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

NCT05785169 | Recruiting DMC

• 2 other identifiers: AAAU15591R01NR020583
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stigma; HIV; Well-Being, Psychological

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Cultural Humility Score

  Baseline, 6, 12, 18, and 24 months

Other Outcomes (5)

• Change in Time to Linkage to Care

  Baseline, 6, 12, 18, and 24 months

• Change in Patients Retained in Care

  Baseline, 6, 12, 18, and 24 months

• Change in Number of Patients HIV Virally Suppressed

  Baseline, 6, 12, 18, and 24 months

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

All-facility Training BEHAVIORAL

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.

Also known as: Health Policy+ infused with US HIV care clinic-relevant content and activities

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rutgers University: collaborator
• Florida State University: collaborator
• RTI International: collaborator
• Duke University: collaborator
• Columbia University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Columbia University School of Nursing

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Social Stigma; Psychological Well-Being

Interventions

Exercise

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Corina Lelutiu-Weinberger, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Felicia A Browne, ScD

  RTI International

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corina T Lelutiu-Weinberger, PhD

CONTACT

212-305-5756; cl4265@cumc.columbia.edu

Felicia A Browne, ScD

CONTACT

919-541-6596; fbrowne@rti.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Health Sciences Research

Model Details: The intervention will be implemented across five clinics simultaneously across six months post-baseline.

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: January 27, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)