Surratt Hilary L, Brown Sarah, Burton Abby L, Cranford Will, Fanucchi Laura C, Green Christie, Mersch Stephanie M, Rains Rebecca, Westgate Philip M
Center on Drug and Alcohol Research, University of Kentucky, 845 Angliana Avenue, #105, Lexington, KY 40508, USA.
Appalachian Regional Healthcare, Barbourville, KY, USA.
Ther Adv Infect Dis. 2025 Jan 29;12:20499361251314766. doi: 10.1177/20499361251314766. eCollection 2025 Jan-Dec.
Kentucky is one of seven states with high, sustained rural HIV transmission tied to injection drug use. Expanding access to pre-exposure prophylaxis (PrEP) has been endorsed as a key HIV prevention strategy; however, uptake among people who inject drugs (PWID) has been negligible in rural areas. Syringe services programs (SSPs) have been implemented throughout Kentucky's Appalachian region, providing an important opportunity to integrate PrEP services.
The primary objective was to examine preliminary efficacy and effect sizes of the study interventions on PrEP initiation among HIV-negative PWID.
Parallel group randomized controlled trial.
Eighty participants were enrolled from two rural SSP locations in southeastern Kentucky. Following informed consent, participants completed a baseline interview, and were randomized to the intervention comparators. The primary endpoint was PrEP initiation, measured by dispensed PrEP prescription, within the 6-month study period. Analyses employed intent-to-treat (ITT) and per protocol approaches.
In total, 77/80 enrollees (96.2%) completed at least one session of their assigned intervention, regardless of trial arm. Seventy (87.5%) were linked to the embedded PrEP provider for the initial clinical visit; 38 (47.5%) completed a follow-up clinical visit with the provider, 22 (27.5%) were issued a prescription, and 7 (8.8%) initiated PrEP during the study period. We observed a 12.1% difference (14.6% vs 2.5%; ITT) and 12.8% difference (15.4% vs 2.6%; per protocol) in the primary outcome (PrEP initiation), in favor of the experimental intervention.
This pilot trial established proof of concept for integrated PrEP care within SSPs in rural areas, and demonstrated a clinically meaningful difference in PrEP initiation between interventions, which warrants examination in a larger trial. Rates of early care discontinuation indicate a need for ongoing patient engagement strategies and implementation support for community SSPs.
Prospective registration with ClinicalTrials.gov, NCT05037513 (registered August 5, 2021).
肯塔基州是与注射吸毒相关的农村地区艾滋病毒持续高传播率的七个州之一。扩大暴露前预防（PrEP）的可及性已被认可为一项关键的艾滋病毒预防策略；然而，农村地区注射吸毒者（PWID）对其的接受程度一直微乎其微。肯塔基州的阿巴拉契亚地区已全面实施了注射器服务项目（SSP），这为整合PrEP服务提供了重要契机。
主要目的是研究该研究干预措施对艾滋病毒阴性的注射吸毒者启动PrEP的初步疗效和效应大小。
平行组随机对照试验。
从肯塔基州东南部的两个农村注射器服务项目地点招募了80名参与者。在获得知情同意后，参与者完成了基线访谈，并被随机分配到干预比较组。主要终点是在6个月的研究期内通过发放的PrEP处方来衡量的PrEP启动情况。分析采用意向性分析（ITT）和符合方案分析方法。
总体而言，80名参与者中有77名（96.2%）完成了至少一次其分配的干预疗程，无论试验分组情况如何。70名（87.5%）参与者在初次临床就诊时与内设的PrEP服务提供者取得联系；38名（47.5%）完成了与该服务提供者的随访临床就诊，22名（27.5%）获得了处方，7名（8.8%）在研究期间启动了PrEP。我们观察到主要结局（PrEP启动）存在12.1%的差异（14.6%对2.5%；ITT）以及12.8%的差异（15.4%对2.6%；符合方案分析），有利于实验性干预措施。
这项试点试验确立了在农村地区注射器服务项目内整合PrEP护理的概念验证，并证明了干预措施在PrEP启动方面存在具有临床意义的差异，这值得在更大规模的试验中进行检验。早期护理中断率表明需要持续的患者参与策略以及对社区注射器服务项目的实施支持。
在ClinicalTrials.gov进行前瞻性注册，NCT05037513（2021年8月5日注册）。
