Community Health Worker Training to Reduce Depression and Substance Use Stigma in TB/HIV Care in South Africa (Siyakhana)

Training CHWs to Support Re-Engagement in TB/HIV Care in the Context of Depression and Substance Use

Poor engagement in care contributes to HIV- and TB-related morbidity and mortality in South Africa (SA). Community health workers (CHWs) are frontline lay health workers who work to re-engage patients who are lost to follow-up (LTFU) in HIV/TB care. Patients with depression and substance use (SU) have a greater likelihood of being LTFU in HIV/TB care, and there is evidence that CHWs may exhibit stigma towards these patients. When CHWs have negative attitudes towards these patients, on average they spend less time with these patients, are less likely to implement evidence-based practices, and deliver less patient-centered care. Therefore, this purpose of this study is to examine the implementation and preliminary effectiveness of a brief training ("Siyakhana"). The purpose of this training is to provide CHWs with psychoeducation, skills, and support around working with HIV/TB patients with depression/SU. The investigators will assess the training's implementation and changes in CHWs' stigma towards HIV/TB patients with depression/SU.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders; Depression; Tuberculosis; Hiv; Mental Health Disorder; Mental Disorder; Health Care Utilization; Treatment Adherence and Compliance; Social Stigma; Attitude of Health Personnel; Community Health Workers; Health Care Delivery
• Intervention / Treatment: Behavioral: Siyakhana CHW Training

Detailed Description

South Africa (SA) has the highest number of people living with HIV in the world and a high tuberculosis (TB) burden. Poor engagement in care contributes to HIV- and TB-related morbidity and mortality. In this context, community health workers (CHWs) are frontline lay health workers who play a central role in re-engaging patients who are lost to follow-up (LTFU) in HIV/TB care. Even with existing CHW programs focused on re-engaging patients who are LTFU, people with depression, hazardous alcohol use, or other substance use (SU) are particularly susceptible to poor engagement in HIV/TB care and have a greater likelihood of being LTFU. At the moment, CHWs receive minimal, if any, training on depression and SU, and there is some evidence that CHWs may exhibit stigma towards these patients. When CHWs have negative attitudes towards these patients, on average they spend less time with these patients, are less likely to implement evidence-based practices, and deliver less patient-centered care. Therefore, the purpose of this study is to examine the implementation and preliminary effectiveness of a brief training ("Siyakhana") focused on providing CHWs with psychoeducation, skills, and support around working with patients with depression/SU. In a Type 2, hybrid effectiveness-implementation trial, and using a stepped wedge design, the investigators will primarily assess the training's implementation (feasibility, acceptability, and fidelity) and changes in CHWs' stigma towards HIV/TB patients with depression/SU.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa
      • South African Medical Research Council

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• At least 18 years old
• Employed as a CHW through a partner non-governmental organization (NGO) that provides HIV/TB CHW services
• Works with patients who have HIV and TB, some of whom may be struggling with depression or substance use

Exclusion Criteria:

• Unable to complete informed consent or study procedures in English or Xhosa

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment As Usual (TAU); Monitoring of treatment as usual (i.e., routine interactions between community health workers (CHWs) and their patients).
Experimental: Siyakhana CHW Training; The Siyakhana CHW Training is a multi-day group training that aims to reduce stigma around mental health and substance use among CHWs. It integrates psychoeducation around TB/HIV, stigma, depression, and substance use, including countering myths and stereotypes around mental health and substance use; skills for CHW self-care; evidence-based skills for working with patients living with depression and substance use, such as components of motivational interviewing and problem-solving therapy; and exposure to individuals with lived experience of mental health and substance use. The training is a combination of informative presentations, discussions, worksheets/activities, and role-plays aimed at increasing awareness of mental health and substance use, reducing stigma, and improving interactions when working with patients with HIV/TB and mental health and substance use concerns.	Behavioral: Siyakhana CHW Training; Please see arm description.; Other Names: Siyakhana; Siyakhana - C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Acceptability subscale of the John Hopkins D&I Measure, a 12-item measure for assessing dissemination and implementation outcomes in low- and middle-income settings. This measure will specifically assess CHW's perceived satisfaction, relevance, usefulness, comprehension, and comfort level of the training. Items are rated on a 0-3 scale, and averaged, with lower scores (closer to 0) indicating low acceptability and higher scores (closer to 3) indicating higher acceptability.	3-months post-training
CHW Stigma Towards Substance Use	CHW stigma towards substance use measured using the Social Distance Scale (SDS). SDS scores range from 6 to 24, with higher scores indicating more desired social distance (more stigma).	Change between baseline assessment and 6-month follow-up (approximately 6-months post-training)
CHW Stigma Towards Depression	CHW stigma towards depression measured using the Social Distance Scale (SDS). SDS scores range from 6 to 24, with higher scores indicating more desired social distance (more stigma).	Change between baseline assessment and 6-month follow-up (approximately 6-months post-training)
Training Feasibility	The number of CHWs who attended all three days of the Siyakhana training. The training will be considered feasible if over 75% of CHWs attend the full training.	3-months post-training
CHW Training Fidelity	20% of CHW role-plays at the 3-month follow-up assessment (approximately 3-months post-training) randomly selected for rating using the ENhancing Assessment of Common Therapeutic factors (ENACT) tool, a 15-item validated measure of fidelity and clinical competence among non-specialist workers, by two independent bilingual assessors. Ratings were given for 15 clinical competencies, giving scores of 1 (harmful), 2 (some basic skills), 3 (all basic skills), or 4 (advanced skills). CHW fidelity scores were calculated based on ENACT items rated as delivered with competence. A cut-off of ≥2 (some basic skills) was used to define fidelity for each item.	3-months post-training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CHW Stigma Towards Substance Use	CHW stigma towards substance use measured using the Social Distance Scale (SDS). SDS scores range from 6 to 24, with higher scores indicating more desired social distance (more stigma).	Change between baseline assessment and 3-month follow-up (approximately 3-months post-training)
CHW Stigma Towards Depression	CHW stigma towards depression measured using the Social Distance Scale (SDS). SDS scores range from 6 to 24, with higher scores indicating more desired social distance (more stigma).	Change between baseline assessment and 3-month follow-up (approximately 3-months post-training)

Collaborators and Investigators

• Sponsor: University of Maryland, College Park
• Collaborators: National Institute of Mental Health (NIMH); Medical Research Council, South Africa
• Investigators: Principal Investigator: Bronwyn J Myers, PhD, Medical Research Council, South Africa; Principal Investigator: Jessica F Magidson, PhD, University of Maryland

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Mental Health; HIV; Social Stigma; Tuberculosis; South Africa; Health Care Utilization; Mental Disorders; Substance-Related Disorders; Global Health; Community Health Workers; Delivery of Health Care; Treatment Adherence and Compliance; Attitude of Health Personnel
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Behavioral Symptoms; Infections; Chemically-Induced Disorders; Mood Disorders; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Psychotic Disorders; Depression; Depressive Disorder; Substance-Related Disorders; Mental Disorders; Tuberculosis
• Other Study ID Numbers: EC039-10/2021; R34MH122268 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After all primary analyses are complete, de-identified data will be available per request of outside individual.
• IPD Sharing Time Frame: After the study has been complete (all data collected; data analysis only), the Study Protocol, Informed Consent Forms (ICFs), and Statistical Analysis Plan (SAP) will be made available per request of outside individual.
• IPD Sharing Access Criteria: Supporting information will be made available per request of outside individuals.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No