RFA-PS-21-001 Development and Pilot Testing of an Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders

RFA-PS-21-001 针对患有物质使用障碍的女性的基于成瘾临床的 PrEP 依从干预措施的开发和试点测试

• 批准号: 10625403
• 负责人: Angela Heads
• 金额: $ 35万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10625403
• 关键词: RFA; PS; 21; 001; Development

Ethnic-minority women continue to bear a disproportionate burden of the health and social consequences of HIV. However, research on effective interventions for engaging women with substance use disorders (SUD) in HIV prevention interventions is lacking. Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention tool but is not widely used by ethnic minority women. According to the Centers for Disease Control and Prevention, in 2016 only 2.1% of the women estimated to have PrEP indications filled PrEP prescriptions. This highlights a significant unmet prevention need. For women who do take PrEP, low adherence to the medication regimen decreases the medication’s ability to prevent HIV. The reasons for low uptake and adherence among women are not completely understood. Based on our work and that of others, individual-level barriers include lack of awareness of personal HIV risk, low knowledge of PrEP, and concerns about stigma. System-level barriers include difficulty accessing providers knowledgeable and willing to prescribe PrEP. The overarching goal of this research is to develop and pilot test an addiction-clinic based bio-behavioral intervention for increasing PrEP uptake and adherence among women who engage in high-risk sexual behaviors and substance use. We will conduct Stage 1A research to identify key issues to address in developing the intervention. Interview data obtained from women undergoing standard SUD treatment will be used to finalize the design of the pilot trial (Stage 1B) comparing standard SUD treatment to SUD treatment integrated with PrEP services and adherence support. The new integrated intervention is expected to include motivational counseling guided by the Information- Motivation-Behavioral Skills Model (IMB) which seeks to influence behavior change via PrEP education, increasing motivation for change, and teaching behavioral skills to increase self-efficacy. This novel intervention will be delivered remotely using the emocha Mobile Health smartphone application and will include contingency management to reward desired behaviors. We hypothesize that compared to standard treatment, 1) the integrated intervention will result in a greater proportion of participants who fill their PrEP prescription; 2) (primary hypothesis) the integrated intervention will result in greater adherence to PrEP in those who fill their prescriptions; and 3) the integrated intervention will be feasible and acceptable by women (enrollment rate, study retention, and participant satisfaction scores). We will explore these hypotheses by pursuing three specific aims; 1) Elicit information on knowledge and attitudes about PrEP use and obtain feedback about the potential design of the integrated intervention; 2) Develop an integrated bio-behavioral intervention to promote PrEP uptake and adherence in women undergoing treatment for SUD who are at high risk for HIV; and 3) Assess initial efficacy, feasibility, and acceptability of the integrated intervention. The approach is innovative in that we will address individual level barriers by focusing on information, motivation, and behavioral skills development utilizing an incentive-based approach to increase adherence to daily PrEP, and we address structural level barriers by integrating the intervention into the addiction treatment setting. The proposed research is significant because it is expected to advance and expand the understanding of barriers and facilitators of PrEP uptake in this understudied vulnerable population.

少数民族妇女继续对艾滋病毒的健康和社会后果承担不成比例的负担。 然而，让患有物质使用障碍(SUD)的妇女参与艾滋病毒预防的有效干预研究 缺乏干预措施。暴露前预防(PrEP)是一种高效的艾滋病毒预防工具，但并未得到广泛应用 由少数族裔妇女实施。根据疾病控制和预防中心的数据，2016年只有2.1%的人 据估计，有PrEP适应症的妇女填写了PrEP处方。这突出了一个重大的未得到满足的预防需求。 对于确实服用PrEP的女性来说，低依从性降低了药物预防的能力 爱滋病毒。女性吸烟率和依从性较低的原因尚不完全清楚。基于我们的工作和 在其他方面，个人层面的障碍包括缺乏对个人艾滋病毒风险的认识，对PrEP的了解较低，以及 对耻辱的担忧。系统层面的障碍包括难以接触到有知识且愿意 开具PrEP处方。这项研究的总体目标是开发和试点测试基于成瘾诊所的生物行为 提高从事高危性行为妇女的PrEP摄入量和依从性的干预措施 物质使用。我们将进行第一阶段研究，以确定在制定干预措施时需要解决的关键问题。 从接受标准sud治疗的妇女那里获得的访谈数据将被用于最终确定试点的设计。 试验(阶段1B)比较标准SUD治疗与结合PrEP服务和依从性的SUD治疗 支持。新的综合干预措施预计将包括由信息指导的动机咨询- 动机-行为技能模型(IMB)，旨在通过PrEP教育影响行为改变，增加 改变的动力，以及教授行为技能以提高自我效能。这一新颖的干预措施将会 远程使用emocha Mobile Health智能手机应用程序，并将包括应急管理以奖励 所需的行为。我们假设，与标准治疗相比，1)综合干预将导致 填写PrEP处方的参与者比例更高；2)(主要假设)综合干预将 3)综合干预将是可行的 并被女性接受(入学率、学习保留率和参与者满意度得分)。我们将探索这些 通过追求三个具体目标进行假设：1)获取关于PrEP使用的知识和态度的信息，并获得 关于综合干预的潜在设计的反馈；2)开发综合生物行为干预以 促进正在接受艾滋病高危人群的SUD治疗的妇女接受和坚持PrEP；以及3)评估 综合干预的初步有效性、可行性和可接受性。这种方法是创新的，因为我们将 通过专注于信息、动机和行为技能的发展，利用 以激励为基础的方法，以增加对日常PrEP的遵守，我们通过整合 对成瘾治疗环境的干预。这项拟议的研究具有重要意义，因为它有望推动 并扩大对这一研究不足的弱势群体中PrEP摄取的障碍和促进者的理解。