PrEP Rapid Access: An Open Pilot Study- Phase 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of participants enrolled
研究概览
简要总结
The goal of phase 1 is to determine the feasibility and acceptability of an intervention ('Rapid PrEP Access') providing people who use drugs (PWUD) one-time access to HIV self-testing at the Victory Program.
Aim 1: To offer HIV self-testing to PWUD in the community through a study called 'Rapid PrEP Access'. The study will be carried out at the Victory Program.
Aim 2: To determine the feasibility and acceptability of 'Rapid PrEP Access' at the Victory Program.
详细描述
For phase 1 of the study, participants will be recruited for a one-time baseline interview and HIV self-testing. A questionnaire will also be administered to assess their interest in the HIV prevention pill (PrEP= pre-exposure prophylaxis), but PrEP will not be offered. Study duration for each participant is one day; participants will not be followed over time.
After the prescreener and consent forms are completed, the Research Assistant (RA) will offer the participant an opportunity to administer an HIV self-test. The participant will be provided the test for unboxing and retrieving the user instructions.
All testing will be performed and interpreted by participants. The RA can provide assistance with reading the instruction on how to obtain a proper sample. Alternatively, the RA will direct them to information in the package insert which includes support offered by the OraQuick® Support Center.
After completing the HIVST, the RA will complete the baseline questionnaire with each participant while waiting for the participants' HIVST results. After the baseline questionnaire is complete, the RA will conduct satisfaction surveys to assess acceptability of the intervention and interest of PrEP initiation using REDCap.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Opioid use that was not prescribed by a health professional in the past 6 months
排除标准
- •Pregnant women
- •Persons with previous HIV diagnosis
- •Individuals currently taking PrEP
- •Individuals who express desire to harm themselves or others
研究组 & 干预措施
PrEP Rapid Access
Participants who are at risk of HIV and being seen at the Victory Program's Mobile Prevention Services Van.
干预措施: PrEP Rapid Access (Other)
PrEP Rapid Access
Participants who are at risk of HIV and being seen at the Victory Program's Mobile Prevention Services Van.
干预措施: HIV self-testing (Other)
PrEP Rapid Access
Participants who are at risk of HIV and being seen at the Victory Program's Mobile Prevention Services Van.
干预措施: Dried blood spot testing (Other)
结局指标
主要结局
Number of participants enrolled
时间窗: 12 months
Feasibility will be assessed by the number of participants enrolled
Acceptability of PrEP rapid Access
时间窗: Through study completion, an average of 1 year
Participants will rate PrEP Rapid Access' acceptability using an investigator-developed scale ranging from 1 to 5 where 1= not acceptable and 5 is very acceptable.
次要结局
- Number of participants interested in initiating PrEP(Through study completion, an average of 1 year)
- Number of participants who perform HIV self-test(Through study completion, an average of 1 year)