostol-only to use the MSZ call centre.&#xD;
&#xD;
        3. To assess the reasons for use and non-use of the call centre advice line among women&#xD;
           purchasing MA from pharmacies&#xD;
&#xD;
        4. To investigate whether correct MA regimen use and acceptability of self-administered MA&#xD;
           are higher among those women who call the call centre, compared to those who&#xD;
           self-administer MA without any call centre support.&#xD;
&#xD;
      The details of the programme intervention will be finalised following an intervention design&#xD;
      workshop but the main components will be as follows:&#xD;
&#xD;
        -  Provide pharmacy workers with either paper pill bags, cards to put in existing pill&#xD;
           bags, or stickers to put on pill packaging, which have the MSZ call centre number&#xD;
           printed on them, along with instructions to ring the hotline for free, confidential&#xD;
           advice about reproductive health issues.&#xD;
&#xD;
        -  Train all pharmacy workers at the pharmacy through one-on-one detailing visits to&#xD;
           encourage all clients buying misoprostol (any brand) or the mifepristone-misoprostol&#xD;
           combined regimen (any brand) to call the number for free, confidential advice on how to&#xD;
           use the pills before they take them.&#xD;
&#xD;
        -  Incentivise pharmacy workers to encourage women to phone the call centre.s.&#xD;
&#xD;
        -  Monthly monitoring visits to remind pharmacy workers to encourage women to phone the&#xD;
           free, confidential phone number (in person or remotely through phone calls).&#xD;
&#xD;
      Women who call the call centre will receive advice on how to take the MA medications. Call&#xD;
      centre staff will have a script detailing essential information on MA and answers to possible&#xD;
      client questions.&#xD;
&#xD;
      To evaluate this intervention, a two arm, single group, superiority, multicentre, cluster&#xD;
      randomised controlled trial with a nested observational study will be conducted at 26&#xD;
      pharmacies in Lusaka, Zambia. A randomised trial design will be used to assess the&#xD;
      effectiveness of the pharmacy-based intervention in increasing use of the call centre. As it&#xD;
      is not possible to randomly assign women to actually use the call centre and use will be&#xD;
      largely based on self-selection, the nested observational study will then compare the&#xD;
      experience of women who use and do not use the call centre.&#xD;
&#xD;
      Data collection will include:&#xD;
&#xD;
        1. Structured interviews with women using medications purchased from pharmacies to assess&#xD;
           call centre use, MA regimen used, and experience of self-administering MA (impact&#xD;
           evaluation and nested-observational study), and&#xD;
&#xD;
        2. Mystery client surveys to assess pharmacy practice (process evaluation).&#xD;
&#xD;
        3. Qualitative analysis of a sample of call recordings (process evaluation).&#xD;
&#xD;
        4. Costing analysis of the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 15, 2017</start_date>
  <completion_date type="Anticipated">June 15, 2018</completion_date>
  <primary_completion_date type="Anticipated">April 15, 2018</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported use of call centre in past two weeks</measure>
    <time_frame>Day 14 after taking the first pill</time_frame>
    <description>Participant called MSZ call centre after purchasing the medication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported use of a correct regimen of MA</measure>
    <time_frame>Day 14 after taking the first pill</time_frame>
    <description>Use of a correct regimen of mifepristone-misoprostol: 200mg mifepristone (oral administration) followed by single dose of 800mcg misoprostol (vaginal, buccal or sublingually), or 400mcg misoprostol orally if under 7 weeks gestation, after a 24-48 hour interval. Use of a correct regimen of misoprostol only: 800mcg of misoprostol vaginally or sublingually, with subsequent doses of 800 mcg every 3 hours up to 3 doses</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported satisfaction with self-administration of MA</measure>
    <time_frame>Day 14 after taking the first pill</time_frame>
    <description>Satisfaction with the overall process, would recommend to a friend who needed an abortion, would use the same method again if needed an abortion again, feeling adequately prepared for various aspects of the medical abortion process.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost of intervention per unit of call centre use</measure>
    <time_frame>Day 14 after taking first pill</time_frame>
    <description>Increased unit cost of intervention per increased unit of call centre use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported abortion completion rate</measure>
    <time_frame>Day 14 and day 60 after taking first pill</time_frame>
    <description>Proportion of women self-reporting that at day 60, they are no longer pregnant(due to self-reported negative result of a urine pregnancy test, self-reported expulsion of pregnancy, self-reported return to regular menstrual cycles, self-reported disappearance of pregnancy symptoms or all of the above), without recourse to a repeat procedure (surgical or medical).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported uptake of post-abortion family planning</measure>
    <time_frame>Day 14 after taking first pill</time_frame>
    <description>Uptake of a post abortion contraceptive: the respondent is using tubal ligation, intrauterine device, implant, injectable, or oral contraceptive pill at day 14 that she has started to use since taking the MA product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported complication rate</measure>
    <time_frame>Day 14 after taking first pill</time_frame>
