Multi-product PrEP Delivery to Young Women Seeking Reproductive Health Services and Coverage of HIV Prevention
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- PrEP initiation
研究概览
简要总结
Following on the heels of large implementation science projects that participated in the launch of widespread daily oral PrEP availability, investigators will launch and study the integration of novel PrEP products - beginning with the dapivirine ring- into existing PrEP programs that reach women seeking reproductive health care at health facilities in Kenya. Intervention delivery will be launched among 12 participating clinics with approximately 1400 AGYW seeking reproductive health services and counseled about PrEP through a stepped wedge cluster randomized trial. investigators will support participating clinics to add dapivirine ring into their existing PrEP services offered to women seeking reproductive health care. The primary aim of the study will be to determine whether the availability of multiple PrEP products to young women will result in greater frequency of PrEP initiation and persistence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •for Adolescent Girls and Young Women seeking reproductive health services:
- •Age ≥18 years and ≤30years. Seeking a reproductive health service from one of the project facilities (reproductive health services include but are not limited to family planning, maternal and child health, postnatal care).
- •AGYW receiving reproductive health-related services through OPD, or other departments are eligible. AGYW receiving reproductive health-related services through other departments are eligible.
- •Willing and able to partake in an informed consent process. Able to speak and read in Kiswahili or English.
排除标准
- 未提供
研究组 & 干预措施
Multiple Product PrEP Program
In the intervention phase, clinics will offer a multi-product PrEP program, which includes daily oral PrEP and other forms of PrEP that are available. To start, the dapivirine vaginal ring will be included among the other forms of PrEP that are available. Others will be added as they become available in Kenya.
干预措施: Multiple Product PrEP Program (Drug)
Routine PrEP Program
In the active comparator, clinics will offer the standard of care PrEP Program, which includes daily oral PrEP for young women.
干预措施: Routine Oral PrEP (Drug)
Multiple Product PrEP Program
In the intervention phase, clinics will offer a multi-product PrEP program, which includes daily oral PrEP and other forms of PrEP that are available. To start, the dapivirine vaginal ring will be included among the other forms of PrEP that are available. Others will be added as they become available in Kenya.
干预措施: Routine Oral PrEP (Drug)
结局指标
主要结局
PrEP initiation
时间窗: From enrolment to 6 months
Women who start to use PrEP
次要结局
- PrEP persistence at 3 months(From enrolment to 3 months)
研究者
Renee Heffron
Professor
University of Alabama at Birmingham