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
|Condition or disease||Intervention/treatment||Phase|
|Abortion, Drug-Induced Pharmacies||Behavioral: Pharmacy encouraged to promote call centre use to clients||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1359 participants|
|Intervention Model:||Parallel Assignment|
|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|
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|
- 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.
- 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
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Katy A Footman, MSc||+44 203 219 firstname.lastname@example.org|
|Contact: Kathryn Church, PhD||+44 207 034 email@example.com|