    <description>Hemorrhage requiring a blood transfusion or uterine aspiration, serious infection from the abortion needing IV antibiotics and undiagnosed (at the time of MA administration) ectopic pregnancy needing surgery or other treatment, a continuing pregnancy needing an uterine aspiration, an incomplete abortion needing uterine aspiration or further medication, severe allergic reaction, severe vomiting or diarrhea and admission to a health facility for any of the above.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Proportion of pharmacy workers encouraging mystery clients to use the MSZ call centre number</measure>
    <time_frame>Within 4 weeks of intervention starting</time_frame>
    <description>During mystery client visit, pharmacy worker verbally mentions the MSZ call centre to the mystery client.</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of mystery clients that receives study materials with call centre phone number on.</measure>
    <time_frame>Within 4 weeks of intervention starting</time_frame>
    <description>During the mystery client visit, pharmacy worker provides the mystery client with the study intervention materials that have the call centre number on.</description>
  </other_outcome>
  <other_outcome>
    <measure>Reasons for use and non-use of the call centre advice line</measure>
    <time_frame>Day 14 after taking first pill</time_frame>
    <description>MA users' self-reported reasons for calling or not calling the call centre.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1359</enrollment>
  <condition>Abortion, Drug-Induced</condition>
  <condition>Pharmacies</condition>
  <arm_group>
    <arm_group_label>Intervention pharmacy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pharmacies in the intervention group will receive training, materials, and monitoring visits to encourage them to inform women who buy mifepristone + misoprostol or misoprostol alone to call the MSZ call centre for advice on how to use the pills before they take them.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control pharmacy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pharmacy encouraged to promote call centre use to clients</intervention_name>
    <description>The details of the intervention will be finalised following an intervention design workshop. The main components will be: Provision of materials with the MSZ call centre number on for pharmacy workers to give women buying MA medications to call the number for free, confidential advice on how to use the pills before they take them; incentives; monthly monitoring visits.</description>
    <arm_group_label>Intervention pharmacy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Pharmacies:&#xD;
&#xD;
          -  Located in Lusaka&#xD;
&#xD;
          -  Supplied with MSZ's Mariprist combination regimen product&#xD;
&#xD;
          -  Selling &gt; 10 products per month&#xD;
&#xD;
          -  Pharmacy owner and at least one pharmacy worker is willing to participate&#xD;
&#xD;
        MA users:&#xD;
&#xD;
          -  Women using combination regimen or misoprostol-alone for MA, purchased from study&#xD;
             pharmacies during the study period&#xD;
&#xD;
          -  Purchased medication by themselves or by a proxy purchaser&#xD;
&#xD;
          -  Have access to a mobile phone and are willing to be followed up by phone with&#xD;
             questions about her abortion at 14 and 60 days after taking the first drug&#xD;
&#xD;
          -  Aged 18 and over&#xD;
&#xD;
          -  Certain of the date of their last menstrual period (LMP) and have gestational age less&#xD;
             than 9 weeks (calculated from LMP)&#xD;
&#xD;
          -  Have a confirmed pregnancy (self-reported positive urine pregnancy test)&#xD;
&#xD;
          -  Willing and able to give informed consent&#xD;
&#xD;
        Mystery clients:&#xD;
&#xD;
          -  Aged 18 and over&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Not pregnant&#xD;
&#xD;
          -  Literate&#xD;
&#xD;
          -  Pro-choice&#xD;
&#xD;
          -  Not current or former employees of pharmacies&#xD;
&#xD;
          -  Not related to current or former employees of pharmacies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Katy A Footman, MSc</last_name>
    <phone>+44 203 219 8103</phone>
    <email>katy.footman@mariestopes.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kathryn Church, PhD</last_name>
    <phone>+44 207 034 2365</phone>
    <email>kathryn.church@mariestopes.org</email>
  </overall_contact_backup>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>June 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03248050
org study id: 011-17
nct id: NCT03248050
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Self-management of medical abortion (MA) pills purchased from pharmacies is considered to be
      one of the reasons behind falling morbidity and mortality from unsafe abortion in recent
      years. While pharmacy workers commonly sell MA medications over the counter, they have
      inadequate knowledge about how women should take the medications and their potential
      complications, and do not offer adequate information and counselling to women buying the
      drugs. This study aims to evaluate if a pharmacy-based intervention to promote use of a
      support hotline (Marie Stopes Zambia (MSZ) call centre) among MA purchasers can increase use
      of the call centre, and to assess whether correct MA use and acceptability of self-
      administered MA is higher among MA users who contact the call centre than those who
      self-administer MA without call centre support.
Self-management of medical abortion (MA) pills purchased from pharmacies is considered to be
      one of the reasons behind falling morbidity and mortality from unsafe abortion in recent
      years. While pharmacy workers commonly sell MA medications over the counter, they have
      inadequate knowledge about how women should take the medications and their potential
      complications, and do not offer adequate information and counselling to women buying the
      drugs.

