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

少数民族妇女继续承受着艾滋病毒造成的健康和社会后果的过重负担。 然而，关于使患有药物使用障碍的妇女参与艾滋病毒预防的有效干预措施的研究 缺乏干预。暴露前预防（PrEP）是一种非常有效的艾滋病毒预防工具，但尚未广泛使用 少数民族妇女。根据疾病控制和预防中心的数据，2016年， 估计有PrEP适应症的妇女填写PrEP处方。这突出表明了一个重大的未满足的预防需求。 对于服用PrEP的女性，对药物治疗方案的低依从性降低了药物预防的能力。 艾滋病。妇女接受和遵守率低的原因尚不完全清楚。根据我们的工作， 对其他人来说，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的了解不足， 对耻辱感的担忧。系统层面的障碍包括难以获得有知识和愿意 这项研究的首要目标是开发和试点测试成瘾诊所为基础的生物行为 干预措施，以增加从事高风险性行为的妇女的PrEP吸收和坚持， 物质使用。我们会进行第一阶段甲的研究，以确定在发展干预措施时需要解决的主要问题。 从接受标准SUD治疗的妇女中获得的访谈数据将用于最终确定试点设计 比较标准SUD治疗与结合PrEP服务和依从性的SUD治疗的试验（1B期） 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， 改变的动机，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在 远程使用emocha移动的健康智能手机应用程序，并将包括应急管理，以奖励 期望的行为。我们假设，与标准治疗相比，1）综合干预将导致 更大比例的参与者填写他们的PrEP处方; 2）（主要假设）综合干预将 导致更多的坚持PrEP在那些谁填写他们的处方;和3）综合干预将是可行的 女性可接受（入组率、研究保留率和参与者满意度评分）。我们将探讨这些 通过追求三个具体目标的假设; 1）获取有关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， 促进接受SUD治疗的HIV高危女性的PrEP吸收和坚持; 3）评估 综合干预措施的初始有效性、可行性和可接受性。这是一个创新的方法，我们将 解决个人层面的障碍，重点是信息，动机和行为技能的发展，利用 以激励为基础的方法，以增加坚持每日PrEP，我们解决结构层面的障碍，通过整合 干预成瘾治疗环境。这项拟议中的研究意义重大，因为它有望推动 并扩大对这一未充分研究的弱势群体中PrEP吸收的障碍和促进因素的理解。

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.