An effectiveness trial of WINGS+PrEP: a syndemic mHealth intervention to increase PrEP uptake among women impacted by heavy alcohol use and partner violence in the criminal legal system

WINGS PrEP 的有效性试验：一种同步流行病移动健康干预措施，旨在提高刑事法律系统中受酗酒和伴侣暴力影响的妇女对 PrEP 的采用

• 批准号: 10541692
• 负责人: Anindita Dasgupta
• 金额: $ 76.58万
• 依托单位: COLUMBIA UNIV NEW YORK MORNINGSIDE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10541692
• 关键词: AIDS prevention; Address; Adherence; Adoption; Age; Alcohols; Area; Biological Assay; Black race; Communities; Decision Making; Drug Legislation; Education; Effectiveness; Eligibility Determination; Enrollment; Ethnic Origin; Female; Fortune; General Population; Goals; HIV; HIV Infections; HIV risk; Heavy Drinking; Housing; Hybrids; Imprisonment; Individual; Intervention; Intervention Studies; Latinx; Legal system; Measures; Medical; Medical Records; Multiple Partners; New York City; Not Hispanic or Latino; Outcome; Outcome Study; Participant; Patient Self-Report; Population; Practical Robust Implementation and Sustainability Model; Prevention strategy; Process; Race; Randomized; Randomized Controlled Trials; Reach Effectiveness Adoption Implementation and Maintenance; Recording of previous events; Reduce health disparities; Reporting; Research Personnel; Risk Behaviors; Safety; Severities; Sex Orientation; Societies; Subgroup; Substance Use Disorder; Supervision; Telemedicine; Tenofovir; Testing; Time; Unsafe Sex; Urine; Violence; Wing; Woman; alcohol screening and brief intervention; base; black women; cis-female; comparative cost effectiveness; comparative effectiveness; contextual factors; cost; cost effectiveness; cost efficient; design; digital; effectiveness implementation trial; effectiveness testing; effectiveness trial; effectiveness-implementation RCT; evidence base; follow-up; hazardous drinking; health equity; health inequalities; high risk; high risk population; hybrid type 1 trial; implementation framework; implementation research; innovation; intimate partner violence; lens; literacy; mHealth; novel; parole; partner violence; peer; post intervention; pre-exposure prophylaxis; prevent; primary outcome; probation; programs; racial health disparity; recidivism; scale up; screening, brief intervention, referral, and treatment; secondary outcome; sex; social stigma; syndemic; tool; uptake; violence exposure

PROJECT SUMMARY The proposed hybrid type 1 Effectiveness and Implementation randomized controlled trial (RCT) will evaluate an m-Health syndemic intervention (WINGS+PrEP) that aims to increase HIV pre-exposure prophylaxis (PrEP) initiation and adherence among women in community supervision programs (CSPs) including probation, parole and alternative-to-incarceration (ATI) programs) in New York City (NYC) who report hazardous drinking. To date, very few PrEP interventions, have focused on cis-gender women, and none have targeted the large population of women in CSPs, who due to racialized drug laws, are disproportionately Black and Latinx. Advancing an effective PrEP intervention for women in CSPs holds promise for reducing HIV disparities by reaching a disproportionately large number of Black and Latinx women who remain at high risk for HIV. PrEP presents a unique opportunity for women to engage in a female-controlled HIV prevention strategy, which is vitally important within the context of hazardous drinking and violent partners. To date, however, there are no evidence-based syndemic-focused PrEP interventions for women that address hazardous drinking and IPV exposure. The proposed study intervention (WING+PrEP) is a 3-session syndemic focused intervention that combines an evidence-based mHealth Alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) tool, and an evidence-based mHealth IPV SBIRT tool - WINGS with an evidence-based PrEP intervention that includes a PrEP decision making aid with novel peer navigation and telemedicine components. The proposed RCT will be conducted with 300 women in CSPs Eligible women will be randomly assigned to: (1) WINGS+PrEP or (2) PrEP Alone that consists of the same evidence-based PrEP decision making aid single session with peer navigation. Both conditions will be delivered by Fortune Society a large community based organization that serves women in CSPs. Repeated assessments will occur at baseline and 3, 6, and 12-months post intervention. This study will be guided by the PRISM/RE-AIM(S) implementation science framework with a health equity lens and will examine how multilevel contextual factors may influence the reach, effectiveness, adoption, implementation, maintenance and sustainability (RE-AIMS) of WINGS+PrEP and PrEP and how these contextual factors and processes may interact to promote or impede health equity. If WINGS+PrEP is found to be effective, it's low threshold format is designed to be scaled up in CSP settings nationwide to curb HIV infection and to reduce HIV disparities among women from heavily impacted communities.

项目摘要 拟议的Hybrid 1型有效性和实施随机对照试验（RCT）将 评估旨在增加艾滋病毒前暴露于HIV的M-Health Syndemip Destrive（Wings+Prep） 妇女在社区监督计划（CSP）中的预防（PREP）启动和遵守 包括纽约市（纽约市）的缓刑，假释和替代范围（ATI）计划 报告有害饮酒。迄今为止，很少有准备干预措施专注于顺式性别妇女，并且 由于种族化的毒品法律，没有人针对CSP中众多的CSP妇女人口 黑色和拉丁裔不成比例。推进CSP中女性的有效准备干预措施 通过达到不成比例的黑色和拉丁裔来减少艾滋病毒差异的承诺 仍然处于艾滋病毒高风险的妇女。准备为女性提供了一个独特的机会 女性控制的艾滋病毒预防策略，在危险饮酒的背景下至关重要 和暴力伴侣。但是，迄今 适用于解决有害饮酒和IPV暴露的女性。拟议的研究干预 （WING+PREP）是一种三局联合集合的干预措施，结合了基于证据的MHealth 酒精筛查，简短的干预和转介治疗（SBIRT）工具以及基于证据的工具 MHealth IPV SBIRT工具 - 带有证据的准备干预措施的机翼，其中包括预先决定 提供新颖的同行导航和远程医疗组件。提议的RCT将进行 CSP中有300名女性合格女性将随机分配给：（1）机翼+PREP或（2）单独准备 这包括与同行导航相同的基于证据的预先决策单一会议。 财富协会将提供这两种条件 CSP的女性。干预后的基线以及第3、6和12个月的重复评估将进行。 这项研究将由具有健康公平的Prism/Re-Aim（S）实施科学框架指导 镜头并将研究多层次上下文因素如何影响覆盖范围，有效性，采用， 机翼+和准备的实施，维护和可持续性（Re-Aims）以及这些 上下文因素和过程可能会互动以促进或阻碍健康公平。如果找到翅膀+准备 为了有效，它的低阈值格式设计为在全国范围内的CSP设置中缩放以遏制HIV 感染并减少受影响严重社区的妇女的艾滋病毒差异。