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Evaluating an Intervention to Increase Use of Call Centre Support for Self-managed Medical Abortion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03248050
Recruitment Status : Unknown
Verified August 2017 by Marie Stopes International.
Recruitment status was:  Not yet recruiting
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Marie Stopes International

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Abortion, Drug-Induced Pharmacies Behavioral: Pharmacy encouraged to promote call centre use to clients Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1359 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : October 15, 2017
Estimated Primary Completion Date : April 15, 2018
Estimated Study Completion Date : June 15, 2018

Arm Intervention/treatment
Experimental: Intervention pharmacy
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.
Behavioral: Pharmacy encouraged to promote call centre use to clients
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.

No Intervention: Control pharmacy



Primary Outcome Measures :
  1. Self-reported use of call centre in past two weeks [ Time Frame: Day 14 after taking the first pill ]
    Participant called MSZ call centre after purchasing the medication.

  2. Self-reported use of a correct regimen of MA [ Time Frame: Day 14 after taking the first pill ]
    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

  3. Self-reported satisfaction with self-administration of MA [ Time Frame: Day 14 after taking the first pill ]
    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.


Secondary Outcome Measures :
  1. Cost of intervention per unit of call centre use [ Time Frame: Day 14 after taking first pill ]
    Increased unit cost of intervention per increased unit of call centre use.

  2. Self-reported abortion completion rate [ Time Frame: Day 14 and day 60 after taking first pill ]
    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).

  3. Self-reported uptake of post-abortion family planning [ Time Frame: Day 14 after taking first pill ]
    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.

  4. Self-reported complication rate [ Time Frame: Day 14 after taking first pill ]
    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.


Other Outcome Measures:
  1. Proportion of pharmacy workers encouraging mystery clients to use the MSZ call centre number [ Time Frame: Within 4 weeks of intervention starting ]
    During mystery client visit, pharmacy worker verbally mentions the MSZ call centre to the mystery client.

  2. Proportion of mystery clients that receives study materials with call centre phone number on. [ Time Frame: Within 4 weeks of intervention starting ]
    During the mystery client visit, pharmacy worker provides the mystery client with the study intervention materials that have the call centre number on.

  3. Reasons for use and non-use of the call centre advice line [ Time Frame: Day 14 after taking first pill ]
    MA users' self-reported reasons for calling or not calling the call centre.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Pharmacies:

  • Located in Lusaka
  • Supplied with MSZ's Mariprist combination regimen product
  • Selling > 10 products per month
  • Pharmacy owner and at least one pharmacy worker is willing to participate

MA users:

  • Women using combination regimen or misoprostol-alone for MA, purchased from study pharmacies during the study period
  • Purchased medication by themselves or by a proxy purchaser
  • Have access to a mobile phone and are willing to be followed up by phone with questions about her abortion at 14 and 60 days after taking the first drug
  • Aged 18 and over
  • Certain of the date of their last menstrual period (LMP) and have gestational age less than 9 weeks (calculated from LMP)
  • Have a confirmed pregnancy (self-reported positive urine pregnancy test)
  • Willing and able to give informed consent

Mystery clients:

  • Aged 18 and over
  • Female
  • Not pregnant
  • Literate
  • Pro-choice
  • Not current or former employees of pharmacies
  • Not related to current or former employees of pharmacies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248050


Contacts
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Contact: Katy A Footman, MSc +44 203 219 8103 katy.footman@mariestopes.org
Contact: Kathryn Church, PhD +44 207 034 2365 kathryn.church@mariestopes.org

Sponsors and Collaborators
Marie Stopes International
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Responsible Party: Marie Stopes International
ClinicalTrials.gov Identifier: NCT03248050    
Other Study ID Numbers: 011-17
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No