Structured Online Contraceptive Counseling at Emergency Contraception Pharmacy Provision - A Cluster Randomized Crossover Trial - (The LOWEC Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Use of effective contraception
研究概览
简要总结
To increase sexual and reproductive health and rights through the improvement of contraceptive counseling and easy access to service and, thus, women's use of effective contraceptives after purchase of an emergency contraceptive pill (ECP).
详细描述
This pragmatic cluster randomised cross-over controlled trial aims to determine whether the composite intervention of online contraceptive counseling at the time of a pharmacy provision of emergency contraceptive pill (ECP), plus an invitation to a sexual and reproductive health clinic, will result in increased use of subsequent effective contraception (hormonal or intrauterine) compared with standard care.
The study will be conducted at approximately 30 pharmacies in the Stockholm Region. Clients who will buy an ECP (without prescription) at one of these pharmacies will be invited by posters and pharmacy personnel to participate in the study. By scanning a quick response (QR) code they will receive more information about the study. Eligible women who choose to participate in the study and give their consent will be allocated to intervention or control group depending on the visited pharmacy's allocation.
Participants at the intervention pharmacies will receive an intervention package with online structured contraceptive counseling followed by an online invitation to a clinic for contraceptive provision. While participants at the control pharmacies will purchase the ECP without any further guidance. The order in which the pharmacies will provide the intervention or control will be randomly assigned at a ratio 1:1 by an independent statistician. The recruitment will halter for an intervening period of at least two weeks when the pharmacies switch to the new group depending on their first allocation (cross-over).
An online baseline questionnaire and follow-up questionnaires will be collected at 1 and 12 months following the ECP provision for participants both from intervention and control pharmacies.
The randomized controlled trial will be conducted together with a process evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women >/=15 years visiting a pharmacy to buy ECP for her own use
- •Has a smartphone with an electronic identification and ability to scan a QR code
- •Ability to read Swedish or English
- •Willing and able to provide informed consent
- •Willing to participate in the follow-up
排除标准
- •* Ongoing pregnancy
研究组 & 干预措施
Online counseling and invitation
Participants receive structured online contraceptive counseling and an online invitation to a clinic for contraceptive provision
干预措施: Online counseling and invitation (Other)
Control
Participants receive standard praxis i.e. no contraceptive counseling or online invitation
结局指标
主要结局
Use of effective contraception
时间窗: at 1 month follow-up from the pharmacy visit
Participant´s self-reported use in a digital questionnaire of regular effective contraception (hormonal or intrauterine)
次要结局
- Contraceptive use(within 12 months follow-up)
- Incidence of pregnancy and abortion(within 12 months follow-up)
- Satisfaction with the intervention(At 1 month follow-up from the pharmacy visit)
- Contraceptive use, pregnancy, abortion and satisfaction in vulnerable groups(within 12 months follow-up)
- Process evaluation(within 12 months follow-up)
研究者
Karin Emtell Iwarsson
Registered nurse-midwife, PhD, Principal Investigator
Karolinska Institutet