Skip to main content
Clinical Trials/NCT05785169
NCT05785169
Recruiting
Not Applicable

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

Columbia University1 site in 1 country1,000 target enrollmentJanuary 27, 2025

Overview

Phase
Not Applicable
Intervention
All-facility Training
Conditions
Not specified
Sponsor
Columbia University
Enrollment
1000
Locations
1
Primary Endpoint
Change in Stigma Index (SI)
Status
Recruiting
Last Updated
12 days ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 27, 2025
End Date
April 1, 2028
Last Updated
12 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Corina Lelutiu-Weinberger

Associate Professor of Health Sciences Research

Columbia University

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: All-facility Training

Outcomes

Primary Outcomes

Change in Stigma Index (SI)

Time Frame: 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 Outcomes

  • Change in Cultural Humility Score(Baseline, 6, 12, 18, and 24 months)
  • Change in Cultural Humility Score(Baseline, 6, 12, 18, and 24 months)

Study Sites (1)

Loading locations...

Similar Trials