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

NCT03248050 | Unknown

• 1 other identifier: 011-17
• Study Type: interventional
• Target: 1,359
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Abortion, Drug-Induced; Pharmacies

Outcome Measures

Primary Outcomes (3)

• Self-reported use of call centre in past two weeks

  Participant called MSZ call centre after purchasing the medication.

  Day 14 after taking the first pill

• Self-reported use of a correct regimen of MA

  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

  Day 14 after taking the first pill

• Self-reported satisfaction with self-administration of MA

  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.

  Day 14 after taking the first pill

Secondary Outcomes (4)

• Cost of intervention per unit of call centre use

  Day 14 after taking first pill

• Self-reported abortion completion rate

  Day 14 and day 60 after taking first pill

• Self-reported uptake of post-abortion family planning

  Day 14 after taking first pill

• Self-reported complication rate

  Day 14 after taking first pill

Other Outcomes (3)

• Proportion of pharmacy workers encouraging mystery clients to use the MSZ call centre number

  Within 4 weeks of intervention starting

• Proportion of mystery clients that receives study materials with call centre phone number on.

  Within 4 weeks of intervention starting

• Reasons for use and non-use of the call centre advice line

  Day 14 after taking first pill

Study Arms (2)

Intervention pharmacy

EXPERIMENTAL

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

Control pharmacy

NO INTERVENTION

Interventions

Pharmacy encouraged to promote call centre use to clients BEHAVIORAL

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.

Intervention pharmacy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Marie Stopes International: lead

Central Study Contacts

Katy A Footman, MSc

CONTACT

+44 203 219 8103; katy.footman@mariestopes.org

Kathryn Church, PhD

CONTACT

+44 207 034 2365; kathryn.church@mariestopes.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: August 14, 2017
• Study Start: October 15, 2017
• Primary Completion: April 15, 2018
• Study Completion: June 15, 2018
• Last Updated: August 14, 2017

Record last verified: 2017-08