NCT06548035

Developing a Resiliency Intervention to Support Healthcare Workers Engaged in the Provision of HIV Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 (e.g. 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 (e.g., 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 rates/measures 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.

Conditions

• Stress
• Burnout, Professional

Interventions

Type	Name	Description
BEHAVIORAL	Adapted Relaxation Response Resiliency Program (3RP)	The 3RP intervention is an integrated program of relaxation response (RR) eliciting meditation and mindfulness exercises, social support, cognitive skills training, and positive psychology focused on developing skills to reduce the stress response, elicit the relaxation response and enhance resiliency.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-08-29
• Completion: 2025-08-29
• First posted: 2024-08-12
• Last updated: 2026-02-13

Locations

1 site across 1 country: South Africa