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
试验速览
- 阶段
- 不适用
- 入组人数
- 1,359
- 主要终点
- Self-reported use of call centre in past two weeks
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
- •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
- •Not pregnant
- •Pro-choice
- •Not current or former employees of pharmacies
- •Not related to current or former employees of pharmacies
排除标准
- 未提供
结局指标
主要结局
Self-reported use of call centre in past two weeks
时间窗: Day 14 after taking the first pill
Participant called MSZ call centre after purchasing the medication.
Self-reported satisfaction with self-administration of MA
时间窗: 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.
Self-reported use of a correct regimen of MA
时间窗: 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
次要结局
- Cost of intervention per unit of call centre use(Day 14 after taking first pill)
- Self-reported abortion completion rate(Day 14 and day 60 after taking first pill)
- Self-reported uptake of post-abortion family planning(Day 14 after taking first pill)
- Self-reported complication rate(Day 14 after taking first pill)