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

Primary Purpose

Substance-Related Disorders, Mental Disorder, Social Stigma

Status
Recruiting
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Siyakhana CHW Training
Sponsored by
University of Maryland, College Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance-Related Disorders focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • South African Medical Research CouncilRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment As Usual (TAU)

Siyakhana CHW Training

Arm Description

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

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.

Outcomes

Primary Outcome Measures

CHW stigma towards depression and substance use
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
The percentage of training sessions attended across all CHWs. The training will be considered feasible if over 75% of sessions are attended.
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.
CHW Training Fidelity
20% of CHW role-plays at the 3-month follow-up assessment (approximately 3-months post-training) will be rated using a fidelity assessment based on training components. A fidelity score will be calculated for each rated role-play based on the proportion of training components delivered as intended during role-plays. A final fidelity score, made up of the average of individual fidelity scores, will then be calculated.

Secondary Outcome Measures

Full Information

First Posted
March 7, 2022
Last Updated
July 2, 2022
Sponsor
University of Maryland, College Park
Collaborators
Medical Research Council, South Africa, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05282173
Brief Title
Community Health Worker Training to Reduce Depression and Substance Use Stigma in TB/HIV Care in South Africa
Acronym
Siyakhana
Official Title
Training CHWs to Support Re-Engagement in TB/HIV Care in the Context of Depression and Substance Use
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, College Park
Collaborators
Medical Research Council, South Africa, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Masking Description
The staff member who conducts role-play assessments with participants will be minimally involved in the Siyakhana training.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment As Usual (TAU)
Arm Type
No Intervention
Arm Description
Monitoring of treatment as usual (i.e., routine interactions between community health workers (CHWs) and their patients).
Arm Title
Siyakhana CHW Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Siyakhana CHW Training
Other Intervention Name(s)
Siyakhana, Siyakhana - C
Intervention Description
Please see arm description.
Primary Outcome Measure Information:
Title
CHW stigma towards depression and substance use
Description
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)
Title
Training Feasibility
Description
The percentage of training sessions attended across all CHWs. The training will be considered feasible if over 75% of sessions are attended.
Time Frame
3-months post-training
Title
Acceptability
Description
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
Title
CHW Training Fidelity
Description
20% of CHW role-plays at the 3-month follow-up assessment (approximately 3-months post-training) will be rated using a fidelity assessment based on training components. A fidelity score will be calculated for each rated role-play based on the proportion of training components delivered as intended during role-plays. A final fidelity score, made up of the average of individual fidelity scores, will then be calculated.
Time Frame
3-months post-training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica F Magidson, PhD
Phone
301-405-5095
Email
jmagidso@umd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen S Regenauer, MS
Phone
301-405-0899
Email
kregenau@umd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica F Magidson, PhD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bronwyn J Myers, PhD
Organizational Affiliation
Medical Research Council, South Africa
Official's Role
Principal Investigator
Facility Information:
Facility Name
South African Medical Research Council
City
Cape Town
State/Province
Western Cape
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bronwyn Myers, PhD
Email
Bronwyn.Myers@mrc.ac.za
First Name & Middle Initial & Last Name & Degree
Kim Johnson, MA
Email
Kim.Johnson@mrc.ac.za

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After all primary analyses are complete, de-identified data will be available per request of outside individual.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
Supporting information will be made available per request of outside individuals.

Learn more about this trial

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

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