Pharmacies Clinical Trial
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03545321 -
RESPOND TO PREVENT: Stepwise Pharmacy Naloxone Study
|
N/A |