An interventional study of PEACHES 2.0 Implementation Strategies in HIV, Gonorrhea and Chlamydia, sponsored by Albert Einstein College of Medicine. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Albert Einstein College of Medicine · Not applicable, Interventional, and Health services research
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.
167 studies on the registry are indexed under Gonorrhea; 31 are open to participants now.
This study's planned enrollment of 8 is below the median of 400 across 125 interventional studies indexed under Gonorrhea.
Browse Gonorrhea studies →Albert Einstein College of Medicine is the lead sponsor of 201 studies on the registry; 21 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 37 (80%) have results posted.
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Exclusion Criteria:
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The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Plan to share: Undecided — Details pending distribution of recent funding notification and corresponding Data Management and Sharing Plan details.
Start is estimated for Feb 2028; primary completion for Jul 2030, 29 months later.
Of 36 non-industry interventional studies with no phase under Gonorrhea, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 29 months is above that.
Counting every sponsor, half of 40 studies reached it within 23 months; a quarter within 11 and three quarters within 41.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Feb 2028, on Oct 13, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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