High-yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya (GIRLS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,198
- 试验地点
- 1
- 主要终点
- Number of Newly Diagnosed Adolescent Girls and Young Women Living With HIV
研究概览
简要总结
Knowledge of HIV status is a first step towards accessing HIV care, treatment, and prevention services.The GIRLS study will rigorously compare two 'seek' recruitment strategies, three 'test' strategies, and two enhancements to an adaptive (SMART trial design) 'linkage' to care intervention, among young at-risk women, 15-24 years old, in Homa Bay County, western Kenya. Additionally, we will evaluate a scalable primary prevention messaging intervention to support identified HIV-negative young women in reducing HIV risk and adhering to recommended HIV re-testing recommendations. We will also conduct an economic evaluation, using cost effectiveness analyses to determine the relative utility of each seek, test, link, and prevention interventions.
Lessons learned will inform Government of Kenya, and other key policymakers, implementing partners and agencies throughout sub-Saharan Africa that are exploring policies about appropriate scale up of these multiple seek, test, link, retain, and prevention strategies to realize the dream of an AIDS-free future for adolescent girls and young women.
详细描述
The GIRLS study will inform best practices to increase adolescent girls and young women's uptake of HIV prevention, testing, and linkage for HIV to care services in a high-HIV burden African setting to optimize engagement in both the HIV prevention and care continua.
Aim 1: To determine the preferred recruitment venue and testing modality that targets and finds the highest number of HIV infected and at risk female youth aged 15-24 years in Homa Bay County, Nyanza region, western Kenya.
- This will be determined by examining the uptake and yield of previously undiagnosed HIV infection of the two (2) 'seek' strategies (community or home-based) and the three (3) 'test' strategies (self-testing, HIV testing services (HTS) in a home/mobile setting, or facility-based HTS) among female youth;
Aim 2: (a) To pilot and evaluate an adaptive intervention to link newly diagnosed HIV-positive female youth to treatment and care services; and (b) To identify barriers and facilitators to seeking HIV care services after receiving a positive diagnosis; (c) To identify barriers and facilitators to seeking HIV prevention services for high risk female youth after receiving a negative HIV test result; (d) To provide an HIV prevention intervention to a randomly selected subset of high risk negatives, and to re-test them; and
Aim 3: To conduct an economic evaluation, using cost effectiveness analyses to determine the relative utility of each seek, test, link, and prevention intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
We utilized an approach called permuted blocks randomization for participant assignment to the SMART trial linkage to care intervention.
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Able to understand spoken English or Kiswahili or Dholuo
- •Resides in Homa Bay County
- •Not previously diagnosed as HIV positive
- •Willing to give informed consent or if younger than 18 years of age has a parent or guardian willing to provide consent in addition to the minor's assent
排除标准
- •Unable to understand spoken English, or Kiswahili or Dholuo
- •Females who do not meet age inclusion criteria
- •Resides outside of Homa Bay County
- •HIV positive
- •If under 18 and not an emancipated minor, unable to get parental consent
结局指标
主要结局
Number of Newly Diagnosed Adolescent Girls and Young Women Living With HIV
时间窗: Baseline
Our primary outcome for comparisons of recruitment and testing strategies was the number of newly diagnosed adolescent girls and young women living with HIV.
次要结局
- SMART Trial Pilot to Link Newly Diagnosed Adolescent Girls and Young Women to HIV Care Services.(Baseline to about 6 weeks)