Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-01 @ 6:26 PM
Study NCT ID:
NCT05785169
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2023-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ending the HIV Epidemic for Patient and Healthcare Staff Well-being
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
Ending the HIV Epidemic: An All-facility Intervention for Patient and Healthcare Staff Well-being
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01NR020583 | NIH | None | https://reporter.nih.gov/quic… | View |