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

Columbia University

Status: Enrolling

Conditions: HIV; Stigma; Well-Being, Psychological

Treatments: Behavioral: All-facility Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05785169

AAAU1559

1R01NR020583 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,400 participants in 3 patient groups

First Cluster

Experimental group

Description:

The intervention will be implemented across three steps with a total of 6 clinics (two clinics per step). The earliest roll-out of the intervention will be at the clinics randomized to Cluster 1. The intervention consists of a mix of Workshops, Interactive Trainings and Learning Circles (virtual and in-person). In the first workshop, the investigators will present baseline findings to all clinic members to 1) raise awareness for the need for intervention to reduce stigma, 2) facilitate collaborative processes, 3) catalyze change for practice change, to 4) guide the intervention process. This workshop will be followed by a series of interactive trainings covering relevant topics, and the creation of a manual to guide the implementation and sustainability of stigma reduction efforts.

Treatment:

Behavioral: All-facility Training

Second Cluster

Experimental group

Description:

The intervention will be implemented across three steps with a total of 6 clinics (two clinics per step). The earliest roll-out of the intervention will be at the clinics randomized to Cluster 1. The intervention consists of a mix of Workshops, Interactive Trainings and Learning Circles (virtual and in-person). In the first workshop, the investigators will present baseline findings to all clinic members to 1) raise awareness for the need for intervention to reduce stigma, 2) facilitate collaborative processes, 3) catalyze change for practice change, to 4) guide the intervention process. This workshop will be followed by a series of interactive trainings covering relevant topics, and the creation of a manual to guide the implementation and sustainability of stigma reduction efforts.

Treatment:

Behavioral: All-facility Training

Third Cluster

Experimental group

Description:

The intervention will be implemented across three steps with a total of 6 clinics (two clinics per step). The earliest roll-out of the intervention will be at the clinics randomized to Cluster 1. The intervention consists of a mix of Workshops, Interactive Trainings and Learning Circles (virtual and in-person). In the first workshop, the investigators will present baseline findings to all clinic members to 1) raise awareness for the need for intervention to reduce stigma, 2) facilitate collaborative processes, 3) catalyze change for practice change, to 4) guide the intervention process. This workshop will be followed by a series of interactive trainings covering relevant topics, and the creation of a manual to guide the implementation and sustainability of stigma reduction efforts.

Treatment:

Behavioral: All-facility Training