Abortion, Drug-InducedNCT03248050
Evaluating an Intervention to Increase Use of Call Centre Support for Self-managed Medical Abortion
A study testing Pharmacy encouraged to promote call centre use to clients in people with Abortion, Drug-Induced and Pharmacies, run by Marie Stopes International.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Drug-Induced, Pharmacies
- What is being tested?
- Pharmacy encouraged to promote call centre use to clients
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,359 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2017to 15 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 21Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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:
- 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.
- 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.
- To assess the reasons for use and non-use of the call centre advice line among women purchasing MA from pharmacies
- 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:
- 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
- Mystery client surveys to assess pharmacy practice (process evaluation).
- Qualitative analysis of a sample of call recordings (process evaluation).
- Costing analysis of the intervention.
- Conditions
- Abortion, Drug-Induced, Pharmacies
- Being tested
- Pharmacy encouraged to promote call centre use to clients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacy encouraged to promote call centre use to clientsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Pharmacy encouraged to promote call centre use to clients |
| Control pharmacy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported use of call centre in past two weeks
Participant called MSZ call centre after purchasing the medication.
Measured: 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
Measured: 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.
Measured: Day 14 after taking the first pill
Secondary outcomes (4)
Cost of intervention per unit of call centre use
Increased unit cost of intervention per increased unit of call centre use.
Measured: Day 14 after taking first pill
Self-reported abortion completion rate
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).
Measured: Day 14 and day 60 after taking first pill
Self-reported uptake of post-abortion family planning
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.
Measured: Day 14 after taking first pill
Self-reported complication rate
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.
Measured: Day 14 after taking first pill
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start15 Oct 2017 (estimated)
- Primary completion15 Apr 2018 (estimated)
- Study completion15 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, Drug-InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,359 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marie Stopes International
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248050
- Sponsor's protocol ID
- 011-17
- Status last verified
- Aug 2017
- First submitted
- 23 Jun 2017
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03248050
- Acronym / sponsor ID
- 011-17
- Conditions
- Abortion, Drug-Induced, Pharmacies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,359 participants (estimated)
- Lead sponsor
- Marie Stopes InternationalUniversity, hospital or other
- Study start
- 15 Oct 2017 (estimated)
- Primary completion
- 15 Apr 2018 (estimated)
- Study completion
- 15 Jun 2018 (estimated)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- To assess the reasons for use and non-use of the call centre advice line among women purchasing MA from pharmacies
- 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:
- 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
- Mystery client surveys to assess pharmacy practice (process evaluation).
- Qualitative analysis of a sample of call recordings (process evaluation).
- Costing analysis of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention pharmacy | Experimental | Behavioral: Pharmacy encouraged to promote call centre use to clientsPharmacies 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. |
| Control pharmacy | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
- Women using combination regimen or misoprostol-alone for MA, purchased from study pharmacies during the study period
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacy encouraged to promote call centre use to clientsThe 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. | Behavioural | Intervention pharmacy |
Primary outcome
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.
4 secondary outcomes
Cost of intervention per unit of call centre use
Time frame: Day 14 after taking first pill
Self-reported abortion completion rate
Time frame: 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
Self-reported complication rate
Time frame: Day 14 after taking first pill
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacy encouraged to promote call centre use to clients in people with Abortion, Drug-Induced and Pharmacies, run by Marie Stopes International.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katy A Footman, MSc (+44 203 219 8103, katy.footman@mariestopes.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported use of call centre in past two weeks (time frame: Day 14 after taking the first pill). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017; AzTrials last refreshed its copy on 29 Oct 2026.