Improving Uptake and Adherence to HIV Prevention Services With PrEP, HIV Self- Testing and Adherence Support for Very High Risk HIV-negative Young Women Aged 15-24 in Kampala, Uganda
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Adherence to PrEP
研究概览
简要总结
The main aim is to develop and assess an intervention to enhance initiation and adherence to PrEP among HIV negative young women of high risk (YWHR). The specific aims are (1) To conduct formative research to enhance our understanding of the dynamics of the social and sexual networks, and context of young HIV-uninfected women (aged 15-24) engaged in high risk sexual behavior in Kampala, Uganda (2) Document barriers and opportunities for PrEP uptake and adherence as well as repeat HIV testing by self test; (3) To develop and test a socially and culturally acceptable and feasible prevention intervention on uptake and adherence to PrEP and HIV self-testing for young women at high risk for HIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Female age 15- to 24-years old
- •Engaging in high-risk sexual behavior having had sex at least once in last three months, --HlV-negative
- •Agree to participate in a minimum of four interviews over a 12-month period; including baseline
- •Willing to receive services at Good Health for Women Project (GHWP)
- •For those initiating PrEP (Truvada):
- •Participants should have immunity to Hepatitis B infection and serum creatinine before
- •Contra-indications for starting Truvada to be considered include Creatinine > 1.2 ( (mgldl) or 0.106 (mmolil) and a weight below 35kg.
排除标准
- •Inability to consent to participation in the study
- •Condition impeding participation in the study, including severe mental reason to the discretion of the principal investigator, cognitive impairment or illness; serious medical illness or developmental disability and any other reason to the discretion of the principal investigator.
研究组 & 干预措施
intervention
participants will receive a behavioral intervention including counseling and offer of HIV oral fluid self test and PrEP
干预措施: POPPi (Behavioral)
comparison
participants will be not be offered HIV oral fluid self test but receive counseling, condoms and offered PrEP
干预措施: Comparison (Behavioral)
结局指标
主要结局
Adherence to PrEP
时间窗: 12 months
Adherence to PrEP using hair analysis measured by the concentration of antiretroviral drug in strands of hair. The results will be measured per participant using concentration in nanograms/milligrams. The number of participants who showed a positive drug concentration in nanograms/milligrams is reported.
Initiation of PrEP
时间窗: 6 months
Initiation of PrEP using the pharmacy records indicating PrEP received by participants.
Initiation of PrEP
时间窗: 6 months
Initiation of PrEP using the pharmacy records indicating PrEP received by participants.
Adherence to PrEP
时间窗: 12 months
Adherence to PrEP using hair analysis measured by the concentration of antiretroviral drug in strands of hair. The results will be measured per participant using concentration in nanograms/milligrams. The number of participants who showed a positive drug concentration in nanograms/milligrams is reported.
次要结局
未报告次要终点