      This study aims to evaluate if a pharmacy-based intervention to promote use of a support
      hotline (Marie Stopes Zambia (MSZ) call centre) among MA purchasers can increase use of the
      call centre, and to assess whether correct MA use and acceptability of self- administered MA
      is higher among MA users who contact the call centre than those who self-administer MA
      without call centre support.

      The objectives of the study are:

        1. To evaluate whether a pharmacy-based intervention to promote the MSZ call centre
           increases contact with the call centre among women purchasing the combination regimen or
           misoprostol alone from pharmacies for MA.

        2. To evaluate whether a pharmacy-based intervention to promote the MSZ call centre can
           increase the proportion of pharmacy workers encouraging mystery clients purchasing the
           combination regimen or misoprostol-only to use the MSZ call centre.

        3. To assess the reasons for use and non-use of the call centre advice line among women
           purchasing MA from pharmacies

        4. To investigate whether correct MA regimen use and acceptability of self-administered MA
           are higher among those women who call the call centre, compared to those who
           self-administer MA without any call centre support.

      The details of the programme intervention will be finalised following an intervention design
      workshop but the main components will be as follows:

        -  Provide pharmacy workers with either paper pill bags, cards to put in existing pill
           bags, or stickers to put on pill packaging, which have the MSZ call centre number
           printed on them, along with instructions to ring the hotline for free, confidential
           advice about reproductive health issues.

        -  Train all pharmacy workers at the pharmacy through one-on-one detailing visits to
           encourage all clients buying misoprostol (any brand) or the mifepristone-misoprostol
           combined regimen (any brand) to call the number for free, confidential advice on how to
           use the pills before they take them.

        -  Incentivise pharmacy workers to encourage women to phone the call centre.s.

        -  Monthly monitoring visits to remind pharmacy workers to encourage women to phone the
           free, confidential phone number (in person or remotely through phone calls).

      Women who call the call centre will receive advice on how to take the MA medications. Call
      centre staff will have a script detailing essential information on MA and answers to possible
      client questions.

      To evaluate this intervention, a two arm, single group, superiority, multicentre, cluster
      randomised controlled trial with a nested observational study will be conducted at 26
      pharmacies in Lusaka, Zambia. A randomised trial design will be used to assess the
      effectiveness of the pharmacy-based intervention in increasing use of the call centre. As it
      is not possible to randomly assign women to actually use the call centre and use will be
      largely based on self-selection, the nested observational study will then compare the
      experience of women who use and do not use the call centre.

