Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548035
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Developing a Resiliency Intervention to Support Healthcare Workers Engaged in the Provision of HIV Care
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Developing a Resiliency Intervention to Support Healthcare Workers Engaged in the Provision of HIV Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Qinisa
Brief Summary:
The purpose of this study is to pilot an adapted resiliency-based mind-body intervention the Relaxation Response Resiliency Program the 3RP for nurses that care for people with HIV PWH in the public sector in South Africa SA In Phase 1 NIH Grant Number R34MH131426 Human Research Ethics Committee HREC Ethics Reference Number 220813 the investigators conducted focus group discussions to solicit feedback on the role of culture and perceptions of stress the lived experiences of stress sources of stress eg occupational trauma related how stress impacts job functioning specifically patient care current coping strategies and the intervention modules content number of sessions session duration program length mode of delivery eg virtual in-person hybrid approaches use of coaches etc In this phase 2 the investigators will conduct a small proof-of-concept study N 8-10 followed by a randomized pilot N 60 of nurses that care for PWH in the public sector in South Africa SA to test the feasibility and acceptability of the adapted intervention
Detailed Description:
This study will pilot test an adapted version of an existing stress management and resiliency-enhancing intervention the Relaxation Response Resiliency Program the 3RP for nurses that care for PWH in the public sector in SA to test the feasibility and acceptability of all study procedures This intervention was adapted and refined from its original format which consisted of eight 90-minute weekly group sessions following focus group discussions FGDs that explored nurses preferences and desired modifications to the intervention Phase 1 of this study
This trial will involve a randomized pilot study N 60 to test the feasibility and acceptability of the adapted intervention among nurses that care for PWH in the public sector in SA
Additionally the randomized control trial RCT will collect anonymous clinic client data on demographics satisfaction with care client-provider trust and likelihood of returning to care We will also collect clinic-level data to understand how to measure client-related outcomes and clinic metrics of HIV care engagement such as expected patient return ratesmeasures of retention percentage of patients with suppressed viral load frequency of viral load collection and percentage of patients initiating second line treatment to best understand how to measure these variables in a larger trial testing the efficacy of the intervention
This trial will involve a randomized pilot study N 60 to test the feasibility and acceptability of the adapted intervention among nurses that care for PWH in the public sector in SA
Additionally the randomized control trial RCT will collect anonymous clinic client data on demographics satisfaction with care client-provider trust and likelihood of returning to care We will also collect clinic-level data to understand how to measure client-related outcomes and clinic metrics of HIV care engagement such as expected patient return ratesmeasures of retention percentage of patients with suppressed viral load frequency of viral load collection and percentage of patients initiating second line treatment to best understand how to measure these variables in a larger trial testing the efficacy of the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None