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

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.

Study Overview

• Status: Completed
• Conditions: Stress; Burnout, Professional
• Intervention / Treatment: Behavioral: Adapted Relaxation Response Resiliency Program (3RP)

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Durban, South Africa, 4001
    • MatCh Research nit (MRU), a Division of Wits Health Consort

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Providing at least some primary HIV care in a public sector clinic (at the level of professional nurse) for at least one year;
• IsiZulu or English speaking;
• Able and willing to sign informed consent.

Exclusion Criteria:

- Participation in cognitive behavioral therapy and/or a mind-body intervention in the past year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The control condition will be a one-time, ~90-minute, didactic stress management session (with no interventionist follow-up). The session will provide information on the four-component model of stress and the energy battery exercise (asks participants to reflect on stressors and things that offset stress).
Experimental: Intervention; The intervention condition will consist of six one-hour group sessions. The sessions will provide information on topics including relaxation response, the components of stress, recuperative sleep, mindful awareness, resilience, and social support. Sessions will also include practice-based exercises (e.g., breathing exercises, mindfulness exercises). Participants will also have the option of accessing a closed WhatsApp group moderated by the interventionist. The interventionist will initiate chats in between group sessions to provide support to participants in practicing stress management skills. All intervention sessions will be delivered by a trained professional nurse, who will be trained and closely supervised by the study team members. Individual supervision will be provided at least bi-weekly, with opportunities for group supervision with US interventionists using the 3RP intervention in other studies as needed.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals.	To assess feasibility, the investigators will track the number of participants screened, eligible, and enrolled; the number of treatment and assessment sessions completed; and reasons for declining enrollment and for prematurely leaving the trial.	Through study completion, approximately 12 months after initiation
Acceptability of Study Procedures, as Assessed by the Client Satisfaction Questionnaire	Acceptability will be measured through the Client Satisfaction Questionnaire (CSQ-8): 8-item measure of how much one values an intervention. Items scored from 1 (poor) to 4 (excellent); higher scores indicate greater satisfaction. Totals range from 8 to 32; with scores between 26 and 32 indicating 'excellent acceptability' and scores between 20 and 25 indicating 'good acceptability'. High internal consistency (alpha = 0.84-0.93) and used in HIV intervention research and resource-limited settings.	Immediately after the intervention
Acceptability of Study Procedures	Acceptability will also be assessed via qualitative exit interviews.	Immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to 3RP intervention skills	Practice notes have been developed to correspond with each module of the 3RP treatment. Participants will be asked to keep brief daily diaries of their out-of-session practice of core skills, which will be used to generate a rating of adherence to out-of-session practice guidelines. Note, completion will be encouraged but is not required.	Weeks 1-6 of intervention
Resilience	Measure of Current Status (MOCS-A): 13-item measure of stress reactivity and coping; statements are rated from 0 (I cannot do this at all) to 4 (I can do this extremely well); total score ranges from 0-52; higher scores suggest better coping skills. Current Experiences Scale (CES): 25-item measure of resiliency domains; scores range from 0-125; higher scores reflect greater resilience.	Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
Perceived Stress	Perceived Stress Scale (PSS-10): 10-item measure of the extent to which past month life situations are appraised as stressful. Scores range from 0-40; higher scores indicate higher perceived stress.	Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
Burnout	Maslach Burnout Inventory Human Services Survey for Medical Personnel (MBI-HSS [MP]): 22-item measure of job burnout in medical professionals. The MBI-HSS comprised 22 questions across 3 subscales; Emotional Exhaustion (EE)-9 questions, Depersonalization (DP)-5 questions, and self-perceived lack of Personal Accomplishment (PA)-8 questions. High scores on the emotional exhaustion and depersonalization dimensions correspond to higher levels of burnout and high scores on the personal accomplishment dimension refer to lower levels of burnout.	Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
Absenteeism	Absenteeism will be measured by assessing unplanned days off from work in the prior 30 days.	Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention.
Compassion Fatigue	Professional Quality of Life Scale (ProQOL) Version 5: 20-item burnout and secondary traumatic stress subscales from larger 30-item measure. Subscale scores range from 10-50; higher scores represent greater burnout and secondary traumatic stress.	Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
Stigma	Measuring HIV Stigma and Discrimination Among Health Facility Staff: Standardized Brief Questionnaire (BL). Higher score represent greater stigma.	Baseline
Anxiety	Generalized Anxiety Disorder (GAD-7) scale: 7- item measure of the severity of anxiety symptoms over the past two weeks. Scores range from 0-21; cutoff scores of 5, 10, and 15 indicate mild, moderate, and severe anxiety.	Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
Depression	Patient Health Questionnaire (PHQ-9): 9-item tool to evaluate the presence and frequency of depressive symptoms in the past two weeks. Scores range from 0-27; cutoffs of 5, 10, 15, and 20 indicate mild, moderate, moderately severe, and severe depression.	Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
Social Support	Coping Orientation to Problems Experienced (COPE) Inventory: Two 4-item subscales of the 53-item COPE Inventory (use of emotional support, use of instrumental support) to assess frequency of use of social support to cope with stress. Subscale scores range from 4-16, with higher scores indicating greater use of emotional or instrumental support.	Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
Optimism	Life Orientation Test - Revised (LOT-R): 10-item measure of generalized optimism vs. pessimism about the future. Total scores range from 0-24; higher scores indicate greater optimism.	Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
Distress Tolerance	Distress Tolerance Scale (DTS): 15-item measure. Total scores range from 15-75; higher scores indicate greater distress tolerance. of emotional distress tolerance.	Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Mental Health (NIMH); Wits Health Consortium (Pty) Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): August 29, 2025
• Study Completion (Actual): August 29, 2025

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: HIV; Resiliency; Nurses
• Additional Relevant MeSH Terms: Occupational Stress; Burnout, Psychological; Behavioral Symptoms; Stress, Psychological; Occupational Diseases; Behavior; Burnout, Professional
• Other Study ID Numbers: 2024P001407; R34MH126753 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No