Hilary L Surratt, Sarah Brown, Abby L Burton, Will Cranford, Laura C Fanucchi, Christie Green, Stephanie M Mersch, Rebecca Rains, Philip M Westgate
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Syringe services programs (SSPs) have been implemented throughout Kentucky's Appalachian region, providing an important opportunity to integrate PrEP services.</p><p><strong>Objectives: </strong>The primary objective was to examine preliminary efficacy and effect sizes of the study interventions on PrEP initiation among HIV-negative PWID.</p><p><strong>Design: </strong>Parallel group randomized controlled trial.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>Prospective registration with ClinicalTrials.gov, NCT05037513 (registered August 5, 2021).</p>","PeriodicalId":46154,"journal":{"name":"Therapeutic Advances in Infectious Disease","volume":"12 ","pages":"20499361251314766"},"PeriodicalIF":3.8000,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11780651/pdf/","citationCount":"0","resultStr":"{\"title\":\"Outcomes of a pilot randomized clinical trial testing brief interventions to increase HIV pre-exposure prophylaxis uptake among rural people who inject drugs attending syringe services programs.\",\"authors\":\"Hilary L Surratt, Sarah Brown, Abby L Burton, Will Cranford, Laura C Fanucchi, Christie Green, Stephanie M Mersch, Rebecca Rains, Philip M Westgate\",\"doi\":\"10.1177/20499361251314766\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>The primary objective was to examine preliminary efficacy and effect sizes of the study interventions on PrEP initiation among HIV-negative PWID.</p><p><strong>Design: </strong>Parallel group randomized controlled trial.</p><p><strong>Methods: </strong>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. 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引用次数: 0
摘要
背景：肯塔基州是与注射毒品使用相关的农村HIV高持续传播的七个州之一。扩大接触前预防（PrEP）的可及性已被认可为一项关键的艾滋病毒预防战略；然而，在农村地区，注射吸毒者（PWID）的吸收量微不足道。注射器服务项目（ssp）已经在肯塔基州的阿巴拉契亚地区实施，为整合PrEP服务提供了重要的机会。目的：主要目的是检查研究干预措施对hiv阴性PWID中PrEP启动的初步疗效和效应量。设计：平行组随机对照试验。方法：80名参与者来自肯塔基州东南部的两个农村SSP地点。在知情同意后，参与者完成基线访谈，并随机分配到干预比较组。主要终点是在6个月的研究期间，通过分配的PrEP处方来衡量PrEP的起始。分析采用意向治疗（ITT）和每个协议方法。结果：无论试验组如何，总共有77/80的入组者（96.2%）完成了至少一个疗程的指定干预。70例（87.5%）与嵌入式PrEP提供者进行首次临床访问；在研究期间，38名（47.5%）完成了与提供者的随访临床访问，22名（27.5%）获得了处方，7名（8.8%）开始了PrEP。我们观察到12.1%的差异(14.6% vs 2.5%；ITT)和12.8%的差异(15.4% vs 2.6%；在主要结局（PrEP启动）中，支持实验性干预。结论：该试点试验证明了在农村地区ssp中进行综合PrEP护理的概念，并证明了不同干预措施在PrEP启动方面具有临床意义的差异，值得在更大规模的试验中进行检查。早期护理中断率表明需要持续的患者参与战略和对社区社会服务提供者的实施支持。试验注册：ClinicalTrials.gov前瞻性注册，编号NCT05037513（于2021年8月5日注册）。
Outcomes of a pilot randomized clinical trial testing brief interventions to increase HIV pre-exposure prophylaxis uptake among rural people who inject drugs attending syringe services programs.
Background: 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.
Objectives: The primary objective was to examine preliminary efficacy and effect sizes of the study interventions on PrEP initiation among HIV-negative PWID.
Design: Parallel group randomized controlled trial.
Methods: 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.
Results: 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.
Conclusion: 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.
Trial registration: Prospective registration with ClinicalTrials.gov, NCT05037513 (registered August 5, 2021).
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