Improving Clinic Delivery of HIV-related Anal Health Services (PEACHES 2)

June 2, 2026 updated by: Albert Einstein College of Medicine

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Mississippi
      • Biloxi, Mississippi, United States, 39530
        • Coastal Family Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEACHES 2.0 Implementation Strategies
Behavioral: PEACHES 2.0 Implementation Strategies
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient uptake of anorectal STI screening
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient uptake of Doxy-PEP
Time Frame: 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 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.
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
Time Frame: 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 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
Time Frame: 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 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Collaborators

Columbia University
Denver Prevention Training Center
Coastal Family Health Center

Investigators

  • Principal Investigator: Bryan Kutner, PhD, MPH, Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

July 31, 2030

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-17659

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Will be revised pending NIH funding.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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