Ignite Creation Date:
2024-05-06 @ 10:24 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03248050
Status:
UNKNOWN
Last Update Posted:
2017-08-14
First Post:
2017-06-23
Brief Title:
Evaluating an Intervention to Increase Use of Call Centre Support for Self-managed Medical Abortion
Sponsor:
Marie Stopes International
Organization:
Marie Stopes International
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 centres
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
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 centres
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None