Ending the HIV Epidemic: An All-facility Intervention for Patient and Healthcare Staff Well-being (TRAnscenDS)

The scope of this study is to engage Ryan White HIV/AIDS Program (RWHAP) funded organizations in the South/East US to co-develop context-responsive programs utilizing evidence-informed interventions to reduce stigma against living with HIV (PLH) who have difficulties accessing and remaining engaged in life-saving treatment. Five RWHAP clinics will be selected for this trial. Clinic members will participate in interactive trainings to raise awareness of and reduce stigma, from the clinic policy level to individual attitudes. Clinic members and select patients will complete self-administered surveys every 6 months over 24 months.

Study Overview

• Status: Recruiting
• Conditions: HIV; Stigma; Well-Being, Psychological
• Intervention / Treatment: Behavioral: All-facility Training

Detailed Description

The scope of this study is to engage HIV care clinics in the United States to co-develop context-responsive programs utilizing evidence-informed interventions to reduce processes and practices perceived as stigmatizing by people living with HIV who have difficulties accessing and remaining engaged in life-saving treatment. HIV-related stigma in a clinical setting directly impacts access to and uptake of healthcare, including engagement in HIV care services. The proposed intervention draws on the evidence-based Health Policy Plus (HP+) 'total' facility HIV stigma-reduction intervention that focuses on the clinics' organizational and interpersonal levels to strengthen patient care and engagement in services, and staff wellbeing. We will conduct an implementation trial of our HIV stigma-reduction intervention. Clinics will receive training to support them in 1) identifying/creating organizational-level policies and practices (e.g., clear understanding of what practices can be experienced as stigmatizing) to reduce HIV stigma, and 2) deliver participatory trainings to all staff (e.g., building awareness of the impact of patient perceptions and experiences of HIV-related stigma on health). In Aim 3, we will evaluate outcomes, including at the organization (primary outcome of Stigma Reduction Index - ratings of mission/vision statements, policies around HIV stigma, comfort level in clinics), interpersonal (secondary outcomes of provider/staff attitudes; behavior), and individual patient and/or staff (tertiary outcomes of clinic-level HIV indicators, reports of HIV care practices that can be experienced as stigmatizing, anxiety, depression, and stress) levels. Assessments will take place every 6 months.

The intervention will generate strategies to improve the wellbeing of the healthcare workforce. Ultimately, the study will produce implementation lessons on how to effectuate clinical practice changes to increase access to effective HIV treatment, as well as the wellbeing of the healthcare workforce.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Corina T Lelutiu-Weinberger, PhD; Phone Number: 212-305-5756; Email: cl4265@cumc.columbia.edu
• Study Contact Backup: Name: Felicia A Browne, ScD; Phone Number: 919-541-6596; Email: fbrowne@rti.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University School of Nursing
      • Contact: Corina Lelutiu-Weinberger, PhD; Email: cl4265@cumc.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Selected Ryan White Clinics. Selection based on the following:

First, clinic leaders will complete a 15-min Site Characteristics Survey, assessing suitability for participation and clinic comparability. Staff and leadership at Ryan White clinics will next complete an anonymous 15-minute Eligibility Survey.

Within each clinic, both clinic staff and patients will be invited to participate.

Exclusion Criteria:

• Non-Ryan White Clinics
• Clinics not located in the geographical area of interest
• Clinics that are not interested in participating

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; The intervention will be implemented across six months with a total of five clinics. The intervention consists of a series of interactive trainings that cover stigma and health-related topics, such as roots, manifestations, and consequences of stigma in healthcare, history of HIV stigma, and stress and stigma. These will be split across several sessions, depending on clinics' schedules. At the end of the intervention, each clinic will create a Code of Practice that will be formalized into a manual for each clinic, to guide the implementation and sustainability of stigma reduction efforts.

Behavioral: All-facility Training; The HP+ curriculum includes total-site training and co-facilitation via participatory modules. To change clinic culture, a multi-level approach that includes the whole facility and reaches all parties is required. The intervention aims to modify top-down mechanisms of influence. The training is modeled on these principles and supports the development of multiple stigma-reduction strategies to improve patient and staff wellbeing.; Other Names: Health Policy+ infused with US HIV care clinic-relevant content and activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stigma Index (SI)	The SI is a rating of clinic mission/vision statements, the anti-stigma policy, and the clinic context. A change in the mean score of SI post-intervention implementation will be measured. Scores range from 0-100, with a higher score indicating increased anti-stigma policies and procedures.	Baseline, 6, 12, 18, and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cultural Humility Score	Cultural humility as measured by the adapted Trauma-Informed, Resilience-Oriented Care (TI-ROC) Cultural Humility Scale, which assess staff's perceptions of colleagues and clinic context. Scores range from 12-60. The negative items are reverse coded such that higher scores indicate higher cultural humility indicating better outcomes.	Baseline, 6, 12, 18, and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Time to Linkage to Care	Change in time to linkage to care from diagnosis at the clinics.	Baseline, 6, 12, 18, and 24 months
Change in Patients Retained in Care	Change in the number of patients retained in care at the clinics.	Baseline, 6, 12, 18, and 24 months
Change in Number of Patients HIV Virally Suppressed	Change in the number of patients virally suppressed at the clinics. Viral suppression defined as less than 200 copies/mL.	Baseline, 6, 12, 18, and 24 months
Change in Depression and Anxiety	A 4-item scale that assesses depression and anxiety (PHQ-4) over the past week. Scores range from 0-63 with a lower score indicating a better outcome.	Baseline, 6, 12, 18, and 24 months
Change in Frequency of Perceived HIV and Other Stigmas	Change in the frequency of perceived stigma-related events by staff and patients attending the clinic as collected by self-administered Experiences of Perceived Stigma survey.	Baseline, 6, 12, 18, and 24 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Nursing Research (NINR); Duke University; Florida State University; RTI International; Rutgers University
• Investigators: Principal Investigator: Corina Lelutiu-Weinberger, PhD, Columbia University; Principal Investigator: Felicia A Browne, ScD, RTI International

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Social Behavior; Psychological Well-Being; Social Stigma; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: AAAU1559; 1R01NR020583 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No