3T-Prevent: Piloting a multi-level, combination intervention strategy to expand HIV and bacterial STI prevention

项目总结 在美国，艾滋病毒和细菌性传播感染(BSTI)的发病率不成比例 在男同性恋者、双性恋者和其他与男性发生性关系的男性中的比例很高--这里指的是性少数男性 (SMM)-与只与女性发生性关系的男性相比。大约10%的艾滋病毒发病率可归因于 SMM中未经治疗的活动性衣原体和淋病感染导致传播率增加， 梅毒病例发生在SMM中。俄克拉荷马州是一个结束艾滋病毒流行的优先农村州 年平均衣原体感染病例，并跻身全国淋病和梅毒感染前十名。 此外，过去俄克拉荷马州SMM的艾滋病毒发病率总体上呈上升趋势 五年了。据估计，SMM中17.1%的艾滋病毒发病率可能会通过将艾滋病毒感染前增加一倍来避免 暴露预防(PrEP)覆盖范围的扩大以及艾滋病毒和梅毒检测的扩大可以帮助治疗AS 预防。此外，患者提供的伴侣疗法(PDPT)是预防BSTI的一种方法，在以下情况下 被诊断为衣原体或淋病的患者被提供药物，直接给他们的伴侣服用。 对PDPT的担忧主要集中在错过艾滋病毒和梅毒检测的机会，这可能是 通过在PDPT中加入艾滋病毒和梅毒自检试剂盒而得到缓解。额外的协同作用是将PrEP与BSTI配对 诊断和PDPT，因为SMM被诊断为BSTI，是PrEP的优先候选者。在Aim 1期间，我们将 成立一个由SMM(包括少数族裔和农村SMM)组成的社区咨询委员会， 俄克拉荷马州的医疗保健提供者、社区倡导者和其他利益相关者。在协作中工作 有了这个小组，我们将开发一种称为3T-预防的干预措施，并基于社区进行迭代细化 来自SMM(n=20)和主要信息者(n=20；临床医生、护士、诊所经理和其他人员)的反馈 利益相关者)。初步干预活动包括详细说明诊所和提供者，以支持分发 仅用于研究目的的带有PDPT至SMM的艾滋病毒和梅毒自检试剂盒.培训和 远程辅导提供者提供理论指导的咨询课程，以支持自我测试、PDPT和 在患者和伴侣中使用Prep；优化PrEP处方/转诊以及与艾滋病毒护理的联系。我们 将在俄克拉荷马州不同环境下的三家诊所试行和评估最终的干预措施 使用混合类型1有效性的HIV/BSTI检测服务--通过阶梯楔形实施设计 模拟未来全州实施策略的随机对照试验。我们将同时招聘 诊所主任(n=3)和提供者(n=9)，以及三家诊所内的108名SMM。重新瞄准(REACH， 有效性、采用、实施和维护)评估将使用融合 对调查(诊所主任、提供者和SMM患者)、电子病历、 以及离职面谈，以评估可行性、可接受性和初步影响。

PROJECT SUMMARY In the U.S., incidence rates of HIV and bacterial sexually transmitted infections (BSTIs) are disproportionately high among gay, bisexual, and other men who have sex with men—referred to herein as sexual minority men (SMM)—compared to men who have sex with women only. Roughly 10% of HIV incidence is attributable to increased transmission due to untreated active chlamydia and gonorrhea infections among SMM, and 64% of syphilis cases occur among SMM. Oklahoma is an Ending the HIV Epidemic priority rural state with above average yearly cases of chlamydia and ranks in the top 10 for gonorrhea and syphilis infections nationwide. Moreover, there has been an overall upward trend in HIV incidence among SMM in Oklahoma over the past five years. An estimated 17.1% of HIV incidence among SMM is likely to be averted with doubling of HIV pre- exposure prophylaxis (PrEP) coverage, and the expansion of HIV and syphilis testing can aid in treatment as prevention. Additionally, patient-delivered partner therapy (PDPT) is a method of BSTI prevention where patients diagnosed with chlamydia or gonorrhea are provided medication to give directly to their partners. Concerns about PDPT have centered around missed opportunities for HIV and syphilis testing, which could be alleviated by including HIV and syphilis self-testing kits with PDPT. Additional synergy is to pair PrEP with BSTI diagnoses and PDPT since SMM diagnosed with BSTIs are priority candidates for PrEP. During Aim 1, we will form a Community Advisory Board comprised of SMM (including racial/ethnic minorities and rural SMM), healthcare providers, community advocates, and other stakeholders in Oklahoma. Working in collaboration with this group, we will develop an intervention called 3T-Prevent with iterative refinement based on community feedback from SMM (n = 20) and key informants (n = 20; clinicians, nurses, clinic managers, and other stakeholders). Preliminary intervention activities include detailing clinics and providers to support distribution of HIV and syphilis self-testing kits with PDPT to SMM for investigational purposes only; training and telementoring providers to deliver theoretically guided counseling sessions to support self-testing, PDPT, and PrEP use among patients and partners; and optimizing PrEP prescribing/referrals and linkage to HIV care. We will pilot and evaluate the finalized intervention in three clinics in varied settings of Oklahoma that offer HIV/BSTI testing services using a hybrid type-1 effectiveness-implementation design via a stepped-wedge randomized controlled trial to mimic a future statewide implementation strategy. We will concurrently recruit clinic directors (n = 3) and providers (n = 9) and 108 SMM within the three clinics. RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) evaluation will be assessed using convergent mixed-method analysis of surveys (clinic directors, providers, and SMM patients), electronic medical records, and exit interviews to assess feasibility, acceptability, and preliminary impact.