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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:
The details of the programme intervention will be finalised following an intervention design workshop but the main components will be as follows:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control pharmacy | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost of intervention per unit of call centre use | Increased unit cost of intervention per increased unit of call centre use. | Day 14 after taking first pill |
| Self-reported abortion completion rate |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of pharmacy workers encouraging mystery clients to use the MSZ call centre number | 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. |
Inclusion Criteria:
Pharmacies:
MA users:
Mystery clients:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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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 | 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 | 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 |
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 | MA users' self-reported reasons for calling or not calling the call centre. | Day 14 after taking first pill |