Clinical trial NCT06548035: Developing a Resiliency Intervention to Support Healthcare Workers Engaged in the Provision of HIV Care
Official title: Developing a Resiliency Intervention to Support Healthcare Workers Engaged in the Provision of HIV Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress
Burnout, Professional
Keywords: Nurses
HIV
Resiliency
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Wits Health Consortium (Pty) Ltd
First posted: 2024-08-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 (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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals.
timeFrame: Through study completion, approximately 12 months after initiation
measure: Acceptability of Study Procedures, as Assessed by the Client Satisfaction Questionnaire
timeFrame: Immediately after the intervention
measure: Acceptability of Study Procedures
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Resilience
timeFrame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
measure: Perceived Stress
timeFrame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
measure: Burnout
timeFrame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
measure: Absenteeism
timeFrame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention.
measure: Compassion Fatigue
timeFrame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
measure: Stigma
timeFrame: Baseline
measure: Anxiety
timeFrame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
measure: Depression
timeFrame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
measure: Social Support
timeFrame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
measure: Optimism
timeFrame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
measure: Distress Tolerance
timeFrame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
measure: Adherence to 3RP intervention skills
timeFrame: Weeks 1-6 of intervention
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: MatCh Research nit (MRU), a Division of Wits Health Consort
Study officials:
References: