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

August 9, 2017 updated by: Marie Stopes International

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1359

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 14 after taking the first pill
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
Day 14 after taking the first pill
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.
Day 14 after taking the first pill

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Day 14 after taking first pill
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).
Day 14 and day 60 after taking first pill
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.
Day 14 after taking first pill
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.
Day 14 after taking first pill

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Within 4 weeks of intervention starting
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.
Within 4 weeks of intervention starting
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.
Day 14 after taking first pill

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marie Stopes International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 011-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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