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| Name | Class |
|---|---|
| Columbia University | OTHER |
| Denver Prevention Training Center | UNKNOWN |
| Coastal Family Health Center | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEACHES 2.0 Implementation Strategies | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEACHES 2.0 Implementation Strategies | Behavioral | PEACHES 2.0 is a set of training and quality improvement implementation strategies to increase provider adoption and patient uptake of evidence-based anal sex-related HIV interventions: anorectal STI screening, Doxy-PEP, PrEP, and anal cancer screening. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient uptake of anorectal STI screening | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient uptake of Doxy-PEP | 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 Doxy-PEP, the number of first Doxy-PEP 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. |
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Inclusion Criteria:
Staff participants ("Strategy Recipients" and "Strategy Recipients")
Patient participants ("Patients")
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bryan Kutner, PhD, MPH | Contact | 415-596-9179 | bryan.kutner@einsteinmed.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bryan Kutner, PhD, MPH | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Family Health Center | Biloxi | Mississippi | 39530 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Fixsen, D. L., Naoom, S. F., Blase, K. A., Friedman, R. M., & Wallace, F. (2005). Implementation research: A synthesis of the literature. Louis de la Parte Florida Mental Health Institute at the University of South Florida (FMHI Publication #231). | ||
| Background | Human Behaviour Change Project. (2025). Behaviour Change Intervention Ontology (BCIO). https://www.bciontology.org/learn | ||
| 39193088 | Background | Wright AJ, Zhang L, Howes E, Veall C, Corker E, Johnston M, Hastings J, West R, Michie S. Specifying how intervention content is communicated: Development of a Style of Delivery Ontology. Wellcome Open Res. 2023 Oct 12;8:456. doi: 10.12688/wellcomeopenres.19899.1. eCollection 2023. | |
| 37091090 |
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Will be revised pending NIH funding.
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| ID | Term |
|---|---|
| D006069 | Gonorrhea |
| D002690 | Chlamydia Infections |
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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The effectiveness of a set of implementation strategies, collectively named PEACHES 2.0, will be evaluated. PEACHES 2.0 comprises training and quality improvement strategies to mitigate stigma and increase patient uptake of anal sex-related HIV services. PEACHES 2.0 will be delivered over the course of 12 months (the "Implementation" period). Using an interrupted time-series analysis, the study team will compare medical record based primary and secondary outcomes across the 12 month period before implementation of PEACHES 2.0 ("Pre-Implementation"), the 12 month period of Implementation, and the 12 month period after implementation ("Maintenance").
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| 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 | 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 PrEP, the number of first PrEP prescriptions 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. | 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 | Clinics will extract deidentified patient level outcomes from their 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 anal cancer screening, the number of annual digital anorectal examination (DARE) with anal cytology performed among all patients with HIV aged ≥ 35 years will be calculated, and the slopes across the three 12-month data collection periods: Pre-Implementation, Implementation, and Maintenance periods, will be compared. | 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. |
| Background |
