Substance-Related DisordersSiyakhanaNCT05282173

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

A study testing Siyakhana CHW Training in people with Substance-Related Disorders and Mental Disorder, run by University of Maryland, College Park at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Substance-Related Disorders, Mental Disorder, Social Stigma
What is being tested?: Siyakhana CHW Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteSouth Africa
Study dates: 8 Jun 2022to 1 Aug 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Africa1 site

South African Medical Research Council
Cape Town, Western Cape

Other trials in South Africa

About this study

Official title: 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.

Read the 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.

Conditions: Substance-Related Disorders, Mental Disorder, Social Stigma, Depression, Treatment Adherence and Compliance, Health Care Utilization
Being tested: Siyakhana CHW Training
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
Medical subject headings: Substance-Related Disorders, Mental Disorders, Social Stigma, Depression, Treatment Adherence and Compliance, Patient Acceptance of Health Care, Acquired Immunodeficiency Syndrome, Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Siyakhana CHW TrainingBehavioural
Also called Siyakhana, Siyakhana - C
Please see arm description.

Study groups in NCT05282173
Study group	Role	What they receive
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. Receives: Behavioral: Siyakhana CHW Training

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3-months post-training

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 20221 Aug 2023

First posted16 Mar 2022
Study start8 Jun 2022
Primary completion1 Aug 2023
Study completion1 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Model description: 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.
Masking: None (open label)
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05282173
Sponsor's protocol ID: EC039-10/2021
Other IDs: R34MH122268
Acronym: Siyakhana
Status last verified: Feb 2025
First submitted: 7 Mar 2022
Last updated: 6 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After all primary analyses are complete, de-identified data will be available per request of outside individual.

Publications

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.
PubMed 39892671
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.
PubMed 38167261

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
Active, not recruiting
Closed-loop TBS Targeting rPO for the Core Clinical Features of Methamphetamine Use Disorder
Methamphetamine Use Disorder, Substance Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All Substance-Related Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Training CHWs to Support Re-Engagement in TB/HIV Care in the Context of Depression and Substance Use
ClinicalTrials.gov ID: NCT05282173
Acronym / sponsor ID: Siyakhana / EC039-10/2021
Conditions: Substance-Related Disorders, Mental Disorder, Social Stigma, Depression, Treatment Adherence and Compliance, Health Care Utilization
Keywords: Substance-Related Disorders, Mental Disorders, Social Stigma, Depression, Treatment Adherence and Compliance, Delivery of Health Care, Attitude of Health Personnel, HIV
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: University of Maryland, College ParkUniversity, hospital or other
Collaborators: Medical Research Council, South Africa, National Institute of Mental Health (NIMH)
Study start: 8 Jun 2022 (actual)
Primary completion: 1 Aug 2023 (actual)
Study completion: 1 Aug 2023 (actual)
First posted: 16 Mar 2022 (actual)
Results: Posted 6 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
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	Behavioral: Siyakhana CHW TrainingThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Siyakhana CHW TrainingAlso: Siyakhana, Siyakhana - CPlease see arm description.	Behavioural	Siyakhana CHW Training

Primary outcome

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).
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).
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.
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.
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.

2 secondary outcomes

CHW Stigma Towards Substance Use
Time frame: Change between baseline assessment and 3-month follow-up (approximately 3-months post-training)
CHW Stigma Towards Depression
Time frame: Change between baseline assessment and 3-month follow-up (approximately 3-months post-training)

Results and safety

Results posted to the registry on 6 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: Approximately 1 Month Treatment as Usual, Siyakhana CHW Training	29	26
Sequence 2: Approximately 2 Months Treatment as Usual, Siyakhana CHW Training	25	23
Sequence 3: Approximately 3 Months Treatment as Usual, Siyakhana CHW Training	28	24

Primary outcome: CHW Stigma Towards Substance Use

Time frame: Change between baseline assessment and 6-month follow-up (approximately 6-months post-training). Mean (Standard Error). Unit: change in units on a scale

Measure	Siyakhana CHW Training n = 73
Value	-0.88 (0.39)

Primary outcome: CHW Stigma Towards Depression

Time frame: Change between baseline assessment and 6-month follow-up (approximately 6-months post-training). Mean (Standard Error). Unit: change in units on a scale

Measure	Siyakhana CHW Training n = 73
Value	0.15 (0.73)

Primary outcome: Training Feasibility

Time frame: 3-months post-training. Count of participants. Unit: Participants

Measure	Sequence 1: Approximately 1 Month Treatment as Usual, Siyakhana CHW Training n = 29	Sequence 2: Approximately 2 Months TAU, Siyakhana CHW Training n = 25	Sequence 3: Approximately 3 Months TAU, Siyakhana CHW Training n = 28
Value	26	25	27

Primary outcome: Acceptability

Time frame: 3-months post-training. Mean (Standard Deviation). Unit: units on a scale

Measure	Sequence 1: Approximately 1 Month TAU, Siyakhana CHW Training n = 27	Sequence 2: Approximately 2 Months TAU, Siyakhana CHW Training n = 23	Sequence 3: Approximately 3 Months TAU, Siyakhana CHW Training n = 25
Value	2.92 (0.29)	2.84 (0.26)	2.80 (0.24)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sequence 1: Approximately 1 Month TAU, Siyakhana CHW Training	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Sequence 2: Approximately 2 Months TAU, Siyakhana CHW Training	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Sequence 3: Approximately 3 Months TAU, Siyakhana CHW Training	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39892671Magidson 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.
Derived from this study: PubMed 38167261Myers 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.
Individual participant dataSharing planned: Yes. After all primary analyses are complete, de-identified data will be available per request of outside individual.

Related trials for Substance-Related Disorders

Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
Active, not recruiting
Closed-loop TBS Targeting rPO for the Core Clinical Features of Methamphetamine Use Disorder
Methamphetamine Use Disorder, Substance Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jessica F Magidson, PhD principal investigator

University of Maryland

Bronwyn J Myers, PhD principal investigator

Medical Research Council, South Africa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Siyakhana CHW Training in people with Substance-Related Disorders and Mental Disorder, run by University of Maryland, College Park at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CHW Stigma Towards Substance Use (time frame: Change between baseline assessment and 6-month follow-up (approximately 6-months post-training)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05282173, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.