      Data collection will include:

        1. Structured interviews with women using medications purchased from pharmacies to assess
           call centre use, MA regimen used, and experience of self-administering MA (impact
           evaluation and nested-observational study), and

        2. Mystery client surveys to assess pharmacy practice (process evaluation).

        3. Qualitative analysis of a sample of call recordings (process evaluation).

        4. Costing analysis of the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Self-reported use of call centre in past two weeks
time frame: Day 14 after taking the first pill
description: Participant called MSZ call centre after purchasing the medication.
measure: Self-reported use of a correct regimen of MA
time frame: Day 14 after taking the first pill
description: Use of a correct regimen of mifepristone-misoprostol: 200mg mifepristone (oral administration) followed by single dose of 800mcg misoprostol (vaginal, buccal or sublingually), or 400mcg misoprostol orally if under 7 weeks gestation, after a 24-48 hour interval. Use of a correct regimen of misoprostol only: 800mcg of misoprostol vaginally or sublingually, with subsequent doses of 800 mcg every 3 hours up to 3 doses
measure: Self-reported satisfaction with self-administration of MA
time frame: Day 14 after taking the first pill
description: Satisfaction with the overall process, would recommend to a friend who needed an abortion, would use the same method again if needed an abortion again, feeling adequately prepared for various aspects of the medical abortion process.
measure: Cost of intervention per unit of call centre use
time frame: Day 14 after taking first pill
description: Increased unit cost of intervention per increased unit of call centre use.
measure: Self-reported abortion completion rate
time frame: Day 14 and day 60 after taking first pill
description: Proportion of women self-reporting that at day 60, they are no longer pregnant(due to self-reported negative result of a urine pregnancy test, self-reported expulsion of pregnancy, self-reported return to regular menstrual cycles, self-reported disappearance of pregnancy symptoms or all of the above), without recourse to a repeat procedure (surgical or medical).
measure: Self-reported uptake of post-abortion family planning
time frame: Day 14 after taking first pill
description: Uptake of a post abortion contraceptive: the respondent is using tubal ligation, intrauterine device, implant, injectable, or oral contraceptive pill at day 14 that she has started to use since taking the MA product.
measure: Self-reported complication rate
time frame: Day 14 after taking first pill
description: Hemorrhage requiring a blood transfusion or uterine aspiration, serious infection from the abortion needing IV antibiotics and undiagnosed (at the time of MA administration) ectopic pregnancy needing surgery or other treatment, a continuing pregnancy needing an uterine aspiration, an incomplete abortion needing uterine aspiration or further medication, severe allergic reaction, severe vomiting or diarrhea and admission to a health facility for any of the above.
measure: Proportion of pharmacy workers encouraging mystery clients to use the MSZ call centre number
time frame: Within 4 weeks of intervention starting
description: During mystery client visit, pharmacy worker verbally mentions the MSZ call centre to the mystery client.
measure: Proportion of mystery clients that receives study materials with call centre phone number on.
time frame: Within 4 weeks of intervention starting
description: During the mystery client visit, pharmacy worker provides the mystery client with the study intervention materials that have the call centre number on.
measure: Reasons for use and non-use of the call centre advice line
time frame: Day 14 after taking first pill
description: MA users' self-reported reasons for calling or not calling the call centre.
arm group label: Intervention pharmacy
arm group type: Experimental
description: Pharmacies in the intervention group will receive training, materials, and monitoring visits to encourage them to inform women who buy mifepristone + misoprostol or misoprostol alone to call the MSZ call centre for advice on how to use the pills before they take them.
arm group label: Control pharmacy
arm group type: No Intervention
intervention type: Behavioral
intervention name: Pharmacy encouraged to promote call centre use to clients
description: The details of the intervention will be finalised following an intervention design workshop. The main components will be: Provision of materials with the MSZ call centre number on for pharmacy workers to give women buying MA medications to call the number for free, confidential advice on how to use the pills before they take them; incentives; monthly monitoring visits.
arm group label: Intervention pharmacy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Katy A Footman, MSc
phone: +44 203 219 8103
email: katy.footman@mariestopes.org
last name: Kathryn Church, PhD
phone: +44 207 034 2365
email: kathryn.church@mariestopes.org
responsible party type: Sponsor
sharing ipd: Undecided