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 拟定的混合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预暴露的移动健康综合症干预（WINGS+PrEP） 社区监督项目（CSP）中妇女的预防（PrEP）启动和依从性 包括缓刑、假释和替代监禁（ATI）计划）， 报告危险饮酒。迄今为止，很少有PrEP干预措施关注顺性别妇女， 没有人针对社区服务提供者中的大量妇女，由于种族化的毒品法， 黑人和拉丁裔的比例很高。为CSP中的妇女推进有效的PrEP干预措施 承诺通过覆盖不成比例的大量黑人和拉丁美洲人， 仍然处于艾滋病毒高风险的妇女。PrEP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，这在危险饮酒的背景下至关重要 和暴力伴侣然而，到目前为止，还没有基于证据的以症状为中心的PrEP干预措施 为妇女解决危险饮酒和IPV暴露问题。拟定的研究干预 (WING+PrEP）是一个3个疗程的综合性重点干预，结合了循证移动健康 酒精筛查、短暂干预和转诊治疗（SBIRT）工具，以及一个基于证据的 mHealth IPV SBIRT工具- WINGS与基于证据的PrEP干预，包括PrEP决策 借助新型同行导航和远程医疗组件提供帮助。将进行拟议的RCT 符合条件的女性将被随机分配到：（1）WINGS+PrEP或（2）单独PrEP 这包括相同的基于证据的PrEP决策辅助单次会议与同行导航。 这两个条件都将由财富协会提供，财富协会是一个大型的社区组织， 妇女在社区服务项目中。将在基线和干预后3、6和12个月进行重复评估。 本研究将遵循PRISM/RE-AIM（S）实施科学框架， 透镜，并将研究如何多层次的背景因素可能会影响范围，有效性，采用， WINGS+PrEP和PrEP的实施，维护和可持续性（RE-AIMS）以及这些 背景因素和过程可能相互作用，促进或阻碍卫生公平。如果发现WINGS+PrEP 为了有效，它的低门槛格式被设计成在全国范围内的CSP环境中扩大规模，以遏制艾滋病毒 艾滋病毒/艾滋病是一个全球性的问题，它有助于减少艾滋病毒感染，并减少来自受严重影响社区的妇女之间的艾滋病毒差距。