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

NCT05282173 | Completed Results

• 2 other identifiers: EC039-10/2021R34MH122268
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance-Related Disorders; Mental Disorder; Social Stigma; Depression; Treatment Adherence and Compliance; Health Care Utilization; Attitude of Health Personnel; Hiv; Tuberculosis; Mental Health Disorder; Community Health Workers; Health Care Delivery

Keywords

Substance-Related Disorders; Mental Disorders; Social Stigma; Depression; Treatment Adherence and Compliance; Delivery of Health Care; Attitude of Health Personnel; HIV; Tuberculosis; Health Care Utilization; Mental Health; Global Health; South Africa; Community Health Workers

Outcome Measures

Primary Outcomes (5)

• 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

• 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 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 Outcomes (2)

• CHW Stigma Towards Substance Use

  Change between baseline assessment and 3-month follow-up (approximately 3-months post-training)

• CHW Stigma Towards Depression

  Change between baseline assessment and 3-month follow-up (approximately 3-months post-training)

Study Arms (2)

Treatment As Usual (TAU)

NO INTERVENTION

Monitoring of treatment as usual (i.e., routine interactions between community health workers (CHWs) and their patients).

Siyakhana CHW Training

EXPERIMENTAL

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

Interventions

Siyakhana CHW Training BEHAVIORAL

Please see arm description.

Also known as: Siyakhana, Siyakhana - C

Siyakhana CHW Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, College Park: lead
• Medical Research Council, South Africa: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

South African Medical Research Council

Cape Town, Western Cape, South Africa

Location

Related Publications (2)

• Magidson JF, Regenauer KS, Johnson K, Ma T, Belus JM, Rose AL, Brown I, Ciya N, Ndamase S, Sacko C, Joska J, Sibeko G, Bassett IV, Myers B. Siyakhana: A hybrid type 2 effectiveness-implementation stepped-wedge trial to reduce stigma towards substance use and depression among community health workers in HIV/TB care in South Africa. J Subst Use Addict Treat. 2025 Apr;171:209634. doi: 10.1016/j.josat.2025.209634. Epub 2025 Jan 31.

  PMID: 39892671 DERIVED

• Myers B, Regenauer KS, Rose A, Johnson K, Ndamase S, Ciya N, Brown I, Joska J, Bassett IV, Belus JM, Ma TC, Sibeko G, Magidson JF. Community health worker training to reduce mental health and substance use stigma towards patients who have disengaged from HIV/TB care in South Africa: protocol for a stepped wedge hybrid type II pilot implementation trial. Implement Sci Commun. 2024 Jan 2;5(1):1. doi: 10.1186/s43058-023-00537-w.

  PMID: 38167261 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Mental Disorders; Social Stigma; Depression; Treatment Adherence and Compliance; Patient Acceptance of Health Care; Acquired Immunodeficiency Syndrome; Tuberculosis; Psychological Well-Being

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Social Behavior; Behavior; Behavioral Symptoms; Health Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Personal Satisfaction

Results Point of Contact

• Title: Dr. Jessica Magidson
• Organization: University of Maryland, College Park

jmagidso@umd.edu

301-405-5095

Study Officials

• Jessica F Magidson, PhD

  University of Maryland

  PRINCIPAL INVESTIGATOR

• Bronwyn J Myers, PhD

  Medical Research Council, South Africa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The staff member who conducts role-play assessments with participants will be minimally involved in the Siyakhana training.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a stepped-wedge design. All groups of CHWs receive both treatment as usual (TAU) and the stigma reduction training ("Siyakhana"). Randomization will dictate the timing/order in which each group receives the Siyakhana training.

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: June 8, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: March 6, 2025
• Results First Posted: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: Supporting information will be made available per request of outside individuals.

Locations

ZA (1)