Ending the HIV Epidemic for Patient and Healthcare Staff Well-being

Not Applicable

Recruiting

• Conditions: Stigma; HIV; Well-Being, Psychological

• Registration Number: NCT05785169
• Lead Sponsor: Columbia University

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. Six RWHAP clinics will be selected to participate and be assigned to one of three sequences (two clinics per cluster). All members will complete participate in interactive trainings to raise awareness of and reduce stigma, from the clinic policy level to individual attitudes. All clinic members and select patients will complete self-administered surveys every 6 months over 24 months.

Detailed Description

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. The proposed intervention draws on the evidence-based Health Policy Plus (HP+) 'total' facility HIV stigma-reduction intervention and Contact Theory, which have demonstrated efficacy in improving inter-group relations. The program targets the clinics' organizational and systems levels to affect patient outcomes and staff wellbeing, at the individual level. In Aim 1, we will rigorously select 6 clinics in the South/East US. In Aim 2, after a baseline assessment (N=180), we will conduct a stepped wedge cluster randomized trial of the stigma reduction intervention. At each of the 3 steps, two randomized clinics will receive the training, which will support clinics to 1) identify/create organizational-level anti-stigma policies and practices to reduce stigma, and 2) deliver participatory trainings to all staff. Each cluster will receive the intervention for 6 months, starting with Cluster Group 1, followed by Cluster Groups 2 and 3. In Aim 3, we will evaluate multi-level outcomes using the Consolidated Framework for Implementation Research (CFIR), including within the organization (primary outcome of Stigma Reduction Index - ratings of mission/vision statements, policies\], clinic environment), systems (secondary outcomes of provider/staff attitudes; behavior), and individual patient level (tertiary outcomes of clinic-level HIV indicators, reports of stigmatization, clinic climate, anxiety, depression) outcomes. Assessments will take place every 6 months, with the clinics randomized to the second or third step having multiple assessments before the intervention. Patients at the clinics will be surveyed at each assessment (N=2,100). Findings will yield a manual for implementing total-facility stigma-reduction processes and content. Other RWHAP-funded clinics and facilities may be able to adopt this manualized, yet highly adaptable intervention packet.

Study Timeline

• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-03-14
• Study First Posted: 2023-03-27
• Study Start: 2025-01-27
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-05
• Last Update Posted: 2025-09-11
• Primary Completion: 2027-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2400

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 for randomization purposes. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Stigma Index (SI)	Baseline, 6, 12, 18, and 24 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Cultural Humility Score	Baseline, 6, 12, 18, and 24 months	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.

Trial Locations

Locations (1)

Columbia University School of Nursing; 🇺🇸 New York, New York, United States