Partnering to Enhance Anal Health Communication and HIV-related Evidence-based Services
| Registry | NCT07464236, acronym PEACHES 2 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, health services research |
| Enrollment | 8 (Estimated) |
| Sponsor | Albert Einstein College of Medicine (Other); collaborators: Columbia University, Denver Prevention Training Center, Coastal Family Health Center, National Cancer Institute (NCI) |
| Conditions | HIV, Gonorrhea, Chlamydia, Anal Cancer Squamous Cell |
| Interventions | PEACHES 2.0 Implementation Strategies (Behavioral) |
| Dates | start 2028-02-01 (estimated), primary completion 2030-07-31 (estimated), completion 2030-07-31 (estimated), first posted 2026-03-11, last updated 2026-10-13 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for HIV All trials for Gonorrhea All trials of PEACHES 2.0 Implementation Strategies
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| PEACHES 2.0 Implementation Strategies | Experimental | Behavioral: PEACHES 2.0 Implementation Strategies |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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| Facility | City | Country | Status |
|---|---|---|---|
| Coastal Family Health Center | Biloxi, Mississippi | United States |
NIH grants: R01CA321103