PrEParing Family Planning Clinics to Streamline Integration of HIV Prevention Services for Young Women in Kenya
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25,457
- 试验地点
- 1
- 主要终点
- Proportion of women accessing family planning services who are screened for HIV risk
研究概览
简要总结
This a prospective, open-label implementation project to catalyze integration of HIV prevention and PrEP care services for adolescent girls and young women in family planning clinics in Kenya.
详细描述
Investigators will conduct a stepped-wedge cluster-randomized programmatic project to integrate PrEP provision within a combination HIV prevention package in 12 family planning clinics in Kisumu, Kenya- a region with an HIV prevalence of up to 28% among young women. The project will optimize and sustain PrEP delivery with existing family planning staff, supported through training and ongoing technical assistance. The investigators will rigorously evaluate program reach, effectiveness, adoption, implementation, maintenance, and impact using validated implementation science frameworks and how clinics build new efficient delivery systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female of reproductive age
- •Sexually active
- •Able and willing to provide informed consent
- •HIV negative, according to national HIV testing algorithm
- •Has at least one risk factor for HIV as defined by the Kenya National AIDS and STI Control Program
排除标准
- •- Otherwise not eligible based on the above inclusion criteria
研究组 & 干预措施
PrEP for HIV-1 uninfected for women accessing family planning
Women accessing family planning will be assessed for HIV risk and PrEP eligibility. If eligible and willing to initiate PrEP, they will be provided PrEP in accordance with national guidelines as part of their standard of care at the family planning clinic.
干预措施: PrEP (Drug)
结局指标
主要结局
Proportion of women accessing family planning services who are screened for HIV risk
时间窗: up to 24 months
Measure HIV risk screening completion among women receiving family planning services
Proportion of women accessing family planning services who uptake PrEP for HIV prevention
时间窗: up to 24 months
Measure PrEP initiation among women receiving family planning services
次要结局
- Develop data tools to expand and support delivery of family planning and HIV prevention services(up to 24 months)
- Proportion of family planning clinics that implement PrEP provision(up to 36 months)
- Proportion of targeted providers who are trained and provide PrEP(up to 24 months)
- Facilitators and barriers to PrEP implementation(up to 24 months)
- Proportion of women who remain HIV-negative(up to 24 months)
- Programmatic costs of providing PrEP in family planning clinics(up to 24 months)
- Proportion of core PrEP delivery components delivered per protocol(up to 24 months)
- PrEP adherence quantified by tenofovir drug levels in blood(up to 24 months)
研究者
Kenneth K Mugwanya
Assistant Professor, Global Health, School of Medicine and School of Public Health,
University of Washington