Improving Clinic Delivery of HIV-related Anal Health Services

NCT07464236 | Not Yet Recruiting

• 1 other identifier: 2026-17659
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; Gonorrhea; Chlamydia; Anal Cancer Squamous Cell

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• 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.

Study Arms (1)

PEACHES 2.0 Implementation Strategies

EXPERIMENTAL

Behavioral: PEACHES 2.0 Implementation Strategies

Interventions

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.

PEACHES 2.0 Implementation Strategies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Columbia University: collaborator
• Denver Prevention Training Center: collaborator
• Coastal Family Health Center: collaborator

Study Sites (1)

Coastal Family Health Center

Biloxi, Mississippi, 39530, United States

Location

Related Publications (20)

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  BACKGROUND

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  PMID: 35090838 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.

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• 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

  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.

  PMID: 32198561 BACKGROUND

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  PMID: 30488143 BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Gonorrhea; Chlamydia Infections; Anus Neoplasms

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Chlamydiaceae Infections; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Study Officials

• Bryan Kutner, PhD, MPH

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryan Kutner, PhD, MPH

CONTACT

415-596-9179; bryan.kutner@einsteinmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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").

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 11, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: June 3, 2026

Record last verified: 2026-06

Locations

US (1)