A 12-month Open-label Randomized Controlled Trial to Evaluate Sayana® Press Suitability for at Home Subcutaneous Self-injection Procedures in Adult Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- FHI 360
- 入组人数
- 735
- 试验地点
- 1
- 主要终点
- To compare continuation rates between women who self-inject Sayana Press compared to women who receive Sayana Press injection from a provider
研究概览
简要总结
The feasibility of Sayana Press self-injection and the potential for this practice to increase contraceptive continuation has never been assessed in family planning programs in low-resource settings. The Malawi Ministry of Health (MOH) and the United States Agency for International Development (USAID) Malawi Mission requested the Advancing Partners and Communities (APC) project to assess self-injection of Sayana Press to inform their decision-making for procurement of Sayana Press and distribution through the health system in Malawi.
详细描述
Sayana® Press is a subcutaneous formulation of depot medroxyprogesterone acetate (DMPA) in a prefilled, auto-disabled injection system called Uniject (Pfizer, Inc., USA). Sayana Press was registered with the Medicines and Health Care Products Regulatory Agency (MHRA) and several other national regulatory agencies. The addition of this method is anticipated to aid in improving provision of family planning services in low-resource settings. As such, Sayana Press could be particularly useful in a country such as Malawi where injectable contraception is the most common method used. DMPA clients and providers are ready to explore the potential of self-injection of Sayana Press. A study conducted in a large family planning clinic in Edinburgh, Scotland found self-administration of DMPA-SC feasible and associated with similar continuation rates and satisfaction to clinician-administered DMPA-IM. A non-comparison study conducted in Planned Parenthood clinics in Florida found continuation of self-injected DMPA-SC high (74%) at the fourth injection. Participants in this study reported the injection to be easy and convenient and were likely to recommend self-administration to other women. Moreover, on September 29, 2014 Pfizer submitted a request to the MHRA to change the Sayana Press label to include self-injection.
If self-injection is found feasible, the results from this research will inform self-injection training materials, messages for providers and clients, and future scale-up efforts in Malawi and elsewhere in sub-Saharan Africa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-40, inclusive
- •In general good health (participant verbally reports she feels well)
- •Able to understand and willing to sign an informed consent document
- •Willing to give contact information for follow-up
- •Agree to have follow-up visits/interviews
- •Willing to be randomized to the self-injection arm or provider-administered injection arm
- •Menstrual period started within the past 7 days (for new DMPA users)
- •Meet eligibility criteria for receiving DMPA per WHO Medical Eligibility Criteria (MEC)
排除标准
- •Plans to become pregnant in the next 12 months
- •Plans to relocate outside the study area in the next 12 months
- •Any condition (social or medical) which in the opinion of the investigator would make study participation unsafe or would interfere with adherence to study requirements or complicate data interpretation
研究组 & 干预措施
self-injection
Women randomized to this arm will be trained to self-inject Sayana Press at home every three months
干预措施: Sayana Press (Drug)
provider injection
Women randomized to this arm will received Sayana press from a family planning provider every three months.
干预措施: Sayana Press (Drug)
结局指标
主要结局
To compare continuation rates between women who self-inject Sayana Press compared to women who receive Sayana Press injection from a provider
时间窗: up to 12 months
Discontinuation of Sayana Press measured at enrollment and every three months through one year
次要结局
- To compare reported side effects between the two study groups(up to 12 months)
- To compare pregnancy rates between the two study groups(12 months)