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NCT Number: NCT05785169

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University School of Nursing

New York, 10032, United States

Location status: Recruiting

Location contact

Corina Lelutiu-Weinberger, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Health Policy+ infused with US HIV care clinic-relevant content and activities

Primary outcomes

  1. 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

  1. Change in Cultural Humility Score

    Time frame: 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.

Other outcomes

  1. Change in Time to Linkage to Care

    Time frame: Baseline, 6, 12, 18, and 24 months

    Change in time to linkage to care from diagnosis at the clinics.

  2. Change in Patients Retained in Care

    Time frame: Baseline, 6, 12, 18, and 24 months

    Change in the number of patients retained in care at the clinics.

  3. Change in Number of Patients HIV Virally Suppressed

    Time frame: Baseline, 6, 12, 18, and 24 months

    Change in the number of patients virally suppressed at the clinics. Viral suppression defined as less than 200 copies/mL.

  4. Change in Frequency of Perceived HIV and Other Stigmas

    Time frame: Baseline, 6, 12, 18, and 24 months

    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.

  5. Change in Depression and Anxiety

    Time frame: Baseline, 6, 12, 18, and 24 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Corina T Lelutiu-Weinberger, PhD

CONTACT

[email protected]

212-305-5756

Felicia A Browne, ScD

CONTACT

[email protected]

919-541-6596

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

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

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2023
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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