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Completed

NCT Number: NCT05282173

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

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.

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Key information

Conditions

Substance-related Disorders Acquired Immunodeficiency Syndrome Actinomycetales Infections Attitude of Health Personnel Bacterial Infections Bacterial Infections and Mycoses Behavior Behavioral Symptoms Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Community Health Workers Depression Genital Diseases Gram-Positive Bacterial Infections HIV HIV Infections Health Behavior Health Care Delivery Health Care Utilization Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorder Mental Disorders Mental Health Disorder Mycobacterium Infections Patient Acceptance of Health Care Personal Satisfaction Psychological Well-Being RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Social Behavior Social Stigma Treatment Adherence and Compliance Tuberculosis Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South African Medical Research Council

Cape Town, Western Cape, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Siyakhana CHW Training

Behavioral

Please see arm description.

Other names: Siyakhana, Siyakhana - C

Primary outcomes

  1. CHW Stigma Towards Substance Use

    Time frame: Change between baseline assessment and 6-month follow-up (approximately 6-months post-training)

    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).

  2. CHW Stigma Towards Depression

    Time frame: Change between baseline assessment and 6-month follow-up (approximately 6-months post-training)

    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).

  3. Training Feasibility

    Time frame: 3-months post-training

    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.

  4. Acceptability

    Time frame: 3-months post-training

    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.

  5. CHW Training Fidelity

    Time frame: 3-months post-training

    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.

Secondary outcomes

  1. CHW Stigma Towards Substance Use

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

    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).

  2. CHW Stigma Towards Depression

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

    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).

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Collaborators

  • Medical Research Council, South Africa
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: Siyakhana

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 16, 2022
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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