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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH122268 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Medical Research Council, South Africa | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Siyakhana CHW Training | Behavioral | Please see arm description. |
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| 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 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica F Magidson, PhD | University of Maryland | Principal Investigator |
| Bronwyn J Myers, PhD | Medical Research Council, South Africa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South African Medical Research Council | Cape Town | Western Cape | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39892671 | Derived | 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. | |
| 38167261 | Derived |
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After all primary analyses are complete, de-identified data will be available per request of outside individual.
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.
Supporting information will be made available per request of outside individuals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: Approximately 1 Month Treatment as Usual, Siyakhana CHW Training | Group 1 was randomized to receive approximately 1-month of TAU then the Siyakhana CHW Training, which 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2023 |
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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.
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The staff member who conducts role-play assessments with participants will be minimally involved in the Siyakhana training.
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| 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) |
| 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. |
| FG001 | Sequence 2: Approximately 2 Months Treatment as Usual, Siyakhana CHW Training | Group 2 was randomized to receive approximately two-months of treatment as usual (TAU) then the Siyakhana CHW Training, which 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. Siyakhana CHW Training: Please see arm description. |
| FG002 | Sequence 3: Approximately 3 Months Treatment as Usual, Siyakhana CHW Training | Group 3 was randomized to receive approximately 3-months of TAU then the Siyakhana CHW Training, which 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Siyakhana CHW Training: Please see arm description. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| CHW Substance Use Stigma | CHW stigma towards substance use was measured using the Social Distance Scale (SDS). SDS scores range from 6 to 24, with higher scores indicating more desired social distance (more stigma). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| CHW Depression Stigma | CHW stigma towards depression was measured using the Social Distance Scale (SDS). SDS scores range from 6 to 24, with higher scores indicating more desired social distance (more stigma). | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Error | change in units on a scale | Change between baseline assessment and 6-month follow-up (approximately 6-months post-training) |
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| Primary | 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). | Posted | Mean | Standard Error | change in units on a scale | Change between baseline assessment and 6-month follow-up (approximately 6-months post-training) |
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| Primary | 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. | Posted | Count of Participants | Participants | 3-months post-training |
| |||||||||||||||||||||||||||||
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 3-months post-training |
| ||||||||||||||||||||||||||||
| Primary | 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. | Note the fidelity measure is a randomly selected 20% of roleplays that were coded by an independent rater across all sessions. | Posted | Mean | Standard Deviation | % of components delivered competently | 3-months post-training |
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| Secondary | 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). | Posted | Mean | Standard Error | change in units on a scale | Change between baseline assessment and 3-month follow-up (approximately 3-months post-training) |
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| Secondary | 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). | Posted | Mean | Standard Error | change in units on a scale | Change between baseline assessment and 3-month follow-up (approximately 3-months post-training) |
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6 months
Definition for AE and/or SAE did not differ from the clinicaltrials.gov definition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sequence 1: Approximately 1 Month TAU, Siyakhana CHW Training | Group 1 was randomized to receive approximately 1-month of TAU then the Siyakhana CHW Training, which 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. | 0 | 29 | 0 | 29 | 0 | 29 |
| EG001 | Sequence 2: Approximately 2 Months TAU, Siyakhana CHW Training | Group 2 was randomized to receive approximately 2-months of TAU then the Siyakhana CHW Training, which 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. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Sequence 3: Approximately 3 Months TAU, Siyakhana CHW Training | Group 3 was randomized to receive approximately 3-months of TAU then the Siyakhana CHW Training, which 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. | 0 | 28 | 0 | 28 | 0 | 28 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Magidson | University of Maryland, College Park | 301-405-5095 | jmagidso@umd.edu |
| Jan 13, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D001523 | Mental Disorders |
| D057545 | Social Stigma |
| D003863 | Depression |
| D000074822 | Treatment Adherence and Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000163 | Acquired Immunodeficiency Syndrome |
| D014376 | Tuberculosis |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
| D015438 | Health Behavior |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D010549 | Personal Satisfaction |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG002 | Sequence 3: Approximately 3 Months TAU, Siyakhana CHW Training | Group 3 was randomized to receive approximately 3-months of TAU then the Siyakhana CHW Training, which 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. |
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| Sequence 2: Approximately 2 Months TAU, Siyakhana CHW Training |
Group 2 was randomized to receive approximately 2-months of TAU then the Siyakhana CHW Training, which 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. |
| OG002 | Sequence 3: Approximately 3 Months TAU, Siyakhana CHW Training | Group 13 was randomized to receive approximately 3-months of TAU then the Siyakhana CHW Training, which 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. |
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| OG001 | Sequence 2: Approximately 2 Months TAU, Siyakhana CHW Training | Group 2 was randomized to receive approximately 2-months of TAU then the Siyakhana CHW Training, which 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. |
| OG002 | Sequence 3: Approximately 3 Months TAU, Siyakhana CHW Training | Group 3 was randomized to receive approximately 3-months of TAU then the Siyakhana CHW Training, which 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. |
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