跳至主要内容
临床试验/NCT07781423
NCT07781423尚未招募不适用

Nurse-Led Rapid Initiation of HIV Pre-Exposure Prophylaxis Care Among Incarcerated Individuals With Continuation of Care Services Post-Incarceration

Rhode Island Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Intervention Feasibility assessed with Exit Interviews

研究概览

简要总结

PrEP is a medication that can help prevent the spread of HIV, but many who might benefit from PrEP do not take it. Individuals experiencing incarceration are interested in starting PrEP while incarcerated, but there are challenges that make it difficult for them to start this medication when they return to the community. This study will test to see if a nurse-led, same-day PrEP start program can help individuals experiencing incarceration start and stay on PrEP. To do this, N = 90 PrEP-eligible patients during their incarceration will test the nurse-led program. Everyone will receive access to a nurse-led behavioral intervention during incarceration and information about PrEP services available in the community. Then, N = 60 participants will receive patient navigation support to help them link with PrEP care in the community and N = 30 participants will receive a list of community resources. Research interviews will be conducted with participants while they are incarcerated and 1, 3, and 6 months after they re-enter the community. Participants are offered compensation for each of the research interviews.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Currently incarcerated at the Rhode Island Department of Corrections
  • At least 18 years of age
  • Not currently pregnant
  • Eligible for PrEP
  • No PrEP use in the 90 days prior to incarceration
  • Interested in starting PrEP
  • Report any criminalized drug use or at least one heavy drinking day in the 90 days prior to incarceration
  • Likely to be incarcerated for more than a week but less than 6 months
  • Able to understand and speak English and provide written and verbal informed consent

排除标准

  • 未提供

结局指标

主要结局

Intervention Feasibility assessed with Exit Interviews

时间窗: 6-Month Follow-up

Participant eligibility rate, enrollment rate, rate of recruitment, and follow-up completion rate will serve as indices of intervention feasibility and will be compiled at the conclusion of the study. In exit interviews with NAV participants, feedback will be solicited regarding the feasibility of the intervention.

Intervention Acceptability assessed with the Client Satisfaction Questionnaire-Revised

时间窗: 6-Month Follow-up

The 8-item Client Satisfaction Questionnaire-Revised will be administered to participants to assess intervention acceptability. Total scores range from 8 to 32, with higher scores representing greater intervention acceptability.

Linkage to Community-Based PrEP Care assessed with medical record review

时间窗: 1, 3, & 6-Month Follow-ups

Operationalized as receipt of prescription from a community-based provider within 6 months of release from incarceration. This will be verified through medical record review.

次要结局

  • PrEP Care Retention(3 & 6-Month Follow-up)
  • PrEP Adherence assessed with 3-item adherence measure(1, 3, & 6-Month Follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验