Attitude of Health Personnel, Community Health Workers, Depression, Health Care Delivery, Health Care Utilization, Hiv, Mental Disorder, Mental Health Disorder, Social Stigma, Substance-Related Disorders, Treatment Adherence and Compliance, Tuberculosis
Conditions
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
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.
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.
Interventions
BEHAVIORALSiyakhana CHW Training
Please see arm description.
Sponsors
Medical Research Council, South Africa
National Institute of Mental Health (NIMH)
University of Maryland, College Park
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
The staff member who conducts role-play assessments with participants will be minimally involved in the Siyakhana training.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CHW Stigma Towards Depression | 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). |
| Acceptability | 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 | 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. |
| CHW Stigma Towards Substance Use | 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). |
| Training Feasibility | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CHW Stigma Towards Depression | 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). |
| CHW Stigma Towards Substance Use | 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). |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 82 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Missed | 3 | 2 | 4 |
Baseline characteristics
| Characteristic | Siyakhana CHW Training |
|---|---|
| Age, Continuous | 46.9 years STANDARD_DEVIATION 8.9 |
| CHW Depression Stigma | 8.33 units on a scale STANDARD_DEVIATION 2.17 |
| CHW Substance Use Stigma | 12.53 units on a scale STANDARD_DEVIATION 3.44 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 82 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment South Africa | 82 participants |
| Sex: Female, Male Female | 81 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 25 | 0 / 28 |
| other Total, other adverse events | 0 / 29 | 0 / 25 | 0 / 28 |
| serious Total, serious adverse events | 0 / 29 | 0 / 25 | 0 / 28 |
Outcome results
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.
Time frame: 3-months post-training
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Siyakhana CHW Training | Acceptability | 2.92 units on a scale | Standard Deviation 0.29 |
| Sequence 2: Approximately 2 Months TAU, Siyakhana CHW Training | Acceptability | 2.84 units on a scale | Standard Deviation 0.26 |
| Sequence 3: Approximately 3 Months TAU, Siyakhana CHW Training | Acceptability | 2.80 units on a scale | Standard Deviation 0.24 |
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).
Time frame: Change between baseline assessment and 6-month follow-up (approximately 6-months post-training)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Siyakhana CHW Training | CHW Stigma Towards Depression | 0.15 change in units on a scale | Standard Error 0.73 |
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).
Time frame: Change between baseline assessment and 6-month follow-up (approximately 6-months post-training)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Siyakhana CHW Training | CHW Stigma Towards Substance Use | -0.88 change in units on a scale | Standard Error 0.39 |
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.
Time frame: 3-months post-training
Population: Note the fidelity measure is a randomly selected 20% of roleplays that were coded by an independent rater across all sessions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Siyakhana CHW Training | CHW Training Fidelity | 86.7 % of components delivered competently | Standard Deviation 8.2 |
| Sequence 2: Approximately 2 Months TAU, Siyakhana CHW Training | CHW Training Fidelity | 85.7 % of components delivered competently | Standard Deviation 11.8 |
| Sequence 3: Approximately 3 Months TAU, Siyakhana CHW Training | CHW Training Fidelity | 82.7 % of components delivered competently | Standard Deviation 10.1 |
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.
Time frame: 3-months post-training
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Siyakhana CHW Training | Training Feasibility | 26 Participants |
| Sequence 2: Approximately 2 Months TAU, Siyakhana CHW Training | Training Feasibility | 25 Participants |
| Sequence 3: Approximately 3 Months TAU, Siyakhana CHW Training | Training Feasibility | 27 Participants |
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).
Time frame: Change between baseline assessment and 3-month follow-up (approximately 3-months post-training)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Siyakhana CHW Training | CHW Stigma Towards Depression | 0.51 change in units on a scale | Standard Error 1.17 |
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).
Time frame: Change between baseline assessment and 3-month follow-up (approximately 3-months post-training)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Siyakhana CHW Training | CHW Stigma Towards Substance Use | -1.22 change in units on a scale | Standard Error 0.35 |