HIVPEACHES 2NCT07464236
Improving Clinic Delivery of HIV-related Anal Health Services
A study testing PEACHES 2.0 Implementation Strategies in people with HIV and Gonorrhea, run by Albert Einstein College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- PEACHES 2.0 Implementation Strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2028to 31 Jul 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Coastal Family Health Center
Biloxi, Mississippi, 39530
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV, Gonorrhea, Chlamydia, Anal Cancer Squamous Cell
- Being tested
- PEACHES 2.0 Implementation Strategies
- Medical subject headings
- Gonorrhea, Chlamydia Infections, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEACHES 2.0 Implementation StrategiesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PEACHES 2.0 Implementation Strategies | Experimental | Not described Receives: Behavioral: PEACHES 2.0 Implementation Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study startFeb 2028 (estimated)
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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").
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Denver Prevention Training Center, Coastal Family Health Center, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bryan Kutner, PhD, MPH, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464236
- Sponsor's protocol ID
- 2026-17659
- Other IDs
- R01CA321103
- Acronym
- PEACHES 2
- Status last verified
- Oct 2026
- First submitted
- 6 Mar 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Details pending distribution of recent funding notification and corresponding Data Management and Sharing Plan details.
Publications
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).
Human Behaviour Change Project. (2025). Behaviour Change Intervention Ontology (BCIO). https://www.bciontology.org/learn
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.
PubMed 39193088Cho 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.
PubMed 37091090Kutner 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.
PubMed 31858301Kutner 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.
PubMed 35090838Kutner 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.
PubMed 31932256Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b.
PubMed 2035047Huijg 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.
PubMed 24641907West, 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
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.
PubMed 32198561Palinkas 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.
PubMed 30488143Hamilton 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.
PubMed 31437661Simoni 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.
PubMed 30666522Saldana, J. M. (2015). The Coding Manual for Qualitative Researchers (3rd ed.). SAGE Publications, Inc.