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临床试验/NCT06666309
NCT06666309Enrolling By Invitation不适用

Optimizing PrEP Care Delivery Through Adaptive Intervention Strategies for Underserved Rural People Who Inject Drugs

Hilary L Surratt, PhD4 个研究点 分布在 1 个国家目标入组 424 人开始时间: 2025年5月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
424
试验地点
4
主要终点
Number of participants initiating PrEP

研究概览

简要总结

During this 5-year study, stepped-care adaptive interventions will be deployed in three rural syringe service programs in a Sequential Multiple Assignment Randomized Trial (SMART) design to test the optimal intervention pathways for HIV PrEP uptake, defined as PrEP initiation (measured by dispensed prescription for oral PrEP) and persistence in PrEP care (measured by refill verification and biomarker confirmation). The study will be accomplished through three Specific Aims. AIM 1: Compare the relative effectiveness of adaptive interventions (AIs) that begin with Peer-led SBCM-PrEP versus those that begin with CDC-PrEP education plus text messaging (TM) on patient-level PrEP care outcomes (initiation and persistence) at 1-, 3- and 6-months; AIM 2: Estimate and rank the effectiveness of four embedded AIs on PrEP care outcomes at 3- and 6-months: (1) CDC-PrEP education, continue TM for responders, add Mobile Outreach for non-responders (NR); (2) CDC-PrEP education, continue TM for responders, add Peer transitional SBCM for NR; (3) Peer-led SBCM-PrEP, continue TM for responders, add Mobile Outreach for NR; (4) Peer-led SBCM-PrEP, continue TM for responders, add Peer transitional SBCM for NR. AIM 3: Across interventions, examine the effects of age, baseline injection frequency, perceived HIV risk, PrEP interest, SSP utilization patterns, and other factors, in predicting PrEP care outcomes at 1-, 3- and 6-months to inform optimally-tailored intervention strategy recommendations.

详细描述

Kentucky's HIV epidemic displays an especially profound and disproportionate impact among people who inject drugs (PWID): 14.8% of males and 54.2% of females newly diagnosed with HIV in 2021 have an injection drug use-related transmission factor, far exceeding the national average for this exposure category. A central pillar of Ending the HIV Epidemic (EHE) is the prevention of new HIV infections through scale up of Pre-Exposure Prophylaxis (PrEP) in key populations, including PWID. For PWID, PrEP uptake remains severely limited, and no evidence-based PrEP interventions specifically targeted for PWID are available. In the previous pilot in KY's Appalachian region, two brief, low-intensity interventions to promote linkage to co-located PrEP care in rural syringe service programs (SSPs) were successfully implemented, including a newly adapted strengths-based case management (SBCM-PrEP) intervention designed to address multi-level barriers to PrEP initiation. The pilot trial has demonstrated proof of concept for integrated PrEP care within rurally-located SSPs and high acceptability among PWID with high uptake of initial clinical interventions. Nevertheless, just 51% returned for test results, and 28% progressed to PrEP prescription, indicating that augmented intervention support is required to optimize PrEP uptake. The stepped-care Adaptive Interventions (AIs) to be tested respond directly to identified challenges in the pilot trial and the need for augmented support among initial non-responders. AIs have shown remarkable promise in diverse behavioral and medical conditions, including areas such as chronic lower back pain, risky drinking and violent behavior, reducing alcohol use, preventing suicidal behavior, and HIV treatment retention

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
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
是

入选标准

  • •self-report of at least one occasion of injection drug use in the past month
  • •use of the SSP in the past 30 days
  • •expressed willingness to participate in a multi-session intervention and follow-up
  • •having an indication for PrEP in the past 6 months based on CDC guidelines

排除标准

  • •being HIV positive
  • •current PrEP care
  • •self-reported severe renal impairment and/or chronic HBV infection

研究组 & 干预措施

CDC-PrEP + Text Messaging

Active Comparator

1 session PrEP education following CDC guidelines delivered to individual clients in the syringe service program

干预措施: CDC-PrEP + Text Messaging (Behavioral)

Strengths Based Case Management - PrEP + Text Messaging

Experimental

Two session Strengths-based Case Management intervention delivered by a peer support specialist to individual clients in the syringe service program

干预措施: SBCM-PrEP + Text Messaging (Behavioral)

Strengths Based Case Management - PrEP + Text Messaging + Peer Transitional SBCM (T-SBCM)

Experimental

SBCM-PrEP + Text Messaging no response by end of month 1, and randomized to rup to 2 sessions of post-linkage transitional SBCM delivered by a peer support specialist

干预措施: SBCM-PrEP + Text Messaging (Behavioral)

Strengths Based Case Management - PrEP + Text Messaging + Peer Transitional SBCM (T-SBCM)

Experimental

SBCM-PrEP + Text Messaging no response by end of month 1, and randomized to rup to 2 sessions of post-linkage transitional SBCM delivered by a peer support specialist

干预措施: T-SBCM (Behavioral)

Strengths Based Case Management - PrEP + Text Messaging + Mobile outreach

Experimental

SBCM-PrEP + Text Messaging no response by end of month 1, and randomized to up to 2 sessions of post-linkage field session visits delivered by a peer support specialist

干预措施: SBCM-PrEP + Text Messaging (Behavioral)

Strengths Based Case Management - PrEP + Text Messaging + Mobile outreach

Experimental

SBCM-PrEP + Text Messaging no response by end of month 1, and randomized to up to 2 sessions of post-linkage field session visits delivered by a peer support specialist

干预措施: Mobile Outreach (Behavioral)

CDC-PrEP + Text Messaging + Peer Transitional SBCM (T-SBCM)

Other

CDC-PrEP + Text Messaging; no response by end of month 1, and randomized to rup to 2 sessions of post-linkage transitional SBCM delivered by a peer support specialist

干预措施: CDC-PrEP + Text Messaging (Behavioral)

CDC-PrEP + Text Messaging + Peer Transitional SBCM (T-SBCM)

Other

CDC-PrEP + Text Messaging; no response by end of month 1, and randomized to rup to 2 sessions of post-linkage transitional SBCM delivered by a peer support specialist

干预措施: T-SBCM (Behavioral)

CDC-PrEP + Text Messaging + Mobile outreach

Other

CDC-PrEP + Text Messaging no response by end of month 1, and randomized to up to 2 sessions of post-linkage field session visits delivered by a peer support specialist

干预措施: CDC-PrEP + Text Messaging (Behavioral)

CDC-PrEP + Text Messaging + Mobile outreach

Other

CDC-PrEP + Text Messaging no response by end of month 1, and randomized to up to 2 sessions of post-linkage field session visits delivered by a peer support specialist

干预措施: Mobile Outreach (Behavioral)

结局指标

主要结局

Number of participants initiating PrEP

时间窗: 6 month post-baseline

Documented PrEP initiation, measured by dispensed prescription

Number of participants initiating PrEP

时间窗: 1 month post-baseline

Documented PrEP initiation, measured by dispensed prescription

Number of participants initiating PrEP

时间窗: 3 months post-baseline

Documented PrEP initiation, measured by dispensed prescription

次要结局

  • Linkage to PrEP Care(6 month post-baseline)
  • PrEP Persistence(6 months post-baseline)
  • PrEP Adherence(6 months post-baseline)
  • PrEP Persistence(3 months post-baseline)
  • Linkage to PrEP Care(1 month post-baseline)
  • Linkage to PrEP Care(3 month post-baseline)
  • PrEP Adherence(3 months post-baseline)

研究者

发起方
Hilary L Surratt, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hilary L Surratt, PhD

Professor

University of Kentucky

研究点 (4)

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