跳至主要内容
临床试验/NCT07464236
NCT07464236尚未招募不适用

Partnering to Enhance Anal Health Communication and HIV-related Evidence-based Services

Albert Einstein College of Medicine1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2026年8月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
8
试验地点
1
主要终点
Patient uptake of anorectal STI screening

研究概览

简要总结

This project will test ways to reduce stigma in healthcare settings so that more providers offer, and more patients receive, important anal sex-related HIV services, including anorectal sexually transmitted infection (STI) testing, preventive medications, and cancer screening. By evaluating these stigma-reduction strategies in eight clinics in the Mississippi Delta, a region with high rates of HIV and STIs, the research team will learn whether and how these approaches work to improve access to care. The results will help guide healthcare systems in using the most effective methods to reduce stigma, making it easier for people to get prevention services and improving public health.

详细描述

This project aims to determine whether scaling PEACHES 2.0, a package of multi-level, multi-component implementation strategies to address anal sex stigma within health services can increase provider adoption and patient uptake of four anal sex-related HIV services (ASHS). These services - anorectal STI testing, HIV pre-exposure prophylaxis (PrEP), Doxy-PEP (gonorrhea and chlamydia doxycycline post-exposure prophylaxis), and anal cancer screening - are endorsed by federal, state and professional organizations as standard-of-care and would effectively accelerate an end to the HIV epidemic, if implemented. Yet provider adoption and patient uptake of these services is suboptimal relative to their indication. Stigma is a fundamental cause underlying the causal chain of this underuse, hindering patient communication, providers' preparedness, and organizational prioritization to deliver care. This project continues preliminary work to develop and pilot test a package of strategies in the U.S. South (PEACHES 1.0, NCT) that used the Capability, Opportunity, Motivation, Behavior (COM-B) Model and the 'total facility approach' as a multi-level framework for stigma reduction. The proposed R01 study now integrates the Behaviour Change Intervention Ontology (BCIO) into Causal Pathway Diagrams (CPDs) to articulate a theory of change for how a refined and standardized package of strategies (PEACHES 2.0), its component behavior change techniques, purported mechanisms of action, and potential effect modifiers, will interact to improve provider adoption and patient uptake of ASHS. The investigator team hypothesizes that changes to the previously piloted package of strategies to improve reach - a true 'total facility approach' - will improve adoption and uptake. In Aim 1, PEACHES 1.0 will be refined and standardized to prepare for larger-scale evaluation of PEACHES 2.0. A training-of-trainers strategy will be added; web-based resources to improve usability and appropriateness will be enhanced; a Clinical Learning Collaborative (CLC) led by anal health experts will be piloted; and an audit-and-feedback electronic medical record (EMR) dashboard that visualizes outcome data for use in quality improvement (QI) coaching will be developed. In Aim 2, a hybrid type 1 implementation-effectiveness, interrupted-time series trial among eight clinical sites in the Mississippi Delta, a region with some of the nation's highest rates of HIV and STIs, will be conducted. The effectiveness of PEACHES 2.0 on increasing EMR-documented provider adoption and patient uptake of ASHS (primarily anorectal STI testing, secondarily Doxy-PEP, PrEP and anal cancer screening), testing hypothesized mechanisms of action and moderators, will be evaluated. The research team will also investigate variability across sites through an exploratory test of emergent mechanisms and moderators based on mixed-methods inquiry using the Rapid Assessment Procedure-Informed Clinical Ethnography (RAPICE) method. This study will generate actionable knowledge to promote provider adoption and patient uptake of ASHS. This implementation science approach - the integration of standardized definitions with causal inference tools using the BCIO and CPDs - will also facilitate synthesis with other studies, enhance replicability, and enable broader insights into how stigma mitigation can improve delivery of essential HIV interventions that protect health.

This registration is specific to Aim 2's evaluation of effectiveness of PEACHES 2.0 on patient uptake of ASHS, among N = 8 participating clinics.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Staff participants ("Strategy Recipients" and "Strategy Recipients")
  • employed at one of eight Coastal Family Health Center clinics at the time of the survey
  • over age 18 years old
  • Patient participants ("Patients")
  • accessing sexual health services at one of eight Coastal Family Health Center clinics in the last 12 months
  • over 18 years old

排除标准

  • Staff or patients who are unable to provide informed consent (e.g., significant cognitive impairment)
  • Individuals currently incarcerated or in state custody
  • Patients whose only visits are for non-HIV, non-STI issues and who do not meet the EMR-based eligibility criteria above

研究组 & 干预措施

PEACHES 2.0 Implementation Strategies

Experimental

干预措施: PEACHES 2.0 Implementation Strategies (Behavioral)

结局指标

主要结局

Patient uptake of anorectal STI screening

时间窗: Data will be collected monthly via the audit-and-feedback data dashboard. First data collection occurs just after month 1 of the Pre-Implementation period, continuing through Implementation and Maintenance periods, for a total of 36 months.

Clinics will extract deidentified patient level outcomes from the medical record system on a monthly basis. This data will be imported into an audit-and-feedback data dashboard developed by the PEACHES 2.0 team. For patient uptake of anorectal STI screening, the number of anorectal STI screening orders per month among all STI orders in that same month will be calculated, and the slopes across the three 12-month data collection periods: Pre-Implementation, Implementation, and Maintenance periods, will be compared.

次要结局

  • Patient uptake of Doxy-PEP(Data will be collected monthly via the audit-and-feedback data dashboard. First data collection occurs just after month 1 of the Pre-Implementation period, continuing through Implementation and Maintenance periods, for a total of 36 months.)
  • Patient uptake of PrEP(Data will be collected monthly via the audit-and-feedback data dashboard. First data collection occurs just after month 1 of the Pre-Implementation period, continuing through Implementation and Maintenance periods, for a total of 36 months.)
  • Patient uptake of anal cancer screening(Data will be collected monthly via the audit-and-feedback data dashboard. First data collection occurs just after month 1 of the Pre-Implementation period, continuing through Implementation and Maintenance periods, for a total of 36 months.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验