| Cho E, Lyon AR, Tugendrajch SK, Marriott BR, Hawley KM. Assessing provider perceptions of training: Initial evaluation of the Acceptability, Feasibility, and Appropriateness Scale. Implement Res Pract. 2022 Apr 5;3:26334895221086269. doi: 10.1177/26334895221086269. eCollection 2022 Jan-Dec. |
| 31858301 | Background | Kutner BA, Wu Y, Balan IC, Meyers K. "Talking About it Publicly Made Me Feel Both Curious and Embarrassed": Acceptability, Feasibility, and Appropriateness of a Stigma-Mitigation Training to Increase Health Worker Comfort Discussing Anal Sexuality in HIV Services. AIDS Behav. 2020 Jun;24(6):1951-1965. doi: 10.1007/s10461-019-02758-4. |
| 35090838 | Background | Kutner BA, Perry NS, Stout C, Norcini Pala A, Paredes CD, Nelson KM. The Inventory of Anal Sex Knowledge (iASK): A New Measure of Sexual Health Knowledge Among Adolescent Sexual Minority Males. J Sex Med. 2022 Mar;19(3):521-528. doi: 10.1016/j.jsxm.2021.12.011. Epub 2022 Jan 26. |
| 31932256 | Background | Kutner BA, Simoni JM, King KM, Goodreau SM, Norcini Pala A, Creegan E, Aunon FM, Baral SD, Rosser BRS. Does Stigma Toward Anal Sexuality Impede HIV Prevention Among Men Who Have Sex With Men in the United States? A Structural Equation Modeling Assessment. J Sex Med. 2020 Mar;17(3):477-490. doi: 10.1016/j.jsxm.2019.12.006. Epub 2020 Jan 10. |
| 2035047 | Background | Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b. |
| 24641907 | Background | Huijg JM, Gebhardt WA, Dusseldorp E, Verheijden MW, van der Zouwe N, Middelkoop BJ, Crone MR. Measuring determinants of implementation behavior: psychometric properties of a questionnaire based on the theoretical domains framework. Implement Sci. 2014 Mar 19;9:33. doi: 10.1186/1748-5908-9-33. |
| Background | West, R., & Michie, S. (2020). A brief introduction to the COM-B Model of behaviour and the PRIME Theory of motivation. Qeios. https://doi.org/10.32388/ww04e6.2 |
| 32198561 | Background | Kutner BA, King KM, Dorsey S, Creegan E, Simoni JM. The Anal Sex Stigma Scales: A New Measure of Sexual Stigma Among Cisgender Men Who have Sex with Men. AIDS Behav. 2020 Sep;24(9):2666-2679. doi: 10.1007/s10461-020-02824-2. |
| 30488143 | Background | Palinkas LA, Zatzick D. Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) in Pragmatic Clinical Trials of Mental Health Services Implementation: Methods and Applied Case Study. Adm Policy Ment Health. 2019 Mar;46(2):255-270. doi: 10.1007/s10488-018-0909-3. |
| 31437661 | Background | Hamilton AB, Finley EP. Qualitative methods in implementation research: An introduction. Psychiatry Res. 2019 Oct;280:112516. doi: 10.1016/j.psychres.2019.112516. Epub 2019 Aug 10. |
| 30666522 | Background | Simoni JM, Beima-Sofie K, Amico KR, Hosek SG, Johnson MO, Mensch BS. Debrief Reports to Expedite the Impact of Qualitative Research: Do They Accurately Capture Data from In-depth Interviews? AIDS Behav. 2019 Aug;23(8):2185-2189. doi: 10.1007/s10461-018-02387-3. |
| Background | Saldana, J. M. (2015). The Coding Manual for Qualitative Researchers (3rd ed.). SAGE Publications, Inc. |
| Background | Patton, & M.Q. (2014). Qualitative Research & Evaluation Methods: Integrating Theory and Practice. SAGE Publications. https://books.google.com/books?id=ovAkBQAAQBAJ |
| Background | Miles, M. B., Huberman, A. M., & Saldana, J. M. (2019). Qualitative Data Analysis (4 (Kindle)). SAGE Publications, Inc. |
| 12234641 | Background | Nich C, Carroll KM. Intention-to-treat meets missing data: implications of alternate strategies for analyzing clinical trials data. Drug Alcohol Depend. 2002 Oct 1;68(2):121-30. doi: 10.1016/s0376-8716(02)00111-4. |
| 12090408 | Background | Schafer JL, Graham JW. Missing data: our view of the state of the art. Psychol Methods. 2002 Jun;7(2):147-77. |
| Background | Hedeker, D., & Gibbons, R. D. (1997). Application of random-effects pattern-mixture models for missing data in longitudinal studies. Psychological Methods, 2(1), 64-78. https://doi.org/10.1037/1082-989x.2.1.64 |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D002694 | Chlamydiaceae Infections |
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |