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

NCT ID: NCT05282173

Last Updated: 2025-03-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-08

Study Completion Date

2023-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

The staff member who conducts role-play assessments with participants will be minimally involved in the Siyakhana training.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment As Usual (TAU)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Siyakhana CHW Training

Intervention Type BEHAVIORAL

Please see arm description.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Siyakhana CHW Training

Please see arm description.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Siyakhana Siyakhana - C

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical Research Council, South Africa

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Maryland, College Park

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jessica F Magidson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Bronwyn J Myers, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Research Council, South Africa

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

South African Medical Research Council

Cape Town, Western Cape, South Africa

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Africa

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39892671 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38167261 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R34MH122268

Identifier Type: NIH

Identifier Source: secondary_id

View Link

EC039-10/2021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Schools Championing Safe South Africa
NCT05869864 COMPLETED PHASE1
Increasing Effective Mental Health Care for LGBT Clients
NCT05352659 ENROLLING_BY_INVITATION NA