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

项目摘要 在美国，艾滋病毒和细菌性性传播感染（BSTI）的发病率不成比例 在同性恋、双性恋和其他与男性发生性关系的男性中--这里指的是性少数男性--高 （SMM）-与只与女性发生性关系的男性相比。大约10%的艾滋病毒感染可归因于 由于未经治疗的活动性衣原体和淋病感染，SMM中的传播增加， 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国家与上述 衣原体感染的年平均病例数在全国范围内排在淋病和梅毒感染的前10位。 此外，在过去的俄克拉荷马州，SMM人群的艾滋病发病率总体呈上升趋势 五年估计17.1%的艾滋病毒发病率在SMM中很可能通过艾滋病毒感染前加倍来避免。 暴露预防（PrEP）覆盖率以及扩大艾滋病毒和梅毒检测可以帮助治疗， 预防此外，患者提供的伴侣治疗（PDPT）是一种预防BSTI的方法， 被诊断患有衣原体或淋病的患者可直接向其伴侣提供药物。 对PDPT的担忧集中在错过艾滋病毒和梅毒检测的机会，这可能是 通过将艾滋病毒和梅毒自我检测试剂盒与PDPT一起使用来缓解。额外的协同作用是将PrEP与BSTI配对 诊断和PDPT是PrEP的优先候选者，因为SMM诊断出患有BSTI。在目标1期间，我们将 成立社区咨询委员会，由SMM（包括种族/族裔少数群体和农村SMM）组成， 医疗保健提供者、社区倡导者和俄克拉荷马州的其他利益相关者。协作 我们将与这个小组一起，开发一种名为3 T预防的干预措施，并根据社区进行反复改进 来自SMM（n = 20）和关键知情人（n = 20;临床医生、护士、诊所经理和其他 利益攸关方）。初步干预活动包括详细说明诊所和提供者，以支持分发 艾滋病毒和梅毒自我检测试剂盒，带有PDPT至SMM，仅用于研究目的;培训和 远程监护提供者提供理论指导的咨询会议，以支持自我测试，PDPT， 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 我将在俄克拉荷马州不同环境的三个诊所试点和评估最终的干预措施， 通过阶梯楔形板使用混合型1有效性实施设计的HIV/BSTI检测服务 随机对照试验，以模拟未来全州范围内的实施策略。我们将同时招募 诊所主任（n = 3）和供应商（n = 9）和108 SMM在三个诊所。RE-AIM（到达， 有效性、采用、实施和维护）评价将使用融合 调查的混合方法分析（诊所主任，提供者和SMM患者），电子病历， 和离职面谈，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.